Daclatasvir

What is Daclatasvir?

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

What are the uses of this medicine?

• 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.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• 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

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 60 mg, 30 mg, and 90 mg

This medicine is available in fallowing brand namesː

• DAKLINZA

What side effects can this medication cause?

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

• headache
• tiredness

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

• headache
• low red blood cell count (anemia)
• tiredness
• nausea

DAKLINZA can cause serious side effects, including:

• Hepatitis B virus reactivation
• Slow heart rate (bradycardia)

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

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.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Manufactured for: Bristol-Myers Squibb Company, Princeton, NJ 08543, USA

Product of Ireland

• DAKLINZA is a trademark of Bristol-Myers Squibb Company.

What should I know about storage and disposal of this medication?

• Store DAKLINZA at room temperature between 68°F and 77°F (20°C and 25°C).
• Keep DAKLINZA and all medicines out of the reach of children.

• Dailymed label info on Daclatasvir
• FDA Daclatasvir

Daclatasvir Resources
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