Interferon alfa-2b recombinant
(rl FN-þ2; þ-2-interferon)
Interferon alfa-2b recombinant (Intron A)
rl FN-þ2 (Intron A)
þ-2-interferon (Intron A)
Interferon Alfa-2b Recombinant
(in-ter- FEER-on AL-fah )
Pregnancy Category: C Intron A (Rx)

Classification: Antineoplastic, miscellaneous agent

Action/Kinetics: A product of recombinant DNA technology using strains of genetically engineered Escherichia coli. The activity is expressed as International Units, which are determined by comparing the antiviral activity of the recombinant interferon with the activity of the international reference standard of human leukocyte interferon. Interferons bind to specific receptors on the cell surface, resulting in inhibition of virus replication in virus-infected cells, suppression of cell proliferation, increase in the phagocytic activity of macrophages, and enhancement of the toxic effects of leukocytes for target cells. Peak serum levels after IM, SC: 18-116 IU/mL after 3-12 hr. t 1/2, IM, SC: 2-3 hr. Peak serum levels after IV infusion: 135-270 IU/mL at the end of the infusion. t 1/2, IV: 2 hr. The main site of metabolism may be the kidney.

Uses: Hairy cell leukemia in clients older than 18 years of age (in both splenectomized and nonsplenectomized clients). Intralesional use for genital or venereal warts ( Condylomata acuminata.) AIDS-related Kaposi's sarcoma in clients over 18 years of age. Chronic hepatitis C in clients at least 18 years of age with compensated liver disease and a history of blood or blood product exposure or who are HCV antibody positive. Chronic hepatitis B in clients over 18 years of age with compensated liver disease and HBV replication (clients must be serum HBsAg positive for at least 6 months and have HBV replication with elevated serum ALT). Chronic hepatitis B in pediatric clients 1 year of age and older. Adjunct therapy for malignant melanoma in those who are 18 years of age or older who are free of the disease but at a high risk for recurrence within 56 days of surgery. With an anthracycline drug for the initial treatment of clinically aggressive non-Hodgkin's lymphoma.
Investigational: The drug has been used for a large number of conditions. Significant activity has been noted against the following neoplastic diseases: locally for superficial bladder tumors, carcinoid tumor, chronic myelogenous leukemia, cutaneous T-cell lymphoma, essential thrombocythemia, low-grade non-Hodgkin's lymphoma, and chronic granulocytic leukemia. Limited activity has been noted in acute leukemias, cervical carcinoma, chronic lymphocytic leukemia, Hodgkin's disease, malignant gliomas, melanoma, multiple myeloma, nasopharyngeal carcinoma, osteosarcoma, ovarian carcinoma, renal carcinoma, and chronic granulomatous disease. Interferon alfa-2b has also been used to treat the following viral infections: Significant activity has been seen against cutaneous warts, CMVs, herpes keratoconjunctivitis, and herpes simplex. Limited activity has been noted against papillomaviruses, rhinoviruses, vaccinia virus, varicella zoster, and HIV (used with foscarnet/AZT). It has also been used to treat multiple sclerosis.

Contraindications: Lactation. Use to treat rapidly progressive visceral disease in AIDS-related Kaposi's sarcoma. Use in clients with decompensated liver disease, autoimmune hepatitis, history of autoimmune disease, or immunosuppressed transplant clients.

Special Concerns: Use with caution in clients with a history of unstable angina, uncontrolled CHF, COPD, diabetes mellitus prone to ketoacidosis, thrombophlebitis, pulmonary embolism, seizure disorders, severe renal and hepatic disease, compromised CNS function, and severe myelosuppression. Safety and efficacy in individuals less than 18 years of age have not been established.

