Multiple Sclerosis (cont.)

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Other medications approved for relapsing multiple sclerosis

Glatiramer acetate (Copaxone)

Glatiramer acetate (Copaxone) is another DMD that is approved for reducing the frequency of relapses in RR-MS. Copaxone was approved by the FDA in 1996. Glatiramer acetate is a synthetic (man-made) amino acid mixture that may resemble a protein component of myelin. It is thought that the immune system reaction against myelin in multiple sclerosis may be blocked or diminished by glatiramer acetate. Glatiramer acetate is injected subcutaneously (under the skin). A reaction occurring immediately after the injection of glatiramer acetate is common, affecting one out of 10 patients. The reaction may involve flushing, chest pain or tightness, palpitations, anxiety, shortness of breath, tightness in the throat, or hives. The reaction usually resolves within 30 minutes and requires no treatment. Some patients may be at risk of developing lipoatrophy, an inflammation and destruction of fat tissue beneath the skin at the site of injection.

Natalizumab (Tysabri)

Natalizumab (Tysabri) is a DMD drug approved by the FDA in 2004 to treat relapsing multiple sclerosis. Natalizumab is a monoclonal antibody against VLA-4, a molecule required for immune cells to adhere to other cells, and penetrate into the brain. It is administered via monthly intravenous infusions. It carries a warning for a potentially fatal disease, progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability. For this reason only patients who have signed up for treatment under a controlled drug distribution program can receive treatment with natalizumab.

Natalizumab is used alone for the treatment of patients with relapsing forms of multiple sclerosis to delay the progression of physical disability and reduce the frequency of clinical relapses. The safety and efficacy of natalizumab beyond 2 years are unknown. The risk of PML may increase with prolonged exposure to natalizumab, with evidence of JC virus seropositivity in the JC virus antibody assay, and with a history of prior exposure to immunosuppressants. Because natalizumab increases the risk of PML, it is generally recommended only for patients who have had an inadequate response to, or are unable to tolerate an alternate multiple sclerosis therapy.

Mitoxantrone (Novantrone)

Mitoxantrone (Novantrone) is a DMD approved by the FDA in 2000 for the treatment of multiple sclerosis (SP-MS, PR-MS, and worsening RR-MS). The commercial Novantrone formulation has been withdrawn from the U.S. market and only generic mitoxantrone is currently prescribed by physicians. Mitoxantrone is a chemotherapy drug that carries the risk of serious cardiac side effects or cancer (leukemia). Because of these serious side effects, physicians tend to reserve its use for more advanced or worsening cases of multiple sclerosis, and there is a limit to the total amount of mitoxantrone that can be administered. Cardiac monitoring prior to each dose and yearly following the last dose of mitoxantrone also is necessary.

Mitoxantrone is used for reducing neurologic disability and/or the frequency of clinical relapses in patients with SP-MS, PR-MS, or worsening RR-MS (for example, patients whose neurologic status is significantly abnormal between relapses). Mitoxantrone is not used in the treatment of patients with PP-MS.

Fingolimod (Gilenya)

Fingolimod (Gilenya) is a DMD for treating MS that was approved by the FDA in 2010, as the first oral medication to treat MS. Although the exact mechanism of action of fingolimod is unclear, it appears to work by reducing the circulation of lymphocytes (a type of white blood cell that is important for immunity and the inflammation process) in the blood. Fingolimod is taken daily in capsule form. It is not a cure for MS, but it has been shown to decrease the number of MS flares and slow down the development of physical disability caused by MS. The long-term safety of fingolimod is unknown. The most common side effects of fingolimod are slowed heart rate, increase in blood pressure, headache, flu, diarrhea, back pain, elevations of liver enzymes in the blood, and cough. Due to the potential risk related to slowed heart rate, patients started on fingolimod require at least 6 hours of monitoring in a clinic or hospital setting following the first dose. Other side effects are also possible including eye problems, so those taking this drug should have regular ophthalmologic evaluations.

Teriflunomide (Aubagio)

Teriflunomide (Aubagio) is an oral medication for treating relapsing MS, approved by the FDA in 2012, as the second oral medication used for this disease. Both 7 mg and 14 mg doses are approved for MS. Teriflunomide acts by inhibiting a mitochondrial enzyme, dihydroorotase dehydrogenase, which is involved in the synthesis of chemicals required for lymphocytes to multiply. Teriflunomide has been shown to reduce the number of flares. The long-term safety of teriflunomide is unknown. Because of the risk of causing major birth defects, teriflunomide has been assigned a pregnancy category X by the FDA, and both men and women taking teriflunomide are required to use contraceptive measures. Adverse events of teriflunomide include liver injury (a black box warning on liver toxicity is included in the label), drops in white blood cell counts and risk of infections, high blood pressure, increase in potassium levels, and damage to peripheral nerves. The most common adverse events are loss of hair, diarrhea, nausea, increase in liver enzymes, influenza, and prickling (tingling and numbness) symptoms.

Medically Reviewed by a Doctor on 8/1/2014

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