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Brand Name
“Solumedrol”

What it is
An injectable medication that is a potent steroid with anti-inflammatory and immunosuppressant properties.

What it does
Decreases active inflammation
Short courses with high doses may stabilize active disease during a relapse
Certain patients may receive regular doses of steroids in an attempt to alter the progression of the disease

How it works
It reduces the immune system’s ability to seek out and attack the nerve cells in the brain and spinal cord.

How it’s given
Intravenously – in the multiple sclerosis center infusion room

  • Infused over 90 minutes
  • Dose
    – 500-1000 mg
    – May be given once daily for 3 – 7 days for a relapse
    – May be given once a month for long term therapy

Possible Side Effects

  • Short-term
    – Report any pain or discomfort near the IV site to your nurse
    – Headache, facial flushing (reddening)
    – Taste disturbances (metallic)
    – Increased blood sugar
    – Increased risk of infection
    – Nausea, vomiting, stomach pain
    – Increased blood pressure
    – Imbalance or increase of water and sodium retention
    – Leg cramps
    – Personality changes, difficulty sleeping, depression, irritability
  • Long-term
    – Increased risk of infection
    – Impaired wound healing
    – Hair loss, thinning of the skin
    – Ulcers of stomach, mouth
    – Weight gain
    – Weakened bones (osteoporosis)
    – Cataracts, glaucoma
    – Rare hip disease called avascular necrosis

Tips
– For difficulty sleeping, some over-the-counter medications such as Benadryl® (diphenhydramine) may help. Tylenol PM® contains the active ingredient in Tylenol® (acetaminophen) plus diphenhydramine and is ok to take but is no better than plain Benadryl® (diphenhydramine) for sleep unless you have pain that you need the acetaminophen for also.

  • Check with your pharmacist or physician before taking over-the-counter medications.

– Having a piece of hard candy may help mask the metallic taste.
– Patients with diabetes should check their blood sugars more frequently during the first 24-48 hours after steroid treatment.
– Your physician may instruct you to take an antacid such as Zantac® or Pepcid® while taking methylprednisolone.
– Drink orange juice or eat bananas on the days that you receive methylprednisolone. This will help to replenish your potassium stores and may help to prevent leg cramps.
– Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
– Most patients on long-term steroid treatments should take a calcium and vitamin D supplement to prevent osteoporosis.
– Talk to your health care provider before receiving any vaccines.

  • Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider
If you are experiencing:
– Chest tightness, trouble breathing, wheezing
– Rash, hives, extreme itchiness
– Swelling of the face or lips and swelling or tingling of the tongue and throat
– High fever, severe sore throat or any other signs of infection
– Fast heartbeat (palpitations), sweating, confusion
– Sudden pain or swelling in the legs, ankles, feet or hands
– Extreme headache, eye pain or trouble seeing
– Abnormal muscle pain or weakness
– If your stool is very black or you see blood in your stool
– Although methylprednisolone may be given to you if you are pregnant or breastfeeding an infant, contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Patient Information For:

  • Interferon beta-1a


Brand Name

  • Avonex® and Rebif®


What it is

  • Avonex® and Rebif® are self-injectable medications, both containing the active ingredient, interferon beta-1a, but are clinically different formulations and should not be interchanged. These are also similar to Betaseron® (interferon beta-1b) but should not be interchanged. These medications are sometimes referred to as “injectables” or “A, B, C therapy.”


What it does

  • Reduces the number of relapses
  • Slows the accumulation of physical disability


How it works

  • Interferon beta-1a is a naturally occurring protein that is usually produced in response to certain infections. Its role, though, is thought to be more of a regulatory one, keeping the immune system in check. It alters the way in which certain white blood cells, T-cells, respond to “foreign” material.


How it’s given
Avonex®

  • Avonex® prefilled syringes are available in cartons of 4 single-use prefilled syringes so it does not have to be prepared or drawn up ahead of time.

                o Each syringe should only be used once and then discarded appropriately.

  • Avonex® is also available in vials containing powder that must be mixed prior to injection. Although, not commonly used, you will be instructed on this process if you are given these and provided with all supplies necessary.
  • Dose: 30 mcg once a week
  • Avonex® is injected intramuscularly (in the muscle)
  • A nurse or your physician should show you how to inject this medication.

                o You should review the information provided for you when you begin Avonex® therapy and with each refill.
                o Your first, self-administered dose should be done under the direct supervision of an appropriately qualified health care practitioner.

  • After the injection, dispose the used syringe into a hard-welled container.

Rebif®

  • Rebif® is available in single-use prefilled syringes so it does not have to be prepared or drawn up ahead of time.

                o Each syringe should only be used once and then discarded appropriately. You may only use part of a syringe when starting therapy (see dosing below), but you should still discard unused portions.

  • Dose: increased slowly to 22 mcg or 44 mcg three times weekly

                o Dose is slowly increased to reduce side effects

Percentage of final dose    For final target dose of Rebif® 22 mcg    For final target dose of Rebif® 44 mcg
Weeks 1-2                20%                                    4.4 mcg                                            8.8 mcg
Weeks 3-4                50%                                    11 mcg                                             22 mcg
Weeks 5+                 100%                                    22 mcg                                            44 mcg

  • Rebif® is injected subcutaneously (under the skin)
  • A nurse or your physician should show you how to inject this medication.

                o You should review the information provided for you when you begin Rebif® therapy and with each refill.
                o Your first, self-administered dose should be done under the direct supervision of an appropriately qualified health care practitioner.

  • After the injection, dispose the syringe into a hard-welled container.


Storage

  • Prefilled Avonex® and Rebif® syringes should be kept in their original blister package and in the original carton, under refrigeration (36-46oF or 2-8oC).

                    o You may store Avonex® in its original blister packages and in the original carton at room temperature (59-86oF or 15-30oC), for up to 7 days.
o You may store Rebif® in its original blister packages and in the original carton at room temperature (59-86oF or 15-30oC), for up to 30 days.
o Avonex® and Rebif® should NEVER be stored in the freezer.
o Avonex® and Rebif® are sensitive to light, meaning that it will degrade with excessive exposure, so you should always protect the syringes from direct light until its time to inject it.
o The solution should be clear but may appear slightly yellow. Do not use a syringe if the solution appears cloudy or you see that it contains particles.  Return it to your pharmacy.

General Injection Information

  • If storing Avonex® or Rebif® under refrigeration, remove the syringe from the refrigerator 30 minutes before you inject, allowing it to warm to room temperature.
  • Always wash and dry your hands before and after injecting.
  • Never inject into the same area on your body more than once a week.
  • Acceptable sites

                o Rebif®: stomach, arm, thigh, hip
– Chose a site that is at least 2 inches from the last site of injection.
o Avonex®: upper arm or thigh muscle
– After the injection, dispose the used syringe into a hard-welled container.

Possible Side Effects

  • Flu-like symptoms: fever, chills, fatigue, muscle aches
  • Dizziness, headache
  • Pain, redness, swelling, and irritation at the injection site
  • Depression, mood changes, anxiety
  • Liver damage: pain in the upper, right area of your torso, yellow coloring of skin and eyes
  • Thyroid changes: feeling hot or cold all of the time or weight change without a change in your diet or activity are common symptoms
  • Blood disorders such as anemia or easy bruising or abnormal bleeding


Tips

  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.

                o Always call your refills in to your pharmacy before you are out of medication to avoid any disruption in therapy.

