Multiple Sclerosis (MS) Treatments
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Generic Name
Beta-1A
Brand Names
Avonex, Rebif, Rebif REBIDOSE
FDA approval date: March 07, 2002
Classification: Interferon beta
Form: Injection, Kit
What is Avonex (Beta-1A)?
AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis , 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 , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Approved To Treat
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Brand Information
AVONEX (interferon beta-1a)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
- Injection: 30 micrograms per 0.5 mL clear, colorless solution in a single-dose prefilled syringe
- Injection: 30 micrograms per 0.5 mL clear, colorless solution in a single-dose prefilled autoinjector
3CONTRAINDICATIONS
AVONEX is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation
The formerly available lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human).
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail in other sections of labeling:
- Depression, Suicide, and Psychotic Disorders
- Hepatic Injury
- Anaphylaxis and Other Allergic-Reactions
- Injection Site Reactions Including Necrosis
- Congestive Heart Failure
- Decreased Peripheral Blood Counts
- Thrombotic Microangiopathy
- Pulmonary Arterial Hypertension
- Seizures
- Autoimmune Disorders
- Laboratory Tests
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of AVONEX cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.
Among 351 patients with relapsing forms of MS treated with AVONEX 30 micrograms (including 319 patients treated for 6 months and 288 patients treated for greater than one year) the most commonly reported adverse reactions (at least 5% more frequent on AVONEX than on placebo) were flu-like symptoms. Symptoms can include chills, fever, myalgia and asthenia occurring within hours to days following an injection. Most people who take AVONEX have flu-like symptoms early during the course of therapy. Usually, these symptoms last for a day after the injection. For many people, these symptoms lessen or go away over time. The most frequently reported adverse reactions resulting in clinical intervention (for example, discontinuation of AVONEX or the need for concomitant medication to treat an adverse reaction symptom) were flu-like symptoms and depression.
Table 2 enumerates adverse reactions that occurred with AVONEX-treated patients at an incidence of at least 2% more than that observed in the placebo-treated patients in the pooled placebo-controlled studies in patients with relapsing forms of MS [see Clinical Studies (.
4.2Postmarketing Experience
The following additional adverse reactions have been identified during post-approval use of AVONEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Hemolytic anemia
- Menorrhagia and metrorrhagia
- Pulmonary Arterial Hypertension
- Rash (including vesicular rash)
- Rare cases of injection site abscess or cellulitis requiring surgical intervention
5DESCRIPTION
Interferon beta-1a, an interferon beta, is a 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 AVONEX is identical to that of natural human interferon beta.
Using the World Health Organization (WHO) International Standard for Interferon, AVONEX has a specific activity of approximately 200 million international units of antiviral activity per mg of interferon beta-1a determined specifically by an
AVONEX (interferon beta-1a) injection is a sterile liquid for intramuscular injection available in a prefilled glass syringe or a prefilled glass syringe surrounded by an autoinjector. Each single-dose prefilled glass syringe or single-dose prefilled autoinjector delivers 0.5 mL of solution containing 30 micrograms of interferon beta-1a, arginine hydrochloride, USP (15.8 mg), glacial acetic acid, USP (0.25 mg), polysorbate 20 (0.025 mg), sodium acetate trihydrate, USP (0.79 mg), and Water for Injection, USP at a pH of approximately 4.8.
6CLINICAL STUDIES
The clinical effects of AVONEX in patients with relapsing forms of multiple sclerosis (MS) were studied in two randomized, multicenter, double-blind, placebo-controlled studies in patients with MS (Studies 1 and 2). Safety and efficacy of treatment with AVONEX beyond 3 years is not known.
In Study 1, 301 patients received either 30 micrograms of AVONEX (n=158) or placebo (n=143) by intramuscular injection once weekly. Patients received injections for up to 2 years, and continued to be followed until study completion. Two hundred eighty-two patients completed 1 year on study, and 172 patients completed 2 years on study. There were 144 patients treated with AVONEX for more than 1 year, 115 patients for more than 18 months and 82 patients for 2 years.
All patients had a definite diagnosis of multiple sclerosis of at least 1 year duration and had at least 2 exacerbations in the 3 years prior to study entry (or 1 per year if the duration of disease was less than 3 years). At entry, study participants were without exacerbation during the prior 2 months and had Kurtzke Expanded Disability Status Scale (EDSS
7PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (
Instruct patients to carefully read the supplied AVONEX Medication Guide and caution patients not to change the AVONEX dose or schedule of administration without medical consultation.
Inform patients that the tip cap of the AVONEX Prefilled Syringe and AVONEX PEN contains natural rubber latex which may cause allergic reactions.