Interferon Beta

Interferon beta-1a is used to treat relapsing forms of multiple sclerosis (MS) , including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Brand names of interferon beta-1a are Avonex , Rebif , and Rebif Rebidose. Avonex is injected into a muscle, usually once weekly at bedtime, on the same day each week (such as every Monday). Rebif is injected under the skin, usually 3 times per week (such as Monday, Wednesday, and Friday). Interferon beta-1a’s mechanism of action resembles that of interferons which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections. Interferon beta-1a is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS. Interferon beta-1a belongs to the drug class called interferons. It may also be called an immunomodulator. Interferon beta-1a will not cure MS , it will only decrease the frequency of relapse symptoms. Interferon beta-1a first gained FDA approval on May 17, 1996 , under the brand name Avonex . Rebif gained FDA approval on March 7, 2002. There is no interferon beta-1a generic.

Interferon beta-1a is used to treat relapsing forms of multiple sclerosis (MS) , including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Brand names of interferon beta-1a are Avonex , Rebif , and Rebif Rebidose. Avonex is injected into a muscle, usually once weekly at bedtime, on the same day each week (such as every Monday). Rebif is injected under the skin, usually 3 times per week (such as Monday, Wednesday, and Friday). Interferon beta-1a’s mechanism of action resembles that of interferons which are proteins naturally produced by our immune system that help regulate the body’s immune response and fight viral infections. Interferon beta-1a is a man-made form of interferon that works in the same way, binding to specific receptors on cell surfaces and decreasing the activity of immune cells that attack the myelin sheath, reducing inflammation in the central nervous system, and helping to suppress the autoimmune response that characterizes MS. Interferon beta-1a belongs to the drug class called interferons. It may also be called an immunomodulator. Interferon beta-1a will not cure MS , it will only decrease the frequency of relapse symptoms. Interferon beta-1a first gained FDA approval on May 17, 1996 , under the brand name Avonex . Rebif gained FDA approval on March 7, 2002. There is no interferon beta-1a generic.

Do not take interferon beta-1a if you are allergic to interferon beta, human albumin, Rebif, Avonex, or any inactive ingredients in the injection (see below for a list of inactive ingredients). Before you take interferon beta-1a, tell your healthcare provider if you have or have had any of the following conditions: mental illness, including depression and suicidal behavior liver problems bleeding problems or blood clots low blood cell counts seizures (epilepsy) thyroid problems drink alcohol you are pregnant or plan to become pregnant you are breastfeeding or plan to breastfeed.

The most common side effects of interferon beta-1a include flu-like symptoms with symptoms such as: muscle aches fever tiredness chills stomach pain. Interferon beta-1a may also cause changes in your liver tests.

Interferon beta-1a can cause the following serious side effects. Behavioral health problems including depression and suicidal thoughts. You may have mood problems while taking interferon beta-1a, for example, depression (feeling hopeless or feeling bad about yourself), or thoughts of hurting yourself or suicide. Contact your healthcare provider immediately. Liver problems or liver failure has been reported in people taking interferon beta-1a. Contact your healthcare provider immediately if you develop any of the following symptoms: nausea loss of appetite tiredness dark-colored urine and pale stools yellowing of your skin or the white part of your eye bleeding more easily than normal confusion sleepiness. Interferon beta-1a may cause serious allergic and skin reactions . Contact your healthcare provider or seek emergency medical attention if you develop any of the following symptoms: itching swelling of your face, eyes, lips, tongue or throat trouble breathing anxiousness feeling faint skin rash, hives, sores in your mouth, or skin blisters and peels. Injection site problems . Interferon beta-1a may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider immediately if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider. Blood problems . Interferon beta-1a can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems. Heart problems , including heart failure, have been reported with interferon beta-1a. Some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after receiving interferon beta-1a. If you already have heart failure, interferon beta-1a may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using interferon beta-1a. Some people using interferon beta-1a may have other heart problems including: low blood pressure fast or abnormal heartbeat chest pain heart attack or a heart muscle problem (cardiomyopathy). Pulmonary arterial hypertension . Pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) can occur with interferon beta products, including interferon beta-1a. Symptoms may include new fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms. Thrombotic microangiopathy (TMA) . TMA is a condition that involves injury to the smallest blood vessels in your body and this has been reported with interferon beta-1a. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking interferon beta-1a if you develop TMA. Seizures . Some people have had seizures while taking interferon beta-1a. Autoimmune diseases . Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta-1a. During your treatment with interferon beta-1a see your healthcare provider regularly and have regular blood tests to check for side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of interferon beta-1a. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Interferon beta-1a can cause the following serious side effects. Behavioral health problems including depression and suicidal thoughts. You may have mood problems while taking interferon beta-1a, for example, depression (feeling hopeless or feeling bad about yourself), or thoughts of hurting yourself or suicide. Contact your healthcare provider immediately. Liver problems or liver failure has been reported in people taking interferon beta-1a. Contact your healthcare provider immediately if you develop any of the following symptoms: nausea loss of appetite tiredness dark-colored urine and pale stools yellowing of your skin or the white part of your eye bleeding more easily than normal confusion sleepiness. Interferon beta-1a may cause serious allergic and skin reactions . Contact your healthcare provider or seek emergency medical attention if you develop any of the following symptoms: itching swelling of your face, eyes, lips, tongue or throat trouble breathing anxiousness feeling faint skin rash, hives, sores in your mouth, or skin blisters and peels. Injection site problems . Interferon beta-1a may cause redness, pain, itching, or swelling at the place where your injection was given. Call your healthcare provider immediately if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider. Blood problems . Interferon beta-1a can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems. Heart problems , including heart failure, have been reported with interferon beta-1a. Some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after receiving interferon beta-1a. If you already have heart failure, interferon beta-1a may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using interferon beta-1a. Some people using interferon beta-1a may have other heart problems including: low blood pressure fast or abnormal heartbeat chest pain heart attack or a heart muscle problem (cardiomyopathy). Pulmonary arterial hypertension . Pulmonary arterial hypertension (high blood pressure in the arteries of the lungs) can occur with interferon beta products, including interferon beta-1a. Symptoms may include new fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms. Thrombotic microangiopathy (TMA) . TMA is a condition that involves injury to the smallest blood vessels in your body and this has been reported with interferon beta-1a. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking interferon beta-1a if you develop TMA. Seizures . Some people have had seizures while taking interferon beta-1a. Autoimmune diseases . Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta-1a. During your treatment with interferon beta-1a see your healthcare provider regularly and have regular blood tests to check for side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of interferon beta-1a. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

0.25 mg (0.25 (0.25)) As recommended. SC — Should be injected every other day. Generally, patients should be started at 0.0625 mg (0.25 mL) subcutaneously every other day, and increased over a six week period to 0.25 mg (1.0 mL) every other day

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interferon beta-1a and other medicines may affect each other causing side effects. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

IM Inj Store Below 25°C. Inj (reconstituted soln) Store at room temperature. Use within 3 hrs if kept at room temperature. SC Inj Store in refrigerator. Do not Freeze.