  • This medication should not be used if you are pregnant or breastfeeding.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.

                        – For information about birth control options, speak with your physician or pharmacist.

  • If you are experiencing flu-like symptoms (fever, chills, fatigue, muscle aches) you can try taking some over-the-counter medications to prevent this. Check with your pharmacist or physician before taking these.

                o Tylenol® (acetaminophen) or Advil® (ibuprofen)

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • If you miss a dose of your medication, take it as soon as you remember:

                o Avonex®: you can resume your regular schedule but don’t take doses within 2 days of each other
                o Rebif®: you should skip the next day if you are scheduled to take it. It should not be taken on 2 consecutive days. You can resume your normal schedule the following week.

  • Always have your blood checked when scheduled by your physician.
  • Talk to your health care provider before receiving any vaccines.

                o Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • Signs and symptoms of depression or any thoughts of suicide
  • If you were told you have liver damage or you think you may be having symptoms of liver toxicity: pain in the upper, right area of your torso, yellow coloring of skin and eyes (jaundice) or itching.

                o Other non-specific symptoms include: fatigue, weakness, abdominal pain, loss of appetite

  • You should not become pregnant or breastfeed an infant while using this medication.

                o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Patient Information For:

  • Interferon beta-1b


Brand Name

  • Betaseron®


What it is

  • “Betaseron” is a self-injectable medication and was the first disease modifying medication approved for treating multiple sclerosis. The active ingredient, interferon beta-1b, is similar to the active ingredient in Avonex® and Rebif®, interferon beta-1a, but is different and should not be interchanged. Betaseron“ is sometimes referred to as one of the “injectables” or “A, B, C therapy.”


What it does

  • Reduces the number of relapses
  • Slows the accumulation of physical disability


How it works

  • Interferon beta-1b is a naturally occurring protein that is usually produced in response to certain infections. Its role, though, is thought to be more of a regulatory one, keeping the immune system in check. It alters the way in which certain white blood cells, T-cells, respond to “foreign” material.


How it’s given
Betaseron®

  • Betaseron® is available in a vial containing powder and comes with a vial of sodium chloride solution (the diluent) so it must be prepared and drawn up before injecting.

                o You will be instructed on this procedure by your physician or a nurse when starting therapy and will be given prescriptions for supplies when necessary and instruction on what additional materials you will need for this procedure.

  • Dose: increased slowly to 0.25 mg every other day

    o Approximately 48 hrs apart so the same time every day is best.
o Dose is slowly increased to reduce side effects

Percentage of final dose    Dose of Betaseron®    Volume
Weeks 1-2    25%                                    0.0625 mg                0.25 ml
Weeks 3-4    50%                                    0.125 mg                    0.5 ml
Weeks 5-6    75%                                    0.1875 mg                0.75 ml
Weeks 7+    100%                                    0.25 mg                        1 ml

 

      • Betaseron® is injected subcutaneously (under the skin)
      • A nurse or your physician should show you how to inject this medication.

            o You should review the information provided for you when you begin Betaseron® therapy and with each refill.
o Your first, self-administered dose should be done under the direct supervision of an appropriately qualified health care practitioner.
– After the injection, dispose the syringe into a hard-welled container.

 

Storage

  • Betaseron® powder and diluent should be stored in the original container and at room temperature, preferably 77oF (25oC), definitely within 59-86oF or 15-30oC.

                o After mixing, the solution should be used right away.
– If you do not use it right away, it should be stored under refrigeration (36-46oF or 2-8oC) and must be used within 3 hours of mixing.
o Always discard unused portions even if you are only using part of a vial.
o Betaseron® should NEVER be stored in the freezer.
o Betaseron® is sensitive to light, meaning that it will degrade with excessive exposure, so you should always protect the powder and                 diluent or prepared solution from direct light until its time to mix or inject it.


General Injection Information

  • Always wash and dry your hands before and after injecting.
  • Never inject into the same area on your body more than once a week.
  • Acceptable sites

                o stomach, arm, thigh, hip
– Chose a site that is at least 2 inches from the last site of injection.

Possible Side Effects

  • Flu-like symptoms: fever, chills, fatigue, muscle aches
  • Dizziness, headache
  • Pain, redness, swelling, and irritation at the injection site
  • Depression, mood changes, anxiety
  • Liver damage: pain in the upper, right area of your torso, yellow coloring of skin and eyes
  • Thyroid changes: feeling hot or cold all of the time or weight change without a change in your diet or activity are common symptoms
  • Blood disorders such as anemia or easy bruising or abnormal bleeding


Tips

  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.

                o Always call your refills in to your pharmacy before you are out of medication to avoid any disruption in therapy.

  • This medication should not be used if you are pregnant or breastfeeding.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.

                        – For information about birth control options, speak with your physician or pharmacist.

  • If you are experiencing flu-like symptoms (fever, chills, fatigue, muscle aches) you can try taking some over-the-counter medications to prevent this. Check with your pharmacist or physician before taking these.

                o Tylenol® (acetaminophen) or Advil® (ibuprofen)

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • If you miss a dose of your medication, take it as soon as you remember

                o Betaseron®: you should skip the next day if you are scheduled to take it. It should not be taken on 2 consecutive days. You can resume your normal schedule the following week.

  • Always have your blood checked when scheduled by your physician.
  • Talk to your health care provider before receiving any vaccines.

                o Some vaccines you should avoid while others may not work while on this medication.


When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • Signs and symptoms of depression or any thoughts of suicide
  • If you were told you have liver damage or you think you may be having symptoms of liver toxicity: pain in the upper, right area of your torso, yellow coloring of skin and eyes (jaundice) or itching.

                o Other non-specific symptoms include: fatigue, weakness, abdominal pain, loss of appetite

  • You should not become pregnant or breastfeed an infant while using this medication.

                o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name

  • “Copaxone”


What it is

  • Glatiramer acetate is a self-injectable medication consisting of 4 naturally occurring proteins, specifically: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. It was chemically designed to mimic myelin basic protein, which is involved with the activation of the immune system to attack the myelin that covers the neurons in the central nervous system. Copaxone“ is sometimes referred to as one of the “injectables” or “A, B, C therapy.”


What it does

  • In studies, glatiramer has been shown to decrease relapse rates in patients with relapsing-remitting multiple sclerosis. Some data suggest that it may slow the progression of multiple sclerosis, and offer a neuroprotective effect.


How it works

  • Although the mechanism is not completely understood, glatiramer is thought to work by modifying the way in which certain white blood cells, including T-helper cells and T-suppressor cells, react to myelin, which is one major target in multiple sclerosis. When administered to multiple sclerosis patients, glatiramer is presented to these T-cells, which induces a protective state that is normally present in non-multiple sclerosis patients.


How it’s given

  • Copaxone“ is available in cartons of 30 single-use prefilled syringes so it does not have to be prepared or drawn up ahead of time.

                    o Each syringe should only be used once and then discarded appropriately.

