entering into [22:<28 kg: Oral: One tablet (emtricitabine 133 mg/tenofovir 200 mg) once daily Children and Adolescents 28 to> <35 kg: Oral: One tablet (emtricitabine 167 mg/tenofovir 250 mg) once daily Children and Adolescents 35 kg: Oral: Refer to adult dosing. HIV-1 nonoccupational postexposure prophylaxis (nPEP) (off-label use): Adolescents: Refer to adult dosing. Dosing: Renal Impairment HIV-1 infection, treatment: Adults: Manufacturer's labeling: CrCl 50 mL/minute: No dosage adjustment necessary CrCl 30 to 49 mL/minute: Increase interval to every 48 hours. CrCl> <30 mL/minute: Not recommended. Hemodialysis: Not recommended. Alternate recommendations (IDSA [Lucas 2014]): CrCl> <50 mL/minute (and not on hemodialysis) or GFR> <60 mL/minute/1.73 m 2 : Avoid use of tenofovir PrEP: Adults: CrCl 60 mL/minute: No dosage adjustment necessary CrCl> <60 mL/minute: Not recommended. Dosing: Hepatic Impairment There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Administration Oral: May be administered with or without food. Dietary Considerations May be taken without regard to meals. Consider calcium and vitamin D supplementation in patients with history of bone fracture or osteopenia. Storage Store tablets at 25 C (77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Dispense only in original container. Drug Interactions Acyclovir-Valacyclovir: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Acyclovir-Valacyclovir. Monitor therapy Adefovir: May diminish the therapeutic effect of Tenofovir Products. Adefovir may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Adefovir. Avoid combination Aminoglycosides: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Monitor therapy Atazanavir: Tenofovir Disoproxil Fumarate may decrease the serum concentration of Atazanavir. Atazanavir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Management: Must use ritonavir-boosting in adults; give combo (atazanavir/ritonavir 300mg/100mg and tenofovir 300mg) as a single daily dose with food. Pediatric patients, pregnant patients, and users of H2-blockers require other dose changes. Consider therapy modification Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Monitor therapy Cidofovir: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Cidofovir. Monitor therapy Cobicistat: May enhance the adverse/toxic effect of Tenofovir Products. More specifically, cobicistat may impair proper tenofovir monitoring and dosing. Monitor therapy Darunavir: Tenofovir Disoproxil Fumarate may increase the serum concentration of Darunavir. Darunavir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Monitor therapy Diclofenac (Systemic): May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to this combination whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. Consider therapy modification Didanosine: Tenofovir Disoproxil Fumarate may diminish the therapeutic effect of Didanosine. Tenofovir Disoproxil Fumarate may increase the serum concentration of Didanosine. Management: Avoid concomitant treatment with tenofovir disoproxil fumarate and didanosine. Consider altering even existing, stable treatment to avoid this combination. Avoid combination Ganciclovir-Valganciclovir: Tenofovir Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenofovir Products. Monitor therapy LamiVUDine: May enhance the adverse/toxic effect of Emtricitabine. Avoid combination Ledipasvir: May increase the serum concentration of Tenofovir Disoproxil Fumarate. Management: Avoidance of this combination is recommended under some circumstances. Refer to full monograph for details. Consider therapy modification Lopinavir: May enhance the nephrotoxic effect of Tenofovir Disoproxil Fumarate. Lopinavir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Monitor therapy Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. Consider therapy modification Orlistat: May decrease the serum concentration of Antiretroviral Agents. Monitor therapy Simeprevir: Tenofovir Disoproxil Fumarate may decrease the serum concentration of Simeprevir. Simeprevir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Monitor therapy Telaprevir: May increase the serum concentration of Tenofovir Disoproxil Fumarate. Monitor therapy Tipranavir: Tenofovir Disoproxil Fumarate may decrease the serum concentration of Tipranavir. Tipranavir may decrease the serum concentration of Tenofovir Disoproxil Fumarate. Monitor therapy Velpatasvir: May increase the serum concentration of Tenofovir Disoproxil Fumarate. Monitor therapy Adverse Reactions See individual agents. ALERT: U.S. Boxed Warning Posttreatment acute exacerbation of hepatitis B: Emtricitabine/tenofovir disoproxil fumarate is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy have not been established in patients coinfected with HBV and HIV-1. Severe, acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued therapy. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue emtricitabine/tenofovir disoproxil fumarate. If appropriate, initiation of antihepatitis B therapy may be warranted. Risk of drug resistance with use for preexposure prophylaxis: Emtricitabine/tenofovir disoproxil fumarate for a preexposure prophylaxis indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use for a preexposure prophylaxis indication following undetected acute HIV-1 infection. Do not initiate for a preexposure prophylaxis indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed. Warnings/Precautions Concerns related to adverse effects: Decreased bone mineral density: In clinical trials, tenofovir disoproxil fumarate has been associated with decreases in bone mineral density in HIV-1 infected adults and increases in bone metabolism markers. Serum parathyroid hormone and 1,25 vitamin D levels were also higher. Decreases in bone mineral density have also been observed in clinical trials of HIV-1 infected pediatric patients. Observations in chronic hepatitis B infected pediatric patients (aged 12-18 years) were similar. In all pediatric clinical trials, skeletal growth (height) appears unaffected. Consider monitoring of bone density in adult and pediatric patients with a history of pathologic fractures or with other risk factors for bone loss or osteoporosis. Consider calcium and vitamin D supplementation for all patients; effect of supplementation has not been studied but may be beneficial. Long-term bone health and fracture risk unknown. If abnormalities are suspected, expert assessment is recommended. Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required. Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, sometimes fatal, have been reported with use of nucleoside analogues, alone or in combination with other antiretrovirals. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (marked transaminase elevation may/may not accompany hepatomegaly and steatosis). Osteomalacia and renal dysfunction: May cause osteomalacia with proximal renal tubulopathy. Bone pain, extremity pain, fractures, arthralgias, weakness and muscle pain have been reported. In patients at risk for renal dysfunction, persistent or worsening bone or muscle symptoms should be evaluated for hypophosphatemia and osteomalacia. Renal toxicity: Tenofovir disoproxil fumarate may cause renal toxicity (acute renal failure and/or Fanconi syndrome); avoid use with concurrent or recent nephrotoxic therapy (including high dose or multiple NSAID use). Acute renal failure has occurred in HIV-infected patients with risk factors for renal impairment who were on a stable tenofovir regimen to which a high dose or multiple NSAID therapy was added. Consider alternatives to NSAIDS in patients taking tenofovir disoproxil fumarate and at risk for renal impairment. Calculate creatinine clearance prior to initiation of therapy and as clinically appropriate during therapy. In patients at risk for renal dysfunction, including patients who have experienced renal events while taking adefovir, assess serum phosphorus, urine glucose, and urine protein prior to and periodically during treatment. IDSA guidelines recommend discontinuing tenofovir (and substituting with alternative antiretroviral therapy) in HIV-infected patients who develop a decline in GFR (a >25% decrease in GFR from baseline and to a level of> <60 mL/minute/1.73 m 2 ) during use, particularly in presence of proximal tubular dysfunction (eg, euglycemic glycosuria, increased urinary phosphorus excretion and hypophosphatemia, proteinuria [new onset or worsening]) (IDSA [Lucas 2014]). Disease-related concerns: Chronic hepatitis B: [US Boxed Warning]: Safety and efficacy during coinfection of HIV and HBV have not been established; acute, severe exacerbations of HBV have been reported following discontinuation of antiretroviral therapy. Not approved for the treatment of chronic hepatitis B virus infection. Closely monitor hepatic function with clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue this therapy. If appropriate, anti-hepatitis B therapy may be warranted. All patients with HIV should be tested for HBV prior to initiation of treatment. Comprehensive prevention program: Preexposure prophylaxis (PrEP) should be accompanied by a comprehensive HIV-1 prevention program (eg, risk reduction counseling, access to condoms), with particular emphasis on medication adherence. In addition, regular monitoring (eg, HIV status of patient and partner(s), risk behavior, adherence, adverse effects, sexually transmitted infections that facilitate HIV-1 transmission) is highly recommended. HIV treatment: Appropriate use: Not recommended as a component of a triple nucleoside regimen due to potential for early virological failure. Clinical trials in HIV-infected patients whose regimens contained only three nucleoside reverse transcriptase inhibitors (NRTI) show less efficacy, early virologic failure and high rates of resistance substitutions. Triple drug regimens with two NRTIs in combination with a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor are usually more effective. HIV treatment and renal impairment: Use with caution in patients with renal impairment (CrCl> <50 mL/minute); dosage adjustment required. Closely monitor renal function and assess serum phosphorus, urine glucose, and urine protein prior to and periodically during treatment. Do not use in patients with CrCl> <30 mL/minute or requiring hemodialysis. IDSA guidelines recommend avoiding tenofovir in HIV patients with preexisting