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AVONEX(interferon beta-1a)injection, for intramuscular injection
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AVONEX safely and effectively. See full prescribing information for AVONEX.
AVONEX (interferon beta-1a) injection, for intramuscular injection
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
AVONEX is an interferon beta indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. (1)
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)
DOSAGE FORMS AND STRENGTHS
■For Injection: 30 micrograms lyophilized powder in a single-use vial (3)
■Injection: 30 micrograms per 0.5 mL solution in single-use prefilled syringe (3)
■Injection: Single-use prefilled autoinjector containing 0.5 mL solution with 30 mcg (3)
CONTRAINDICATIONS
■History of hypersensitivity to natural or recombinant interferon beta, albumin or any other component of the formulation (4)
WARNINGS AND PRECAUTIONS
■Depression, Suicide, and Psychotic Disorders: advise patients to immediately report any symptoms of depression, suicidal ideation, and/or psychosis; consider discontinuation of AVONEX if depression occurs (5.1)
■Hepatic Injury: monitor liver function tests; monitor patients for signs and symptoms of hepatic injury; consider discontinuation of AVONEX if hepatic injury occurs (5.2, 5.8)
■Anaphylaxis and Other Allergic-Reactions: Discontinue if occurs (5.3)
■Congestive Heart Failure: monitor patients with pre-existing significant cardiac disease for worsening of cardiac symptoms (5.4)
■Decreased Peripheral Blood Counts: monitor complete blood count (5.5, 5.8)
■Autoimmune Disorders: consider discontinuation of AVONEX if new autoimmune disorder occurs (5.7, 5.8)
ADVERSE REACTIONS
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 Idec at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
■Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION, Medication Guide, and FDA-approved patient labeling.
Revised: 02/2012
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Important Administration Instructions (All Dosage Forms)
2.3 Premedication for Flu-like Symptoms
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Depression, Suicide, and Psychotic Disorders
5.2 Hepatic Injury
5.3 Anaphylaxis and Other Allergic-Reactions
5.4 Congestive Heart Failure
5.5 Decreased Peripheral Blood Counts
5.6 Seizures
5.7 Autoimmune Disorders
5.8 Laboratory Tests
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
11.1 AVONEX Lyophilized Powder Vial
11.2 AVONEX Single-Use Prefilled Syringe
11.3 AVONEX PEN Single-Use Prefilled Autoinjector
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 AVONEX Lyophilized Powder Vial
16.2 AVONEX Single-Use Prefilled Syringe
16.3 AVONEX PEN Single-Use Prefilled Autoinjector
17 PATIENT COUNSELING INFORMATION
17.1 Instruction on Self-injection Technique and Procedures
17.2 Pregnancy
17.3 Depression
17.4 Liver Disease
17.5 Allergic Reactions and Anaphylaxis
17.6 Congestive Heart Failure
17.7 Seizures
17.8 Flu-like Symptoms
*
Sections or subsections omitted from the full prescribing information are not listed
FULL PRESCRIBING INFORMATION
11 INDICATIONS AND USAGE
AVONEX (interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
22 DOSAGE AND ADMINISTRATION
2.12.1 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.
Table 1: Schedule for Dose Titration
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AVONEX Dose1 |
Recommended Dose |
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Week 1 |
7.5 micrograms |
1/4 dose |
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Week 2 |
15 micrograms |
1/2 dose |
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Week 3 |
22.5 micrograms |
3/4 dose |
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Week 4+ |
30 micrograms |
full dose |
2.22.2 Important Administration Instructions (All Dosage Forms)
All AVONEX dosage forms are single-use (injection of reconstituted solution, prefilled syringe, and prefilled autoinjector). See Patient's Instructions for Use for complete administration instructions.
The first AVONEX injection should be performed under the supervision of an appropriately qualified health care professional. If patients or caregivers are to administer AVONEX, train them in the proper intramuscular injection technique and assess their ability to inject intramuscularly to ensure the proper administration of AVONEX.
Advise patients and caregivers to:
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rotate sites for intramuscular injections with each injection to minimize the likelihood of injection site reactions
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NOT inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way
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Check the injection site after 2 hours for redness, swelling, or tenderness
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Contact their doctor or nurse if they have a skin reaction and it does not clear up in a few days
A 25 gauge, 1” needle for intramuscular injection with AVONEX prefilled syringe or injection of reconstituted solution may be substituted for the 23 gauge, 1 ¼” needle by the healthcare provider, if deemed appropriate. A 25 gauge, 5/8” needle specific to the prefilled autoinjector is supplied with the AVONEX PEN Administration Dose Pack. DO NOT use any other needle with the autoinjector.
Use safe disposal procedures for needles and syringes. Do not re-use needles, syringes, prefilled syringes, or autoinjectors. Following the administration of each titrated dose, discard any remaining product.
2.32.3 Premedication for Flu-like Symptoms
Concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with AVONEX use.
33 DOSAGE FORMS AND STRENGTHS
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For injection: 30 micrograms lyophilized powder in a single-use vial
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Injection: 30 micrograms per 0.5 mL solution in a single-use prefilled syringe
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Injection: 30 micrograms per 0.5 mL solution in a single-use prefilled autoinjector
44 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 lyophilized vial formulation of AVONEX is contraindicated in patients with a history of hypersensitivity to albumin (human).
55 WARNINGS AND PRECAUTIONS
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