  • Dose: 20 mg every day
  • Copaxone“ is injected subcutaneously (under the skin)
  • A nurse or your physician should show you how to inject this medication.

                o You should review the Copaxone® injection patient information leaflet, which will be presented to you before you begin Copaxone“ therapy and with each refill.
o Your first, self-administered dose should be done under the direct supervision of an appropriately qualified health care practitioner.

Storage

  • Prefilled Copaxone“ syringes should be kept in their original blister package and in the original carton, under refrigeration (36-46oF or 2-8oC).

            o You may store Copaxone“ in its original blister packages and in the original carton at room temperature (59-86oF or 15-30oC), for up to 30 days.
– Do not store Copaxone“ at room temperature for longer than 30 days and NEVER in the freezer.
o Copaxone“ is sensitive to light, meaning that it will degrade with excessive exposure, so you should always protect the syringes from direct light until its time to inject it.
o Do not use a syringe if the solution appears cloudy or you see that it contains particles. Return it to your pharmacy.

General Injection Information

Refer to the COPAXONE® INJECTION PATIENT INFORMATION Leaflet for more information. Shared Solutions™ at (800)-887-8100 has several educational materials that may also be helpful.

  • If storing Copaxone“ under refrigeration, remove the syringe from the refrigerator 20 minutes before you inject, allowing it to warm to room temperature.
  • Always wash and dry your hands before and after injecting.
  • Never inject into the same area on your body more than once a week.

                o Acceptable sites: stomach, right and left arm, right and left thigh, right and left hip.
– Chose a site that is at least 2 inches from the last site of injection.

  • Do not rub the injection site on the same day as you have injected yourself.
  • After the injection, dispose the used syringe into a hard-welled container.


Possible Side Effects

  • Redness, pain, swelling, itching, or a lump at the injection site
  • A permanent depression under the skin at the injection site may occur
  • Swelling of the lymph nodes in the neck, armpits or groin areas
  • Fluid retention, facial swelling, weight gain
  • Nausea, vomiting, shortness of breath, sweating
  • Tremor, muscle pain, neck pain, weakness
  • Anxiety, hand shakes
  • Low blood pressure – dizziness, heart beating fast when standup
  • Immediate Post-Injection Reaction (IPIR)

                o In approximately 10% of patients given Copaxone“ in trials, a post-injection reaction occurred, usually within minutes after injecting, and included flushing (feeling warmth and/or appearing red), chest tightness or pain with palpitations, anxiety and trouble breathing. Referred to as the Immediate Post-Injection Reaction (IPIR), symptoms lasted for only a few minutes and resolved without any treatment required. Generally, this reaction happens several months after starting the medication but may occur anytime. Most patients only have it once but it can happen several times. If you experience this after being on Copaxone“ for a while, it is important to try to relax, keep your head upright, and breathe slowly. If this reaction does not go away on its own or if you have symptoms of tongue or face swelling, or experience extreme trouble breathing, seek immediate medical attention. Either way, you should contact your physician describing the experience, and do not give yourself anymore injections until your physician tells you to begin again.

  • Chest pain

                o In trials, several patients experienced chest pain as a lone symptom that was not related to any other symptom as described above with the IPIR and did not necessarily occur immediately after injecting. It lasted only a few minutes and most episodes occurred after at least one month of therapy.

  • Increased risk of infection (theoretical, as this has not been observed or evaluated)


Tips

  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.

                o Always call your refills in to your pharmacy well before you are out of medication to avoid any disruption in therapy. Most mail order pharmacies require at least a week to confirm your prescription and ship the medication.

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • You should not use this medication if you are allergic to glatiramer or mannitol.
  • This medication should not be used if you are pregnant or breastfeeding.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.

When to contact your healthcare provider

  • If you think you have had an Immediate Post-Injection Reaction (IPIR) as described above. Do not give yourself any more injections until your physician tells you to begin again.
  • Severe injection site pain or severe pain anywhere
  • Painful lumps in the neck, groin or armpits
  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • You should not become pregnant or breastfeed an infant while using this medication without discussing it with your physician first.

                    o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name

  • Gammagard Liquid, Gammagard S/D, Gammunex (several other brands exist)


What it is

  • IgG is an injectable medication, which contains many different antibodies that are normally present in the body. It is collected from large pools of human plasma and is screened and treated extremely well for potentially infectious agents including hepatitis B and C, HIV and others.


What it does

  • In some studies IgG has been shown to decrease the frequency and severity of relapses in patients with relapsing forms of multiple sclerosis. Studies also suggest that IgG given to women with multiple sclerosis after giving birth, decreases the relapse rate during the following 6 months, which is typically a period associated with an abnormally elevated rate.


How it works

  • Many mechanisms have been described:

                o One thought is that it binds to white blood cells and decreases their attraction to and destruction of the nerve cells in the brain.
o It may also work by overloading your own immune system, which tricks it into reacting less to your own nerve cells.

How it’s given

  • Intravenously – in the multiple sclerosis center infusion room

            o Infused over several hours depending on your dose and prior use
o Dose
– Based on weight: 1 gm per kilogram
– Usually given once monthly

            o Duration: Infusions can take up to 6 hours. You should schedule your infusion to start first thing in the morning.

Possible Side Effects

  • Short-term

            o Report any pain or discomfort near the IV site to your nurse
o Headache, dizziness, nausea, vomiting
o Fever, chills, shaking

  • Long-term

            o Back pain
o Increased risk of infections
o Kidney problems

Tips

  • You may be given Tylenol‚ (acetaminophen) and Benadryl‚ (diphenhydramine) or Claritin‚ (loratadine) before your infusion to reduce the risk of having an infusion reaction.

                    o If you are driving and/or Benadryl‚ makes you very drowsy, tell your nurse.

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often
  • Tell your physician, nurse or pharmacist if you have gained or lost any weight as this may change your dose.
  • This medication is typically not given if you are pregnant.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before     breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.

  • Talk to your health care provider before receiving any vaccines.

                o Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives, extreme itchiness
  • Swelling of the face or lips and swelling or tingling of the tongue and throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat (palpitations), sweating, confusion
  • Loss of appetite, unusual tiredness or low-grade fever for more than 2 days
  • Extreme headache, painful eye movements, difficulty tolerating bright light, or painful neck or head movements
  • Although fetal and infant risk appear minimal if immune globulin is given to pregnant or breastfeeding women, you should contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name

  • Trexall™, Rheumatrex®


What it is

  • An oral or self-injectable chemotherapy agent with immunosuppressant and anti-inflammatory properties approved for treating certain malignancies including leukemia, breast cancer and others. It’s also approved for treating severe rheumatoid arthritis and psoriasis.


What it does

  • May delay the progression of multiple sclerosis
  • May reduce relapse rates


How it works

  • Methotrexate produces immunosuppressive effects with high doses by inhibiting folic acid production. Folic acid is necessary for the synthesis of DNA and the reproduction of cells. With low, once-weekly dosing, its anti-inflammatory effects are utilized, resulting from the suppression of white blood cell activity.


