by the way [12:<50 copies/mL) on their current regimen for ≥6 months, have no history of treatment failure, and are infected with HIV-1 with no known substitutions associated with resistance to the components of the fixed combination. 244 Emtricitabine/rilpivirine/tenofovir DF fixed combination (Complera ) can be used alone as a complete treatment regimen in antiretroviral-naive adults and adolescents ≥12 years of age weighing ≥35 kg with baseline plasma HIV-1 RNA levels 100,000 copies/mL; 233 also can be used to replace a stable antiretroviral regimen in antiretroviral-experience patients who are virologically suppressed (i.e., plasma HIV-1 RNA levels> <50 copies/mL) on their current regimen for ≥6 months, are currently receiving only their first or second antiretroviral regimen, have no history of treatment failure, and have no current evidence or history of resistance to the components of the fixed combination. 233 Preexposure Prophylaxis for Prevention of HIV-1 Infection (PrEP) Emtricitabine/tenofovir DF (Truvada ) used for preexposure prophylaxis (PrEP) in conjunction with safer sex practices to reduce the risk of sexually acquired HIV-1 in HIV-1-negative adults at high risk. 197 230 450 457 463 Adults at high risk include those with partner(s) known to be infected with HIV-1 or those engaging in sexual activity within a high prevalence area or social network and with ≥1 of the following factors: inconsistent or no condom use, diagnosis of sexually transmitted infections, exchange of sex for commodities (e.g., money, food, shelter, drugs), use of illicit drugs, alcohol dependence, incarceration, or partner(s) of unknown HIV-1 status with any of these risk factors. 230 PrEP with emtricitabine/tenofovir DF not always effective in preventing acquisition of HIV-1 infection; must be used as part of a comprehensive prevention strategy that includes safer sex practices. 230 (See Precautions Related to HIV-1 Preexposure Prophylaxis [PrEP] under Cautions.) Postexposure Prophylaxis following Occupational Exposure to HIV (PEP) Postexposure prophylaxis of HIV infection following occupational exposure † (PEP) in health-care personnel and others exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV. 199 Used in conjunction with other antiretrovirals. 199 USPHS recommends 3-drug regimen of raltegravir in conjunction with emtricitabine and tenofovir DF as the preferred regimen for PEP following occupational exposures to HIV. 199 Several alternative regimens that include an INSTI, NNRTI, or PI and 2 NRTIs (dual NRTIs) also recommended. 199 Preferred dual NRTI option for PEP regimens is emtricitabine and tenofovir DF (may be given as emtricitabine/tenofovir DF; Truvada ); 199 alternative dual NRTI options are tenofovir DF and lamivudine, lamivudine and zidovudine (may be given as lamivudine/zidovudine; Combivir ), or zidovudine and emtricitabine. 199 Management of occupational exposures to HIV is complex and evolving; 199 consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or National Clinicians Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) whenever possible. 199 Do not delay initiation of PEP while waiting for expert consultation. 199 Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP) Postexposure prophylaxis of HIV infection following nonoccupational exposure † (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that might contain HIV when the exposure represents a substantial risk for HIV transmission. 198 Used in conjunction with other antiretrovirals. 198 When nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF; Truvada ); 198 alternative regimen recommended in these patients is ritonavir-boosted darunavir used in conjunction with emtricitabine/tenofovir DF (Truvada ). 198 Consult infectious disease specialist, clinician with expertise in administration of antiretroviral agents, and/or the National Clinicians Postexposure Prophylaxis Hotline (PEPline at 888-448-4911) if nPEP indicated in certain exposed individuals (e.g., pregnant women, children, those with medical conditions such as renal impairment) or if considering a regimen not included in CDC guidelines, source virus is known or likely to be resistant to antiretrovirals, or healthcare provider is inexperienced in prescribing antiretrovirals. 