Elbasvir with grazoprevir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of elbasvir with grazoprevir.
Drugs List
Therapeutic Indications
Uses
Hepatitis C - chronic
Dosage
Adults
One tablet, once a day.
Hepatitis C: Genotype 1a
Treatment duration of 12 weeks.
Consider a treatment duration of 16 weeks with ribavirin in patients with baseline HCV RNA level greater than 800,000 IU/ml and/or the presence of specific NS5A polymorphisms which are causing at least a 5-fold reduction in activity of elbasvir in order to minimise the risk of treatment failure.
Hepatitis C: Genotype 1b
Treatment duration of 12 weeks.
Hepatitis C: Genotype 4
Treatment duration of 12 weeks.
Consider a treatment duration of 16 weeks with ribavirin in patients with baseline HCV RNA level greater than 800,000 IU/ml in order to minimise the risk of treatment failure.
If used in combination with ribavirin, consult ribavirin product information.
Children
Children aged 12 years and older weighing at least 30kg:
(See Dosage; Adult).
Additional Dosage Information
If vomiting occurs within 4 hours, advise patient to take an another tablet. If vomiting occurs more than 4 hours after taking, additional dosing is not required.
If a dose is missed within 16 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 16 hours have passed, the missed dose should not be taken and usual dosing can resume. Avoid double dosing.
Contraindications
Children under 12 years
Galactosaemia
Hepatic impairment - Child-Pugh score greater than 7
Precautions and Warnings
Restricted sodium intake
Breastfeeding
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatitis B
Lactose intolerance
Liver transplant
Pregnancy
Contains more than 1 mmol (23 mg) sodium per dose
Monitor HBV levels during and after treatment in patients with co-infection
Advise ability to drive/operate machinery may be affected by side effects
Before initiating screen all patients for hepatitis B infection
Treatment to be initiated and supervised by a specialist
Contains lactose
Monitor hepatic function before treatment, at week 8 and as indicated
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor hepatic function on long term therapy at treatment week 12
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Consider discontinuing treatment if ALT >10 times upper limit of normal
Reactivation of hepatitis B may occur in chronic carriers
Discontinue if ALT raised and signs of hepatotoxicity
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 4 hours
Discontinue if ALT is raised and accompanied by symptoms of liver inflammation or increases in conjugated bilirubin, alkaline phosphate, or international normalised ratio.
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
Use elbasvir with grazoprevir with caution during pregnancy.
The manufacturer advises elbasvir with grazoprevir should only be used if the benefit of treatment outweighs the potential risk to the foetus.
At the time of writing, there are no adequate studies with elbasvir with grazoprevir in pregnant women. Animal studies have not shown reproductive toxicity.
If used in combination with ribavirin, consult ribavirin product information.
Lactation
Use elbasvir with grazoprevir with caution during breastfeeding.
The manufacturer advises a decision whether to stop breastfeeding or discontinue treatment with elbasvir with grazoprevir should be made taking into account the benefits of breastfeeding and benefits of treatment.
At the time of writing it is unknown whether elbasvir or grazoprevir are excreted in breast milk. Animal studies have shown excretion in milk. Elbasvir and grazoprevir are both highly bound to maternal plasma proteins so amounts in breast milk are thought to be low.
If used in combination with ribavirin, consult ribavirin product information.
Side Effects
Abdominal pain
Alopecia
Anaemia
Anxiety
Arthralgia
Asthenia
Constipation
Decreased appetite
Depression
Diarrhoea
Dizziness
Dry mouth
Fatigue
Headache
Increase in ALT level
Insomnia
Irritability
Myalgia
Nausea
Pruritus
Serum bilirubin increased
Transient ischaemic attack
Upper abdominal pain
Vomiting
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: April 2019
Reference Sources
Summary of Product Characteristics: Zepatier 50 mg/100 mg film coated tablets. Merck Sharp and Dohme Ltd. Revised December 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Elbasvir Last revised: 07 February 2019
Last accessed: 16 April 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Grazoprevir Last revised: 07 February 2019
Last accessed: 16 April 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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