- What is daclatasvir (Daklinza)?
- What brand names are available for daclatasvir?
- Is daclatasvir (Daklinza) available as a generic drug?
- Do I need a prescription for daclatasvir (Daklinza)?
- What are the uses for daclatasvir (Daklinza)?
- What are the side effects of daclatasvir (Daklinza)?
- What is the dosage for daclatasvir (Daklinza)?
- Which drugs or supplements interact with daclatasvir (Daklinza)?
- Is daclatasvir (Daklinza) safe to use during pregnancy or while breastfeeding?
- What else should I know about daclatasvir (Daklinza)?
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 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:
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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.
- Rifampin, carbamazepine, phenytoin, and St. John's wort may reduce blood levels of daclatasvir and reduce its effectiveness by increasing its metabolism (break-down) in the intestine. Therefore, daclatasvir should not be combined with rifampin, carbamazepine (Tegretol, Tegretol XR, Equetro, Carbatrol), phenytoin (Dilantin, Dilantin-125), or St. John's wort.
Other drugs that also may reduce blood levels of Daclatasvir include:
- nafcillin (Nafcil)
- bosentan (Tracleer)
- nevirapine (Viramune)
- dexamethasone (Decadron)
- efavirenz (Sustiva)
- atazanavir (Reyataz)
- darunavir (Prezista)
- lopinavir/ritonavir (Kaletra)
- etravirine (Intelence)
- modafanil (Provigil)
Drugs that increase blood levels of daclatasvir by reducing its break down in the liver include:
- atazanavir (Reyataz) with ritonavir (Norvir)
- nelfinavir (Viracept)
- indinavir (Crixivan)
- saquinavir (Invirase)
- clarithromycin (Biaxin)
- itraconazole (Sporanox)
- nefazodone (Serzone)
- posaconazole (Noxafil)
- telithromycin (Ketek)
- voriconazole (Vfend)
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?
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.
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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:
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.