198 Do not delay initiation of nPEP while waiting for expert consultation. 198 Emtriva Dosage and Administration Administration Oral Administration Emtricitabine (Emtriva ): Administer orally once daily without regard to meals. 1 Use in conjunction with other antiretrovirals. 1 Emtricitabine/tenofovir alafenamide (Descovy ): Administer orally once daily without regard to meals. 245 Use in conjunction with other antiretrovirals for treatment of HIV-1. 245 Emtricitabine/tenofovir DF (Truvada ): Administer orally once daily without regard to meals. 230 Use in conjunction with other antiretrovirals for treatment of HIV-1; 230 use alone as a complete regimen for PrEP for prevention of sexually transmitted HIV-1. 197 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Administer orally once daily on an empty stomach, preferably at bedtime. 232 Use alone as a complete regimen or in conjunction with other antiretrovirals for treatment of HIV-1. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Administer orally once daily with a meal. 244 Use alone as a complete treatment regimen. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Administer orally once daily with a meal. 233 Use alone as a complete treatment regimen. 233 Because antiretrovirals contained in the fixed combinations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals. 230 232 233 244 245 (See Precautions Related to Use of Fixed Combinations under Cautions.) Dosage Emtricitabine (Emtriva ) capsules and oral solution are not bioequivalent. 1 (See Bioavailability under Pharmacokinetics.) Pediatric Patients Treatment of HIV Infection Oral Emtricitabine (Emtriva oral solution containing 10 mg/mL) in infants 0 3 months of age: 3 mg/kg once daily. 1 Emtricitabine (Emtriva oral solution containing 10 mg/mL) in children and adolescents 3 months to 17 years of age: 6 mg/kg (up to a maximum of 240 mg) once daily. 1 Emtricitabine (Emtriva capsules) in children weighing >33 kg who can swallow intact capsule: 200 mg once daily. 1 Emtricitabine/tenofovir alafenamide (Descovy ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg and tenofovir alafenamide 25 mg) once daily. 230 Emtricitabine/tenofovir DF (Truvada ) in children weighing ≥35 kg: 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) once daily. 230 Emtricitabine/tenofovir DF (Truvada ) in children weighing 17 to> <35 kg: Base dosage on weight and use a low-strength fixed-combination tablet. 230 (see Table 1) Table 1. Emtricitabine/tenofovir DF (Truvada) Dosage for Treatment of HIV-1 Infection in Children Weighing ≥17 kg230 Weight (kg) Dosage of Emtricitabine/tenofovir DF given Once Daily 17 to> <22 kg 1 tablet (emtricitabine 100 mg and tenofovir DF 150 mg) 22 to> <28 kg 1 tablet (emtricitabine 133 mg and tenofovir DF 200 mg) 28 to> <35 kg 1 tablet (emtricitabine 167 mg and tenofovir DF 250 mg) ≥35 kg 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) Efavirenz/emtricitabine/tenofovir DF (Atripla ) in adolescents ≥12 years of age weighing ≥40 kg: 1 tablet (efavirenz 600 mg, emtricitabine 200 mg, and tenofovir DF 300 mg) once daily. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ) in adolescents ≥12 years of age weighing ≥35 kg: 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 233 Adults Treatment of HIV Infection Oral Emtricitabine (Emtriva ): 200-mg capsule once daily. 1 Alternatively, 240 mg (24 mL) as the oral solution containing 10 mg/mL once daily. 1 Emtricitabine/tenofovir alafenamide (Descovy ): 1 tablet (emtricitabine 200 mg and tenofovir alafenamide 25 mg) once daily. 245 Emtricitabine/tenofovir DF (Truvada ): 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) once daily. 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): 1 tablet (efavirenz 600 mg, emtricitabine 200 mg, and tenofovir DF 300 mg) once daily. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide 25 mg) once daily. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 233 Preexposure Prophylaxis for Prevention of HIV-1 Infection (PrEP) HIV-1-negative Adults at High Risk Oral Emtricitabine/tenofovir DF (Truvada ): 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) once daily. 