daclatasvir (Daklinza)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

blood test hepatitis C std lab

What is daclatasvir (Daklinza)?

Daclatasvir (Daklinza) is an oral tablet used for the treatment of chronic infection with the hepatitis C virus (HCV), genotype 1 or 3. It belongs to a class of drugs called direct-acting antiviral agents (DAAs). Similar drugs include:

  • boceprevir (Victrelis)
  • sofosbuvir (Sovaldi)
  • simeprevir (Olysio)
  • telaprevir (Incivek)
  • Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir)
  • ledipasvir and sofosbuvir (Harvoni)
  • elbasvir and grazoprevir (Zepatier)

What brand names are available for daclatasvir?

  • Daklinza is the only brand available for daclatasvir in the US.

Quick GuideHepatitis C (Hep C) Symptoms and Treatment

Hepatitis C (Hep C) Symptoms and Treatment

Is daclatasvir (Daklinza) available as a generic drug?

  • No

Do I need a prescription for daclatasvir (Daklinza)?

  • Yes

What are the uses for daclatasvir (Daklinza)?

What are the side effects of daclatasvir (Daklinza)?

Common side effects include:

Other side effects include:

Serious side effects include:

  • Severe reduction in heart rate (bradycardia) has occurred in people who were treated with daclatasvir and sofosbuvir while also being treated with amiodarone (Cordarone).
  • Daclatasvir may cause reactivation of hepatitis B virus (HBV) in people who are infected with HBV and HCV.

Quick GuideHepatitis C (Hep C) Symptoms and Treatment

Hepatitis C (Hep C) Symptoms and Treatment

What is the dosage for daclatasvir (Daklinza)?

  • The recommended dose of daclatasvir is 60 mg once daily with or without food for 12 weeks.
  • Daclatasvir is used in combination with sofosbuvir.
  • The dose should be reduced to 30 mg once daily when drugs that block the breakdown of daclatasvir are being used.
  • The dose should be increased to 90 mg once daily when drugs that increase the breakdown of daclatasvir are being used. (See the drug interactions section for examples of interacting drugs.)

Which drugs or supplements interact with daclatasvir (Daklinza)?

Daclatasvir has many drug interactions.

Other drugs that also may reduce blood levels of Daclatasvir include:

Drugs that increase blood levels of daclatasvir by reducing its break down in the liver include:

Daclatasvir increases blood levels of

Side effects of statins such as muscle pain should be monitored.

Daclatasvir also increases blood levels of

Is daclatasvir (Daklinza) safe to use during pregnancy or while breastfeeding?

  • Daclatasvir has not been adequately evaluated in pregnant women. However, ribavirin, which may be combined with daclatasvir, should not be used by pregnant women or their male partners.
  • It is not known whether daclatasvir is secreted into breast milk.

What else should I know about daclatasvir (Daklinza)?

What preparations of daclatasvir (Daklinza) are available?
  • Tablets: 30 and 60 mg
How should I keep daclatasvir (Daklinza) stored?
  • Daclatasvir should be stored at room temperature, between 20 C to 25 C (68 F to 77 F).
How does daclatasvir (Daklinza) work?
  • Daclatasvir directly blocks replication of HCV by interfering with a hepatitis C virus protein called nonstructural protein 5A (NS5A). Daclatasvir interferes with proteins and processes needed by hepatitis C virus to multiply and make new viruses, thus reducing the overall viral load. The efficacy of Daclatasvir has been established in subjects with hepatitis C virus genotypes 1 and 3.
  • Daclatasvir is given with sofosbuvir and may be administered with or without ribavirin. In clinical studies, 95% of patients were cured after 12 weeks of treatment with daclatasvir plus sofosbuvir with or without ribavirin. Cure was defined as undetectable levels of hepatitis C virus in the blood when measured three months after the completion of treatment.
When was daclatasvir (Daklinza) approved by the FDA?
  • The FDA approved daclatasvir in February 2016.

REFERENCE: FDA Prescribing Information

Quick GuideHepatitis C (Hep C) Symptoms and Treatment

Hepatitis C (Hep C) Symptoms and Treatment

Summary

Daclatasvir (Daklinza) is a prescription medication used in combination with sofosbuvir to treat chronic hepatitis C (HCV) genotype 1 or 3 infection. Daclatasvir belongs to the class of drugs called direct-acting antiviral agents (DAAs). Side effects include:

Drug interactions, dosing, and pregnancy and breastfeeding information should be reviewed prior to taking any medication.

Treatment & Diagnosis

Medications & Supplements

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Reviewed on 1/6/2017
References
REFERENCE: FDA Prescribing Information

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