How it’s given

  • Methotrexate is available in a pill form and in an injection form.

                o The injectable form is usually supplied as a solution in a glass vial, so it does not have to be mixed but has to be drawn up before      injecting.
– Methotrexate rarely may be supplied in a powder form. If you receive this product from your pharmacy, it will need to be         mixed with the proper solution before drawing up. Speak with the pharmacist if this is the case.
o You will be instructed on this procedure by your physician or a nurse when starting therapy and will be given prescriptions for supplies when necessary and instruction on what additional materials you will need for this procedure.

  • Typical Dose: 7.5 mg to 30 mg by mouth once weekly; doses are increased or decreased as needed
  • Methotrexate is taken orally in a tablet form or injected subcutaneously (under the skin) or intramuscularly (in the muscle).
  • A nurse or your physician should show you how to inject this medication.

                o Your first, self-administered dose should be done under the direct supervision of an appropriately qualified health care practitioner.
o After the injection, dispose the syringe into a hard-welled, chemo-safe container.

Possible Side Effects

  • Pain, redness, swelling, and irritation at the injection site
  • Susceptibility to infection
  • Nausea, vomiting, lack of appetite (more common with tablets)
  • Mouth sores, headache, fever, chills
  • Allergic reaction
    • o Itching, hives, swelling in your face or hands, chest tightness
  • Lung disease
  • Dry, non-productive (not coughing up sputum) cough
  • Liver damage
    • o Pain in the upper, right area of your torso, yellow color of skin and eyes
  • Blood disorders such as anemia or easy bruising or abnormal bleeding
  • Increased sensitivity to sun or UV lights, skin color changes, hair loss
  • Malignancies

                o This risk may persist even after stopping this medication

Tips

  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.

                o Always call your refills in to your pharmacy before you are out of medication to avoid any disruption in therapy.

  • If you miss a dose of your medication, take it as soon as you remember:

                o You can resume your regular schedule the next week but don’t take doses within 3 days of each other.

  • You will need to have your blood checked regularly for blood and liver damage and before beginning treatment.

                o Always have your blood checked when schedules if requested by your physician.

  • Limit the use of alcohol while taking methotrexate, which may put you at an increased risk of liver problems.
  • This medication should not be used if you are pregnant or breastfeeding.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before                 breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.

  • If a couple is planning on becoming pregnant, both men and women receiving methotrexate should continue using contraceptives for 3 months after discontinuing methotrexate, before trying to conceive.
  • Methotrexate will cause you to be more sensitive to sun

                o Wear protective clothing while outdoors
o Wear sunscreen of at least SPF 30 on exposed areas
o Do not use sun lamps or booths

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • Before taking antibiotics such as Bactrim® or a penicillin (penicillin VK, amoxicillin, ampicillin, etc.) make sure your physician is aware that you are taking methotrexate as this may increase your risk of methotrexate toxicity.
  • Make sure your physician is aware if you are taking an NSAID (i.e. Advil®, Motrin®, Aleve®) on a regular basis while on methotrexate as this may increase your risk of methotrexate toxicity.

                o However, this is usually not a problem with low, once-weekly dosing.

  • Talk to your health care provider before receiving any vaccines.

                o Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives, blistering or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • Bruising, black, tarry stools, blood in urine
  • You should not become pregnant or breastfeed an infant while using this medication.
  • Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name

  • “Cytoxan”

 

What it is

  • An injectable chemotherapy agent with immunosuppressant properties approved for treating certain malignancies including breast cancer, lung cancer, and several others.


What it does

  • Lowers the number of white blood cells in your body
  • May slow down the progression of progressive forms of multiple sclerosis
  • May decrease the frequency and severity of relapses in patients with very aggressive forms of relapsing multiple sclerosis
  • How it works:
    • It decreases the amount of white blood cells in the blood
    • The formation of white blood cells in the bone marrow is decreased


How it’s given

  • Intravenously – in the multiple sclerosis center infusion room

                o Infused over 30 – 60 minutes. In addition, intravenous steroids and intravenous fluids will be infused over an additional 1-2 hours.
o Dose
– Based on body surface area
– Calculated using height and weight
– Most patients receive between 1000 – 3000 mg per dose
– Your dose may be adjusted based on the number of white blood cells in your blood
– Your physician will instruct you on how and when to have your blood checked after your infusion
– May be given for up to 3 years or longer. A typical administration schedule may be as follows:
– Once monthly for 1 year
– Once every 6 weeks for the second year
– Once every 8 weeks for the third year

Possible Side Effects

  • Short-term
  • Report any pain or discomfort near the IV site to your nurse
  • Susceptibility to infection
  • Nausea, vomiting, lack of appetite
  • Mouth sores
  • Headache, fever, chills
  • Hair loss, skin and nail discoloration
  • Irregular or loss of menstrual cycle
  • Long-term
  • Infertility – inability to become pregnant
  • It is still very important to use birth control if you are sexually active as pregnancy may still occur
  • Hemorrhagic cystitis – inflammation of the bladder
  • This risk may persist even after stopping this medication
  • Malignancies
  • This risk may persist even after stopping this medication
  • Impaired wound healing


Tips

  • You will receive medication to prevent nausea before your infusion and a prescription for medication to be taken at home.
  • It’s usually easier to prevent nausea than it is to remove it once it is present so use your medication as prescribed even if you think you can tolerate the nausea without it.
  • You must take in 3 liters of fluid after your infusion to prevent bladder problems.
  • All or part of this can be given to you at the multiple sclerosis center as an intravenous infusion or you may drink all or part of this at home.
  • Caffeinated beverages (soda, coffee) should be avoided
  • You must also take in 3 liters of fluid on the day following your infusion.
  • Try to avoid foods and smells that may trigger your nausea.
  • Always have your blood checked as instructed to ensure proper dosing of your medication.
  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • This medication should not be used if you are pregnant or breastfeeding.
  • Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
  • For information about birth control options, speak with your physician or pharmacist.
  • Cytoxan” therapy increases your risk for skin cancer
  • Wear protective clothing while outdoors
  • Wear sunscreen of at least SPF 30 on exposed areas
  • Do not use sun lamps or booths
  • Talk to your health care provider before receiving any vaccines.
  • Some vaccines you should avoid while others may not work while on this medication.


When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • Nausea not controlled by your medication
  • Blistering of peeling of you skin
  • Pain when urinating or blood in your urine (pink urine)
  • Extreme tiredness, abnormal bleeding or easily bruising
  • You should not become pregnant or breastfeed an infant while using this medication.
  • Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name

  • “Novantrone“


What it is

  • An injectable chemotherapy agent with immunosuppressant properties approved for treating certain malignancies and is the only currently approved medication for secondary-progressive multiple sclerosis. In addition, it is approved for treating worsening forms of relapsing remitting multiple sclerosis.


What it does

  • Lowers the number of white blood cells in your body
  • May reduce the progression of disability in secondary-progressive multiple sclerosis
  • May decrease the frequency and severity of relapses in patients with relapsing forms of multiple sclerosis


How it works

  • It decreases the amount of white blood cells in the blood
  • The formation of white blood cells in the bone marrow is decreased


How it’s given

  • Intravenously – in the multiple sclerosis center infusion room

            o Infused over 15 – 30 minutes
o Dose is based on body surface area, which is calculated using height and weight
– Most patients receive between 10 and 20 mg
– A single dose is given once every 3 months

            o An echocardiogram must be performed prior to every infusion. Results must be sent to the MS Center prior to infusion.

            o An echocardiogram must also be performed annually after treatment with Mitoxantrone has ended (FDA guidelines, July 2008).

