Interferon beta-1b

What is Interferon beta-1b?

• Interferon beta-1b (Extavia; Betaseron) is an interferon beta used for the treatment of relapsing forms of multiple sclerosis (MS).

1AU1 Human Interferon-Beta

What are the uses of this medicine?

• Interferon beta-1b (Extavia ; Betaseron) used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• Interferon beta-1b (Extavia;Betaseron) is similar to certain interferon proteins that are produced in the body.

How does this medicine work?

• Interferon (in" ter feer' on) beta is a type I interferon produced by fibroblasts and macrophages in response to viral infection and antigenic stimuli.
• Interferon beta is structurally and antigenically distinct from interferon alfa, but they share the same cell surface receptors.
• Despite having a common receptor, the two interferons have different intracellular effects, acting through related but different pathways to trigger changes in gene expression that modulate inate and adaptive immune responses and antiviral pathways.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Interferon beta-1b.

Is this medicine FDA approved?

• Betaseron – interferon ß-1b, subcutaneous injection (250 mcg) every other day. Approved 1993.
• Betaferon/Betaseron is marketed today by Bayer Pharma.
• The originator was Schering AG (Berlex in North America), now part of Bayer Pharms.
• Novartis has also introduced Extavia, a new brand of interferon beta-1b, in 2009.

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• Extavia; BETASERON is given by injection under your skin (subcutaneous injection) every other day.
• Take Extavia; Betaseron exactly as your healthcare provider tells you to take it.
• If your healthcare provider feels that you or someone else may give you the injections, then you or the other person should be trained by your healthcare provider in how to give an injection.
• Do not try to give yourself or have another person give you injections until you or both of you understand and are comfortable with how to prepare your dose and give the injection.
• You may be started on a lower dose when you first start taking Extavia. Your healthcare provider will tell you what dose of Extavia;Betaseron to use.
• Your healthcare provider may change your dose of Extavia;Betaseron. You should not change your dose without talking to your healthcare provider.
• If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Your next injection should be taken about 48 hours (2 days) after that dose. Do not take Extavia;Betaseron on 2 consecutive days. If you accidentally take more than your prescribed dose, or take it on 2 consecutive days, call your healthcare provider right away.
• Always use a new, unopened vial of Extavia;Betaseron and pre-filled diluent syringe for each injection. Throw away any unused medicine. Do not re-use any vials, syringes, or needles.
• It is important for you to change your injection site each time you inject Extavia;Betaseron. This will lessen the chance of you having a serious skin reaction at the site where you inject Extavia;Betaseron. Avoid injecting Extavia;Betaseron into an area of skin that is sore, reddened, infected, or has other problems.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 0.3 mg of lyophilized powder in a single-dose vial for reconstitution

This medicine is available in fallowing brand namesː

• Extavia; Betaseron

What side effects can this medication cause?

The most common side effects of this medicine include:

• low white blood cell count
• headache
• pain
• increases in your liver enzymes
• increases in your muscle tension
• rash
• problems sleeping
• weakness
• stomach pain

This medicine can cause serious side effects, including:

• liver problems, including liver failure
• serious allergic reactions
• depression or suicidal thoughts
• heart problems
• Injection site problems
• flu-like symptoms
• seizures

What special precautions should I follow?

• Severe hepatic injury, including cases of hepatic failure, some of which have been due to autoimmune hepatitis, has been rarely reported in patients taking Interferon beta-1b.
• Anaphylaxis has been reported as a rare complication of interferon beta-1b use. Discontinue if anaphylaxis occurs.
• Depression and suicide have been reported to occur with increased frequency in patients receiving interferon beta products, including interferon beta-1b. Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuation of this medicine if depression occurs.
• Monitor patients with preexisting congestive heart failure (CHF) for worsening of their cardiac condition during initiation of and continued treatment with interferon beta-1b.
• Injection site reactions, including injection site necrosis, can occur with the use of interferon beta products. Do not administer Extavia, Betaseron into affected area until fully healed; if multiple lesions occur, change injection site or discontinue Extavia until healing of skin lesions.
• Leukopenia was reported in 18% of patients receiving interferon beta-1b. Monitor complete blood count.
• Cases of thrombotic microangiopathy (TMA) have been reported. Discontinue Extavia , Betaseron if clinical symptoms and laboratory findings consistent with TMA occur and a relationship to Extavia, Betaseron is suspected.
• Flu-like symptom complex for patients on interferon beta-1b was reported. Consider analgesics and/or antipyretics on injection days.
• Cases of drug-induced lupus erythematosus have been reported. Discontinue Extavia, Betaseron if patients develop new characteristic signs and symptoms.
• In addition to those laboratory tests normally required for monitoring patients with MS, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests, are recommended at regular intervals (one, three, and six months) following introduction of Extavia ,Betaseron therapy, and then periodically thereafter in the absence of clinical symptoms.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: interferon beta-1b
• Inactive ingredients: albumin (human), mannitol
• Diluent contains sodium chloride solution.

Who manufactures and distributes this medicine?

Betaseron: Manufactured for:

• Bayer HealthCare Pharmaceuticals Inc.
• Whippany, NJ 07981
• Manufactured in Germany

Extavia: Manufactured by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

What should I know about storage and disposal of this medication?

Extavia:

• Before mixing, store Extavia at room temperature between 68°F to 77°F (20°C to 25°C).
• Before mixing, Extavia may be stored for up to 3 months between 59°F and 86°F (15°C and 30°C).
• After mixing, you can refrigerate Extavia for up to 3 hours before using. Your Extavia must be used within 3 hours of mixing even if refrigerated.

Betaseron:

• Before mixing, store Betaseron between 36°F to 86°F (2°C to 30°C).
• After mixing, you can refrigerate Betaseron for up to 3 hours before using. Your Betaseron must be used within 3 hours of mixing even if refrigerated.
• Do not freeze.

• Dailymed label info on Interferon beta-1b
• FDA Interferon beta-1b