Extavia (Interferon beta 1b) for Multiple Sclerosis

Overview
Extavia 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. Extavia is an alternate brand name for the drug Interferon beta 1b, which is also sold under the brand name Betaseron. Medically and clinically, these products are identical. Extavia 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.

Extavia must be used with caution and closely monitored in people with a history of depression, seizures or heart or liver problems. Extavia 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 Extavia works by reducing inflammation in the brain. It may also promote nerve growth.

How do I take it?
Extavia 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.

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

Your doctor may start you on a low dose of Extavia and gradually increase the dosage. Before or during your treatment with Extavia, 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 Extavia.

Results
The FDA approved Extavia in 2009. Since Extavia is identical to Betaseron, the FDA approved Extavia on the basis of existing clinical trials.

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 Extavia. 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 Extavia can include liver and heart problems, seizures, and skin damage. Some people on Extavia 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 Extavia 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 Extavia experience mood or behavioral problems including depression, suicidal thoughts, anxiety, irritability or hallucinations. Tell your doctor if you experience these side effects.

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