Glecaprevir with pibrentasvir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of glecaprevir with pibrentasvir.
Drugs List
Therapeutic Indications
Uses
Hepatitis C - chronic
Dosage
Adults
Tablets containing glecaprevir 100mg with pibrentasvir 40mg
Take 3 tablets once a day at the same time with food.
Suggested treatment durations are listed below.
Patients previously untreated for chronic hepatitis C without cirrhosis
Hepatitis C virus genotypes 1, 2, 3, 4, 5 and 6
8 weeks.
Patients previously untreated for chronic hepatitis C with cirrhosis
Hepatitis C virus genotypes 1, 2, 3, 4, 5 and 6
8 weeks.
Patients without cirrhosis who have failed prior chronic hepatitis C therapy with either peginterferon and ribavirin with or without sofosbuvir, or with sofosbuvir and ribavirin
Hepatitis C virus genotypes 1, 2, 4, 5 and 6
8 weeks.
Hepatitis C virus genotype 3
16 weeks.
Patients with cirrhosis who have failed prior chronic hepatitis C therapy with either peginterferon and ribavirin with or without sofosbuvir, or with sofosbuvir and ribavirin
Hepatitis C virus genotypes 1, 2, 4, 5 and 6
12 weeks.
Hepatitis C virus genotype 3
16 weeks.
Liver or kidney transplant patients
12 weeks. Longer therapy durations of 16 weeks can be considered in patients with hepatitis C virus genotype 3 who have had previous treatment with peginterferon and ribavirin with or without sofosbuvir, or with sofosbuvir and ribavirin.
Children
Children weighing 45kg or more should use the tablet formulation. As the formulations have different pharmacokinetic profiles, the tablets and the coated granules are not interchangeable. A full course of treatment with the same formulation is required.
Children aged 12 to 18 years old weighing 45kg or more
(See Dosage; Adult).
Children aged 3 to 12 years old
Weighing 30 to 45kg: 5 sachets once a day with food.
Weighing 20 to 30kg: 4 sachets once a day with food.
Weighing 12 to 20kg: 3 sachets once a day with food.
Suggested treatment durations are listed below.
Patients previously untreated for chronic hepatitis C without cirrhosis
Hepatitis C virus genotypes 1, 2, 3, 4, 5 and 6
8 weeks.
Patients previously untreated for chronic hepatitis C with cirrhosis
Hepatitis C virus genotypes 1, 2, 3, 4, 5 and 6
8 weeks.
Patients without cirrhosis who have failed prior chronic hepatitis C therapy with either peginterferon and ribavirin with or without sofosbuvir, or with sofosbuvir and ribavirin
Hepatitis C virus genotypes 1, 2, 4, 5 and 6
8 weeks.
Hepatitis C virus genotype 3
16 weeks.
Patients with cirrhosis who have failed prior chronic hepatitis C therapy with either peginterferon and ribavirin with or without sofosbuvir, or with sofosbuvir and ribavirin
Hepatitis C virus genotypes 1, 2, 4, 5 and 6
12 weeks.
Hepatitis C virus genotype 3
16 weeks.
Additional Dosage Information
Missed dose.
If vomiting occurs within 3 hours of taking, advise patient to take another dose.
If vomiting occurs more than 3 hours after taking, additional dosing is not required.
If a dose is missed within 18 hours of the time it is usually taken, advise patient to take another dose as soon as possible and to resume normal dosing.
If more than 18 hours have passed, the missed dose should not be taken and usual dosing can resume. Avoid double dosing.
Administration
Granules formulations
The granules for the total daily dose should be sprinkled on a small amount of soft food with a low water content that will stick to a spoon and can be swallowed without chewing (e.g. peanut butter, chocolate hazelnut spread, soft/cream cheese, thick jam or Greek yoghurt). Liquids or foods that drip or slide off the spoon should not be used as the medicine may dissolve quickly and become less effective. The mixture should be swallowed immediately. Granules should not be administered via enteral feeding tubes.
Contraindications
Children under 3 years
Weight below 12kg
Breastfeeding
Galactosaemia
Pregnancy
Severe hepatic impairment
Precautions and Warnings
Children under 12 years
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatitis B
Kidney transplantation
Lactose intolerance
Liver transplant
Moderate hepatic impairment
Before initiating screen at risk patients for hepatitis B infection
Not all formulations are suitable for use in children under 12 years
Treatment should be started by a doctor experienced in hepatitis management
Contains lactose
Some formulations contain propylene glycol
Advise patient to take with or after food
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for and manage hepatitis reactivation during treatment
Bioavailability differs with preparations;caution on changing formulations
Advise patient not to take St John's wort concurrently
Advise patients with diabetes of the increased risk of hypoglycaemia
Take another dose if vomiting occurs within 3 hours
Glecaprevir with pibrentasvir is not recommended in patients who have had previous therapy containing NS3/4A and/or NS5A inhibitors.
Patients with diabetes may experience improved glucose control and symptomatic hypoglycaemia following treatment initiation. Monitor blood glucose levels closely, particularly within the first 3 months, and adjust diabetic medication as necessary.
Inform specialist in charge of diabetic care of treatment initiation.
Pregnancy and Lactation
Pregnancy
Glecaprevir with pibrentasvir is contraindicated during pregnancy.
The manufacturer suggests as a precautionary measure glecaprevir with pibrentasvir is not recommended during pregnancy. At the time of writing, there are limited data on the use of glecaprevir with pibrentasvir in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Maternal toxicity associated with embryo-foetal loss has been observed.
Lactation
Glecaprevir with pibrentasvir is contraindicated during breastfeeding.
The manufacturer suggests a decision whether to discontinue breastfeeding or avoiding glecaprevir with pibrentasvir therapy should be made taking in to account the benefit of breastfeeding for the child and the benefit of therapy for the patient.
It is unknown whether glecaprevir or pibrentasvir are excreted in human milk. Animal studies have shown excretion of both glecaprevir and pibrentasvir in milk.
Side Effects
Angioedema
Asthenia
Diarrhoea
Fatigue
Headache
Hyperbilirubinaemia
Nausea
Pruritus
Serum bilirubin increased
Transient ischaemic attack
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2019
Reference Sources
Summary of Product Characteristics: Maviret 50mg/20mg coated granules in sachet. AbbVie Ltd. Revised November 2021.
Summary of Product Characteristics: Maviret 100mg/40mg film-coated tablets. AbbVie Ltd. Revised April 2020.
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