INTERFERON ALFA-2a (in-ter-feer'on) Roferon-A Injection Classifications: immunomodulator; interferon Pregnancy Category: C
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3 million IU/mL, 6 million IU/mL, 9 million IU/mL, 36 million IU/mL, 6 million IU/0.5 mL, 9 million IU/0.5 mL injection.
Interferon (IFN) alfa-2a, one of 4 types of alpha interferon, is a highly purified protein and natural product of human leukocytes
within 46 h after viral stimulation. Also produced by recombinant DNA technology (rIFN-A).
Antiviral action:
Reprograms virus-infected cells to inhibit various stages of virus replication.
Antitumor action:
Suppresses cell proliferation.
Immunomodulating action:
Enhances phagocytic activity of macrophages and augments specific cytotoxicity of lymphocytes for target cells. IFN is species
specific but not virus specific; it partially inhibits viral replication and is immediately produced at site of viral entry
by any cell; thus, the immune system and the interferon system of defense are complementary.
Has a broad spectrum of antiviral, cytotoxic, and immunomodulating activity (i.e., favorably adjusts immune system to better
combat foreign invasion of antigens and viruses).
To induce hairy cell leukemia remission in splenectomized and nonsplenectomized patients; treatment of hepatitis C, adjunct
to surgery for malignant melanoma.
Chronic hepatitis B virus infection, solid tumors, human papillomavirus (HPV)-associated diseases, AIDS associated Kaposi's
sarcoma.
Hypersensitivity to alpha interferons or any component of product and to mouse immunoglobulin. Safe use during pregnancy (category
C), lactation, or by children <18 y is not established.
Cardiac disease or history of cardiac illness, severe cardiac, renal, or hepatic disease; seizure disorders, compromised CNS
function; myelosuppression; chickenpox (existing or recent, including recent exposure), herpes zoster.
Hairy Cell Leukemia Adult: SC/IM 3 million U/d for 1624 wk, may be reduced to 3 times/wk for maintenance therapy
AIDS-related Kaposi's Sarcoma Adult: SC/IM 36 million U/d for 1012 wk, may then be reduced to 3 times/wk
Genital and Anal Warts Adult: Intralesional 1 million U injected in each lesion 3 times/wk on alternate days for 3 wk
Chronic Viral Hepatitis Adult: SC/IM 13 million U/d for 1 wk, then 3 times/wk for 4852 wk
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Note: IFN should be administered under the guidance of a qualified physician.
Subcutaneous/Intramuscular
- Reconstitute by adding supplied diluent to the sterile powder vial.
- Use reconstituted solutions within 30 d. Inspect solution for particulate matter and discoloration before administration.
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Note: SC administration is recommended especially for patient who is at risk for bleeding (platelet count less than 50,000).
- Store sterile powder and its accompanying diluent, reconstituted solution, and injectable solution in refrigerator at 2°8°
C (36°46° F). Do not freeze or shake solution.
Body as a Whole:
Flu-like syndrome (fever, chills, myalgia, headache).
CNS:
Fatigue, dizziness, confusion, paresthesias, lethargy, psychosis, depression, nervousness, forgetfulness. CV: Dyspnea, edema, hypertension, palpitations. GI:
Nausea, vomiting, diarrhea, anorexia, abdominal pain, change in taste, mild to moderate hepatotoxicity. Hematologic: Leukopenia, neutropenia, thrombocytopenia, myelosuppression. Skin:
Rash, dry skin, pruritus, partial alopecia (eyelash growth increases), urticaria, reactivation of herpes labialis. Respiratory: Dryness or inflammation of oropharynx, coughing. Other: Transient impotence, arthralgia.
Decreased Hgb, Hct; elevated fasting blood sugar, serum phosphorus, serum creatinine, AST, ALT, alkaline phosphatase, LDH;
hypocalcemia.
Drug: May increase theophylline levels; additive myelosuppression with antineoplastics, zidovudine may increase hematologic toxicity, increase doxorubicin toxicity, increase neurotoxicity with vinblastine.
Aldesleukin (IL-2) may potentiate the risk of renal failure.
Absorption: Well absorbed after IM or SC injection. Peak: 1560 min IV; 18 h IM. Distribution: Widely distributed, concentrating in spleen, kidney, liver, and lung. Metabolism: Metabolized principally in kidney. Half-Life: 5.1 h.
Assessment & Drug Effects
- Lab tests: Establish baseline data for CBC and platelet count, peripheral and bone marrow hairy cells, liver and renal function.
Monitor monthly during treatment.
- Monitor I&O ratio and pattern. Patient should be well hydrated during early stages of treatment. Encourage increased intake
to at least 2500 mL if tolerated.
- Be aware of potential side effects. If detected early, most are reversible.
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Note: Flu-like syndrome (fever, chills) occurs in most patients 26 h after a dose of IFN. Anorexia may persist after such
an episode. Symptoms tend to lessen with continued therapy.
- Monitor for ecchymoses, petechiae, unexplained bleeding.
- Monitor BP, vital signs, and cardiac function. Older adults are particularly susceptible to cardiotoxicity.
- Monitor for gait difficulty, dizziness, and hypotension. Advise against hazardous activity until response to drug is known.
- Monitor for oral superinfection with Candida albicans. Alert physician if stomatitis (sore mouth with ulceration), gingivitis, or white patches on oropharyngeal membrane surfaces
are evidenced.
Patient & Family Education
- Understand the risks of severe and even fatal adverse reactions as well as the benefits from IFN therapy.
- Learn to self-administer after therapy is well established. Read and keep handy patient information sheet about IFN.
- Avoid exposure to infection during nadir period.
- Follow up with careful periodic neuropsychiatric monitoring.
- Notify physician promptly if symptoms of infection develop (sore throat, fever, vomiting, diarrhea).
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Note: Fertile, nonpregnant women need to use effective contraception.
- Do not change brands of interferon alfa without first consulting the physician (because of risk of dosage change).
- Do not breast feed while taking this drug without consulting physician.