Drug Guide

Generic Name

Interferon Beta-1b

Brand Names Betaseron

Classification

Therapeutic: Immunomodulator, used in Multiple Sclerosis

Pharmacological: Interferon, cytokine

FDA Approved Indications

  • Relapsing forms of multiple sclerosis (MS)

Mechanism of Action

Modulates the immune system by inhibiting the proliferation of activated T-cells, reducing inflammatory cytokines, and limiting blood-brain barrier permeability, thereby decreasing MS relapses.

Dosage and Administration

Adult: Initial dose is 250 mcg subcutaneously every other day. Dose may be increased gradually based on response and tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: Use with caution, as response may be variable and side effects more prominent.

Renal Impairment: No specific dosage adjustment; monitor kidney function.

Hepatic Impairment: Use with caution; no specific dosage guidelines.

Pharmacokinetics

Absorption: Subcutaneously absorbed with peak levels in 3-10 hours.

Distribution: Distributed mainly in plasma and extracellular fluid.

Metabolism: Metabolized by proteolytic enzymes.

Excretion: Excreted mainly in the urine after degradation; no significant renal clearance.

Half Life: Approximately 8 hours.

Contraindications

  • Hypersensitivity to interferons or any component of the formulation.

Precautions

  • Monitor for development of neutralizing antibodies, flu-like symptoms, liver function abnormalities, depression, and injection site reactions. Use with caution in patients with depression or suicidal ideation.
  • Pregnancy Category C; use only if clearly needed.

Adverse Reactions - Common

  • Injection site reactions (redness, swelling, pain) (Very common)
  • Flu-like symptoms (fever, chills, malaise) (Common)

Adverse Reactions - Serious

  • Hepatotoxicity (elevated liver enzymes, hepatitis) (Uncommon)
  • Neuropsychiatric effects (depression, suicidal ideation) (Rare)
  • Myelosuppression (neutropenia, thrombocytopenia) (Uncommon)
  • Autoimmune disorders (thyroiditis) (Rare)

Drug-Drug Interactions

  • Live vaccines (contraindicated)
  • Other immunomodulators

Drug-Food Interactions

  • None significant

Drug-Herb Interactions

  • None established

Nursing Implications

Assessment: Baseline and periodic liver function tests, CBC, thyroid function, neuropsychiatric assessment.

Diagnoses:

  • Risk for infection
  • Imbalanced nutrition: less than body requirements due to flu-like symptoms
  • Risk for mood disturbance

Implementation: Administer subcutaneously as prescribed; educate patient on injection technique and side effects; monitor for adverse reactions.

Evaluation: Assess reduction in relapse rate, monitor for adverse effects, ensure laboratory parameters remain within normal limits.

Patient/Family Teaching

  • Instruct on proper injection site rotation and technique.
  • Report severe side effects like depression or liver issues.
  • Explain the importance of regular blood tests.
  • Discuss flu-like symptoms and measures to alleviate them.
  • Emphasize adherence to therapy.

Special Considerations

Black Box Warnings:

  • Suicide warning: Use with caution due to possible neuropsychiatric effects.

Genetic Factors: Presence of neutralizing antibodies can reduce efficacy.

Lab Test Interference: May cause transient abnormal liver function tests and hematological changes.

Overdose Management

Signs/Symptoms: Severe flu-like symptoms, injection site reactions, or symptoms of hypersensitivity.

Treatment: Supportive care; no specific antidote.

Storage and Handling

Storage: Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze.

Stability: Stable until the expiration date when stored properly.

This guide is for educational purposes only and is not intended for clinical use.