Uses of Dasvir 30 mg: - Chronic hepatitis C virus (HCV) infection Chronic hepatitis C virus infection in adults. Hypersensitivity. Co-administration w/ strong CYP3A4 inducers & P-gp eg phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.

Hepatic viral infections (Hepatitis C)

Daclatasvir stops HCV viral RNA replication and protein translation by directly inhibiting HCV protein NS5A. NS5A is critical for HCV viral transcription and translation.

How to use Daclatasvir: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Daclatasvir may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Hepatitis C Indicated for use with sofosbuvir for chronic hepatitis C virus (HCV) genotypes 1 and 3 infection Genotype 1 Without cirrhosis or with compensated (Child-Pugh A) cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks Decompensated (Child-Pugh B or C) cirrhosis or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks Genotype 3 Without cirrhosis: 60 mg (plus sofosbuvir 400 mg) PO qDay for 12 weeks Compensated (Child-Pugh A) or decompensated (Child-Pugh B or C) cirrhosis, or posttransplant: 60 mg (plus sofosbuvir 400 mg) PO qDay plus ribavirin for 12 weeks Hepatic impairment (any degree): No dose adjustment required Renal Dose: Renal impairment (any degree): No dose adjustment required

May lead to lower exposure & loss of efficacy w/ phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone & St. John's wort. Decreased plasma levels & therapeutic effect w/ strong or moderate CYP3A4 & P-gp inducers. Increased plasma levels w/ strong CYP3A4 inhibitors. May increase systemic exposure of P-gp, OATP, 1B1, OCT1 or BCRP substrates. Boceprevir, telaprevir, atazanavir/ritonavir, efavirenz, cobicistat-containing, clarithromycin, telithromycin, erythromycin, dabigatran, etexilate, posaconazole, voriconazole, amiodarone, digoxin, Ca channel blockers, HMG-CoA reductase inhibitors.

Hypersensitivity. Co-administration w/ strong CYP3A4 inducers & P-gp eg phenytoin, carbamazepine, oxcarbazepine, phenobarb, rifampicin, rifabutin, rifapentine, systemic dexamethasone, St. John's wort.

Common - Fatigue - Headache - Nausea - Insomnia (difficulty in sleeping) - Anemia (low number of red blood cells) >10% Headache (14%),Fatigue (14%) 1-10% Nausea (8%),Diarrhea (5%),Elevated lipase, >3 x ULN (2%)

Daclatasvir should not be used during pregnancy or in women of childbearing potential not using contraception. Use of highly effective contraception should be continued for 5 weeks after completion of Daclatasvir therapy. It is not known whether daclatasvir is excreted in human milk.

Precaution: Patients w/ genotype 1 infection & compensated cirrhosis; receiving amiodarone; decompensated liver disease; prior exposure to a NS5A inhibitor; pre-, peri- or post-liver transplant or other organ transplant; HIV/HCV, HBV co-infected patients. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Women of childbearing potential. Pregnancy & lactation. Childn & adolescents <18 yr. Lactation Unknown if distributed in human breast milk

There is no known antidote for overdose of Daclatasvir. Treatment of overdose with Daclatasvir should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Because Daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

Store at room temperature below 30°C, protect from light. keep out of the reach of children.

Hepatic viral infections (Hepatitis C)

Inhibits NS5A, a nonstructural protein encoded by HCV. Binds to the N-terminus within domain 1 of NS5A, which may cause structural distortions that interfere with NS5A functions, and thereby inhibits both viral RNA replication and virion assembly.

Pregnancy No data in pregnant women are available If daclatasvir and sofosbuvir are administered with ribavirin, the warnings and precautions for ribavirin, in particular the pregnancy avoidance warning, apply to this combination regimen (see ribavirin prescribing information) Lactation Unknown if distributed in human breast milk The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition