BETASERON Rx

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BETASERON

Multiple sclerosis
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Generic Name and Formulations:

Interferon beta-1b 0.3mg; per vial; pwd for SC inj after reconstitution; contains albumin (human), mannitol; preservative-free.

Select therapeutic use:

Indications for BETASERON:

To reduce the frequency of clinical exacerbations of relapsing forms of multiple sclerosis (MS) in patients who have experienced a first clinical episode and have MRI features consistent with MS.

Adult:

Pre-medicate with analgesics and/or antipyretics on treatment days to ameliorate flu-like symptoms. May be administered by syringe and needle or Betaconnect autoinjector. ≥18yrs: initially 0.0625mg (0.25mL) SC every other day; increase by 25% every 2 weeks to target dose of 0.25mg (1mL) SC every other day.

Children:

<18yrs: not established.

Warnings/Precautions:

Monitor for signs/symptoms of hepatic injury; consider discontinuing if elevated transaminase levels or jaundice occurs. Depression. Suicidal ideation. Pre-existing CHF: monitor for worsening cardiac function at initiation and during treatment. Risk of thrombotic microangiopathy, drug-induced lupus erythematosus; discontinue if occurs. Myelosuppression. Monitor CBCs, differential, platelets, blood chemistries; liver function (at 1, 3, and 6 months then periodically). Pregnancy (Cat.C; may be abortifacient). Nursing mothers: not recommended.

Interactions:

Risk of hepatic injury with concomitant hepatotoxic drugs or alcohol.

Pharmacological Class:

Immunomodulator.

Adverse Reactions:

Inj site reactions, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, asthenia; inj site necrosis (suspend therapy if multiple lesions occur); rare: hepatic injury, anaphylaxis, possible seizures.

How Supplied:

Single-use vials (w. prefilled diluent syringe, supplies)—5, 14

BETASERON 0.3mg kits (Qty:1)

appx. price $6790.00