Generic Name and Formulations:
Daclatasvir 30mg, 60mg; tabs.

Company:
Bristol-Myers Squibb
Indications for DAKLINZA:
In combination with sofosbuvir, to treat chronic HCV genotype 3 infection.

Limitations Of use:
Reduced SVR rates in genotype 3-infected patients with cirrhosis receiving daclatasvir with sofosbuvir for 12 weeks.

Adult:
≥18yrs: 60mg once daily for 12 weeks (with sofosbuvir). Concomitant strong CYP3A inhibitors (eg, clarithromycin, itraconazole, ketoconazole, ritonavir): reduce to 30mg once daily. Concomitant moderate CYP3A inducers (eg, bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine): increase to 90mg once daily. If sofosbuvir is permanently discontinued, daclatasvir should also be discontinued.

Children:
<18yrs: not established.

Contraindications:
Concomitant strong CYP3A inducers (eg, phenytoin, carbamazepine, rifampin, St. John’s wort).

Warnings/Precautions:
Increased risk of symptomatic bradycardia when concomitant amiodarone and with sofosbuvir, esp. in patients taking beta-blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Decompensated cirrhosis. Liver transplant patients. Pregnancy. Nursing mothers.

Interactions:
See Adults & Contraindications. Concomitant amiodarone with daclatasvir in combination with sofosbuvir: not recommended; if no alternatives, monitor cardiac function. May potentiate P-gp, OATP 1B1, OATP 1B3, or BCRP substrates, statins (monitor). May be potentiated by strong CYP3A inhibitors. Concomitant moderate CYP3A inhibitors (eg, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil); monitor. Potentiates dabigatran etexilate mesylate: not recommended in specific renal impairment groups (see full labeling). Concomitant digoxin: if already on daclatasvir, initiate digoxin at lowest appropriate dose and monitor; if already receiving digoxin prior to daclatasvir initiation, reduce digoxin dose by 30–50% or modify dosing frequency and monitor.

Pharmacological Class:
HCV NS5A inhibitor.

Adverse Reactions:
Headache, fatigue, nausea, diarrhea; symptomatic bradycardia.

Note:
For sofosbuvir specific dosing and safety information, refer to the prescribing information.

Generic Availability:
NO

How Supplied:
Tabs—28