Adult Dosing
Chronic Hepatitis C
Monotherapy
Combination therapy with ribavirin
- Genotype 1, 4: 180 mcg SC qwk x 48 wks
- Genotype 2, 3: 180 mcg SC qwk x 24 wks
Note:
- Refer package insert of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen, duration and administration of the protease inhibitor in combination with Pegasys and ribavirin
HIV Coinfection
- Monotherapy:180 mcg SC qwk x 48 wks
- Combination therapy with ribavirin: 180 mcg SC qwk x 48 wks irrespective of genotype
Note:
- Discontinue the therapy if patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA titer by 12 wks or undetectable HCV RNA after 24 wks of therapy
Chronic Hepatitis B
Note:
- For toxicity related dose adjustments see package insert
Pediatric Dosing
- Safety and efficacy in pediatric patients <5 years old have not been established
Chronic Hepatitis C
Combination therapy with ribavirin
- 180 mcg/1.73 m2 x BSA SC qwk x 24 wks (genotype 2 or 3) and 48 wks (other genotypes)
Note:
- Refer package insert of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen, duration and administration of the protease inhibitor in combination with Pegasys and ribavirin
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Renal impairment
- <30 mL/min: Reduce dose to 135 mcg; if severe adverse reaction reduce to 90 mcg
- Hemodialysis: Reduce dose to 135 mcg
Hepatic Dose Adjustment
- Hepatic impairment
- Increase in ALT level above base line: Reduce dose to 135 mcg with frequent monitoring of liver function
- Progressive increase in ALT despite dose reduction or accompanied by increased bilirubin: Discontinue therapy
- Autoimmune hepatitis: Contraindicated
- Hepatic decompensation (Child-Pugh class B and C) in cirrhotic patients: Contraindicated
- Hepatic decompensation (Child-Pugh class B and C) with HIV: Contraindicated
Adult with moderate to severe adverse reactions
- Reduce peginterferon alfa-2a to 135 mcg/wk. May reduce further to 90 mcg/wk if adverse reactions persist.
- Consider dose re-escalation if adverse events improves
Pediatric with moderate to severe adverse reactions
- Reduce peginterferon alfa-2a to 135 mcg/1.73 m2 x BSA once weekly. May further reduce to 90 mcg/1.73 m2 x BSA once weekly x BSA or to 45 mcg/1.73 m2 x BSA once weekly.
- Adjust dosage up to 3 times before discontinuing therapy
Adult neutropenia
- If ANC is less than 750 cells/mm3, decrease dose to 135 mcg/wk. If ANC is less than 500 cells/mm3 discontinue treatment. Restart peginterferon alfa-2a at 90 mcg/wk when the ANC is greater than 1000 cells/mm3 and monitor closely
Pediatric neutropenia
- If ANC 750-999 cells/mm3 during weeks 1 or 2 of therapy, reduce dose to 135 mcg/1.73 m2 x BSA once weekly. During weeks 3 to 48, no dose adjustment needed.
- If ANC 500 to 749 cells/mm3during weeks 1 or 2 of therapy, delay or hold peginterferon alfa-2a until ANC is greater then 750 cells/mm3, then resume at 135 mcg/1.73 m2 x BSA once weekly. Monitor weekly for 3 consecutive readings above 750 cells/mm3. During weeks 3 to 48 of therapy modify the dosage to 135 mcg/1.73 m2 x BSA once weekly.
- If ANC 250 to 499 cells/mm3 during weeks 1 or 2 of therapy, delay or hold peginterferon alfa-2a until ANC is greater then 750 cells/mm3, then resume at 90 mcg/1.73 m2 x BSA once weekly. Monitor weekly for 3 consecutive readings above 750 cells/mm3 then resume at 90 mcg/1.73 m2 x BSA once weekly. During weeks 3 to 48 of therapy delay or hold therapy until ANC is greater than 750 cells/mm3, then resume at 135 mcg/1.73 m2 x BSA once weekly.
