BETASERON- interferon beta-1b kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INTERFERON BETA-1B (UNII: TTD90R31WZ) (INTERFERON BETA-1B - UNII:TTD90R31WZ)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

INTERFERON BETA-1B

Composition:

INTERFERON BETA-1B 0.25 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BETASERON 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. BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation. Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of BETASERON to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose (see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk o

Product summary:

BETASERON is supplied as a lyophilized powder in a clear glass, single-dose vial (3 mL capacity). Each carton contains 5 single-dose cartons (NDC 50419-524-05) or 14 single-dose cartons (NDC 50419-524-35). Each single-dose carton contains: A single-dose vial containing 0.3 mg BETASERON (interferon beta-1b) A pre-filled single-dose syringe containing 1.2 mL diluent (Sodium Chloride, 0.54% solution) A vial adapter with a 30-gauge needle attached 2 alcohol prep pads The optional BETACONNECT autoinjector is not supplied with BETASERON, but is available for patients with a prescription for BETASERON by calling the BETAPLUS patient support program toll-free number at 1-800-788-1467. BETASERON and the diluent are for single-dose only. Discard unused portions. The reconstituted product contains no preservative. Store BETASERON vials between 36°F to 86°F (2°C to 30°C). After reconstitution, if not used immediately, refrigerate the reconstituted solution and use within three hours. Do not freeze.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Bayer HealthCare Pharmaceuticals Inc.
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MEDICATION GUIDE
Medication Guide
BETASERON
(bay-ta-seer-on)
interferon beta-1b
(in-ter-feer-on beta-one-be)
What is the most important information I should know about BETASERON?
BETASERON can cause serious side effects, including:
•
liver problems including liver failure. Symptoms of liver problems may
include:
•
yellowing of your eyes
•
itchy skin
•
nausea or
vomiting
•
feeling very tired
•
flu-like symptoms
•
bruising
easily or
bleeding
problems
Your healthcare provider will do blood tests to check for these
problems while you take
BETASERON.
•
serious allergic reactions. Serious allergic reactions can happen
quickly and may
happen after your first dose of BETASERON or after you have taken
BETASERON many times. Symptoms may include difficulty breathing or
swallowing, swelling of the mouth or tongue, rash, itching, or skin
bumps.
•
depression or suicidal thoughts. Call your healthcare provider right
away if you
have any of the following symptoms, especially if they are new, worse,
or worry
you:
•
thoughts about suicide or dying
•
new or worse depression
•
•
new or worse anxiety
trouble sleeping (insomnia)
•
acting aggressive, being angry, or
violent
•
acting on dangerous impulses
•
hallucinations
•
other unusual changes in behavior or
mood
What is BETASERON?
BETASERON is a prescription medicine used to treat relapsing forms of
multiple
sclerosis, to include clinically isolated syndrome,
relapsing-remitting disease, and active
secondary progressive disease, in adults. BETASERON is similar to
certain interferon
proteins that are produced in the body.
It is not known if BETASERON is safe and effective in children.
Who should not take BETASERON?
Do not take BETASERON if you are allergic to interferon beta-1b, to
another interferon
beta, to human albumin, or mannitol. See the end of this leaflet for a
complete list of
ingredients in BETASERON.
What should I tell my healthcare provider before taking BETASERON?
Before you take BETASERON

Summary of Product characteristics

BETASERON- INTERFERON BETA-1B
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETASERON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETASERON.
BETASERON (INTERFERON BETA-1B) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions (5.8) 7/2023
INDICATIONS AND USAGE
BETASERON is an interferon beta 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. (1)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
_For injection:_ 0.3 mg of lyophilized powder in a single-dose vial
for reconstitution (3)
CONTRAINDICATIONS
History of hypersensitivity to natural or recombinant interferon beta,
albumin or mannitol (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
In controlled clinical trials, the most common adverse reactions (at
least 5% more frequent on
BETASERON than on placebo) were: injection site reaction, lymphopenia,
flu-like symptoms, myalgia,
leukopenia, neutropenia, increased liver enzymes, headache,
hypertonia, pain, rash, insomnia, abdominal
pain, and asthenia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAYER HEALTHCARE
PHARMACEUTICALS AT
1-888-842-2937 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)
For subcutaneous use only (2.1)
The recommended dose is 0.25 mg every other day. Generally, start at
0.0625 mg (0.25 mL) every
other day, and increase over a six-week period to 0.25 mg (1 mL) every
other day. (2.1)
Reconstitute lyophilized powder with supplied diluent (2.2)
_Hepatic Injury:_ Monitor liver function tests and signs and symptoms
of hepatic injury; consider
discontinuing BETASERON if serious hepatic injury occurs. (5.1, 5.11)
_Anaphylaxis and Oth