Tenofovir alafenamide


Generic Medicine Info
Indications and Dosage
Oral
Chronic hepatitis B
Adult: In patient with decompensated liver disease: 25 mg once daily.
Child: ≥12 years >35 kg: Same as adult dose.
Renal Impairment
 CrCl (mL/min)  Dosage
 <15  Not recommended.
Hepatic Impairment
Child-Pugh class B or C: Not recommended.
Contraindications
Hypersensitivity.
Special Precautions
Patient with HBV and HIV-1 co-infection. Renal and hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Acute renal failure and/or Fanconi syndrome.
Gastrointestinal disorders: Diarrheoa, vomiting, nausea, abdominal pain, abdominal distention, flatulence.
General disorders and administration site conditions: Fatigue.
Investigations: Decreased bone mineral density, increased serum alanine aminotransferase.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain.
Nervous system disorders: Dizziness, headache.
Respiratory, thoracic and mediastinal disorders: Cough.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Lactic acidosis, hepatomegaly with steatosis.
PO: Z (Current evidence suggests that tenofovir disoproxil does not increase the risk of pregnancy-related adverse effects. Tenofovir disoproxil is one of the recommended antiviral agents in management of HIV and/or hepatitis B during pregnancy.)
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
Monitoring Parameters
Perform HIV testing prior to initiation of therapy. Monitor urine glucose, urine protein prior to initiation and as clinically indicated; LFT, serum creatinine, serum phosphorus.
Drug Interactions
Increased plasma concentration with P-gp strong inhibitors (e.g. itraconazole, ketoconazole). Decreased plasma concentration with carbamazepine, phenobarbital, fosphenytoin, phenytoin, tipranavir, ritonavir, rifampin, primidone. May diminish the therapeutic effect of cladribine.
Food Interaction
Decreased plasma concentration with St. John’s wort.
Action
Description: Tenofovir alafenamide is a phosphonamidite prodrug of tenofovir which inhibits hepatitis B virus (HBV) replication through incorporation into the viral DNA by HBV reverse transcriptase resulting to DNA chain termination.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: 0.48 hours.
Distribution: Crosses placenta, enters breast milk. Plasma protein binding: 80%.
Metabolism: Hydrolysed intracellularly into tenofovir then phosphorylated to the active form, tenofovir diphosphate; minimally metabolised by CYP3A4.
Excretion: Via urine (<1%); faeces (31.7%). Elimination half-life: 0.51 hours.
Chemical Structure

Chemical Structure Image
Tenofovir alafenamide

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9574768, Tenofovir alafenamide. https://pubchem.ncbi.nlm.nih.gov/compound/Tenofovir-alafenamide. Accessed Feb. 24, 2021.

Storage
Store below 30°C.
MIMS Class
ATC Classification
J05AF13 - tenofovir alafenamide ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
References
Anon. Tenofovir Alafenamide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/02/2021.

Buckingham R (ed). Tenofovir. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2021.

Joint Formulary Committee. Tenofovir Alafenamide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/02/2021.

Vemlidy Tablet (Gilead Sciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/02/2021.

Disclaimer: This information is independently developed by MIMS based on Tenofovir alafenamide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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