 

Possible Side Effects

  • Short-term

            o Slight discoloration around or along the vein in which the drug is being infused; this may be ok or may indicate misplacement of your IV
– Immediately report any pain, discomfort or discoloration near the IV site to your nurse
o Susceptibility to infection
o Nausea, vomiting, lack of appetite
o Mouth sores
o Headache, fever, chills
o Temporary hair loss
o Temporary (2 – 3 days) bluish/green discoloring of the urine or the white part of the eye
o Irregular or loss of menstrual cycle

  • Long-term

            o Cardiac (heart) toxicity
o You will be required to have a simple test done before each dose.
– An ultrasound of your heart called an echocardiogram allows your doctor to check for any damage.
o Infertility – inability to become pregnant

                    – It is still very important to use birth control if you are sexually active as pregnancy may still occur
o Malignancies, including increased risk of lymphoma. This risk may persist even after stopping this medication.
o Impaired wound healing

Tips

  • You will receive medication to prevent nausea before your infusion and a prescription for medication to be taken at home.

                o It’s usually easier to prevent nausea than it is to remove it once it is present so use your medication as prescribed even if you think you can tolerate the nausea without it.

  • Avoid foods and smells that can trigger your nausea.
  • Always keep your appointment for your echocardiogram.
  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • This medication can make your urine, eyes and nails blue-green color.

                o This is temporary and usually goes away within a couple days after your infusion.

  • This medication should not be used if you are pregnant or breastfeeding.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.

  • Talk to your health care provider before receiving any vaccines.

                o Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • Nausea not controlled by your medication
  • Blistering of peeling of you skin
  • Extreme tiredness, abnormal bleeding or easily bruising
  • Shortness of breath or swelling of the ankles
  • You should not become pregnant or breastfeed an infant while using this medication.

                o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name
Tysabri


What it is
An injectable medication that is a manufactured antibody designed to prevent certain types of white blood cells from moving out of the bloodstream and into organs, namely the brain. Although it has been studied in patients with Crohn’s disease, an autoimmune disease similar to multiple sclerosis in that the immune system is attacking the intestines, currently, natalizumab’s only approved indication is for treating patients with active relapsing forms of multiple sclerosis.

What it does
In patients with relapsing forms of multiple sclerosis, natalizumab has been shown to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.

How it works
Natalizumab binds to a specific site, or receptor on T-cells and prevents them from binding to other specific receptors on the inside of blood vessels. T-cells normally rely on binding to these receptors in order to cross into the central nervous system. Inhibiting this interaction keeps the activated T-cells out of the central nervous system, preventing them from attacking the myelin sheath that covers brain and spinal cord nerve cells.

PML
The FDA approved Tysabri“ in November of 2004. Biogen Idec and Elan stopped the use of all Tysabri“ infusions in the public and in research studies in February 2005 because of reports of progressive multifocal leukoencephalopathy (PML). PML is a rare neurological disease that is caused by the JC virus that can cause death or severe disability. There is no known cure for PML. This disease can affect people with a weakened immune system. Three patients, developed PML out of over 3000 that had received Tysabri“ treatment in research studies. All of these patients that developed PML had received additional medications that suppressed the immune system either in combination, or just prior to the administration of Tysabri. A full review of the safety data from Tysabri“ studies in MS has now been completed. No new confirmed cases of PML were found. The decision to start using the drug again was based on the results of this safety evaluation. Any new information that might affect you or your treatment will be shared with you as soon as possible. Since the risk of developing PML exists, Tysabri“  is generally recommended for patients whom have not responded adequately to, or who have not tolerated other treatments for MS. Patients receiving Tysabri“ must be enrolled in the TOUCH‘ Prescribing Program.  During the second post-marketing phase, of Tysabri, 2 new cases of PML were  diagnosed in August 2008, out of a total of  6,600 patients who were treated for 18 months or longer. The risk of PML still remains at approximately 1/1000.

The TOUCH™ Prescribing Program
Tysabri“ is only given by physicians and infusion centers that are enrolled in the TOUCH‘ Prescribing Program with Biogen. The Partners MS Center and participating physicians are enrolled in the TOUCH‘ Prescribing Program.

Once a physician at the Partners MS Center has deemed you an appropriate candidate to receive Tysabri“, you must read, discuss and understand the medication guide and all forms given to you regarding this medication.
Once approved through Biogen and your insurance, you may set up an appointment at the infusion center at 1 Brookline Place.

In order to start Tysabri“ and at follow-up monitoring, you will need a:
o Neurological exam: before and about 3 months after you begin treatment
o MRI scans: before and every 6 months while on treatment
o Regular exams with your physician every 6 months per our standard care

    o Before every infusion an infusion nurse will ask you questions regarding your health and medications.

How it’s given:
o Intravenously – in the multiple sclerosis center infusion room
o Infused over 60 minutes followed by a 60 minute observation period
o Dose
– 300 mg every four weeks


Warning: Tysabri“ should not be used in patients who have or have had PML or have a condition that weakens the immune system:

o HIV infection or AIDS, leukemia or lymphoma, or an organ transplant, and others


Warning: Tysabri“ should not be used in combination with:
o Any investigational (research) treatment
o Other monoclonal antibodies (i.e. Zenapax, Rituxan)
o IV immunoglobulin (IVIg or IgG)
o Plasmapheresis or cytapheresis
o Total lymphoid irradiation
o T-cell or T-cell receptor vaccination
o Immunosuppressive medications (Cytoxan, methotrexate, cladribine)
o Immunomodulatory treatments:
– Avonex (interferon beta-1a)
– Rebif (interferon beta-1a)
– Betaseron (interferon beta-1b)
– Copaxone (glatiramer acetate or co-polymer-1)

Possible Side Effects
– Itching, hives, swelling in your face or hands, chest tightness, low blood pressure
– Headache, nausea, diarrhea, stomach pain
– Fatigue, trouble sleeping, depression
– Dizziness or tremor
– Difficulty urinating
– Increased risk of PML
– Increased risk of other infections and infection outbreaks
– Urinary tract infections, vaginitis, lung infections, herpes zoster (shingles), herpes outbreaks
– Arm and leg pain, joint pain
    – Liver damage: pain in the upper, right area of your torso, yellow skin and eyes
    – Irregular, reduced or loss of menstruation
– Appendicitis; rare

    – Melanoma; rare
o Report to your physician any significant changes in the size, shape or color of any moles on your body

  o Report any pain or discomfort near the IV site to your nurse
o Allergic reaction – typically occurs within 2 hours of the start of the infusion, but may happen several hours after

Tips
– Always bring an updated list of your current medications to your physician or infusion appointment and show it to your physician, nurse or pharmacist.
– Tell all of your physicians that you are taking Tysabri“.
– Always have your blood drawn when your physician requests it.
– Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
– This medication should not be used if you are pregnant or breastfeeding.


o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.
o Talk to your health care provider before receiving any vaccines.
o Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider

– If you have any new or suddenly worsening neurological symptoms that keep getting worse and affect your thinking, eyesight, balance or strength:
o You must contact your physician within 48 hours
o You may need to visit the clinic within 5 days of the start of the symptoms. If your physician feels it is necessary, you may need to have these tests done:
– Neurological exam
– MRI with and without gadolinium dye
– An injection into an arm vein of gadolinium (a “dye”) during the MRI scan. The gadolinium helps us see the changes from MS more clearly.
– Blood and urine collection
– Lumbar puncture. This procedure is to remove a small sample of cerebral spinal fluid from your lower spine. A hollow needle is inserted between the vertebrae (backbones) in the lower back and into the space that contains the spinal fluid. We may need to collect this fluid to test for the JC virus. A lumbar puncture takes approximately 30 minutes and is done using a local anesthetic. The physician will do it here in the clinic and full explanation will be given.


