Classifications: immunomodulator; interferon; antineoplastic; Therapeutic: immunomodulator; interferon
Prototype: Interferon alfa-2a
Pregnancy Category: C
0.3 mg vial
Interferon beta-1b is a glycoprotein produced by recombinant DNA techniques using a strain of E. coli.
Both natural and recombinant DNA interferon beta-1b possess antiviral, antiproliferative, antitumor, and immunomodulatory
activity. The effectiveness of interferon beta-1b for multiple sclerosis (MS) is based on the assumption that MS is an immunologically
Relapsing and relapsing-remitting multiple sclerosis.
AIDS, AIDS-related Kaposi's sarcoma, metastatic renal cell carcinoma, malignant melanoma, cutaneous T-cell lymphoma, acute
Previous hypersensitivity to interferon beta-1b or human albumin, mannitol hypersensitivity; pregnancy (category C) but
may cause a spontaneous abortion, lactation.
Suicidal/mental disorders especially chronic depression; seizures; cardiac disease. Safety and efficacy in children <18
y are not established.
Route & Dosage
Adult: SC 0.25 mg (8 million IU) q.o.d.
- Reconstitute by adding 1.2 mL of the supplied diluent (0.54% NaCl) to vial and gently swirl. Do NOT shake. The resultant solution contains 0.25 mg (8 million units)/mL.
- Discard reconstituted solution if it contains particulate matter or is discolored. Also discard unused solution.
- Rotate injection sites; use 27-gauge needle to administer drug.
- Store vials under refrigeration, 2°8° C (36°46° F) or at room temperature.
Adverse Effects (≥1%)CNS:
Headache, fever, fatigue
, dizziness, lethargy, depression
, somnolence, weakness, agitation, malaise, confusion or reduced ability to concentrate,
anxiety, dementia, emotional lability, depersonalization, suicide attempts. CV:
Tachycardia, peripheral edema, CHF (rare). GI:
Nausea, vomiting, diarrhea. Hematologic: Leukopenia, thrombocytopenia,
Hypocalcemia, elevated serum creatinine, elevated liver transaminases, autoimmune hepatitis, hepatic failure. Skin:
Local skin necrosis at injection site, rash, pain at injection site. Body as a Whole:
Alopecia, myalgias, flu-like syndrome.
InteractionsDrug: Zidovudine (AZT)
levels are increased, resulting in toxicity.
About 50% absorbed from SC sites. Distribution:
Penetrates intact bloodbrain barrier poorly; crosses placenta; distributed into breast milk. Metabolism:
Rapidly inactivated in body fluids and tissue.
Assessment & Drug Effects
- Monitor vital signs, neurologic status, and neuropsychiatric status frequently during therapy.
- Lab tests: Monitor liver function at 1, 3, and 6 mo after initiation of therapy and as clinically warranted thereafter; monitor
renal function, complete blood counts, and serum electrolytes periodically.
- Assess for and promptly treat flu-like symptom complex (fever, chills, myalgia, etc.).
- Assess injection sites; pain and redness are common reactions. Report tissue ulceration promptly.
Patient & Family Education
- Learn and understand potential adverse drug reactions.
- Learn proper technique for solution preparation and injection.
- Self-medicate with acetaminophen (if not contraindicated) if flu-like symptom complex develops.
- Avoid prolonged exposure to sunlight.
- Use caution when performing hazardous activities until response to drug is known.