Zifam Pinnacle


Pinnacle House
Concise Prescribing Info
Combination therapy w/ other medicinal products for chronic HCV infection in adults.
Dosage/Direction for Use
60 mg once daily. HCV genotype 1 or 4 w/o cirrhosis Daclatasvir + sofosbuvir for 12 wk. Consider prolonging to 24 wk for patients w/ prior treatment including an NS3/4A PI, genotype 1 or 4 w/ compensated cirrhosis Daclatasvir + sofosbuvir for 24 wk. Consider shortening to 12 wk for previously untreated patients w/ cirrhosis & positive prognostic factors (eg, IL28B CC genotype &/or low baseline viral load), & adding ribavirin for patients w/ very advanced liver disease or w/ other negative prognostic factors (prior treatment experience), genotype 3 w/o cirrhosis Daclatasvir + sofosbuvir for 12 wk. May be added w/ ribavirin for 24 wk, genotype 4 Daclatasvir for 24 wk in combination w/ peginterferon α + ribavirin for 24-48 wk. If patient has undetectable HCV RNA at both wk 4 & 12, continue all 3 components for a total of 24 wk. If patient achieves undetectable HCV RNA but not at both wk 4 & 12, discontinue Daclatasvir at 24 wk & continue peginterferon α & ribavirin for a total of 48 wk. Co-administration w/ strong CYP3A4 inhibitors 30 mg once daily, moderate CYP3A4 inducers 90 mg once daily.
May be taken with or without food.
Hypersensitivity. Co-administration w/ strong CYP3A4 & P-gp inducers eg, phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.
Special Precautions
Not to be administered as monotherapy. Patients w/ HCV genotypes 5 & 6. Concomitant use w/ sofosbuvir in combination w/ amiodarone w/ or w/o drugs that lower heart rate. Not to be used during pregnancy & lactation or by women of childbearing potential not using contraception.
Adverse Reactions
Fatigue, headache, nausea. Dizziness. Combination therapy w/ peginterferon α & ribavirin: Pruritus, anaemia, influenza-like illness, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrexia, myalgia, irritability, cough, diarrhoea, dyspnoea, arthralgia. Attention disturbance, blurred vision & reduced visual acuity.
Drug Interactions
Boceprevir, telaprevir, atazanavir/ritonavir, cobicistat, atazanavir/cobicistat, clarithromycin, telithromycin, ketoconazole, other strong CYP3A4 inhibitors; efavirenz; dabigatran etexilate or other intestinal P-gp substrates w/ a narrow therapeutic range; digoxin; rosuvastatin or other substrates of OATP1B1 or BRCP. Co-administration w/ etravirine or nevirapine is not recommended. May have increased conc w/ erythromycin, Ca channel blockers, verapamil. Modest increases in conc w/ fluconazole.
MIMS Class
ATC Classification
J05AP07 - daclatasvir ; Belongs to the class of antivirals for treatment of HCV infections. Used in the treatment of hepatitis C viral infections.
Dacatec FC tab 60 mg
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