– If you are diagnosed with a medical condition that weakens your immune system.
– If you start taking medications that may weaken your immune system.

– If you are experiencing:
o New neurological symptoms such as new weakness, numbness, change in vision, change in speech or cognition, imbalance or dizziness.
o Chest tightness or pain, trouble breathing, wheezing
o Rash, hives, extreme itchiness
o Swelling of the face or lips and swelling or tingling of the tongue and throat
o High fever, severe sore throat or any other signs of infection
o Fast heartbeat (palpitations), sweating, confusion

 

– You should not become pregnant or breastfeed an infant while using this medication.
o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name

  • “Rituxan“


What it is

  • An injectable chemotherapy agent with immunosuppressant properties approved for treating certain malignancies including Non-Hodgkin’s lymphoma and certain types of leukemia. It’s also been used for treating lupus and rheumatoid arthritis.


What it does

  • In patients with relapsing forms of multiple sclerosis, rituximab has been shown to reduce MRI measured activity of lesions and to reduce the number of relapses. It may also decrease progression to disability.


How it works

  • Rituximab binds to a site or receptor on the surface of certain white blood cells, specifically B-cells and specifically to the CD20 receptor. This results in the elimination of B-cells from the body that lasts for up to a year.


How it’s given

  • Intravenously – in the multiple sclerosis center infusion room

                o Infused slowly over several hours
o The usual treatment regimen is: 1000 mg x 2 doses, given 2 weeks apart
For example: 1000mg on December 1st and 1000mg on December 15th. This “cycle” is given once a year

Possible Side Effects

  • Report any pain or discomfort near the IV site to your nurse
  • Allergic reaction

                o Itching, hives, swelling in your face or hands, chest tightness

  • Headache, nausea, vomiting, stomach pain, cough
  • Fatigue, trouble sleeping
  • Dizziness, tremor, or changes in vision
  • Difficulty urinating
  • Increased risk of infections, including progressive multifocal leukoencephalopathy (PML)
  • Impaired wound healing
  • Difficulty walking or loss of coordination
  • Cardiac arrhythmia: palpitations, shortness of breath
  • Blood disorders such as anemia or easy bruising or abnormal bleeding


Tips

  • You may be given Tylenol‚ (acetaminophen) and Benadryl‚ (diphenhydramine) or Claritin‚ (loratadine) before your infusion to reduce the risk of having an infusion reaction.

                    o If you are driving and/or Benadryl‚ makes you very drowsy, tell your nurse.

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • Tell your physician, nurse or pharmacist if you have gained or lost any weight as this may change your dose.
  • You may experience a reaction during the infusion (fever, chills, or change in blood pressure)

                    o You will be closely monitored during the infusion by nurses but report any unusual symptoms if they occur.

  • This medication should not be used if you are pregnant or breastfeeding.

                    o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.

  • Talk to your health care provider before receiving any vaccines.

                    o Some vaccines you should avoid while others may not work while on this medication.

When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives, extreme itchiness
  • Swelling of the face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat (palpitations), sweating, confusion
  • Changes in vision, difficulty walking or loss of coordination
  • Bruising, black and tarry stools, blood in urine
  • You should not become pregnant or breastfeed an infant while using this medication.

                o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

What it is

  • Daclizumab (Zinbryta) is an FDA approved medication for the treatment of relapsing remitting MS.

 

What it does

  • In clinical trials, Daclizumab therapy led to a 50% or more reduction in annual MS disease relapse and MRI activity compared to placebo or interferon beta in clinical trials

How it works

  • Originally developed as a prophylactic agent against solid organ allograft rejection, this humanized monoclonal antibody selectively targets the IL-2 receptor and inhibits activated T cell signaling.

How it’s given

  • Daclizumab is a once a month subcutaneous injection

Possible Risks and Side Effects

  • Daclizumab should generally be used only in patients who have had an inadequate response to two or more MS drugs because daclizumab has some serious safety risks, including liver injury and immune conditions. Because of the risks, daclizumab has a boxed warning and is available only through a restricted distribution program
  • The boxed warning tells prescribers that the drug can cause severe liver injury. Your doctor should perform blood tests to monitor your liver function prior to starting daclizumab, monthly before each dose, and for up to six months after the last dose.
  • Daclizumab can also cause inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy).
  • Finally, some patients may have hypersensitivity reactions (anaphylaxis or angioedema) with the injections, and may experience increased risk of infections, and symptoms of depression and/or suicidal ideation.
  • The most common adverse reactions reported by patients receiving daclizumab in the clinical trial that compared it to Avonex (interferon beta-1a)  include cold symptoms (nasopharyngitis), upper respiratory tract infection, rash, influenza, dermatitis, throat (oropharyngeal) pain, eczema, and enlargement of lymph nodes.
  • The most common adverse reactions reported by patients receiving daclizumab when compared to placebo were depression, rash, and increased alanine aminotransferase (AST) – a liver enzyme.

Brand Name

  • CellCept, Myfortic


What it is

  • An oral immunosuppressant that is approved for preventing rejection in patients receiving solid-organ transplants. In addition to multiple sclerosis, it has been successfully used off-label for treating lupus, certain types of skin diseases, and other immune related conditions.


What it does

  • CellCept“ is usually given in combination with other medications to patients with relapsing forms of multiple sclerosis. Small studies have shown that it may decrease the amount of relapses and may slow the progression of the disease.


How it works

  • It inhibits an enzyme in the body that is necessary for the production of specific purines. These specific purines are necessary for certain white blood cells, specifically T- and B-cells, to carry out an attack against offending material. This leads to less damage of myelin and neurons in the brain.


How it’s given

  • Orally – two forms exist but they are not equivalent in dosing. Currently, CellCept“ is the brand that is typically used for multiple sclerosis.

    o Both forms of mycophenolate should be taken one hour before or two hours after food intake for proper absorption.
o Tablets should not be crushed, chewed, or cut and capsules should not be opened prior to ingesting. Tablets and capsules should be swallowed whole.
o CellCept – mycophenolate mofetil capsules and tablets typical dosing regimen:

                    -250 mg by mouth twice daily for week 1 then,
                    -500 mg by mouth twice daily for week 2 then,
                    -750 mg by mouth twice daily for week 3 then,
                    -1000 mg by mouth twice daily, thereafter    o Myfortic – mycophenolate sodium delayed-release tablets
-720 mg by mouth twice daily on an empty stomach

  •     If you miss a dose, take it as soon as you remember but do not double up with the next dose.

