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See related Pegasys pre-filled inj information |
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Manufacturer |
Roche |
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Distributor |
DKSH |
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Contents |
Peginterferon α-2a |
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Indications |
Treatment of both HBeAg positive & HBeAg negative chronic hepatitis B (CHB) in noncirrhotic & cirrhotic patients w/ compensated liver disease, evidence of viral replication & liver inflammation. Used alone or in combination w/ Copegus (ribavirin) in chronic hepatitis C for both naive patients & patients w/ prior treatment failure in noncirrhotic and cirrhotic patients w/ compensated liver disease. HIV-HCV co-infection.
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Dosage |
Chronic hepatitis C Monotherapy: 180 mcg SC once wkly for 48 wk. Combination w/ ribavirin depends on viral genotype. Genotype 1, 4: 180 mcg SC once wkly + ribavirin 1,000-1,200 mg daily for 48 wk. Treatment for 24 wk may be considered in genotype 1 w/ low viral load (LVL)(≤800,000 IU/mL) at baseline & become HCV RNA-negative at wk 4. Treatment for 24 wk may be considered in genotype 4 who become HCV RNA-negative at wk 4. Genotype 2, 3: 180 mcg once wkly + ribavirin 800 mg daily for 24 wk. Treatment for 16 wk may be considered in genotype 2, 3 w/ LVL (≤800,000 IU/mL) at baseline & become HCV RNA-negative at wk 4. Chronic hepatitis B (both HBeAg positive & HBeAg negative) 180 mcg SC once wkly for 48 wk.
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Overdosage |
View Pegasys overdosage for action to be taken in the event of an overdose. |
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Contraindications |
Autoimmune hepatitis, neonates & infants up to 3 yr, decompensated hepatic disease, HIV-HCV w/ cirrhosis & a child-pugh score ≥6.
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Special Precautions |
History of depression, preexisting cardiac disease, autoimmune disorders, myelodepression; baseline neutrophil count <1,500 cells/mm3, baseline platelet count <75,000 cells/mm3 or hemoglobin decrease <10 g/dL; psoriasis. Perform complete blood counts prior to initiation of therapy & monitor routinely during therapy. Avoid driving or operating machinery.
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Adverse Drug Reactions |
Fatigue, rigors, pyrexia, inj site reaction, pain, GI disorders, anorexia, myalgia, arthralgia, back pain, headache, insomnia, dizziness, conc impairment, depression, irritability, alopecia, pruritus.
View ADR Monitoring Form |
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Drug Interactions |
Increase in AUC of theophylline.
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Pregnancy Category (US FDA) |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
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Caution For Usage |
For caution against possible variation of physical aspect of medicine... click to view Pegasys detailed prescribing infomation |
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Storage |
View Pegasys storage conditions for details to ensure optimal shelf-life. |
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Description |
View Pegasys description for details of the chemical structure and excipients (inactive components). |
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Mechanism of Action |
View Pegasys mechanism of action for pharmacodynamics and pharmacokinetics details. |
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