Tenofovir alafenamide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing tenofovir alafenamide.
Drugs List
Therapeutic Indications
Uses
Chronic hepatitis B
Dosage
Adults
25mg once daily.
Children
Children aged 12 years and older with a body weight of at least 35kg
25mg once daily.
Additional Dosage Information
In HBeAg positive patients without cirrhosis, treatment should be administered for at least 6 to 12 months after confirmed HBe seroconversion, or until a loss of efficacy, or until HBS seroconversion.
In HBeAg negative patients without cirrhosis, treatment should be administered for at least until HBs seroconversion or loss of efficacy. Treatment duration past 2 years requires regular assessment for appropriateness of treatment.
Haemodialysis patients should take tablet after haemodialysis session.
Contraindications
Children under 12 years
Weight below 35kg
Breastfeeding
Galactosaemia
Precautions and Warnings
Decompensated liver disease
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
Lactose intolerance
Pregnancy
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Cirrhosis: Monitor for signs and symptoms of hepatic decompensation
Haemodialysis patients: administer drug after dialysis
Not recommended in pts with CrCl <15mL/min not receiving haemodialysis
Therapy cessation not recommended in decompensated liver disease/cirrhosis
Treatment does not prevent risk of transmission of Hepatitis B
If unknown HIV status,antibody testing should be offered prior to treatment
Treatment to be initiated by specialist
Contains lactose
Monitor renal function before treatment and regularly during treatment
Evaluate renal function if signs of proximal renal tubulopathy occur
Hepatitis B:Monitor liver function for at least 6months after discontinuing
Monitor closely patient with Child-Pugh C hepatic impairment
On discontinuation, may cause recurrence of hepatitis B
Prolonged use may lead to nephrotoxicity
Raised ALTs may be due to HBV clearance
Discontinue if renal function deteriorates
Advise patient not to take St John's wort concurrently
Pregnancy and Lactation
Pregnancy
Use tenofovir alafenamide with caution in pregnancy.
The manufacturer recommends that the use of tenofovir alafenamide may be consider during pregnancy, if necessary. At the time of writing there is limited published information regarding the use of tenofovir alafenamide during pregnancy. Studies using tenofovir disoproxil fumarate, indicate no neonatal toxicity or malformations when used in pregnant women. Animal studies do not indicate any reproductive toxicity effects.
Lactation
Tenofovir alafenamide is contraindicated in breastfeeding.
The manufacturer does not recommend the use of tenofovir alafenamide during breastfeeding. At the time of writing there is limited published information regarding the use of tenofovir alafenamide during breastfeeding, the risk to the infant cannot be excluded. It is unknown if tenofovir alafenamide is secreted into human breast milk. Animal studies show that tenofovir is secreted into milk.
Counselling
If dose is missed by less than 18 hours, patient should take missed dose as soon as possible and resume normal dosing schedule afterwards.
If dose is missed by more than 18 hours, patient should not take missed dose and resume normal dosing schedule.
If patient vomits within 1 hour of taking tablet, patient should take another tablet.
Tablets to be swallowed whole with food.
Advise patient not to take St John's Wort concurrently.
Side Effects
Abdominal distension
Abdominal pain
Angioedema
Arthralgia
Diarrhoea
Dizziness
Fatigue
Flatulence
Headache
Increase in ALT level
Nausea
Pruritus
Rash
Urticaria
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: August 2019.
Reference Sources
Summary of Product Characteristics: Vemlidy 25mg film coated tablets. Gilead Sciences Limited. Revised January 2021.
Summary of Product Characteristics: Vemlidy 25mg film coated tablets (Northern Ireland). Gilead Sciences Limited. Revised September 2020.
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
Tenofovir Last revised: 07 February 2019
Last accessed: 07 August 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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