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DAKLINZA
Viral infections
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Drug Name:

DAKLINZA Rx

Generic Name and Formulations:
Daclatasvir 30mg, 60mg, 90mg; tabs.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for DAKLINZA:

In combination with sofosbuvir, with or without ribavirin, to treat chronic HCV genotype 1 or 3 infection.

Limitations Of use:

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

Adult:

Test for HBV infection prior to initiation. ≥18yrs: 60mg once daily for 12 weeks (with sofosbuvir). For recommended treatment regimens and duration based on HCV genotype and patient population: see full labeling. Concomitant strong CYP3A inhibitors (eg, clarithromycin, itraconazole, ketoconazole, ritonavir, nefazodone), protease inhibitors, cobicistat-containing regimens (except with darunavir): 30mg once daily. Concomitant moderate CYP3A inducers (eg, bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine, nevirapine): 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). When co-administered with sofosbuvir and ribavirin, their contraindications also apply to this combination regimen (eg, Pregnancy).

Warnings/Precautions:

Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. 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. Pregnancy. Nursing mothers.

Interactions:

See Adult & Contraindications. Concomitant amiodarone with daclatasvir in combination with sofosbuvir: not recommended; if no alternatives, monitor cardiac function. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May potentiate P-gp, OATP 1B1, OATP 1B3, or BCRP substrates, buprenorphine, statins (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 15–30% or modify dosing frequency and monitor.

Pharmacological Class:

HCV NS5A inhibitor.

Adverse Reactions:

Headache, fatigue, nausea, diarrhea; symptomatic bradycardia; with ribavirin: anemia.

Note:

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

Generic Availability:

NO

How Supplied:

Tabs—28

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