Rebif

DRUG DESCRIPTION

Rebif® (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of Rebif® (interferon beta-1a) is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (Rebif® (interferon beta-1a) ) are glycosylated with each containing a single N-linked complex carbohydrate moiety.

Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), Rebif® (interferon beta-1a) has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus.

Rebif® (interferon beta-1a) 8.8 mcg, 22 mcg and 44 mcg contain approximately 2.4 MIU, 6 MIU or 12 MIU, respectively, of antiviral activity using this method. Rebif® (interferon beta-1a) is formulated as a sterile solution in a prefilled syringe intended for subcutaneous (sc) injection. Each 0.5 mL (0.5 cc) of Rebif® contains either 22 mcg or 44 mcg of interferon beta-1a, 2 or 4 mg albumin (human) USP, 27.3 mg mannitol USP, 0.4 mg sodium acetate, Water for Injection USP.

Each 0.2 mL (0.2 cc) of Rebif® contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human) USP, 10.9 mg mannitol USP, 0.16 mg sodium acetate, and Water for Injection USP.

What are the precautions when taking interferon beta-1a (Rebif)?

Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g.,...

Read All Potential Precautions of Rebif »


Rebif Consumer (continued)

SIDE EFFECTS: Pain, redness, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

Flu-like symptoms such as headache, nausea, fever, chills, tiredness, and muscle aches/pain may occur, especially when you first start this medication. You can reduce these side effects by injecting this medicine at bedtime and using fever reducers/pain relievers such as acetaminophen or ibuprofen. Consult your doctor or pharmacist for more information.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., depression, rare thoughts of suicide), vision changes, gradual change in weight, intolerance to cold or heat, increased urination, signs of infection (e.g., fever, persistent sore throat, cough), easy bruising/bleeding, fast/irregular heartbeat, sudden increase in weight, swelling hands/legs/feet, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., anemia, low platelets, low white blood cells), heart disease (e.g., heart failure, irregular heartbeat), liver disease, mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), seizures, thyroid disease, history of alcohol dependence.

Limit alcoholic beverages while using this medication. Ask your doctor or pharmacist about how to drink alcohol safely while using this drug.

This medication is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.



Related Drugs Index: