EXTAVIA- 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:

Novartis Pharmaceuticals Corporation

INN (International Name):

INTERFERON BETA-1B

Composition:

INTERFERON BETA-1B 0.25 mg in 1.0 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

EXTAVIA 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. EXTAVIA is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, albumin (human), or any other component of the formulation. Risk Summary Although there have been no well-controlled studies in pregnant women, available data, which include prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of interferon beta-1b 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% to 4% and 15% to 20%, respective

Product summary:

EXTAVIA (interferon beta-1b) for injection is supplied as a white to off-white lyophilized powder in a clear glass, single-dose vial (3 mL capacity). Each carton contains 15 blister units: NDC 0078-0569-12. Each blister unit contains: EXTAVIA and the diluent are for single-use only. Discard unused portions. The reconstituted product contains no preservative. Store EXTAVIA vials at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F) for up to 3 months [see USP Controlled Room Temperature]. 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

Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: July 2023
Medication Guide
EXTAVIA
(ex tā vee uh)
interferon beta-1b
(in-ter-feer-on beta-one-be)
for injection, for subcutaneous use
Read this Medication Guide before you start taking EXTAVIA 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 EXTAVIA?
EXTAVIA can cause serious side effects, including:
• liver problems, including liver failure. Symptoms of liver
problems may include:
• yellowing of your eyes
• flu-like symptoms
• itchy skin
• nausea or vomiting
• feeling very tired
• bruising easily or
bleeding problems
Your healthcare provider will do blood tests to check for these
problems while you take EXTAVIA.
• serious allergic reactions. Serious allergic reactions can happen
quickly and may happen after your first
dose of EXTAVIA or after you have taken EXTAVIA many times. Symptoms
may include: difficulty
breathing or swallowing or 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
• trouble sleeping (insomnia)
• hallucinations
• new or worse depression
• acting aggressive, being angry, or
violent
• other unusual changes in behavior or
mood
• new or worse
anxiety
• acting on
dangerous impulses
What is EXTAVIA?
EXTAVIA is a prescription medicine used to treat relapsing forms of
multiple sclerosis (MS), to include
clinically isolated syndrome, relapsing-remitting disease, and active
secondary progressive disease, in adults.
EXTAVIA is similar to certain interferon proteins that are produced in
the body. It is not known if
EXTAVIA is

Summary of Product characteristics

EXTAVIA- INTERFERON BETA-1B
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXTAVIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXTAVIA.
EXTAVIA (INTERFERON BETA-1B) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1993
RECENT MAJOR CHANGES
Warnings and Precautions, Pulmonary Arterial Hypertension (5.8)
7/2023
INDICATIONS AND USAGE
EXTAVIA is an interferon beta 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. (1)
DOSAGE AND ADMINISTRATION
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; the removable
diluent cap contains natural rubber
latex. (2.2)
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 (human) or mannitol. (4)
WARNINGS AND PRECAUTIONS
_Hepatic Injury:_ Monitor liver function tests and signs and symptoms
of hepatic injury; consider
discontinuing EXTAVIA if serious hepatic injury occurs. (5.1, 5.11)
_Anaphylaxis and Other Allergic Reactions:_ Discontinue if anaphylaxis
occurs. (5.2)
_Depression and Suicide:_ Advise patients to immediately report any
symptom of depression and/or
suicidal ideation; consider discontinuation of EXTAVIA if depression
occurs. (5.3)
_Congestive Heart Failure (CHF):_ Monitor patients with CHF for
worsening of cardiac symptoms; consider
discontinuation of EXTAVIA if worsening of CHF occurs. (5.4)
_Injection Site Reactions Including Necrosis:_ Do not administer
EXTAVIA into affected area until fully
healed; if multiple lesio