Interferon alfa-2a recombinant
(rl FN-A; IFLrA)
Interferon alfa-2a recombinant (Roferon-A)
rl FN-A (Roferon-A)
IFLrA (Roferon-A)
Interferon Alfa-2a Recombinant
(in-ter- FEER-on AL-fah)
Pregnancy Category: C Roferon-A (Rx)

Classification: Antineoplastic, miscellaneous agent

Action/Kinetics: Interferon alfa-2a is the product of recombinant DNA technology using strains of genetically engineered Escherichia coli. Activity is expressed as International Units, which are determined by comparing the antiviral activity of recombinant interferons 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: 3.8-7.3 hr. t 1/2: 3.7-8.5 hr. Metabolized by the kidney.

Uses: Hairy cell leukemia in clients older than 18 years of age. Can be used in splenectomized and nonsplenectomized clients. AIDS-related Kaposi's sarcoma in clients older than 18 years of age. Chronic myelogenous leukemia. Chronic hepatitis C. Investigational: The drug has been used for a large number of other conditions. Significant activity has been noted against the following neoplastic diseases: locally for superficial bladder tumors, carcinoid tumor, cutaneous T-cell lymphoma, essential thrombocythemia, low-grade non-Hodgkin's lymphoma. Limited activity has been noted in acute leukemias, cervical carcinoma, chronic lymphocytic leukemia, Hodgkin's disease, malignant gliomas, melanoma, multiple myeloma, mycosis fungoides/Sèzary syndrome, nasopharyngeal carcinoma, osteosarcoma, ovarian carcinoma, renal carcinoma. Interferon alfa-2a also has significant activity against the following viral infections: chronic non-A, non-B hepatitis, condylomata acuminata, cutaneous warts, cytomegaloviruses, herpes keratoconjunctivitis; limited activity is seen against herpes simplex, HIV infection to slow progression, papillomaviruses, rhinoviruses, vaccinia virus, varicella zoster, and viral hepatitis B.

Contraindications: Lactation.

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, arthralgia, myalgias, chills, weight loss, dizziness. CV: Hypotension, arrhythmias syncope, hypertension, edema, palpitations, transient ischemic attacks, pulmonary edema, CHF, cardiac murmur, MI, stroke, cardiomyopathy hot flashes, Raynaud's phenomenon, thrombophlebitis. Respiratory: Coughing, dyspnea, dryness or inflammation of oropharynx, chest pain or congestion, bronchospasm pneumonia, tachypnea, rhinitis, rhinorrhea, sinusitis. CNS: Depression, confusion, dizziness, headache, paresthesia, anxiety, ataxia, aphasia, aphonia, dysarthria, amnesia, weakness, nervousness, emotional lability, impotence, numbness, lethargy, sleep disturbances, visual disturbances, vertigo, decreased mental status, memory loss, disturbances of libido, involuntary movements, suicidal ideation, seizures forgetfulness, neuropathy, tremor. GI: Anorexia, N&V;, diarrhea, emesis, abdominal pain, hypermotility, abdominal fullness, abdominal pain, flatulence, constipation, gastric distress. Hematologic: Thrombocytopenia, neutropenia, leukopenia, decreased hemoglobin, severe anemia, severe cytopenias, coagulopathy, Coombs' positive hemolytic anemia, aplastic anemia. Musculoskeletal: Joint or bone pain, arthritis, polyarthritis, poor coordination, muscle contractions, gait disturbances. Dermatologic: Rash, pruritus, dry skin, ecchymosis, petechiae, skin flushing, alopecia, urticaria, diaphoresis, cyanosis, bruising. Miscellaneous: Generalized pain, back pain, inflammation at injection site, epistaxis, bleeding gums, weight loss, alteration of taste, altered hearing, edema, night sweats, earache, eye irritation, hypothyroidism, hypertriglyceridemia.

Laboratory Test Alterations: AST, ALT, LDH, BUN, serum creatinine, alkaline phosphatase, bilirubin, uric acid, serum glucose, serum phosphorus. H&H.; Hypocalcemia, proteinuria.

Drug Interactions: Interleukin-2 / Risk of renal failure Theophylline / Theophylline clearance

How Supplied: Injection: 3 million IU/0.5 mL, 3 million IU/mL, 6 million IU/0.5 mL, 6 million IU/mL, 9 million IU/0.5 mL, 9 million IU/0.9 mL, 36 million IU/mL

Dosage
?IM, SC Hairy cell leukemia.
Induction: 3 million IU/day for 16-24 weeks; maintenance, 3 million IU 3 times/week. Doses higher than 3 million IU are not recommended.
AIDS-related Kaposi's sarcoma.
Induction: 36 million IU/day for 10-12 weeks; or, 3 million IU/day on days 1-3; 9 million IU/day on days 4-6; and 18 million IU/day on days 7-9 followed by 36 million IU/day for the remainder of the 10 to 12-week induction period. Maintenance: 36 million IU 3 times/week. If severe side effects occur, the dose can be withheld or reduced by one-half.
Chronic myelogenous leukemia.
Induction: 9 million IU/day. The dose can be graded during the first week of therapy to improve short-term tolerance by giving 3 million IU/day for 3 days to 6 million IU/day for 3 days and then to the target dose of 9 million IU/day. Maintenance: Optimal dose and duration of therapy have not been determined. Continue the regimen until the disease progresses.
Chronic hepatitis C.
3 million IU, SC or IM, 3 times/week for 12 months.