Interferon alfa 2b 3 million i.u./ 5million i.u injection,
|3 million i.u||641.11||vial injection|
|5 milion i.u.||884.00||vial injection|
List of Related Indications:
- Chronic Hepatitis B
List Of Drugs:
- Interferon alpha 2b @ (July 1982)
Indication Type Description:
Dosages/ Overdosage Etc
Pregnancy and lactation
Body as a whole- abcess, cachexia, dehydartion, fungal infection, herpes zoster, hyperecalcemia, lymphadenopathy periphreal edema, stye, substernal chest pain, trichomonliasis, viral infection, weakness.
Cardiovascular- arrhthmia, artial fibrillation, bradycardia, cardiacfailure, cardiomyopathy, extrasystoles, hypertension,hypotension, palpitations, postural hypotension, tachycardia,
CNS- abnormal coordination, dreaming, gait and thinking, aggravated depression, aggresive reaction. agitation, apathy,apasisa, ataxia, CNS dysfunction, coma, convulsions, dysphonia, emotional lability, extrapyradimal disoreder, feeling of flushing , hot flashes, hyperesthesia, hyperkinesia, hypertonia, hypokinesia, impaired consciouness,migraine, neuropathy, neurosis, paresis, paroniria, parosmia, personality disorder,polyneuropathy, sucide attempt,syncope, tremor.
Dermatologic- abnormal hair texture, acne, cyanosis of the hand, cold/clammy skin, dermatitis lichenoids, epidermal necrolysis, erythema, folliculitis, furunculosis, increased hair growth, lipoma, melanosis, nail disorders, nonherpetic cold sores, depigmenation, skin discoloration.
Endocrine- aggravation of diabetes mellitus, gynaecomastia, thyroid disorder, virilism
GI- abdominal distention, acites, dysphagia, eructation, esophagitis, flatulence, gall stones, gastric ulcer, gastroenteritis, GI haemorrhage, GI mucosaal discoloration, gingival bleeding, gum hyperplasia, hallitosis, increased appetite, increased saliva, melena, oral leukoplakia, rectal bleeding after stool, rectal hemoprrhage, stomatitis,ulcerative stomatitis.
GU- albumin/protein in urine.amenorrhea, impotence, incontinence, increased BUN, hematuria, leukoorhea, menorrhagia, micturation disorder/frequency, nocturia, pelvic pain, polyuria, uterine bleeding
Hematologic- anemia, granuloctopenia, hemolytioc anemia, leukopenia, thrombocytopenia.
Hepatic- abnormal hepatic function, bilirubinemia, increased transaminase, jaundice, right upper quadrant, hepatic encephalopathy, hepatic failure.
Musculoskeletal- arthritis, arthrosis, bone pain, leg cramps
Respiratory- bronchitis, bronchospasm, cyanosis, episataxis, llung fibrosis, pleural pain, pneumonia, rhinitis, rhinorrhea,seneezing, wheezing
Special senses- abnormal/ blurred vision, conjuctivitis, diplopia, dry eyes, earache, eye pain, hearing disorder, lacrimal gland disorder, periorbital edema, photophobia, speech disorder, taste loss, tinnitus, vertigo,
Hypersensitivity, severe pre-existing cardiac disease, myeloid, renal or hepatic impairment, CNS disorders.
Monitoring- in addition to tests normally required for monitoring patients, the following are recommended for all patients on interferon therapy, prior to beginning treatment and periodically thereafter.- Standard blood haemotological tests with complete blood counts and differtial , platelet counts, blood chemistry, electrolytes and liver function tests.
Patients with preexisting cardiac abnormalities or in advanced stages of cancer, should have an ECG taken before and during treatment. Base line- chest X-rays are suggested, repeat if clinically indicated.
For malignant melanoma patients, monitor differential WBC count and liver function tests weekly during the the induction phase of therapy and monthly during the maintenance phase of therapy
Photosentivity- may occur. Therefore caution patients to take protective masures (eg.sinscreens, protective clothing) against exposure to ultraviolet light or sunlight. until tolerance is determined.
Hairy cell leukemia- Monitoring- before initiating therapy, perform tests to quantitate peripheral blood hemoglobin , platelets, granulocytes and bone marrow hairy cells. Do not give IM to patients with polatelets counts < 50,000 /mm3
Cardiovascular- adverse experiences such as significant hypotension, arrhythmias, or tachcardia were observed
. CNS effects- depression, confusion, other alterartions of mental status were seen in aabout 2% of hairy cell leukemia patients.
