Emtricitabine and tenofovir disoproxil fumarate

What is Emtricitabine and tenofovir disoproxil fumarate?

• Emtricitabine and tenofovir disoproxil fumarate (TRUVADA) is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors used to treat and prevent HIV/AIDS.

Tenofovir disoproxil fumarate and emtricitabine

What are the uses of this medicine?

TRUVADA is used:

• to treat HIV-1 infection when used with other anti-HIV-1 medicines in adults and children who weigh at least 37 pounds (at least 17 kg).
• for HIV-1 PrEP to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (at least 35 kg).

How does this medicine work?

• TRUVADA is a fixed-dose combination of antiviral drugs.
• Emtricitabine: FTC, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate (FTC-TP), which inhibits the activity of the HIV-1 reverse transcriptase (RT) by competing with the natural substrate deoxycytidine 5'-triphosphate and by being incorporated into nascent viral DNA which results in chain termination. FTC-TP is a weak inhibitor of mammalian DNA polymerases α, β, ε and mitochondrial DNA polymerase γ.
• Tenofovir Disoproxil Fumarate: TDF is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate. TDF requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate (TFV-DP), which inhibits the activity of HIV-1 RT by competing with the natural substrate deoxyadenosine 5′-triphosphate and, after incorporation into DNA, by DNA chain termination. TFV-DP is a weak inhibitor of mammalian DNA polymerases α, β, and mitochondrial DNA polymerase γ.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• already have HIV-1 infection
• do not know your HIV-1 infection status
• TRUVADA can only help reduce your risk of getting HIV-1 before you are infected.

What drug interactions can this medicine cause?

• Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted.
• Coadministration decreases atazanavir concentrations. When coadministered with TRUVADA, use atazanavir given with ritonavir.
• Coadministration of TRUVADA with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

• 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.
• 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).

Recommended dosage: 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.
• 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.
• Recommended dosage in renally impaired HIV-1 infected adult patients:

Creatinine clearance (CrCl) 30−49 mL/min: 1 tablet every 48 hours. CrCl below 30 mL/min or hemodialysis: TRUVADA is not recommended.

HIV-1 Pre-Exposure Prophylaxis:

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

Administration:

• Take TRUVADA 1 time each day with or without food.
• Children who take TRUVADA are prescribed a lower strength tablet than adults. Children should swallow the TRUVADA tablet. Tell your healthcare provider if your child cannot swallow the tablet, because they may need a different HIV-1 medicine.
• Your healthcare provider will change the dose of TRUVADA as needed based on your child's weight.
• Do not change your dose or stop taking TRUVADA without first talking with your healthcare provider. Stay under a healthcare provider's care when taking TRUVADA. Do not miss a dose of TRUVADA.
• If you take too much TRUVADA, call your healthcare provider or go to the nearest hospital emergency room right away.
• When your TRUVADA supply starts to run low, get more from your healthcare provider or pharmacy.
• If you are taking TRUVADA for treatment of HIV-1, the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TRUVADA and become harder to treat.
• If you are taking TRUVADA for HIV-1 PrEP, missing doses increases your risk of getting HIV-1 infection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 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

This medicine is available in fallowing brand namesː

• TRUVADA

What side effects can this medication cause?

The most common side effects of TRUVADA for treatment of HIV-1 include:

• diarrhea
• nausea
• tiredness
• headache
• dizziness
• depression
• problems sleeping
• abnormal dreams
• rash

Common side effects in people who take TRUVADA for HIV-1 PrEP include:

• headache
• stomach-area (abdomen) pain
• decreased weight

TRUVADA may cause serious side effects, including:

• Worsening of hepatitis B virus infection (HBV)
• New or worse kidney problems, including kidney failure
• Changes in your immune system (Immune Reconstitution Syndrome)
• Bone problems
• Too much lactic acid in your blood (lactic acidosis)
• Severe liver problems

What special precautions should I follow?

• Use TRUVADA for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes other prevention measures, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
• Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in HBV-infected individuals who have discontinued TRUVADA. All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating TRUVADA.
• Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of TDF, a component of TRUVADA. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs.
• Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including TRUVADA. May necessitate further evaluation and treatment.
• TRUVADA may cause 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.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including FTC and TDF, components of TRUVADA, alone or in combination with other antiretrovirals. Discontinue TRUVADA in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

What to do in case of emergency/overdose?

Management of overdosage: If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Emtricitabine: Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis. Tenofovir Disoproxil Fumarate: Tenofovir is efficiently removed by hemodialysis.

Can this medicine be used in pregnancy?

• Data on the use of TRUVADA during pregnancy from observational studies have shown no increased risk of major birth defects.

Can this medicine be used in children?

Treatment of HIV-1 Infection

• No pediatric clinical trial was conducted to evaluate the safety and efficacy of TRUVADA in patients with HIV-1 infection.

HIV-1 PrEP

• Safety and effectiveness of Truvada for HIV-1 PrEP in pediatric patients weighing less than 35 kg have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: emtricitabine and tenofovir disoproxil fumarate.
• Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The 200 mg/300 mg strength tablets are coated with Opadry II Blue Y-30-10701, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg strength tablets are coated with Opadry II Blue, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

• Manufactured for and distributed by:

Gilead Sciences, Inc. Foster City, CA TRUVADA is a trademark of Gilead Sciences, Inc., or its related companies.

What should I know about storage and disposal of this medication?

• Store TRUVADA at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep TRUVADA in its original container.
• Keep the container tightly closed.
• Do not use TRUVADA if seal over bottle opening is broken or missing.

• Dailymed label info on Emtricitabine and tenofovir disoproxil fumarate
• FDA Emtricitabine and tenofovir disoproxil fumarate

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