Immunosuppressive Treatments

While Betaseron®, Avonex®, Copaxone®, and Rebif® belong to a category of medications called immunomodulators (modulating or moderating the immune system), other medications exist that generally, and less specifically, suppress the immune sys tem. Some are taken by mouth (azathio-prine, methotrexate), while others are administered intravenously (mitoxantrone, cyclophosphamide).

Novantrone® (mitoxantrone) belongs to the general group of medicines called antineoplastics. Prior to its approval for use in MS, mitoxantrone was used only to treat certain forms of cancer. It acts in MS by suppressing the activity of T cells, B cells, and macrophages that are thought to lead the attack on the myelin sheath and axons.

The use of Novantrone® for the treatment of MS has been evaluated in a series of European studies over a period of 10 years. In a recent randomized, placebo-controlled, multicenter clinical trial involving patients with secondary-progressive or progressive-relapsing disease, participants received 12 mg/m2 of Novantrone® by short intravenous infusion once every 3 months for 24 months. Novantrone® was found to delay the time to first treated relapse and time to disability progression. It also reduced the number of treated relapses and number of new lesions detected by MRI.

Based on findings from these studies, the FDA approved Novantrone® in October 2000 for reducing neurologic disability and/or the frequency of clinical relapses (attacks) in:

• Secondary progressive MS (SPMS—dis-ease that has changed from relapsing-remitting to a progressive course).

• Progressive relapsing MS (PRMS—dis-ease characterized by a gradual increase in disability from onset with clear relapses along the way).

• Worsening relapsing-remitting MS (Worsening RRMS—disease characterized by clinical attacks without complete remission, resulting in a stepwise worsening of disability).

Novantrone® has not been approved for the treatment of primary progressive MS

(PPMS—characterized by progression from disease onset with no acute attacks or remissions). At this time, there is no FDA-approved therapy for PPMS.

The evaluation of cardiac output is necessary before treatment is started. The drug should be used only in those with normal cardiac function, once every 3 months, at a dose of 12 mg/m2. Periodic cardiac monitoring is required throughout the treatment period.

The lifetime cumulative dose is limited to 140 mg/m2 (approximately 8-12 doses over 2 to 3 years) because of possible effects on the heart. Because Novantrone® can increase the risk for infection by decreasing the number of protective white blood cells, blood counts and liver function tests should be evaluated prior to each dose.

It is important that your doctor check your progress at regular intervals to make sure that this medicine is working properly and to check for unwanted side effects.

While being treated with this medication, and during the period following treatment, do not have any immunizations (vaccinations) with live virus vaccines without your doctor's approval. Novantrone® may lower your body's resistance to infection, making you susceptible to the infection that the immunization is designed to help you avoid. Neither you nor anyone in your household should take the oral polio vaccine.

If possible, avoid people with infections. Contact your physician if you think you are getting an infection, or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

When receiving Novantrone®, it is important for your physician to know if you are taking any cancer medications or are being treated with radiation therapy.

The presence of other medical problems may affect the use of Novantrone®. Let your doctor know if you have any of the following:

• Chicken pox or recent exposure to it

• Herpes zoster (shingles)

• Gout or history of gout or kidney stones

• Heart disease

• Liver disease

The fluid for infusion is dark blue and may cause your urine to become blue-green in color for 24 hours after each administration. The whites of the eyes may also appear bluish in color.

You should tell your doctor if you are pregnant or intending to have children. This medicine may cause birth defects if either the man or woman is receiving it at the time of conception. A pregnancy test is recommended prior to each treatment for women of childbearing age. Many medications of this type can cause permanent sterility. Be sure you have discussed this with your physician before taking this medication.

Because Novantrone® is excreted in human milk, breast-feeding should be discontinued before a woman starts treatment.

A higher incidence of leukemia has been reported in cancer patients previously treated with chemotherapy who were then treat ed with Novantrone®; however, the dose used was higher than that prescribed for treating MS.

Side effects that may go away as your body adjusts to the medication and do not require medical attention unless they continue or are bothersome include nausea, temporary hair loss, and menstrual disorders in women. Side effects that should be reported to your physician as soon as possible include fever or chills, lower back or side pain, painful or difficult urination, swelling of feet and lower legs, black tarry stools, cough or shortness of breath, sores in mouth and on lips, and stomach pain.

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