230 Use PrEP only in high-risk adults confirmed to be HIV-1-negative; 230 do not initiate if signs or symptoms of acute HIV-1 infection are present and recent (> <1 month) exposure to HIV-1 is suspected. 230 (See Precautions Related to HIV-1 Preexposure Prophylaxis [PrEP] under Cautions.) Postexposure Prophylaxis following Occupational Exposure to HIV (PEP) † Oral Emtricitabine (Emtriva capsules): 200 mg once daily. 199 Use in conjunction with other antiretrovirals (see Postexposure Prophylaxis following Occupational Exposure to HIV under Uses). 199 Emtricitabine/tenofovir DF (Truvada ): 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) once daily. 199 Use in conjunction with a recommended INSTI, NNRTI, or PI (see Postexposure Prophylaxis following Occupational Exposure to HIV [PEP] under Uses). 199 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 199 Use as a complete regimen for PEP. 199 Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours); continue for 4 weeks, if tolerated. 199 Postexposure Prophylaxis following Nonoccupational Exposure to HIV (nPEP) † Oral Emtricitabine (Emtriva capsules): 200 mg once daily. 198 Usually used in conjunction with tenofovir DF and a preferred or alternative INSTI, NNRTI, or PI (see Postexposure Prophylaxis following Nonoccupational Exposure to HIV [nPEP] under Uses). 198 Emtricitabine/tenofovir DF (Truvada ): 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) once daily. 199 Use in conjunction with a preferred or alternative INSTI, NNRTI, or PI. 198 Emtricitabine/rilpivirine/tenofovir DF (Complera ): 1 tablet (emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir DF 300 mg) once daily. 198 Use as a complete regimen for nPEP. 198 Initiate nPEP as soon as possible (within 72 hours) following nonoccupational exposure that represents a substantial risk for HIV transmission and continue for 28 days. 198 nPEP not recommended if exposed individual seeks care >72 hours after exposure. 198 Prescribing Limits Pediatric Patients Treatment of HIV Infection Oral Emtricitabine (Emtriva ) in children 3 months to 17 years of age: Maximum 240 mg (as the oral solution) once daily. 1 Special Populations Hepatic Impairment Treatment of HIV Infection Emtricitabine not metabolized by liver enzymes; not specifically studied, but clinically important changes in metabolism not expected in patients with hepatic impairment. 1 Emtricitabine/tenofovir alafenamide (Descovy ): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); 245 not studied in those with severe hepatic impairment (Child-Pugh class C). 245 Emtricitabine/tenofovir DF (Truvada ): Not studied in hepatic impairment. 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Use usual dosage in patients with mild hepatic impairment; 232 caution advised. 232 Not recommended in those with moderate or severe hepatic impairment. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); 244 not studied in those with severe hepatic impairment (Child-Pugh class C). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Use usual dosage in patients with mild or moderate hepatic impairment (Child-Pugh class A or B); 233 not studied in those with severe hepatic impairment (Child-Pugh class C). 233 Renal Impairment Treatment of HIV Infection Oral Emtricitabine (Emtriva ): Reduce dosage in adults with Cl cr> <50 mL/minute (see Table 2). 1 Emtricitabine (Emtriva ): Data insufficient to make specific emtricitabine dosage recommendations for pediatric patients with renal impairment; consider reducing dose and/or increasing dosing interval. 1 Table 1. Emtricitabine (Emtriva) Dosage for Treatment of HIV-1 Infection in Adults with Renal Impairment1200 Cl cr (mL/minute) Dosage of Capsules Dosage of Oral Solution 30 49 200 mg every 48 hours 120 mg every 24 hours 15 29 200 mg every 72 hours 80 mg every 24 hours> <15 200 mg every 96 hours 60 mg every 24 hours Hemodialysis patients 200 mg every 96 hours; on day of dialysis, give dose after the procedure 60 mg every 24 hours; on day of dialysis, give dose after the procedure Emtricitabine/tenofovir alafenamide (Descovy ): Use usual dosage in patients with estimated Cl cr ≥30 mL/minute; 245 not recommended in those with severe renal impairment (estimated Cl cr> <30 mL/minute). 