REBIF 22 ug/.5mL
INTERFERON BETA-1A · INJECTION, SOLUTION · EMD Serono, Inc.
REBIF is a injection, solution containing interferon beta-1a at 22 ug/.5mL, taken subcutaneous. Manufactured by EMD Serono, Inc..
Key Facts
- Brand Name
- REBIF
- Generic Name
- INTERFERON BETA-1A
- NDC Code (Product)
44087-0022- Manufacturer
- EMD Serono, Inc.
- Strength
- 22 ug/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA103780
- Drug Class
- Interferon beta [EPC]
- Marketing Start
- 03/07/2002
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE REBIF is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Rebif is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For subcutaneous injection only ( 2.1 ) The recommended dose is either 22 mcg or 44 mcg injected subcutaneously three times per week ( 2.1 ) Titration: Generally, the starting dose should be 20% of the prescribed dose three times per week, and increased over a 4 week period to the targeted recommended dose of either 22 mcg or 44 mcg injected subcutaneously three times per week ( 2.1 ) Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms ( 2.3 ) 2.1 Dosing Information The recommended dose of REBIF is either 22 mcg or 44 mcg injected subcutaneously three times per week. REBIF should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g., Monday, Wednesday, and Friday) at least 48 hours apart each week. Generally, patients should be started at 20% of the prescribed dose three times per week and increased over a 4-week period to the targeted dose, either 22 mcg three times per week (see Table 1 ) or 44 mcg three times per week (see Table 2 ). Patients prescribed a targeted dose of 22 mcg three times per week should use the prefilled syringes for titration. A …
Contraindications
4 CONTRAINDICATIONS REBIF is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation. History of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in the Warnings and Precautions section of the label: Depression and Suicide [see Warnings and Precautions (5.1) ] Hepatic Injury [see Warnings and Precautions (5.2) ] Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions (5.3) ] Injection Site Reactions including Necrosis [see Warnings and Precautions (5.4) ] Decreased Peripheral Blood Counts [see Warnings and Precautions (5.5) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.6) ] Pulmonary Arterial Hypertension [ see Warnings and Precautions (5.7) ] Seizures [see Warnings and Precautions (5.8) ] Laboratory Tests [see Warnings and Precautions (5.9) ] The most common adverse reactions in controlled clinical trials were injection site disorders, influenza-like symptoms, abdominal pain, depression, elevation of liver enzymes and hematologic abnormalities ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed…
Frequently Asked Questions
What is REBIF used for?
REBIF contains INTERFERON BETA-1A. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is REBIF a controlled substance?
REBIF is not classified as a controlled substance by the DEA.
What is the generic name for REBIF?
The generic name for REBIF is INTERFERON BETA-1A. There are 8 other brand versions of INTERFERON BETA-1A.
What is the NDC code for REBIF 22 ug/.5mL?
The NDC (National Drug Code) for REBIF 22 ug/.5mL is 44087-0022, listed by EMD Serono, Inc..