Multiple Sclerosis

FDA-Approved Multiple Sclerosis Drug Therapies

Oral Products

Aubagio® (teriflunomide) – One tablet daily

Gilenya® (fingolimod) – One capsule daily

Tecfidera® (dimethyl fumarate) – One capsule twice daily

Self-administered Injectables

Avonex® (interferon beta-1a) – Intramuscular injection once weekly

Betaseron® (interferon beta-1b) – Subcutaneous injection every other day

Copaxone® (glatiramer acetate) – Subcutaneous injection daily or three times per week

Glatopa® (glatiramer acetate) – Subcutaneous injection daily or three times per week

Extavia® (interferon beta-1b) – Subcutaneous injection every other day

Plegridy® (pegylated interferon beta-1a) – Subcutaneous injection every 14 days

Rebif® (interferon beta-1a) – Subcutaneous injection three times a week

Zinbryta® (daclizumab) – Subcutaneous injection once monthly

Intravenous Infusions

Lemtrada® (alemtuzumab) – Intravenous infusion once yearly

Tysabri® (natalizumab) – Intravenous infusion every four weeks

Oral Products

Aubagio® (teriflunomide)

Description

Aubagio® may reduce the number of overactive immune cells that may cause swelling. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis.

Dosing and Administration

Aubagio® is taken once daily by mouth in 7 mg or 14 mg tablets.

Common Side Effects

Side effects include diarrhea, nausea, numbness or tingling in hands and feet, thinning hair, (this returns to normal in most cases within a few months) and possible infections (due to lower white blood cell count).

Additional Patient Information

Lab testing for tuberculosis and a pregnancy test for females will be needed before starting this therapy. Liver enzymes should also be monitored every six months while on this therapy to monitor for liver toxicities. Drug interactions may occur in patients taking cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, oral contraceptives, paclitaxel, pioglitazone, repaglinide, rifampin, rosiglitazone, statins, warfarin, and zidovudine. If you are taking any of these drugs you should discuss with a pharmacist or health care provider.

Gilenya® (fingolimod)

Description

Gilenya® stops swollen and other immune cells from entering the central nervous system and attacking neurons. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses and to delay the accumulation of physical disability.

Dosing and Administration

Gilenya® is taken once daily by mouth in a 0.5 mg capsule.

Common Side Effects

Common side effects include headache, flu-like symptoms, diarrhea, back pain, increased liver enzymes, and cough.

Additional Patient Information

Within six months before starting this treatment, you must complete lab work, screenings, and heart and lung tests (including VZV (Varicella) antibody, complete blood count, bilirubin, liver transaminase, ophthalmologic assessment, and an electrocardiogram) through the Risk Evaluation and Mitigation Strategy (REMS) program. Afterwards, you will need to take your first dose in your doctor’s office for monitoring of your heart for 6 hours to be sure your heart rate doesn’t slow (called Bradycardia). Another eye exam must be performed 3 – 4 months after starting this medication to check for macular edema, a condition that causes swelling inside of the eye. This medication may also put you at risk for developing infections. Drug interactions may occur in patients taking citalopram, chlorpromazine, haloperidol, methadone, erythromycin, ketoconazole, live vaccines, oncology medications, corticosteroids, methotrexate, azathioprine, leflunomide, beta blockers, digoxin, diltiazem, or verapamil. If you are taking any of these drugs you should discuss with a pharmacist or health care provider.

Tecfidera® (dimethyl fumarate)

Description

Tecfidera® works to reduce disease activity in multiple sclerosis through an unknown mechanism. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis.

Dosing and Administration

Tecfidera® is taken twice daily by mouth. The starting dose is 120 mg twice daily for 7 days followed by maintenance of 240 mg twice daily.

Common Side Effects

Side effects include redness, itching, rash, nausea, vomiting, diarrhea, flushing, stomach pain, and indigestion. Flushing and stomach problems are the most common reactions, especially at the start of therapy, and usually lessen over time. A risk of infection and the inability to fight injection may also occur.

Additional Patient Information

Your doctor may check your white blood cell count before you start therapy and usually every 6 months during treatment. A risk of infection and the inability to fight infection may also occur. Flushing can occur in 40% of patients which tends to resolve over one month. Flushing can be reduced by taking Tecfidera® with food and aspirin 30 minutes prior to dosing.