Side Effects: Flu-like symptoms: Fever, headache, fatigue, myalgia, chills. CV: Hypotension, arrhythmias tachycardia, syncope, hypertension, coagulation disorders, chest pain, palpitations, flushing, atrial fibrillation, bradycardia, cardiac failure, cardiomyopathy extrasystoles, postural hypotension. CNS: Depression, confusion, somnolence, migraine, dizziness, ataxia, insomnia, irritability, paresthesia, anxiety, nervousness, emotional lability, amnesia, impaired concentration, weakness, tremor, syncope, abnormal coordination, hypoesthesia, hypesthesia, abnormal coordination, aggravated depression, aggressive reaction, hypertonia, hypokinesia, impaired consciousness, neuropathy, agitation, apathy, aphasia, dysphonia, extrapyramidal disorder, hot flashes, hyperesthesia, hyperkinesia, neurosis, paresis, paroniria, parosmia, personality disorder, seizures, coma polyneuropathy, suicide attempt. GI: N&V;, diarrhea, stomatitis, weight loss, anorexia, flatulence, thirst, dehydration, constipation, eructation, abdominal pain, loose stools, abdominal distention, dysphagia, esophagitis, gastric ulcer, GI hemorrhage GI mucosal discoloration, gum hyperplasia, gingival bleeding, gingivitis, increased saliva, increased appetite, melena, oral leukoplakia, rectal bleeding after stool, rectal hemorrhage ulcerative stomatitis, ascites, gallstones, gastroenteritis, halitosis. Hematologic: Thrombocytopenia, granulocytopenia, anemia, hemolytic anemia leukopenia. Musculoskeletal: Arthralgia, leg cramps, asthenia, arthrosis, arthritis, muscle pain or weakness, back pain, bone pain, rigors, CTS. Respiratory: Pharyngitis, coughing, dyspnea, sinusitis, rhinitis, epistaxis, nasal congestion, dry mouth, bronchospasm pleural pain, pneumonia, rhinorrhea, sneezing, wheezing, bronchitis, cyanosis, lung fibrosis. EENT: Alteration or loss of taste, tinnitus, hearing disorders, conjunctivitis, photophobia, vision disorders, eye pain, diplopia, dry eyes, earache, lacrimal gland disorder, periorbital edema, vertigo, speech disorder. Dermatologic: Rash, pruritus, alopecia, urticaria, dry skin, dermatitis, purpura, photosensitivity, acne, nail disorder, facial edema, moniliasis, reaction at injection site, abnormal hair texture, cold/clammy skin, cyanosis of the hand, epidermal necrolysis, dermatitis lichenoides, furunculosis, increased hair growth, erythema, melanosis, nonherpetic cold sores, peripheral ischemia, skin depigmentation or discoloration, vitiligo, folliculitis, lipoma, psoriasis. GU: Amenorrhea, hematuria, impotence, leukorrhea, menorrhagia, urinary frequency, nocturia, polyuria, uterine bleeding, increased BUN, incontinence, pelvic pain. Endocrine: Gynecomastia, thyroid disorder, aggravation of diabetes mellitus, virilism. Hepatic: Jaundice, upper right quadrant pain, hepatic encephalopathy, hepatic failure. Other: Pain, increased sweating, malaise, decreased libido, herpes simplex, lymphadenopathy, chest pain, abscess, cachexia, hypercalcemia, peripheral edema, stye, substernal chest pain, weakness, sepsis, dehydration, fungal infection, herpes zoster, viral infection, trichomoniasis.

Laboratory Test Alterations: AST, ALT, LDH, BUN, serum creatinine, alkaline phosphatase. H&H.; Abnormal hepatic function tests, bilirubinemia.

Drug Interactions: Aminophylline / Clearance of aminophylline due to breakdown by the liver AZT / Risk of neutropenia

How Supplied: Solution for Injection: 3 million IU/0.2 mL, 3 million IU/0.5 mL, 5 million IU/0.2 mL, 5 million IU/0.5 mL, 6 million IU/mL, 10 million IU/0.2 mL, 10 million IU/0.5 mL; Kit: 3 million IU/0.5 mL, 5 million IU/0.5 mL, 10 million IU/mL; Powder for injection: 3 million IU, 5 million IU, 10 million IU, 18 million IU, 25 million IU, 50 million IU

Dosage
?IM, SC Hairy cell leukemia.
2 million IU/m ² 3 times/week. Higher doses are not recommended. May require 6 or more months of therapy for improvement. Do not use the 50-million-IU strength of the powder for injection for treating hairy cell leukemia.
AIDS-related Kaposi's sarcoma
30 million IU/m ² 3 times/week SC or IM using only the 50-million-IU vial. Using this dose, clients should tolerate an average dose of 110 million IU/week at the end of 12 weeks of therapy and 75 million IU/week at the end of 24 weeks of therapy.
Chronic hepatitis C.
3 million IU 3 times/week for 16 weeks. At 16 weeks, extend treatment to 18 to 24 months at 3 million IU 3 times/week to improve the sustained response of normalization of ALT. Discontinue therapy if there is no response after 16 weeks.
Chronic hepatitis B.
30-35 million IU/week SC or IM, given as either 5 million IU/day or 10 million IU 3 times/week for 16 weeks. If serious side effects occur, the dose may be decreased by 50%.
?IV Malignant melanoma.
20 million IU/m ² IV on 5 consecutive days/week for 4 weeks. Maintenance: 10 million IU/m ² SC 3 times/week for 48 weeks.
?Intralesional Condylomata acuminata (genital or venereal warts).
1 million IU/lesion 3 times/week for 3 weeks. For this purpose, use only the vial containing 10 million units and reconstitute using no more than 1 mL diluent. To reduce side effects, give in the evening with acetaminophen. Maximum response usually occurs within 4-8 weeks. If results are unsatisfactory after 12-16 weeks, a second course may be started.