No

Biological Response Modulator

Reduces the frequency of clinical exacerbations in ambulatory patients with relapsing-remitting multiple sclerosis (MS)

C

Hypersensitivity to E. coli derived products, natural or recombinant interferon beta, albumin human or any other component of the formulation

The safety and efficacy of interferon beta-1b in chronic progressive MS have not been evaluated; use in breast-feeding women is not recommended; flu-like symptoms complex (ie, myalgia, fever, chills, malaise, sweating) is reported in 53% of patients who receive interferon beta-1b

Due to the pivotal position of interferon in the immune system, toxicities can affect nearly every organ system: Injection site reactions, injection site necrosis, flu-like symptoms, menstrual disorders, depression (with suicidal ideations), somnolence, palpitations, peripheral vascular disorders, hypertension, blood dyscrasias, dyspnea, laryngitis, cystitis, gastrointestinal complaints, seizures, headache, and liver enzyme elevations

Symptoms of overdose include CNS depression, obtundation, flu-like symptoms, myelosuppression

Treatment is supportive

Decreases clearance of zidovudine thus increasing zidovudine toxicity

Store solution at 2°C to 8°C (36°F to 46°F); do not freeze or shake solution; use product within 3 hours of reconstitution

Interferon beta-1b differs from naturally occurring human protein by a single amino acid substitution and the lack of carbohydrate side chains; alters the expression and response to surface antigens and can enhance immune cell activities. Properties of interferon beta-1b that modify biologic responses are mediated by cell surface receptor interactions; mechanism in the treatment of MS is unknown.

Limited data due to small doses used

Time to peak serum concentration: 1-8 hours

S.C.:

Adults >18 years: 0.25 mg (8 million units) every other day

Hemoglobin, liver function, and blood chemistries

May cause sedation, depression, suicidal ideation, anxiety, agitation, or confusion

May cause leukopenia; use caution with clozapine and carbamazepine; concurrent use with psychotropics may produce additive sedation

No information available to require special precautions

No effects or complications reported

This is not a cure for MS; you will continue to receive regular treatment and follow-up for MS. Use as directed; do not change dosage or schedule of administration without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience flu-like syndrome (acetaminophen may help); nausea, vomiting, or loss of appetite (frequent small meals, frequent mouth care, sucking lozenges, or chewing gum may help); drowsiness, dizziness, agitation, or abnormal thinking (use caution when driving or engaging in tasks requiring alertness until response to drug is known). Report unusual bruising or bleeding; persistent abdominal disturbances; unusual fatigue; muscle pain or tremors; chest pain or palpitations, swelling of extremities; visual disturbances; pain, swelling, or redness at injection site; or other unusual symptoms. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Patient should be informed of possible side effects, especially depression, suicidal ideations, and the risk of abortion; flu-like symptoms such as chills, fever, malaise, sweating, and myalgia are common

Powder for injection, lyophilized: 0.3 mg [9.6 million units]

Nokta M, Loh JP, Douidar SM, et al, "Metabolic Interaction of Recombinant Interferon-Beta and Zidovudine in AIDS Patients," J Interferon Res, 1991, 11(3):159-64.

Quesada JR, Talpaz M, Rios A, et al, "Clinical Toxicity of Interferons in Cancer Patients: A Review," J Clin Oncol, 1986, 4(2):234-43.

Sheremata WA, Taylor JR, and Elgart GW, "Severe Necrotizing Cutaneous Lesions Complicating Treatment With Interferon Beta-1b," N Engl J Med, 1995, 332(23):1584.

Vial T and Descotes J, "Clinical Toxicity of the Interferons," Drug Saf, 1994, 10(2):115-50.