interferon beta 1b (Rx)

Brand and Other Names:Betaseron, Extavia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for injection

  • 0.3mg/vial supplied with diluent for reconstitution
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Relapsing/Remitting Multiple Sclerosis, Exacerbations

0.0625 mg SC every other day initially

Gradually increase over 6 wk to 0.25 mg (8 million U; 1 mL) SC every other day: may increase by 0.0625 mg q2wk

Betaconnect injectable devise

  • No cost autoinjector for use only with Betaseron syringes
  • Autoinjector offers customizable injection speed and depth settings
  • Patients should speak to a healthcare provider or nurse before making any changes to injection depth or speed settings
  • Automatic needle insertion and retraction Betaconnect has an optional backup reminder function to alert patient for next injection
  • Device lets patients know when the injection is complete with a visual and audio end-of-dose indication

Non-A/Non-B Hepatitis (Orphan)

Treatment of acute non-A, non-B hepatitis

Orphan indication sponsor

  • Biogen, Inc; 14 Cambridge Center; Cambridge, MA 02142

Dosing Considerations

Monitor Hgb, WBC, Plts, LFTs

Dosage Forms & Strengths

lyophilized powder for injection

  • 0.3mg/vial supplied with diluent for reconstitution
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Multiple Sclerosis (Off-label)

Safety and efficacy not established

Limited data suggests to titrate as in adults; children 10 years or older typically tolerate full adult doses, although decreased tolerance may occur in younger children

0.0625 mg SC every other day initially

Gradually increase over 6 wk to 0.25 mg (8 million U; 1 mL) SC every other day: may increase by 0.0625 mg q2wk

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Interactions

Interaction Checker

and interferon beta 1b

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site reaction (85%)

            Flu-like syndrome (60%)

            Headache (57%)

            Myasthenia (46%)

            Fever (36%)

            Nausea (27%)

            Chills (25%)

            Constipation (20%)

            Abd pain (19%)

            Leukopenia (18%)

            Chest pain (11%)

            1-10%

            Malaise (8%)

            Inj site necrosis (5%)

            Hypersensitivity (3%)

            Lymphopenia (>5%)

            Myalgia (>5%)

            Neutropenia (>5%)

            Increased liver enzymes (>5%)

            Hypertonia (>5%)

            Pain (>5%)

            Rash (>5%)

            Insomnia (>5%)

            Abdominal pain (>5%)

            Asthenia (>5%)

            <1%

            Aggravation of seizure disorders

            Abortifacient potential

            Postmarketing Reports

            Blood and lymphatic system disorders: Anemia, thrombocytopenia

            Endocrine disorders: Hypothyroidism, hyperthyroidism, thyroid dysfunction

            Metabolism and nutrition disorders: Triglyceride increased, anorexia, weight decrease, weight increase

            Psychiatric disorders: Anxiety, confusion, emotional lability

            Nervous system disorders: Convulsion, dizziness, psychotic symptoms

            Cardiac disorders: Cardiomyopathy, palpitations, tachycardia

            Vascular disorders: Vasodilatation

            Respiratory, thoracic and mediastinal disorders: Bronchospasm

            Gastrointestinal disorders: Diarrhea, nausea, pancreatitis, vomiting

            Hepatobiliary disorders: Hepatitis, increased GGT

            Skin and subcutaneous tissue disorders: Alopecia, pruritus, skin discoloration, urticaria

            Musculoskeletal and connective tissue disorders: Arthralgia, lupus erythematosus

            Reproductive system and breast disorder: Menorrhagia

            General disorders and administration site conditions: Fatal capillary leak syndrome

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            Warnings

            Contraindications

            Hypersensitivity to beta interferons, human albumin or other ingredients

            Cautions

            Risk of hepatotoxicity; injection site necrosis; leukopenia; monitor liver function tests and signs and symptoms of hepatic injury; consider discontinuing therapy if serious hepatic injury occurs

            Discontinue if anaphylaxis occurs

            Do not administer into affected area until fully healed; if multiple lesions occur, discontinue therapy until skin lesions heal

            Advise patients to immediately report any symptom of depression and/or suicidal ideation; consider discontinuing therapy if depression occurs

            Abortifacient potential

            Flu-like symptoms may occur

            Increased risk of infection

            Betaseron & Extavia, although dosed similarly, not considered therapeutically equivalent

            Monitor patients with CHF for worsening of cardiac symptoms; consider discontinuation of therapy if worsening of CHF occurs

            Leukopenia may occur; monitor complete blood count

            In addition to laboratory tests normally required for monitoring patients with multiple sclerosis, 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 interferon 1b therapy, and periodically thereafter in absence of clinical symptoms

            Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported; some cases have been reported several weeks to years after starting interferon beta products; discontinue therapy if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated

            Consider analgesics and/or antipyretics on injection days if flu-like symptoms occur

            Cases of drug-induced lupus erythematosus have reported;. discontinue therapy if patients develop new characteristic signs and symptoms

            Removable rubber cap of the diluent (sodium chloride, 0.54% solution) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk, do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant interferon; antiviral, antiproliferative, immunoregulatory protein; alters response to surface antigen and may inhance immune cell activities

            Pharmacokinetics

            Peak plasma time: 1-8 hr

            Concentration: 40 IU/mL

            Half-Life: 8 min - 4.3 hr

            Onset: 6-12 hr

            Bioavailability: 50%

            Vd: 0.25-2.88 L/kg

            Clearance: 9.4-28.9 mL/min

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            Administration

            Instructions

            Reconstitute with 1.2 mL of 0.54% NaCl diluent (provided); the removable diluent cap contains natural rubber latex

            Rotate SC injection site between upper outer arm, thight, and abdomen

            See prescribing information for detailed instructions for preparation

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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