Betaseron (Interferon beta 1b) for Multiple Sclerosis

Overview
Betaseron is a prescription medication approved by the Food and Drug Administration (FDA) for adults who have had their first episode of multiple sclerosis (MS) symptoms and whose magnetic resonance imaging (MRI) scans are compatible with a diagnosis of MS. The drug name of Betaseron is Interferon beta 1b. Betaseron is also sold under the brand name of Extavia, which is an identical product. Betaseron is not a cure for MS, but it can decrease the number of flare-ups, increase time between flare-ups, and decrease the severity of flare-ups in people with relapsing forms of MS.

Betaseron must be used with caution and closely monitored in people with a history of depression, seizures or heart or liver problems. Betaseron is not suitable for use by pregnant women, women who plan to become pregnant, or women who are breastfeeding. It should also not be taken by anyone allergic to interferon beta, human albumin (a type of protein) or mannitol.

It is believed that Betaseron works by reducing inflammation in the brain. It may also promote nerve growth.

How do I take it?
Betaseron is given every other day as a subcutaneous (under the skin) injection in the upper arm or upper or outer thigh. You can learn to inject yourself, have a friend or family member learn how to inject you, or receive your injection from a medical professional. You should change to a different site each time you inject, and never inject into any part of the skin that is scarred, infected, bruised or irritated.

Betaseron comes in prefilled, single-use syringe and single-use vial set which must be combined before it is injected. Betaseron should be stored at room temperature.

Your doctor may start you on a low dose of Betaseron and gradually increase the dosage. Before or during your treatment with Betaseron, your doctor may order extra blood tests to monitor your liver function and blood cell counts.

Always follow your doctor’s instructions exactly when taking Betaseron.

Results
Interferon beta 1b (Betaseron) was approved by the FDA in 1993 on the basis of four clinical trials. The first study, completed in 1991, involved 372 people with relapsing MS. There were 25 MS-related hospitalizations among those taking .25mg of Interferon beta 1b versus 48 MS-related hospitalizations among those taking placebos. Those taking Interferon beta 1b also displayed significantly fewer new brain lesions, and smaller increases in the size of existing brain lesions, in comparison with those who took the placebo over the three-year period.

Studies 2 and 3, completed in 1993, each involved approximately 900 people with progressive MS. Studies 2 and 3 also showed significantly lower rates of relapse, smaller brain lesions, and fewer brain lesions among people taking Interferon beta 1b compared with people taking placebos.

Study 4, completed in 2006, involved 468 people who had had one attack of MS-like symptoms and an MRI compatible with an MS diagnosis. Of those taking Interferon beta 1b, 28 percent suffered a second attack during the two-year study, while 45 percent of those taking the placebo suffered a second attack. Participants taking Interferon beta 1b also developed fewer new brain lesions during the trial.

In 2009, a 16-year follow-up study found that people who began taking Interferon beta 1b early in the course of their disease and kept taking it long-term suffered lower rates of disability.

Side effects
It is very common to experience flu-like symptoms during the first few days of taking Betaseron. Over-the-counter pain relievers can be taken to ease the discomfort. These side effects may disappear over time.

Less common but serious side effects of Betaseron can include liver and heart problems, seizures, and skin damage. Some people on Betaseron develop liver problems or experience a worsening of existing liver problems. Signs of liver problems can include yellowing skin, jaundice (yellowing of the white part of the eye), nausea, loss of appetite, feeling very tired, dark urine and pale feces, and bleeding or bruising more easily than usual.

Other side effects can include seizures and the worsening of heart conditions such as congestive heart failure. If you experience seizures or symptoms of congestive heart failure including swollen ankles, shortness of breath, a rapid heartbeat or a tight feeling in your chest, notify your doctor right away.

A few people taking Betaseron experience injection site necrosis, a type of damage to cells where the drug is injected. Some of these cases required skin grafting surgery. Always use the proper aseptic injection technique you are taught by your doctor. If you experience swelling, blue-black discoloration or fluid drainage at injection sites, report this to your doctor immediately.

Some people taking Betaseron experience mood or behavioral problems including depression, suicidal thoughts, anxiety, irritability or hallucinations. Tell your doctor if you experience these side effects.

Betaseron can also cause allergic reactions. Get medical help immediately if you experience difficulty breathing or swelling in the face, throat, eyes, lips or tongue.