ℹ️ Compiled from public regulatory records · Last regulator revision: March 10, 2026🚩 Report this page
Tenofovir
Active ingredient
CA Health Canada
Drug class
-
Availability
See label
Routes
Oral
Markets covered
1
Products on record
2
Overview
Tenofovir is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS ...................................................................................
4 ADVERSE REACTIONS ................................................................................................... 10 DRUG INTERACTIONS ...................................................................................................
22 DOSAGE AND ADMINISTRATION ............................................................................... 34 OVERDOSAGE .................................................................................................................
36 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 38 STORAGE AND STABILITY ........................................................................................... 42 SPECIAL HANDLING INSTRUCTIONS .........................................................................
Sources & citations
[1]Health Canada (DPD) · 02512327 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
42 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 42 PART II: SCIENTIFIC INFORMATION .............................................................................. 43 PHARMACEUTICAL INFORMATION ...........................................................................
69 PART III: CONSUMER INFORMATION ............................................................................. 71 PrTENOFOVIR (Tenofovir disoproxil fumarate Tablets) Product Monograph Page 3 of 74 PrTENOFOVIR Tenofovir disoproxil fumarate Tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form/Strength Nonmedicinal Ingredientsa Oral Tablet tenofovir disoproxil fumarate 300 mg lactose monohydrate, pregelatinized starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and Opadry II Blue (hypromellose, lactose monohydrate, titanium dioxide, triacetin, indigo carmine, and indigo carmine aluminum lake) aFor a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING section.
INDICATIONS AND CLINICAL USE HIV-1 Infection TENOFOVIR (tenofovir disoproxil fumarate [TDF]) is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients 12 years of age and older. Chronic Hepatitis B TENOFOVIR is indicated for the treatment of chronic hepatitis B infection in patients 18 years of age and older, with: Compensated liver disease, with evidence of active viral replication, with elevated serum alanine aminotransferase (ALT) levels or evidence of fibrosis (based on liver biopsy or a noninvasive procedure); Evidence of lamivudine-resistant hepatitis B virus; or Decompensated liver disease.
Geriatrics (≥65 years of age) Clinical studies of tenofovir disoproxil fumarate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. PrTENOFOVIR (Tenofovir disoproxil fumarate Tablets) Product Monograph Page 4 of 74 Pediatrics (12 to 18 years of age) The safety and efficacy of tenofovir disoproxil fumarate in adolescent patients aged 12 to <18 years is supported by data from one randomized study in which tenofovir disoproxil fumarate was administered to HIV-1 infected treatment experienced subjects.
In this study, the pharmacokinetic profile of tenofovir disoproxil fumarate was similar to that found to be safe and effective in adult populations. Safety and efficacy in pediatric patients less than 12 years of age have not been established.
CONTRAINDICATIONS TENOFOVIR is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, alone or in combination with other antiretrovirals (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Post-Treatment Exacerbation of Hepatitis B Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including TENOFOVIR.
If appropriate, resumption of anti-hepatitis B therapy may be warranted (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). Nephrotoxicity Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir disoproxil fumarate during clinical practice (see WARNINGS AND PRECAUTIONS, Renal).
General PrTENOFOVIR (Tenofovir disoproxil fumarate Tablets) Product Monograph Page 5 of 74 For the effect of coadministered drugs, see DRUG INTERACTIONS section. Clinical studies in HIV-infected patients have demonstrated that certain regimens that only contain three nucleoside reverse transcriptase inhibitors (NRTI) are generally less effective […]