daclatasvir (Daklinza): Hep C Drug Side Effects & Dosage

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.

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)?

• Daclatasvir is used in combination with
  sofosbuvir
  (Sovaldi) for the treatment of
  chronic
  hepatitis C genotype 1 or 3 infection. It may be used with or without
  ribavirin (Rebetol, Ribasphere).

What are the side effects of daclatasvir (Daklinza)?

Common side effects include:

• Fatigue
• Headache
• Anemia (when combined with ribavirin)
• Nausea
• Elevated lipase

Other side effects include:

• Diarrhea
• Insomnia
• Drowsiness
• Rash

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.

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)
• ketoconazole
• nefazodone (Serzone)
• posaconazole (Noxafil)
• telithromycin (Ketek)
• voriconazole
  (Vfend)

Daclatasvir increases blood levels of

• atorvastatin (Lipitor),
• rosuvastatin
  (Crestor), and
• other statins.

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

Daclatasvir also increases blood levels of

• buprenorphine (Buprenex,
  Subutex)
  and
• digoxin.

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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.