AIDS related acuminata- do not use 3,5 aand 25 million IU strengths intralesionally, the dilution would result in a hypertonic solution.
AIDS realted Kaposis sarcoma- Monitoring- perform lesuon measurements and blood counts prior to initiation of therapy. Monitor periodically during treatment Rapidly progressive visceral dfisease- do not use
Chronic hepatitis- NANB/C Monitoring- perform liver biopsy to eatablish diagnosis.est for the presence of antibody to HCV.
Prexisting psychiatric condition/history of severe psychiatric disorder- donot treat, discontinue therapy in any patient developing severe depression
Chronic hepatitis B- Monitoring- perform liver biopsy to establish presence of chronic hepatitis and extent of liver damage. Establish that the patient has compensated liver disease.
Hepatic function impairment- chronic hepatitis B patients with evidence of decreasing hepatic synthetic functions (eg decreasing albumin levels prolongation of PT) may be increased risk of clinical decompensation in association with a flare of aminotransferases.
Fever/flu-lke symptoms- because of fecer and othervflu=like symptoms associated withnthis drug, use cautiously in debilating medical conditions such as those with a history of cardiovascular disease.
Pulmonary infiltrates- pneumonitis and pneumonia, including fatality have been observed rarely.
Hypersensitivity reactions- (eg urticaria, angioedema, bronchoconstriction , anaphylaxis ) have not been observed in patients receiving interferon alf-2b.. However,if such aacute reaction develops, discontinue the drug immediately and institute medical therapy.
Hepatic function impairment- do not treat patients with decomponsated liver disease., autoimmuune hepatitis, history of auto-immune disease, or immunosuppressed transplant receipients,. In these patients, worsening liver disease, including jaundice,hepatic encephalopathy, hepatic failure and death have occured following therapy.
Fertility impairment- interferon may imair fertilty. Fertile women should not receive interferon alfa 2b unless they are using effective contraception. Use with caution in fertile men.
Pregnancy- use during pregnancy only if the potential benefit justifies the potential risjk to the fetus.
Lactation- becasue ofvthe potential for serious adverse reactions in nursing infants, decide whether to stop nursing or to stop nursing or to stop the drug, taking into account the importance of the drug to the mother.
Children- safety and efficacy in children < 18 years of age have not been established.
Dosages/ Overdosage Etc:
Indications and dosage:
Chronic myelogenous leukemia-
5MIU s/c for 122- 36 months Chronic hepatitis B: 5 MIU s/c for 16 weeks
Chronic hepatitis C: 3 MIU s/c thrice for 24-48 weeks with ribavirin 1000-1200 mg daily orally for 24-48 weeks
Renal cell carcinoma: 5-10 MIU/m2 administered thrice a week intravenously Multiple myeloma: 2 MIU/m2 thrice a week
Hairy cell leukemia: 2 MIU/m2 administered s/c three times a week AIDs related
Kaposis sarcoma: 50MIU/m2 daily as a 30min IV infusion for 5 consecutive days
Malignant melonoma: 10 MIU/m2 administerd s/c three times a week
Basal cell carcinoma: 1.5MIU intralesionally three times a week on alternate days for three weeks
Non-Hodgins lymphona: 5MIU/m2 s/c three times a week for a period of 18 months
1. Do not change brands of interferon, changes in dosage may result
2. The most common adverse efects are- flu-like symptoms, such as fever,headache, fatigue, anorexia, nausea and vomiting. These appear to decrease in severity as treatment continues.
3. Some of these flu-like symptoms may be minimized by bed time doses.
4. Use acetoaminophen to prevent or partially alleviate fever and headache
The exact mechanisim of action is unknown, but it is known to exert its effects by binding to a membrane receptor. Receptor binding initiates a series of intracellular signalling events that ultimately leads to enhanced expression of certain genes. This leads to the enhancement and induction of cetain cellular activities including augmentation of target cell killing by lymphocytes and inhibition of virus replication in infected cells. IFN is known to have antiviral, antiproliferative and immunomodulatory action.
Following subcutaneous administration of IFN alpha 2b peak plasma concentration is reached at 4 to 5 hrs. It is widely distributed and is excreted primarily through kidney and liver
Pregnancy and lactation:
Use during pregnancy only if the potential benefit justifies the potential risjk to the fetus.
Becasue ofvthe potential for serious adverse reactions in nursing infants, decide whether to stop nursing or to stop nursing or to stop the drug, taking into account the importance of the drug to the mother.
Safety and efficacy in children < 18 years of age have not been established.