Tenofovir — Membership Pricing

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What Tenofovir is approved for (FDA label)

Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 35 kg. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 2 years of age and older weighing at least 35 kg.

Source: Read the full FDA label on DailyMed. Label effective date: July 13, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Tenofovir (FDA label)

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) 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 HBV-infected patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.1) ] . WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Hepatic function should be monitored closely in HBV-infected patients who discontinue tenofovir disoproxil fumarate. If appropriate, resumption of anti-hepatitis B therapy may be warranted. ( 5.1 )

Source: FDA prescribing information (DailyMed). Set ID: e0ae0aa2-3baa-4b75-9e85-68b5338c3c14. SPL document ID: 1d924bad-47a1-48dd-bf2e-5a44ebc48d60. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Tenofovir (FDA label)

Tenofovir disoproxil fumarate is available as tablets. • 300 mg Tablets: 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil): almond-shaped, blue, film coated, debossed with “32” on one side. Tablets: 300 mg of tenofovir disoproxil fumarate. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: e0ae0aa2-3baa-4b75-9e85-68b5338c3c14. SPL document ID: 1d924bad-47a1-48dd-bf2e-5a44ebc48d60. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Tenofovir (FDA label)

The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1) ]. New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.2) ] . Immune Reconstitution Syndrome [see Warnings and Precautions (5.4) ] . Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5) ] . Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6) ] . In HIV-infected adult subjects: Most common adverse reactions (incidence greater than or equal to 10%, Grades 2–4) were rash, diarrhea, nausea, headache, pain, depression, and asthenia. ( 6.1 ) In HBV-infected subjects with compensated liver disease: Most common adverse reaction (all grades) was nausea (9%). ( 6.1 ) In HBV-infected subjects with decompensated liver disease: Most common adverse reactions (incidence greater than or equal to 10%, all grades) were abdominal pain, nausea, insomnia, pruritus, vomiting, dizziness, and pyrexia. ( 6.1 ) In pediatric subjects: Adverse reactions in pediatric subjects were consistent with those observed in adults. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Florida Pharmaceutical Products, LLC at 1-800-315-0985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: e0ae0aa2-3baa-4b75-9e85-68b5338c3c14. SPL document ID: 1d924bad-47a1-48dd-bf2e-5a44ebc48d60. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Tenofovir (FDA label)

None. None. ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: e0ae0aa2-3baa-4b75-9e85-68b5338c3c14. SPL document ID: 1d924bad-47a1-48dd-bf2e-5a44ebc48d60. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Tenofovir (FDA label)

New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering tenofovir disoproxil fumarate with concurrent or recent use of nephrotoxic drugs.( 5.2 ) HIV testing: HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with tenofovir disoproxil fumarate.

Source: FDA prescribing information (DailyMed). Set ID: e0ae0aa2-3baa-4b75-9e85-68b5338c3c14. SPL document ID: 1d924bad-47a1-48dd-bf2e-5a44ebc48d60. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Tenofovir (FDA label)

Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. ( 7.2 ) Coadministration decreases atazanavir concentrations. When coadministered with tenofovir disoproxil fumarate, use atazanavir given with ritonavir. ( 7.2 ) Coadministration of tenofovir disoproxil fumarate with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity. ( 7.2 ) Consult Full Prescribing Information prior to and during treatment for important drug interactions. ( 7.2 ) 7.1 Drugs Affecting Renal Function Tenofovir is primarily eliminated by the kidneys [ see Clinical Pharmacology (12.3) ]. Coadministration of tenofovir disoproxil fumarate with drugs that are eliminated by active tubular secretion may increase concentrations of tenofovir and/or the coadministered drug.

Source: FDA prescribing information (DailyMed). Set ID: e0ae0aa2-3baa-4b75-9e85-68b5338c3c14. SPL document ID: 1d924bad-47a1-48dd-bf2e-5a44ebc48d60. Label effective date: July 13, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.