Self-Administered Injectables

Interferon Beta Products

Avonex® (interferon beta-1a), Betaseron®Extavia® (interferon beta-1b), Plegridy® (pegylated interferon beta-1a), Rebif® (interferon beta-1a)

Description

Interferon medications are some of the most commonly used medications used in multiple sclerosis. They work to reduce disease activity through unknown inflammatory processes. They are FDA approved for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical relapses.

Dosing and Administration

Avonex® is dosed as a 30 mcg injection into the muscle once weekly.
Betaseron® and Extavia® are dosed as 25 mcg subcutaneous injections once every other day
Plegridy® is dosed as a 125 mcg subcutaneous injection once every two weeks
Rebif® is dosed as either a 22 mcg or 44 mcg subcutaneous injection three times per week

Common Side Effects

Side effects include flu-like symptoms, tiredness, and depression. Tell your doctor or healthcare professional about any history of depression or mood disorders or blood, thyroid, heart, and liver disorders before starting any of these therapies.

Glatiramer Acetate Products

Copaxone® (glatiramer acetate), Glatopa® (glatiramer acetate)

Description

Glatiramer acetate is synthetic or man-made compound of four amino acids that stops the immune system from attacking myelin tissue. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa® is an FDA approved generic formulation of Copaxone® 20 mg/mL once daily.

Dosing and Administration

Glatiramer acetate is available a pre-filled syringe and is dosed subcutaneously. It can be dosed either as 20 mg per mL once daily (Copaxone® or Glatopa®) or 40 mg per mL three times weekly (Copaxone® only)

Common Side Effects

Side effects include skin reactions where the injection was given and flu-like symptoms including aches, fever, chills, flushing, shortness of breath, and rapid heartbeat which will usually stop within 30 minutes of the injection.

Zinbryta® (daclizumab)

Description

Zinbryta® works to reduce disease activity through unknown inflammatory processes. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis, but generally should be reserved for patients who had an inadequate response to at least two other multiple sclerosis drugs.

Dosing and Administration

Zinbryta® is dosed 150 mg subcutaneously once every four weeks.

Common Side Effects

Zinbryta® may be associated with serious safety risks, including liver injury and development of other immune-related disorders. Additional side effects may include hypersensitivity reactions, increased risk of infections, and symptoms of depression and/or suicidal ideation.

Additional Patient Information

Liver function tests should be performed monthly to monitor for early signs of potentially serious side effects.

Intravenous Infusions

Lemtrada® (alemtuzumab)

Description

Lemtrada® works to reduce disease activity through unknown inflammatory processes. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis, but generally should be reserved for patients who had an inadequate response to at least two other multiple sclerosis drugs.

Dosing and Administration

Lemtrada® is infused by a health care professional over 5 consecutive days and then again for three consecutive days 12 months later.

Common Side Effects

Side effects may include serious infusion reactions that can occur up to 24 hours or longer after infusing this drug. Tell your doctor right away if you have chest pain; passing out; fast or slow heartbeat; a heartbeat that does not feel normal; fever; hives; itching; rash; severe headache or dizziness; shortness of breath or trouble breathing; swelling of the mouth, face, lips, throat, or tongue; tightness in the chest or throat; hoarseness that is not normal; or wheezing. This drug may also raise the chance of cancers like thyroid cancer, skin cancer, and lymphoma. Baseline and yearly skin exams should be performed.

Additional Patient Information

Lemtrada® cannot be used in patients with HIV. Complete blood count, serum creatinine levels, urinalysis, and thyroid function tests must be performed before beginning treatment and periodically (usually monthly) for 48 months following the last dose.

Tysabri® (natalizumab)

Description

Tysabri® works to reduce disease activity through unknown inflammatory processes. It is FDA approved for the treatment of patients with relapsing forms of multiple sclerosis.

Dosing and Administration

Tysabri® is infused by a health care professional over one hour once every four weeks.

Common Side Effects

Side effects may include infusion reactions, increased risk of infection, and a small risk of a rare brain infection called Primary Multifocal Leukoencephalopathy (PML).

Additional Patient Information

Tysabri® increases the risk of PML, possible fatal viral infection. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil), and presence of anti-JCV antibodies. These factors should be considered in the context of expected benefit when initiating and continuing treatment with Tysabri®. An anti-JCV antibody test should be performed before considering whether to initiate treatment.