HIGHLIGHTS OF PRESCRIBING INFORMATION Recommended dosage ...

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA.

TRUVADA? (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP)

IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning.

? Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued TRUVADA. Hepatic function should be monitored closely in these individuals who discontinue TRUVADA. If appropriate anti-hepatitis B therapy may be warranted. (5.1)

? TRUVADA used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drugresistant HIV-1 variants have been identified with the use of TRUVADA for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for HIV-1 PrEP if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. (5.2)

-------------------------------INDICATIONS AND USAGE------------------------HIV-1 Treatment (1.1) TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: ? in combination with other antiretroviral agents for the treatment of

HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP (1.2): ? TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP.

------------------------DOSAGE AND ADMINISTRATION---------------------? Testing: Prior to or when initiating TRUVADA test for hepatitis B

virus infection. Prior to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus. (2.1) ? HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating TRUVADA for HIV-1 PrEP and at least once every 3 months while taking TRUVADA, and upon diagnosis of any other sexually transmitted infections (STIs). (2.2) Treatment of HIV-1 Infection ? Recommended dosage in adults and pediatric patients weighing at least 35 kg: One TRUVADA tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food. (2.3) ? Recommended dosage in pediatric patients weighing at least 17 kg: One TRUVADA low-strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food. (2.4) ? Recommended dosage in renally impaired HIV-1 infected adult patients: o Creatinine clearance (CrCl) 30-49 mL/min: 1 tablet every 48

hours. (2.6) o CrCl below 30 mL/min or hemodialysis: TRUVADA is not

recommended. (2.6) HIV-1 Pre-Exposure Prophylaxis (PrEP) ? Recommended dosage in HIV-1 uninfected adults and adolescents

weighing at least 35 kg: One TRUVADA tablet (containing 200 mg

? of FTC and 300 mg of TDF) once daily taken orally with or without food. (2.5)

? Recommended dosage in renally impaired HIV-uninfected individuals: TRUVADA is not recommended in HIV-uninfected individuals if CrCl is below 60 mL/min. (2.6)

-----------------------DOSAGE FORMS AND STRENGTHS-------------------Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg of emtricitabine and tenofovir disoproxil fumarate, respectively. (3)

--------------------------------CONTRAINDICATIONS-----------------------------TRUVADA for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status. (4)

-------------------------WARNINGS AND PRECAUTIONS---------------------? Comprehensive management to reduce the risk of acquiring HIV-1

when TRUVADA is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule. (5.2) ? Management to reduce the risk of acquiring HIV-1 drug resistance when TRUVADA is used for HIV-1 PrEP: refer to full prescribing information for additional detail. (5.2) ? New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs. (5.3) ? Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment. (5.4) ? Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. (5.5) ? Lactic acidosis/severe hepatomegaly with steatosis: Discontinue TRUVADA in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.6)

--------------------------------ADVERSE REACTIONS----------------------------? In HIV-1 infected patients, the most common adverse reactions

(incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. (6.1) ? In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-445-3235 or FDA at 1-800-FDA-1088 or medwatch

---------------------------------DRUG INTERACTIONS----------------------------? 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 TRUVADA, use atazanavir given with ritonavir. (7.2) ? Coadministration of TRUVADA 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)

---------------------------USE IN SPECIFIC POPULATIONS-------------------Lactation: Mothers infected with HIV-1 or suspected of having acquired HIV-1 infection should be instructed not to breastfeed due to the potential for HIV transmission. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2023

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FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION 1 INDICATIONS AND USAGE

1.1 Treatment of HIV-1 Infection 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) 2 DOSAGE AND ADMINISTRATION 2.1 Testing Prior to Initiation of TRUVADA for Treatment of HIV-1

Infection or for HIV-1 PrEP 2.2 HIV-1 Screening for Individuals Receiving TRUVADA for HIV-1

PrEP 2.3 Recommended Dosage for Treatment of HIV-1 Infection in

Adults and Pediatric Patients Weighing at Least 35 kg 2.4 Recommended Dosage for Treatment of HIV-1 Infection in

Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Tablet 2.5 Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg 2.6 Dosage Adjustment in Individuals with Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection 5.2 Comprehensive Management to Reduce the Risk of Sexually Transmitted Infections, Including HIV-1, and Development of HIV-1 Resistance When TRUVADA Is Used for HIV-1 PrEP 5.3 New Onset or Worsening Renal Impairment 5.4 Immune Reconstitution Syndrome 5.5 Bone Loss and Mineralization Defects 5.6 Lactic Acidosis/Severe Hepatomegaly with Steatosis 5.7 Risk of Adverse Reactions Due to Drug Interactions

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience

7 DRUG INTERACTIONS 7.1 Drugs Affecting Renal Function 7.2 Established and Significant Interactions

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment

10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action 12.3 Pharmacokinetics 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Overview of Clinical Trials 14.2 Clinical Trial Results for Treatment of HIV-1: Study 934 14.3 Clinical Trial Results for HIV-1 PrEP: iPrEx 14.4 Clinical Trial Results for HIV-1 PrEP: Partners PrEP 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.

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FULL PRESCRIBING INFORMATION

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-

EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBVinfected individuals who have discontinued TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue TRUVADA. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].

TRUVADA used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

1.1 Treatment of HIV-1 Infection

TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies (14)].

1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)

TRUVADA is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to Initiation of TRUVADA for Treatment of HIV-1 Infection or for HIV-1 PrEP

Prior to or when initiating TRUVADA, test individuals for hepatitis B virus infection [see Warnings and Precautions (5.1)].

Prior to initiation, and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.3)].

2.2 HIV-1 Screening for Individuals Receiving TRUVADA for HIV-1 PrEP

Screen all individuals for HIV-1 infection immediately prior to initiating TRUVADA for HIV-1 PrEP and at least once every 3 months while taking TRUVADA, and upon diagnosis of any other sexually transmitted infections (STIs) [see Indications and Usage (1.2), Contraindications (4), and Warnings and Precautions (5.2)].

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