Elbasvir and grazoprevir

What is Elbasvir and grazoprevir?[edit | edit source]

elbasivir

grazoprevir

Elbasvir is a drug used in combination with grazoprevir under the trade name Zepatier

What are the uses of this medicine?[edit | edit source]

ZEPATIER® is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adults.

How does this medicine work?[edit | edit source]

The substance blocks NS5A, a protein necessary for hepatitis C virus replication and assembly.

Who Should Not Use this medicine?[edit | edit source]

contraindicated in patients with moderate or severe hepatic impairment

OATP1B1/3 inhibitors that are known or expected to significantly increase grazoprevir plasma concentrations, strong CYP3A inducers, and efavirenz

Is this medicine FDA approved?[edit | edit source]

Elbasvir is a drug approved by the FDA in January 2016 for the treatment of hepatitis C

What Tests Are Done Prior to Initiation of Therapy?=[edit | edit source]

Test all patients for HBV infection by measuring HBsAg and anti-HBc.
Genotype 1a: Testing for the presence of virus with NS5A resistance-associated polymorphisms is recommended.
Obtain hepatic laboratory testing.

What are the dosage forms and brand names of this medicine?[edit | edit source]

Recommended dosage: One tablet taken orally once daily with or without food
50 mg elbasvir and 100 mg grazoprevir
No dosage adjustment of ZEPATIER is recommended in patients with any degree of renal impairment including patients on hemodialysis
No dosage adjustment of ZEPATIER is recommended in patients with mild hepatic impairment
ZEPATIER is the brand name .
It is available as a beige-colored, oval-shaped, film-coated tablet debossed with "770" on one side and plain on the other. Each tablet contains 50 mg elbasvir and 100 mg grazoprevir.

What side effects can this medication cause?[edit | edit source]

What special precautions should I follow?[edit | edit source]

Pregnancy
Lactation
Females and Males of Reproductive Potential
If ZEPATIER is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen
Females and Males of Reproductive Potential If ZEPATIER is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen

What to do in case of emergency/overdose?[edit | edit source]

No specific antidote is available for overdose with ZEPATIER. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

Can this medicine be used in pregnancy?[edit | edit source]

If ZEPATIER is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant.

Can this medicine be used in children?[edit | edit source]

Safety and efficacy in pediatric patients have not been established in pediatric patients less than 18 years of age.

What should I know about storage and disposal of this medication?[edit | edit source]

The tablets are packaged into a carton (NDC 0006-3074-02) containing two (2) 14-count child-resistant dose packs for a total of 28 tablets.
Store ZEPATIER in the original blister package until use to protect from moisture.
Store ZEPATIER at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (between 59°F to 86°F) [see USP Controlled Room Temperature]

Elbasvir and grazoprevir Resources
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