 

Possible Side Effects

  • Short-term

                        – Increased risk of infection, including progressive multifocal leukoencephalopathy (PML)
– Nausea, stomach pain, diarrhea
– Increasing the dose slowly reduces these effects
– These effects may return for a day or two when doses are increased
– Weakness
– Dizziness, difficulty sleeping

  • Long-term

                        – Malignancies: skin, lymphoma.  This risk may persist even after stopping this medication
– Ulcers or stomach bleeding
Tips

  • Increasing the dose slowly will lessen the incidence of side effects.
  • If you still experience stomach side effects realize that these do get better over time, even though they may reappear while     increasing the dose.
  • Avoid taking antacids containing aluminum or magnesium (i.e. Maalox®, Mylanta®) at the same time as mycophenolate as these will affect how much drug you absorb. It should be taken at least one hour before or two hours after taking antacids.
  • Some medications used to lower cholesterol such as cholestyramine should not be taken if you are taking mycophenolate, as they will inhibit your absorption of the medication regardless of when you take them. Tell your physician if you are taken cholestyramine or a similar medication.
  • Avoid taking calcium supplements or iron supplements at the same time as mycophenolate as these will affect how much drug you absorb. It should be taken at least one hour before or two hours after taking these supplements.
  • Avoid taking antacids containing aluminum or magnesium (i.e. Maalox®, Mylanta®) at the same time as mycophenolate as these will affect how much drug you absorb. It should be taken at least one hour before or two hours after taking antacids
  • Tell your physician if you are taking Zovirax® (acyclovir) while taking mycophenolate as this may increase its levels and you may have to have your blood checked while on both.
  • Birth control pills may not work while taking mycophenolate so couples should use alternate forms of birth control during mycophenolate therapy and for 6 weeks after stopping therapy. If you are or think you may be pregnant, notify your physician immediately.
  • Always have your blood checked when schedules if requested by your physician.
  • You might be at a higher risk for certain skin cancers. Exposure to sunlight and UV light should be limited by wearing protective clothing and using a strong sunscreen (at least SPF-30) when you are outdoors. Avoid sunlamps and tanning beds.
  • Talk to your health care provider before receiving any vaccines.Some vaccines you should avoid while others may not work while on this medication.
  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.
  • Always call your refills in to your pharmacy before you are out of medication to avoid any disruption in therapy.
  • This medication should not be used if you are pregnant or breastfeeding.

            – Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
– For information about birth control options, speak with your physician or pharmacist.

When to contact your healthcare provider
If you are experiencing:

  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • Tell your physician if you have any uncontrolled digestive system conditions
  • High fever, severe sore throat or any other signs of infection
  • If your stool is very black or you see blood in your stool
  • Extreme tiredness, abnormal bleeding or easily bruising
  • You should not become pregnant or breastfeed an infant while using this medication.
      • Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.

Brand Name
Gilenya

What it is
A disease-modifying oral agent that is indicated to reduce the frequency of MS exacerbations and to delay the progression of physical disability in patients with relapsing forms of MS.

What it does
Gilenya is a disease-modifying drug used as monotherapy to reduce exacerbations and accumulation of disability in relapsing forms of MS. Two major clinical trials were done to assess the efficacy and safety of the drug. One tested Gilenya versus a placebo, the other tested Gilenya versus interferon. One trial demonstrated a significant delay in disability progression and both trials showed a significantly lower relapse rate.

How it works
The mechanism of Gilenya is not fully understood. It binds to receptors in the body that block progression of lymphocytes (white blood cells) into the blood and may reduce the movement of lymphocytes into the central nervous system (brain and spinal cord). Lymphocytes are part of the auto-immune response in MS; they play a role in inflammation and the demyelination (removal of protective covering) of axons.

How it’s taken
Orally
Gilenya 0.5 mg orally once daily.

-Take the tablet whole. Do not break, crush, chew, or dissolve before swallowing as this may increase the risk for side effects.
-May be taken with or without food.
-Do not discontinue Gilenya without first talking to your physician.
-If you miss a dose, take when you remember, but if it is too close to the next dose DO NOT DOUBLE UP. You will be monitored for six hours after the first dose for signs of bradycardia (slow heart rate).
-If you are taking an anti-arrhythmic medication (including calcium channel blockers and beta-blockers) or have other cardiac risk factors such as congestive heart failure an EKG will be obtained prior to beginning therapy.
-If you have not had chickenpox before or a varicella zoster virus (VZV) vaccine, you may be tested for antibodies to VZV. If you do not have antibodies to VZV, you may be asked to receive the vaccination prior to starting therapy.
-A complete blood count, bilirubin, and liver function tests will be obtained before initiation of therapy.
-An eye exam will be administered before initiation of therapy and 3-4 months into therapy.

Possible Side Effects
Common
-Headache
-Influenza (flu)
-Diarrhea
-Back pain
-Cough
-Increase in liver enzymes

Serious
-Infections
-AV block and bradyarrhythmia
-Macular Edema
-Leuokopenia

All side effects should be reported to your physician. You may report side effects to the FDA at 1-800-FDA-1088.

Tips
-If discontinued for more than two weeks, re-initiation of therapy will require another six-hour monitoring period after the re-initiation dose.
-Certain vaccines should be avoided while on Gilenya and two months following discontinuation of therapy.
-Gilenya greatly increases your risk of infections. Report any signs of infection (fever, sore throat, cough, etc) to your healthcare provider.
-Gilenya may cause macular edema; a serious condition of the eye. Please notify your physician of any changes in vision. If you are diabetic or have a history of uveitis, your risk is increased.
-Inform your physician if you have any shortness of breath.
-Gilenya may affect your liver enzymes. Inform your doctor if you have any nausea, vomiting, stomach pain, weight loss, yellowness of eyes, or dark urine.
-Do not change the dose or dosing schedule without speaking with your physician.
Animal studies of Gilenya have demonstrated harm to the fetus. Effective birth control is recommended while taking Gilenya and two months after discontinuing.
-Gilenya remains in your system two months after discontinuation. Lymphocytes may continue to be low during these two months.
-Notify your physician and pharmacist before starting any new prescription medications, over the counter medications or herbal supplements. Certain heart medications and anti-fungal drugs may strongly interact with Gilenya and need to be monitored.
-Your progress with this drug will need to be monitored. It is important to keep all scheduled appointments.

Pregnancy Risk
-Gilenya is classifed as pregnancy risk category C, which means there are no adequate and well-controlled studies in pregnant women. Animal studies demonstrated fetal toxicity. Women taking this medication should practice adequate birth control.
-Gilenya should be stopped for at least 2 months prior to conceiving.

When to contact your healthcare provider
-If you become pregnant
-If you are experiencing or have experienced:
Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
Any signs of infection (fever, sore throat, cough, etc)
Changes in vision
Shortness of breath
Nausea, vomiting, stomach pain, weight loss, yellowness of eyes, dark urine

Who to contact
For problems or concerns please call the MS Center at 617-525-6550 Monday through Friday 9am –5:00pm. During off-hours, please call the on-call doctor at 617-732-5656 then beeper #11378.

Brand Name
Aubagio

What it is
Aubagio (teriflunomide) is a once a day oral pill that was approved by the FDA September 12, 2012 for use in relapsing forms of multiple sclerosis.


