Adult Dosing
Chronic Hepatitis C
- 3 MIU 3x/wk SC x12 months (48-52 wks
- Alt: 6 MIU 3x/wk for the first 3 months (12 wks) followed by 3 MIU 3x/wk for 9 months (36 wks)
- 3 MIU 3x/wk or 6 MIU 3x/wk x6-12 months for retreatment following relapse
Notes:- Patients responding to this drug with a reduction in ALT should complete 12 months of treatment
- Consider discontinuation of therapy in patients who do not respond to this drug within 3 months of therapy
- If required retreat patients who tolerate and partially or completely respond to therapy with this drug but conditions relapse following its discontinuation
- Temporary reduce dose by 50% in patients who do not tolerate the prescribed dose; on resolution of adverse events re-initiate treatment with the original prescribed dose
- Cessation of therapy at least temporarily is recommended in patients who cannot tolerate the reduced dose
Chronic myelogenous leukemia
- 9 MIU/day SC
- Alt: 3 MIU/day x3 days, then 6 MIU/day x3 days, then 9 MIU/day for the duration of therapy for improving short-term tolerance
Notes:- Perform diagnosis of Philadelphia chromosome positive CMI in chronic phase by the appropriate peripheral blood bone marrow and other diagnostic testing prior to initiation of therapy
- Monitor hematologic parameters regularly
Hairy cell leukemia
- Induction dose
- 3 MIU/day for 16-24 wks SC
Notes:- Discontinue therapy if patients does not respond within 6 months
- Reduce dose by one-half or withhold individual doses on development of severe adverse reactions
- Perform tests to quantitate peripheral blood hemoglobin, platelets, granulocytes and hairy cells and bone marrow hairy cells prior to initiation of therapy and periodically
Pediatric Dosing
Chronic myelogenous leukemia
Notes:- Perform diagnosis of Philadelphia chromosome positive CMI in chronic phase by the appropriate peripheral blood bone marrow and other diagnostic testing prior to initiation of therapy
- Monitor hematologic parameters regularly
[Outline]
Renal impairment (Based on CrCl)
- <50 mL/min: Use with caution; dose adjustments not defined
Hepatic impairment
- Child-Pugh class B and C: Contraindicated
See Supplemental Patient Information
- Administer this drug under the guidance of a qualified physician. Adequate facilities are essential for appropriate management of the therapy and its complications
- Depression and suicidal behavior including suicidal ideation, suicidal attempts and suicides may occur in association with therapy in patients with and without previous psychiatric illness. Closely monitor patients for the occurrence of depressive symptomatology. Consider psychiatric intervention and or cessation of treatment in patients experiencing depression. Depression may persist and suicides may occur after withdrawal of therapy. Decreased mental status, dizziness, impaired memory, agitation, manic behavior and psychotic reactions may occur. Rare occasions of severe obtundation and coma may also occur. Careful periodic neuropsychiatric monitoring of all patients is essential
- Acute, self-limited toxicities (i.e. fever, chills) frequently associated with administration of this drug may exacerbate preexisting cardiac conditions. Rare occasions of myocardial infarction, cardiomyopathy may occur
- Rare occasions of serious, acute hypersensitivity reactions (e.g. urticaria, angioedema, bronchoconstriction and anaphylaxis) as well as skin rashes may occur. On development of a serious reaction during treatment with this drug discontinue treatment and immediately institute appropriate medical therapy. Transient rashes does not warrants interruption of therapy
- Transient liver abnormalities in patients with poorly compensated liver disease may result in increased ascites, hepatic failure or death on initiation of therapy in chronic hepatitis C
- Infrequent severe or fatal GI hemorrhage may occur in association with this drug. Ulcerative and hemorrhagic/ischemic colitis, sometimes fatal may occur within 12 wks after initiation of therapy. Immediately discontinue this drug on development of symptoms of these disease
- Fever associated with the flu-like syndrome may occur during therapy. Serious and severe infections (bacterial, viral, fungal) of which some may be fatal may occur. Immediately start appropriate anti-infective therapy and consider discontinuation of therapy
- This drug suppresses bone marrow function and may result in severe cytopenias and anemia including very rare events of aplastic anemia. Cytopenias (e.g., leukopenia, thrombocytopenia) may lead to an increased risk of infections or hemorrhage. Prior to therapy obtain complete blood counts (CBC) and routinely monitor during therapy. Discontinue therapy in patients who develop severe reduction in neutrophil (<0.5 x 109/L) or platelet counts (<25 x 109/L). Synergistic toxicity may occur when this drug is administered in combination with zidovudine
- Hypothyroidism and hyperthyroidism may be aggravated. Hyperglycemia may occur in patients treated with this drug. Measure blood glucose in symptomatic patients and follow-up accordingly. Adjustment of their anti-diabetic regimen may require in patients with diabetes mellitus
- Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis of which some resulting in respiratory failure and or patient deaths may be induced or aggravated. Discontinue treatment in patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment
- Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, and papilledema are induced or aggravated following therapy with this drug. Perform ocular examination at baseline. Perform periodic ophthalmologic examination during therapy in patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy). Perform prompt and complete eye examination in patients who develop ocular symptoms. Discontinue therapy in patients who develop new or worsening ophthalmologic disorders
- Pancreatitis may occur in patients receiving this drug including those who developed marked triglyceride elevations; fatalities may occur in some cases. Suspend therapy on development of symptoms or signs suggestive of pancreatitis. Consider discontinuation of therapy in patients diagnosed with pancreatitis
- In instances where the use of this drug is considered for chemotherapy evaluate the need and usefulness of the drug against the risk of adverse reactions. On occurrence of severe reactions reduce the drug in dosage or discontinue and undertake appropriate corrective measures according to the clinical judgment of the physician. Exercise caution during reinstitution of therapy with adequate consideration of the further need for the drug and maintain alertness for possible recurrence of toxicity
- The minimum effective doses of this drug for treatment of hairy cell leukemia and chronic myelogenous leukemia have not been evaluated
- Using different brands of interferon in a single treatment regimen is not recommended
- The safety and efficacy of this drug has not been established in organ transplant recipients
- Severe renal toxicities, sometimes requiring renal dialysis may occur with alpha-interferon therapy alone or in combination with IL-2. Closely monitor signs and symptoms of interferon toxicity in patients with impaired renal function
- Development or exacerbation of autoimmune diseases including idiopathic thrombocytopenic purpura, vasculitis, Raynaud's phenomenon, rheumatoid arthritis, psoriasis, interstitial nephrtis, thyroiditis, lupus erythematosus, hepatitis, myositis and rhabdomyolysis may occur. Closely monitor patients developing an autoimmune disorder during treatment and if appropriate discontinue therapy
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Seizure disorders
- Compromised CNS function
- History of depression
- Cardiac disease
- History of cardiac illness
- Myelosuppression
- Combination with agents inducing myelosuppression
Supplemental Patient Information
- Inform patients that depression and suicidal ideation may be side effects of treatment and advise them to report these side effects immediately to the prescribing physician
- Caution patients against performing tasks that require complete mental alertness such as operating machinery or driving a motor vehicle
Pregnancy Category:C
Breastfeeding: Unknown whether this drug is excreted in human milk. According to manufacturer's data a decision should be made for discontinuing nursing or the drug taking into account the importance of the drug to the mother.
18 yrs of age
