No

Biological Response Modulator

Patients greater than or equal to 18 years of age: Condylomata acuminata, intralesional treatment of refractory or recurring genital or venereal warts; useful in patients who do not respond or are not candidates for usual treatments; indications and dosage regimens are specific for a particular brand of interferon

C

Patients with known hypersensitivity to alpha interferon, mouse immunoglobulin, or any component of the product

Use with caution in patients with seizure disorders, brain metastases, compromised CNS function, cardiac disease, severe renal or hepatic impairment, multiple sclerosis; safety and efficacy in children <18 years have not been established.

>10%:

Central nervous system: Fatigue, malaise, fever (usually within 4-6 hours), chills, dizziness

Dermatologic: Rash

Gastrointestinal: Xerostomia, nausea, vomiting, diarrhea, abdominal cramps, weight loss, metallic taste, anorexia

Hematologic: Mildly myelosuppressive and well tolerated if used without adjunct antineoplastic agents; thrombocytosis has been reported, leukopenia (mainly neutropenia), anemia, thrombocytopenia, decreased hemoglobin, hematocrit, platelets

Myelosuppressive:

WBC: Mild

Platelets: Mild

Onset (days): 7-10

Nadir (days): 14

Recovery (days): 21

Neuromuscular & skeletal: Arthralgia, rigors

Miscellaneous: Flu-like syndrome, diaphoresis

1% to 10%:

Central nervous system: Headache, delirium, somnolence, neurotoxicity

Dermatologic: Alopecia, dry skin

Gastrointestinal: Stomatitis

Hepatic: Hepatotoxicity

Neuromuscular & skeletal: Peripheral neuropathy, leg cramps

Ocular: Blurred vision

Miscellaneous: Diaphoresis

<1%: Tachycardia, arrhythmias, chest pain, hypotension, SVT, edema, EEG abnormalities, confusion, sensory neuropathy, confusion, psychiatric effects, depression, hypothyroidism, increased uric acid level, change in taste, increased hepatic transaminase, increased ALT/AST, sensitivity to injection, myalgia, visual disturbances, proteinuria, increased BUN/creatinine, coughing, dyspnea, cough, nasal congestion, neutralizing antibodies, usually patient can build up a tolerance to side effects

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

Treatment is supportive

Increased effect: Cimetidine: May augment the antitumor effects of interferon in melanoma

Increased toxicity:

Vinblastine: Enhances interferon toxicity in several patients; increased incidence of paresthesia has also been noted

Theophylline: Clearance has been reported to be decreased in hepatitis patients receiving interferon

Store solution at 2°C to 8°C (36°F to 46°F); do not freeze or shake solution

Interferons interact with cells through high affinity cell surface receptors. Following activation, multiple effects can be detected including induction of gene transcription. Inhibits cellular growth, alters the state of cellular differentiation, interferes with oncogene expression, alters cell surface antigen expression, increases phagocytic activity of macrophages, and augments cytotoxicity of lymphocytes for target cells

Adults: Inject 250,000 units (0.05 mL) in each wart twice weekly for a maximum of 8 weeks; therapy should not be repeated for at least 3 months after the initial 8-week course of therapy

Inject into base of wart with a small 30-gauge needle

Dizziness and drowsiness are common; may rarely cause delirium or depression

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

No information available to require special precautions

>10% of patients experience dry mouth and metallic taste

Warts are highly contagious until they completely disappear, abstain from sexual activity or use barrier protection; inform nurse or physician if allergy exists to eggs, neomycin, mouse immunoglobulin, or to human interferon alpha; acetaminophen can be used to treat flu-like symptoms

Injection: 5 million units (1 mL)

Jeffrey LP, Chairman, National Study Commission on Cytotoxic Exposure. Position Statement. "The Handling of Cytotoxic Agents by Women Who Are Pregnant, Attempting to Conceive, or Breast-Feeding," January 12, 1987.

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