What it does

  • In a phase III trial, TEMSO, compared to placebo the higher dose of Aubagio (14mg) reduced relapse rate 31%, 3 month disability progression 30%, and total MRI lesion volume 67%.

How it works

  • Teriflunomide acts  in multiple sclerosis by reducing white blood cells through effects on DNA synthesis.

How it’s given

  • Teriflunomide is a daily pill.  It is available in doses of 7mg and 14mg.  There is a better effect on the disease if patients taking the 14mg dose and the side effect profile is comparable between the two

Storage

  • Room temperature

Possible Side Effects

  • Patients taking this drug were potentially more susceptible to hair loss (13% vs 3% in placebo), diarrhea (18% vs. 9% in placebo) and nausea (14% vs. 7% placebo) Serious effects on the fetus have been seen with a drug similar to Aubagio, leflunomide, which might apply to Aubagio as well.  For this reason the FDA has recommended not taking this drug within two years of trying to conceive a child unless a wash out procedure is performed.  Because the drug may potentially cross into the sperm this also applies to men.
  • A TB test should be performed prior to starting this drug as should basic bloodwork.
  • Because mild liver irritation or damage (57% vs. 36% placebo) can occur blood is monitored monthly for six months.

Tips

  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.
  • This medication should not be used if you are pregnant or breastfeeding.

Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.

For information about birth control options, speak with your physician or pharmacist.

Brand Name

Tecfidera®

 

What it is

A disease-modifying oral agent that is indicated to reduce the frequency of  MS relapses and to slow the worsening of physical disability in patients with  relapsing forms of MS.

 

What it does

Dimethyl fumarate is a disease-modifying drug used as monotherapy to reduce exacerbations and accumulation of disability in relapsing forms of MS.  There were two major trials to assess the safety and efficacy of the drug. In one trial, dimethyl fumarate was tested versus a placebo.  In another, dimethyl fumarate and glatiramer acetate (Copaxone) were tested versus a placebo.  Both trials demonstrated a reduced relapse rate and a reduction in lesions detectable by MRI.  One trial demonstrated a delay in disability progression. In the second trial, dimethyl fumarate demonstrated greater relapse reduction and MRI lesion reduction than glatiramer acetate.

 

How it works

The mechanism of dimethyl fumarate is not fully understood. The proposed mechanism is that it reduces cellular stress in the body. By reducing this stress, dimethyl fumarate may lessen the inflammatory response that occurs in MS.

 

Most importantly:

We recommend starting the medication according to the following schedule:

-Week 1+ 2 :   120mg once a day after large meal

-Week 3 + 4:   240mg once a day after large meal

-Week 5:   240mg after breakfast and 240mg after dinner

-Week 6 and beyond:  Continue at the week 5 dose

 

In order to minimize gastrointestinal discomfort and flushing.  You should always take the medication with food.

For the first month take a tablespoon of peanut butter 5 minutes prior to taking the medication. 

 

Recommendation:

  • Healthy alternative to peanut butter: nuts, peanut butter, fatty fish, avocados, flaxseed, tofu, olive oil)
  • Take 81mg aspirin (not enteric coated) 30 minutes before if flushing occurs.  May take for about 4-6 weeks and then check with your doctor if flushing continues.
  • Take Pepto-Bismol/Kaopectate for nausea/diarrhea
  • Stop any medication used for bowel regulation.  If Tecfidera does not affect your GI system, you may resume.
  • Take the capsule whole. Do not crush, chew, or open contents.
  • Call your doctor if you experience persistent flushing or stomach problems.
  • Do not discontinue dimethyl fumarate without first talking to your physician.
  • If you miss a dose, take it when you remember, but if it is too close to the next dose DO NOT DOUBLE UP.
  • A complete blood count will be obtained before initiation of therapy and at regular intervals during therapy.

 

Possible Side Effects

Common

o   Diarrhea

o   Flushing

o   Itching

o   Nausea

o   Rash

o   Stomach pain

o   Vomiting

 

Serious

o   Lymphocytopenia

 

All side effects should be reported to your physician. You may report side effects to the FDA at 1-800-FDA-1088.

 

 

Tips

  •  Although it is a rare side effect, dimethyl fumarate may decrease a particular type of white blood cells called lymphocytes. These cells are responsible for fighting infection in your body. Take extra care to maintain hygiene and wash hands as regularly as possible. Report any signs of infection (fever, sore throat, cough, etc.) to your healthcare provider.
  •   Animal studies of dimethyl fumarate have demonstrated harm to the fetus. Effective birth control is recommended while taking dimethyl fumarate.
  •   Notify your physician and pharmacist before starting any new prescription medications, over the counter medications or herbal supplements.
  •   Your progress with this drug will need to be monitored. It is important to keep all scheduled appointments.

 

When to contact your healthcare provider

  •  If you become pregnant
  • If you are experiencing or have experienced:

o   Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.

o   Any signs of infection (fever, sore throat, cough, etc.)

 

Who to contact

For problems or concerns please call the MS Center at 617-525-6550 Monday through Friday 9:00am – 5:00pm.

During off-hours, please call the on-call practitioner at 617-732-5656 then beeper #11378.

On March 28th 2017, the US Food and Drug Administration (FDA) approved the humanized monoclonal antibody ocrelizumab (Ocrevus) for both relapsing multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) in adults.

 

Have there been clinical trials? 

The drug’s approval was based on results from several clinical trials including OPERA 1 & 2 and ORATORIO phase 3 trials. The first two trials each included about 800 patients with RRMS who received intravenous ocrelizumab or the subcutaneous interferon b-1a Rebif®Ocrelizumab demonstrated superior efficacy on the three major markers of disease activity; it reduced relapses per year by nearly half, slowed the worsening of disability and significantly reduced MRI lesions compared with Rebif® over a 2 year period (T1 gadolinium lesion reduction 94% and 95% in RRMS trials.)

ORATORIO included 732 patients with PPMS who received the treatment or matching placebo. PPMS patients on the medication were about 25% less likely to have their disability worsen.

 

How does it work? 

Ocrelizumab is humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to the MS disease process.  It works in a similar way to rituximab (Rituxan).

 

When will it be available?

We are very excited to have this as an option to offer to patients. However, we will be unable to administer this medication until we receive the medication from the drug company, Genentech.  Then, the medication must be approved and available though our hospital pharmacy.  We hope to be able to provide this medication as soon as possible.

 

How is the medication administered?

This medication will be given in the infusion center.  You will have a dose of 300mg then 300mg two weeks later. After that, you will receive a 600mg dose every 6 months

 

What labs will be checked before starting?

Before your first infusion we will routinely check the following labs:

  • Complete Blood Count (CBC)
  • Hepatitis Serologies (HBsAg, anti-HBV, HbcAb)
  • Serum protein electrophoresis (SPEP)

 

Before re-dosing, every 6 months we will check:

  • CD 19 count
  • CBC
  • SPEP

 

Your doctor may also check:

  • JCV Ab titer
  • Liver function tests (LFTs)
  • CD20
  • Tuberculosis test (TB quantiferon)
  • HIV
  • Pregnancy (hCG)

 

Additional screening tests will be considered at the discretion of the prescribing physician.

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