Adult Depression
- Dosage may need adjustment in moderate depression. Decrease peginterferon alfa-2a to 135 mcg/wk. Some patients may need further dosage reductions to 90 mcg/wk. Monitor closely and obtain psychiatric consultation
Pediatric Depression
- Dosage may need adjustment in moderate depression. Decrease peginterferon alfa-2a to 135 mcg/1.73 m2 x BSA once weekly. Some patients may need further dosage reductions to 90-45 mcg/1.73 m2 x BSA once weekly. Monitor closely and obtain psychiatric consultation
- Monitor the patient for life threatening conditions and withdraw the therapy if there are persistently severe or worsening signs or symptoms [US Black Box Warning]
- Combination therapy with ribavirin can cause birth defects and/or death of the fetus. Before starting the therapy make sure of negative pregnancy test and advise patient to use two forms of effective contraception during treatment and for at least 6 months after treatment [US Black Box Warning]
- Use with Ribavirin can cause hemolytic anemia, with maximum hemoglobin drop during first 8 wks. Evaluate hemoglobin or hematocrit level before treatment and at wk 2 and wk 4 of therapy or more frequently if clinically indicated, during combination therapy with ribavirin [US Black Box Warning]
- Monotherapy is not recommended unless a significant contraindication or intolerance to ribavirin is present
- Asses the patient for underlying cardiac disease before initiation of ribavirin therapy, as fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by ribavirin. Do not use ribavirin in patients with a history of significant or unstable cardiac disease
- Alpha interferon can cause new development or exacerbation of autoimmune disorders like myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and SLE. Use cautiously in patients with prexisting autoimmune disorders
- 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
- Ulcerative and hemorrhagic/ischemic colitis manifested as abdominal pain, bloody diarrhea, and fever, sometimes fatal may occur within 12 wks after initiation of therapy. Immediately discontinue this drug on development of symptoms of these disease
- Life-threatening or fatal neuropsychiatric reactions including suicide, suicidal ideation, homicidal ideation, depression, relapse of drug addiction, and drug overdose, with and without previous psychiatric illness has been reported with peginterferon alfa 2a therapy
- Concomitant use of ribavirin can cause birth defects and/or death of the fetus. Hence extreme care should be taken to avoid pregnancy in female patients and in female partners of male patients
- Exacerbations of hepatitis during hepatitis B therapy characterized by severe increases in serum ALT have been reported. Monitor the patient with ALT flares more frequently and consider dose reduction. Discontinue the therapy if evidence of hepatic decompensation
- Chronic hepatitis C patients with cirrhosis and those coinfected with HIV receiving highly active antiretroviral therapy are at risk of hepatic decompensation and death when treated with alpha interferons
- Ischemic and hemorrhagic cerebrovascular events has been reported in patients treated with interferon alfa
- Pancytopenia with concomitant use of azathioprine has been reported. Discontinue therapy if occurs
- Hypertension, supraventricular arrhythmias, chest pain, and myocardial infarction have been reported with peginterferon alfa 2a therapy. Use cautiously in patients with pre-existing cardiac disease
- Monitor all the patients on peginterferon alfa 2a therapy for evidence of depression and other psychiatric symptoms. In severe cases discontinue the therapy immediately and institute psychiatric treatment
- Peginterferon alfa 2a can cause bone marrow suppression resulting into severe cytopenias. Ribavirin may potentiate the neutropenia and lymphopenia induced by alpha interferons. Obtain CBC at baseline and periodically thereafter
- Endocrine disorders such as hypothyroidism, hyperthyroidism hyperglycemia, hypoglycemia, and diabetes mellitus has been observed to develop in patients treated with peginterferon alfa 2a. Do not start interferon therapy if these conditions preexist and if patient develops it during treatment, discontinue the therapy
- 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
- Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis resulting in respiratory failure and/or patient deaths has been reported with alpha interferon therapy. Discontinue treatment in patients who develop persistent or unexplained pulmonary infiltrates or pulmonary function impairment
- Pancreatitis may occur in patients receiving this drug; fatalities may occur in some cases. Suspend therapy on development of symptoms or signs suggestive of pancreatitis and discontinue in patients diagnosed with pancreatitis
- Serious, acute hypersensitivity reactions (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
- Delay in weight and height was observed in pediatric patients after 48 wks of treatment with combination of peginterferon alfa 2a and ribavirin as compared with baseline
- Peripheral neuropathy has been reported with alpha interferons and telbivudine combination therapy
- My reduce growth velocity in pediatric patients in combination with ribavirin
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- History of depression
- History of cardiac disease
- Myelosuppression
- Autoimmune disorders
- Eye diseases
- Pulmonary diseases
- Neutrophil counts <1,500 cells/mm3
- Platelet count <90,000 cells/mm3
- Hemoglobin <10 g/dL
- Cardiac Disease
Pregnancy Category:X
Breastfeeding: The effect of orally ingested peginterferon on the nursing infant has not been evaluated. It is not known whether peginterferon or its components are excreted in human milk. Because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue the treatment.
Pricing data from www.DrugStore.com in U.S.A.
- Pegasys 180 MCG/ML SOLN [Vial] (GENENTECH)
1 ml = $700
4 ml = $2699.91 - Pegasys 180 MCG/0.5ML KIT [Box] (GENENTECH)
1 0.5ml = $2454.02
3 0.5ml = $7333.28
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
