Avonex Pen 30 ug/.5mL
Interferon Beta-1a · INJECTION, SOLUTION · Biogen Inc.
Avonex Pen is a injection, solution containing interferon beta-1a at 30 ug/.5mL, taken intramuscular. Manufactured by Biogen Inc..
Key Facts
- Brand Name
- Avonex Pen
- Generic Name
- Interferon Beta-1a
- NDC Code (Product)
59627-003- Manufacturer
- Biogen Inc.
- Strength
- 30 ug/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA103628
- Drug Class
- Interferon beta [EPC]
- Marketing Start
- 05/23/2003
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AVONEX 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. AVONEX is 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 intramuscular use only ( 2.1 ) Recommended dose: 30 micrograms once a week ( 2.1 ) AVONEX may be titrated, starting with 7.5 micrograms for first week, to reduce flu-like symptoms ( 2.1 ) Increase dose by 7.5 micrograms each week for next 3 weeks until recommended dose of 30 micrograms ( 2.1 ) See patient instructions for use for complete administration instructions ( 2.2 ) Perform first injection under the supervision of an appropriately qualified health care professional ( 2.2 ) Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms ( 2.3 ) 2.1 Dosing Information AVONEX is administered intramuscularly. The recommended dose is 30 micrograms once a week. To reduce the incidence and severity of flu-like symptoms that may occur when initiating AVONEX therapy at a dose of 30 micrograms, AVONEX may be started at a dose of 7.5 micrograms and the dose may be increased by 7.5 micrograms each week for the next three weeks until the recommended dose of 30 micrograms is achieved (see Table 1 ). An AVOSTARTGRIP™ kit containing 3 titration devices can be used for titration and is to be used only with AVONEX Prefilled Syringes. Tab…
Contraindications
4 CONTRAINDICATIONS AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see Warnings and Precautions ( 5.3 )] . The formerly available lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human). History of hypersensitivity to natural or recombinant interferon beta, albumin or any other component of the formulation ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of labeling: Depression, Suicide, and Psychotic Disorders [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 )] Congestive Heart Failure [see Warnings and Precautions ( 5.5 )] Decreased Peripheral Blood Counts [see Warnings and Precautions ( 5.6 )] Thrombotic Microangiopathy [see Warnings and Precautions ( 5.7 )] Pulmonary Arterial Hypertension [see Warnings and Precautions ( 5.8 )] Seizures [see Warnings and Precautions ( 5.9 )] Autoimmune Disorders [see Warnings and Precautions ( 5.10 )] Laboratory Tests [see Warnings and Precautions ( 5.11 )] The most common adverse reactions (at least 5% more frequent on AVONEX than on placebo) were flu-like symptoms including chills, fever, myalgia, and asthenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical t…
Frequently Asked Questions
What is Avonex Pen used for?
Avonex Pen contains Interferon Beta-1a. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Avonex Pen a controlled substance?
Avonex Pen is not classified as a controlled substance by the DEA.
What is the generic name for Avonex Pen?
The generic name for Avonex Pen is Interferon Beta-1a. There are 9 other brand versions of Interferon Beta-1a.
What is the NDC code for Avonex Pen 30 ug/.5mL?
The NDC (National Drug Code) for Avonex Pen 30 ug/.5mL is 59627-003, listed by Biogen Inc..