Indicated for:

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.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

The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:

• It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen
• TRUVADA should not be coadministered with ATRIPLA, COMPLERA, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, VEMLIDY, VIREAD, or lamivudine-containing products
• In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history
• TRUVADA should not be administered to patients with estimated creatinine clearance below 30 mL/min or patients requiring hemodialysis

When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:

• Prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection
• Counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule
• Confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
• Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min

When considering TRUVADA for HIV-1 PrEP, factors that help to identify individuals at risk may include: has partner(s) known to be HIV-1 infected, or engages in sexual activity within a high prevalence area or social network and has additional risk factors for HIV-1 acquisition, such as: inconsistent or no condom use, diagnosis of sexually transmitted infections, exchange of sex for commodities (such as money, food, shelter, or drugs), use of illicit drugs or alcohol dependence, incarceration, partner(s) of unknown HIV-1 status with any of the factors listed above.

Some HIV-1 tests only detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating TRUVADA for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, or a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash).

If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection.

While using TRUVADA for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs.

If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, convert the HIV-1 PrEP regimen to an HIV treatment regimen until negative infection status is confirmed using a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection.

Counsel HIV-1 uninfected individuals to strictly adhere to the once daily TRUVADA dosing schedule. The effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 is strongly correlated with adherence, as demonstrated by measurable drug levels in clinical trials of TRUVADA for HIV-1 PrEP. Some individuals, such as adolescents, may benefit from more frequent visits and counseling to support adherence.

The safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1.

Do not use TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-infected patients only in combination with other antiretroviral agent.

TRUVADA should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. Because it is a fixed-dose combination tablet, TRUVADA cannot be adjusted for patients of lower weight.

TRUVADA is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of TRUVADA in adults and in pediatric patients weighing at least 35 kg is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.

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.

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected 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.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir DF and emtricitabine, components of TRUVADA, alone or in combination with other antiretrovirals.

Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of VIREAD.

Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of tenofovir DF.

Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including TRUVADA. During the initial phase of combination antiretroviral treatment, HIV-1 infected patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

TRUVADA should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs [NSAIDs].

Do not co-administer TRUVADA with other drugs containing emtricitabine, tenofovir DF, or tenofovir alafenamide, including ATRIPLA, COMPLERA, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, VEMLIDY, or VIREAD.

Due to similarities between emtricitabine and lamivudine, do not co-administer TRUVADA with other drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Triumeq (abacavir sulfate/dolutegravir/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine).

Patients receiving TRUVADA concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir should be monitored for tenofovir DF-associated adverse reactions.

Do not co-administer TRUVADA with HEPSERA (adefovir dipivoxil).

Co-administration of TRUVADA and EPCLUSA (sofosbuvir/velpatasvir) or HARVONI (ledipasvir/sofosbuvir has been shown to increase tenofovir exposure.

Co-administration of TRUVADA and didanosine should be undertaken with caution, and patients receiving this combination should be monitored closely for didanosine-associated adverse reactions.

TRUVADA should not be co-administered with atazanavir without ritonavir.

Because the studies in humans cannot rule out the possibility of harm, TRUVADA should be used during pregnancy only if clearly needed.

The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.

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• Use in patients weighing less than 17 kg. GoToSource

• Use in patients co-infected with HBV and HIV-1. GoToSource

• Aicardi-goutières syndrome and lupus erythematosus. GoToSource

• Use with anti-cancer drugs to enhance the cytotoxic effect of doxorubicin, a drug for the treatment of relapsed, chemo-resistant cancer. GoToSource

• Use in pre-and post liver transplantations for hepatitis B management. GoToSource

Lipoatrophy (loss of subcutaneous fat in face and extremities), lipohypertrophy (dorsocervical fat pad and central abdominal fat accumulation) and new onset or worsening kidney impairment. GoToSource

Decreased bone mineral density. GoToSource

Drug rashes, hyperpigmentation, hair loss, hypersensitivity reactions, urticarial reaction (hives), erythema multiforme, toxic epidermal necrolysis or stevens–johnson syndrome (severe skin reactions). GoToSource

Fanconi’s syndrome (disorder of the kidney tubes), hyperkalemia (high level of potassium in blood) and interstitial nephritis (kidney disorder). GoToSource 

New-onset obsessive-compulsive symptoms. GoToSource 

Exacerbations of hepatitis B. GoToSource

Lactic acidosis (elevated blood lactic levels). GoToSource

Kidney failure and severe hepatomegaly with steatosis (enlarged liver with accumulation of fat in the liver). GoToSource

Osteomalacia (softening of bones) and renal tubular damage (damage to the tubule cells of the kidneys). GoToSource

Immune reconstitution inflammatory syndrome (clinical worsening of a known condition or the appearance of a new condition after initiating antiretroviral therapy). GoToSource

Liver failure. GoToSource

Lawsuits filed for kidney failure and osteoporosis.