245 Emtricitabine/tenofovir DF (Truvada ): Use usual dosage in adults with Cl cr 50 80 mL/minute; however, monitor calculated Cl cr , serum phosphorus, urine glucose, and urine protein. 230 In adults with Cl cr 30 49 mL/minute, reduce dosage to 1 tablet (emtricitabine 200 mg and tenofovir DF 300 mg) once every 48 hours; monitor clinical response and renal function since dosage not evaluated clinically. 230 Do not use in adults with Cl cr> <30 mL/minute (including hemodialysis patients). 230 Data insufficient to make dosage recommendations for treatment of HIV-1 infection in pediatric patients with renal impairment. 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Use usual dosage in patients with Cl cr ≥50 mL/minute; 232 do not use in those with estimated Cl cr> <50 mL/minute. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Use usual dosage in patients with estimated Cl cr ≥30 mL/minute; 244 not recommended in those with severe renal impairment (estimated Cl cr> <30 mL/minute). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Cl cr> <50 mL/minute) or if dialysis required. 233 Preexposure Prophylaxis for Prevention of HIV-1 Infection Oral Emtricitabine/tenofovir DF (Truvada ): Use usual dosage in adults with Cl cr ≥60 mL/minute; however, monitor calculated Cl cr , serum phosphorus, urine glucose, and urine protein. 230 If Cl cr decreases, evaluate potential causes and reassess potential risks and benefits of continued use. 230 Do not use if Cl cr> <60 mL/minute. 230 Geriatric Patients Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. 1 230 232 233 Cautions for Emtriva Contraindications Known hypersensitivity to emtricitabine or any ingredient in the formulation. 1 Emtricitabine/tenofovir alafenamide (Descovy ): Manufacturer states none known. 245 Emtricitabine/tenofovir DF: Do not use alone for treatment of HIV-1 infection; 230 do not use for preexposure prophylaxis of HIV-1 infection in individuals with unknown or positive HIV-1 status. 230 (See Precautions Related to HIV-1 Preexposure Prophylaxis [PrEP] under Cautions.) Efavirenz/emtricitabine/tenofovir DF (Atripla ): History of clinically important hypersensitivity reaction (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic skin eruption) to efavirenz; 232 concomitant use with voriconazole contraindicated (because of efavirenz component). 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ) or emtricitabine/rilpivirine/tenofovir DF (Complera ): Concomitant use with certain drugs that induce CYP3A or elevate gastric pH contraindicated (because of rilpivirine component); 233 244 substantially decreased plasma concentrations of rilpivirine may occur and may result in loss of virologic response and development of resistance to rilpivirine and/or class resistance to HIV NNRTIs. 233 244 Fixed combinations containing emtricitabine: Consider contraindications associated with each drug in the fixed combination. 230 232 233 244 245 Warnings/Precautions Warnings Lactic Acidosis and Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving HIV NRTIs, including emtricitabine with or without a tenofovir prodrug, in conjunction with other antiretrovirals. 1 230 232 233 244 245 Reported most frequently in women; 1 230 232 233 244 245 obesity and long-term NRTI therapy also may be risk factors. 1 230 232 233 244 245 Cases reported in patients with no known risk factors. 1 230 232 233 244 245 Use emtricitabine (single entity or fixed combinations) with caution in patients with known risk factors for liver disease. 1 230 232 233 244 245 Discontinue if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations). 1 230 232 233 244 245 Individuals with HBV Infection Test all HIV-infected patients for presence of HBV before initiating antiretroviral therapy. 1 230 232 233 244 245 Emtricitabine (single entity or fixed combinations) not indicated for treatment of chronic HBV infection. 1 230 232 233 244 245 Safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV. 1 230 232 233 244 245 (See Treatment of HIV Infection under Uses.) Severe acute exacerbations of HBV reported following discontinuance of emtricitabine with or without a tenofovir prodrug. 