kidney disease (CrCl> <50 mL/minute and not on hemodialysis or GFR> <60 mL/minute/1.73 m 2 ) when other effective HIV treatment options exist because data suggest risk of chronic kidney disease (CKD) is increased (IDSA [Lucas 2014]). PrEP and renal impairment: Routinely monitor serum phosphorus, urine glucose, and urine protein prior to and periodically during treatment in patients with mild renal impairment. Do not use in CrCl> <60 mL/minute. Resistance risk with PrEP: [US Boxed Warning]: Confirm HIV-1 negative status immediately before and at least every 3 months during therapy. Do not start PrEP if signs or symptoms of acute HIV-1 infection are present unless HIV-1 negative status is confirmed by a test approved by the Food and Drug Administration (FDA) as an aid to detect HIV-1 infection (including acute or primary infection). Risk of drug resistant HIV-1 variants with PrEP use if patient had undetected acute HIV-1 infection. Some HIV-1 tests (eg, rapid tests) do not detect acute HIV-1 infection. Screen PrEP candidates for acute viral infections and potential exposure events within 1 month of starting PrEP. If infections or events exist, wait 1 month to start PrEP and reconfirm HIV-1 negative status. If symptoms consistent with acute HIV-1 infection develop following a potential exposure during PrEP, discontinue PrEP until negative infection status is confirmed. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Duplicate therapy: Do not use concurrently with emtricitabine, lamivudine, tenofovir disoproxil fumarate, tenofovir alafenamide, or any combination of these drugs. Monitoring Parameters CBC with differential, reticulocyte count, creatine kinase, CD4 count, HIV RNA plasma levels, serum phosphorus; serum creatinine (prior to initiation and as clinically indicated during therapy), urine glucose and urine protein (in patients with mild renal impairment [CrCl 30-49 mL/minute], at risk for renal impairment or who experienced renal impairment while taking adefovir), hepatic function tests, bone density (patients with a history of bone fracture or have risk factors for bone loss); testing for HBV is recommended prior to the initiation of antiretroviral therapy; weight (children). Patients with HIV and HBV coinfection should be monitored for several months following tenofovir discontinuation. HIV-1 preexposure prophylaxis (PrEP) (CDC 2011; CDC 2012): Pregnancy test for women receiving PrEP (every visit); documented negative HIV test (immediately prior to use, every 2-3 months, and following discontinuation of PrEP), assess risk behaviors and symptoms of sexually-transmitted infections (STIs) or acute HIV-1 infection and provide condoms (immediately prior to use, then every 2-3 months during therapy); BUN and serum creatinine (prior to initiation, 3 months after initiation, then every 6 months); urine glucose and urine protein (in patients at risk for renal impairment or who experienced renal impairment while taking adefovir); testing for HBV (prior to initiation) and STIs (prior to initiation, then at least every 6 months, even if asymptomatic) HIV occupational postexposure prophylaxis (PEP) (Kuhar 2013): Documented HIV test (at baseline and 6 weeks, 12 weeks and 6 months after exposure); if confirmation that a fourth generation HIV p2 antigen-HIV antibody test is being used, monitor at baseline, 6 weeks and 4 months after exposure. CBC, renal and hepatic function assessments at baseline and 2 weeks after exposure (minimum recommendations, others dictated by clinical assessment) Pregnancy Risk Factor B Pregnancy Considerations Animal reproduction studies have not been conducted with this combination. An increased risk of birth defects has not been observed following use of this combination for pre-exposure prophylaxis (PrEP). Although pregnancy is not a contraindication to PrEP when used for the prevention of HIV-1 infection in adults who are at high risk for infection, long term use in pregnancy is not well studied. In general, women who become pregnant on a stable combination antiretroviral therapy (cART) regimen may continue that regimen if viral suppression is effective, appropriate drug exposure can be achieved, contraindications for use in pregnancy are not present, and the regimen is well tolerated. The Health and Human Services (HHS) Perinatal HIV Guidelines consider emtricitabine with tenofovir disoproxil fumarate to be a preferred NRTI backbone for initial therapy in antiretroviral-naive pregnant women. The guidelines also consider emtricitabine plus tenofovir disoproxil fumarate a recommended dual NRTI backbone in regimens for HIV/HBV-coinfected pregnant women (HHS [perinatal] 2016). Refer to individual monographs. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience nausea, diarrhea, insomnia, dizziness, headache, nightmares, weight loss, or loss of strength and energy. Have patient report immediately to prescriber signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), depression, bone pain, muscle pain, muscle weakness, painful extremities, anxiety, burning or numbness feeling, or signs of infection (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. 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