AVONEX- interferon beta-1a kit AVONEX PEN- interferon beta-1a injection, solution AVONEX- interferon beta-1a injection, soluti

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

interferon beta-1a (UNII: XRO4566Q4R) (interferon beta-1a - UNII:XRO4566Q4R)

Available from:

Biogen Inc.

INN (International Name):

interferon beta-1a

Composition:

interferon beta-1a 30 ug in 0.5 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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). Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent (see Data). In a study in pregnant monkeys, administration of interfer

Product summary:

AVONEX (interferon beta-1a) injection is a clear, colorless solution in a single-dose prefilled glass syringe or a single-dose prefilled autoinjector for intramuscular injection available in the following packaging configurations: Refrigerate AVONEX prefilled syringes and autoinjectors at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. DO NOT FREEZE. Once removed from the refrigerator, allow prefilled syringes and autoinjectors to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm AVONEX. Should refrigeration be unavailable, a prefilled syringe or autoinjector may be stored at room temperature up to 25°C (77°F) for a period up to 7 days. DO NOT EXPOSE TO HIGH TEMPERATURES. Once the product is removed from the refrigerator, it must not be stored above 25°C (77°F). If the product has been exposed to conditions other than those recommended, DISCARD THE PRODUCT and DO NOT USE . Do not use beyond the expiration date. AVONEX Prefilled Syringe and AVONEX PEN contain natural rubber latex which may cause allergic reactions.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

AVONEX PEN- INTERFERON BETA-1A INJECTION, SOLUTION
AVONEX- INTERFERON BETA-1A INJECTION, SOLUTION
Biogen Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 7/2023
MEDICATION GUIDE
AVONEX® (a-vuh-necks)
(interferon beta-1a) Injection for intramuscular use
Read this Medication Guide before you start using AVONEX, and each
time you get a refill. There may be
new information. This information does not take the place of talking
with your healthcare provider about
your medical condition or your treatment.
What is the most important information I should know about AVONEX?
AVONEX can cause serious side effects. Tell your healthcare provider
right away if you have any of the
symptoms listed below while taking AVONEX.
1. Depression, suicidal thoughts, hallucinations or other behavioral
health problems. Some people taking
AVONEX may develop mood or behavior problems including:
•
irritability (getting upset easily)
•
depression (feeling hopeless or feeling bad about yourself)
•
nervousness
•
anxiety
•
aggressive behavior
•
thoughts of hurting yourself or suicide
•
hearing or seeing things that others do not hear or see
(hallucinations)
If you have any of these mood or behavior problems, your healthcare
provider may tell you to stop taking
AVONEX.
2. Liver problems, or worsening of liver problems including liver
failure and death. Tell your healthcare
provider right away if you have any of these symptoms:
•
nausea
•
loss of appetite
•
tiredness
•
dark colored urine
and pale stools
•
yellowing of your
skin or the white
part of your eye
•
bleeding more
easily than normal
•
confusion
•
sleepiness
During your treatment with AVONEX you will need to see your healthcare
provider regularly and have
regular blood tests to check for side effects. Tell your healthcare
provider about all the medicines you take
and if you drink alcohol before you start taking AVONEX.
3. Serious allergic and skin reactions. Serious allergic and skin
reactions can happen

Summary of Product characteristics

AVONEX- INTERFERON BETA-1A
AVONEX PEN- INTERFERON BETA-1A INJECTION, SOLUTION
AVONEX- INTERFERON BETA-1A INJECTION, SOLUTION
BIOGEN INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions (5.8)
7/2023
INDICATIONS AND USAGE
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 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
Injection: 30 micrograms per 0.5 mL solution in single-dose prefilled
syringe (3)
Injection: 30 micrograms per 0.5 mL solution in single-dose prefilled
autoinjector (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,