Elbasvir and grazoprevir

What is Elbasvir and grazoprevir?

Elbasvir and grazoprevir

elbasivir

grazoprevir

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

What are the uses of this medicine?

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

How does this medicine work?

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

Who Should Not Use this medicine?

• 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?

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?=

• 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?

• 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?

• Anemia
• Headache
• Fatigue
• Dyspnea
• Rash or Pruritus
• Irritability
• Abdominal pain
• Depression
• Arthralgia
• Diarrhea

What special precautions should I follow?

• 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?

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?

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?

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?

• 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]

• Dailymed label info on Elbasvir and grazoprevir
• FDA Elbasvir and grazoprevir

Elbasvir and grazoprevir Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

• Sources:Dailymed(FDA)