Daclatasvir

What is Daclatasvir?[edit | edit source]

Daclatasvir (DAKLINZA) is a hepatitis C virus (HCV) NS5A inhibitor used to treat chronic hepatitis C virus (HCV) genotype 3 infections.

This medicine is used to treat chronic (lasting a long time) hepatitis C genotype 1 or genotype 3 infection in adults.
Take DAKLINZA with sofosbuvir or with sofosbuvir and ribavirin.
You should not take DAKLINZA by itself.

Daclatasvir (dak lat' as vir) is an oral antiviral agent with specific activity against the NS5A region of the hepatitis C virus.
The role of the NS5A region and how daclatasvir inhibits its function are not well defined, but NS5A is necessary for formation of the replicative complex of HCV and the various NS5A inhibitors, such as daclatasvir, appear to bind to this polypeptide and prevent its participation in forming the intracellular complex that is necessary for HCV replication.
In cell culture and in animal models, daclatasvir caused a rapid and marked decrease in viral replication and HCV RNA levels.
In several prospective, placebo controlled trials, daclatasvir in combination with other antiviral agents (such as sofosbuvir, asunaprevir, peginterferon and ribavirin) was found to decrease HCV RNA levels and lead to sustained loss of HCV RNA in a high proportion of patients with chronic hepatitis C.

This medicine cannot be used in patients who use Strong inducers of CYP3A, including phenytoin, carbamazepine, rifampin, and St. John’s wort.

Test all patients for HBV infection by measuring HBsAg and anti-HBc.
HCV genotype 1a with cirrhosis, consider testing for the presence of virus with NS5A resistance-associated polymorphisms.

Recommended Dosage:

60 mg taken orally once daily with or without food in combination with sofosbuvir with or without ribavirin. (2.2)
Recommended treatment duration: 12 weeks.
Dose modification: Reduce dosage to 30 mg once daily with strong CYP3A inhibitors and increase dosage to 90 mg once daily with moderate CYP3A inducers.

Administration

Take DAKLINZA exactly how you are told to by your healthcare provider.
Do not change your dose unless you are told to by your healthcare provider.
Do not stop taking DAKLINZA without first talking with your healthcare provider.
Take DAKLINZA one time each day with or without food.
If you miss a dose, call your healthcare provider or pharmacist. It is important that you do not miss or
skip doses of DAKLINZA during treatment.
If you take too much DAKLINZA

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

The most common side effects of DAKLINZA when used in combination with sofosbuvir include:

The most common side effects of DAKLINZA when used in combination with sofosbuvir and ribavirin include:

DAKLINZA can cause serious side effects, including:

Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment. Monitor HCV/HBV coinfected patients for HBV reactivation and hepatitis flare during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Serious symptomatic bradycardia may occur in patients taking amiodarone with sofosbuvir in combination with another HCV direct-acting agent, including DAKLINZA, particularly in patients also receiving beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with DAKLINZA in combination with sofosbuvir is not recommended. In patients with no alternative treatment options, cardiac monitoring is recommended.

Management for overdosage:

There is no known antidote for overdose of DAKLINZA.
Treatment of overdose with DAKLINZA should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status.
Because daclatasvir is highly protein bound (>99%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.

No adequate human data are available to determine whether or not DAKLINZA poses a risk to pregnancy outcomes.

Safety and effectiveness of DAKLINZA in pediatric patients younger than 18 years of age have not been established.

Active ingredient: daclatasvir
Inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide,
magnesium stearate, and Opadry green. Opadry green contains hypromellose, titanium dioxide,

polyethylene glycol 400, FD&C blue #2/indigo carmine aluminum lake, and yellow iron oxide.

Product of Ireland

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