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The information in this medication sheet has been adapted from the FDA-approved prescribing information for Betaseron.

Description

Betaseron is a medication manufactured by a biotechnological process from one of the naturally occurring interferons (a type of protein). In a clinical trial of 372 ambulatory patients with relapsing-remitting MS, those taking the currently recommended dose of the medication experienced fewer exacerbations, a longer time between exacerbations, and exacerbations that were generally less severe than those of patients taking a lower dose of the medication or a placebo. Additionally, patients on interferon beta-1b had no increase in total lesion area, as shown on MRI, in contrast to the placebo group, that had a significant increase.

Approval by the U.S. Food and Drug Administration (FDA)

Betaseron is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. Relapsing forms of MS include individuals with secondary-progressive MS who continue to experience relapses or acute attacks. Betaseron is also approved for used in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with multiple sclerosis.

Proper Usage

• Betaseron is injected subcutaneously (between the fat layer just under the skin and the muscles beneath) every other day. The physician or nurse will instruct you in the injection procedure, using a specially designed set of training materials. Do not attempt to inject yourself until you are sure that you understand the procedures.
• Betaseron is supplied with a pre-filled diluant syringe to which the medication needs to be added prior to injection; no refrigeration is necessary.
• Do not reuse needles or syringes. Dispose of the syringes as directed by your physician and keep them out of the reach of children.
• Since flu-like symptoms are a common side effect associated with at least the initial weeks of taking Betaseron, it is recommended that the medication be taken at bedtime. Taking acetaminophen (Tylenol®) or ibuprofen (Advil®) thirty minutes before each injection will also help to relieve the flu-like symptoms.
• Because injection site reactions (swelling, redness, discoloration, or pain) are relatively common, it is recommended that the sites be rotated according to a schedule provided for you by your physician. Injection site necrosis [skin damage], which occurs in about 5% of patients during the first four months of therapy, has been reported in post-marketing studies even after a year of treatment. In other to avoid infection and other complications, you should report promptly any break in the skin, which may be associated with blue-black discoloration, swelling, or drainage of fluid from the injection site. Your physician will determine whether to continue treatment while the skin lesions are being treated.

Warnings and Precautions

• In response to post-marketing findings (events that have been reported by patients and doctors since Betaseron was approved for use), the FDA has added warnings and precautions to the prescribing information for this medication:
  • Depression and suicide
    Betaseron should be used with caution in people who are depressed, a condition which is very common in MS. Depression, suicidal thoughts, and suicidal attempts have been reported in people receiving various interferon products, including Betaseron. Anyone who experiences significand mood changes or suicidal thoughts should report them promptly to his or her physician.
  • Liver problems
    Betaseron, like other interferon medications, can affect liver functions. In post-marketing studies, a few people have developed severe liver injury. Periodic blood tests to measure liver functions are recommended for any person taking an interferon medication.
  • Allergic reactions
    Some people taking Betaseron have developed a severe allergic reaction that interferes with breathing. An allergic reaction can occur after the first dose, or not until after several doses. Less severe reactions—including itching, skin bumps, a rash, or swelling of the mouth and tongue can also occur. Anyone who develops any kind of allergic reaction should stop the medication immediately and contact his or her physician.
  • Seizures
    Betaseron should be used with caution in individuals with a seizure disorder since seizures have been associated with the use of beta interferon medications.
• Because of the potential of Betaseron to affect the thyroid gland, and to alter the levels of white blood cells, red blood cells, and platelets in a person’s system, blood tests are recommended at regular intervals.
• Betaseron should not be used during pregnancy or by any woman who is trying to become pregnant. Women taking Betaseron should use birth control measures at all times.

Possible Side Effects

• Common side effects include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating) and injection site reactions (swelling, redness, discoloration, and pain). Most of these symptoms tend to disappear over time. If they continue, become more severe, or cause significant discomfort, be sure to talk them over with your physician. Contact your physician if the injection sites become inflamed, hardened, or lumpy, and do not inject into any area that has become hardened or lumpy.
• Depression, including suicide attempts, has been reported by patients taking Betaseron. Common symptoms of depression are sadness, anxiety, loss of interest in daily activities, irritability, low self-esteem, guilt, poor concentration, indecisiveness, confusion, and eating and sleep disturbances. If you experience any of these symptoms for longer than a day or two, contact your physician promptly.