1 230 232 233 244 245 HBV exacerbations have been associated with hepatic decompensation and hepatic failure. 1 230 232 233 244 245 If emtricitabine (single entity or fixed combinations) used in patients coinfected with HIV and HBV, closely monitor hepatic function (using both clinical and laboratory follow-up) for at least several months after emtricitabine or fixed combinations containing emtricitabine are discontinued. 1 230 232 233 244 245 If appropriate, initiation of HBV treatment may be warranted. 1 230 232 233 244 245 Precautions Related to HIV-1 Preexposure Prophylaxis Use emtricitabine/tenofovir DF (Truvada ) for HIV-1 PrEP only in HIV-1-negative adults at high risk. 230 Confirm a negative HIV-1 test immediately prior to initiating PrEP and screen for HIV-1 infection at least once every 3 months during PrEP. 230 Also test for HBV prior to initiating PrEP. 230 (See Individuals with HBV Infection under Cautions.) Emtricitabine/tenofovir DF PrEP not always effective in preventing acquisition of HIV-1 infection. 230 Must be used as part of a comprehensive HIV prevention strategy that includes other prevention measures (e.g., safer sex practices). 230 (See REMS.) Counsel all uninfected individuals about safer sex practices that include consistent and correct use of condoms, knowledge of their own HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (e.g., syphilis, gonorrhea). 230 Inform and support uninfected individuals regarding efforts to reduce sexual risk behavior. 230 Because emtricitabine/tenofovir DF alone does not constitute a complete antiretroviral regimen for treatment of HIV-1 infection, HIV-1 resistance-associated mutations may emerge if emtricitabine/tenofovir DF PrEP is used in individuals with undetected HIV-1 infection. 230 Drug-resistant HIV-1 variants have been identified in such individuals. 230 Many HIV-1 tests (e.g., rapid tests) detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. 230 Prior to initiating PrEP, evaluate HIV-negative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, rash) and ask about any potential exposure events within the last month (e.g., unprotected sex, condom broke during sex with HIV-infected partner). 230 If clinical symptoms consistent with acute viral infection are present and recent (> <1 month) exposures to HIV-1 are suspected, delay initiating PrEP for at least 1 month and reconfirm HIV-1 status or use a test approved by FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. 230 During PrEP, if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, discontinue the drugs until negative infection status is confirmed using a test approved by FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. 230 Counsel uninfected individuals to strictly adhere to recommended emtricitabine/tenofovir DF dosage schedule. 230 (See Preexposure Prophylaxis [PrEP] for Prevention of HIV-1 Infection under Dosage and Administration.) Effectiveness in reducing risk of acquiring HIV-1 is strongly correlated with adherence. 230 Adverse effects similar to those reported in HIV-infected patients receiving the drugs for treatment of HIV-1 infection. 230 Other Warnings/Precautions Precautions Related to Use of Fixed Combinations Emtricitabine/tenofovir alafenamide, emtricitabine/tenofovir DF, efavirenz/emtricitabine/tenofovir DF, emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination. 230 232 233 244 245 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug. 230 232 233 244 245 Because the antiretrovirals contained in the fixed-combination preparations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals. 230 232 233 244 245 Do not use multiple emtricitabine-containing preparations concomitantly. 1 230 232 233 244 245 Because of similarities between emtricitabine and lamivudine, do not use emtricitabine (single entity or fixed combinations) concomitantly with any preparation containing lamivudine. 1 200 232 233 244 245 In addition, do not use fixed combinations containing tenofovir DF concomitantly with adefovir. 200 232 233 Adipogenic Effects Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement ( buffalo hump ), peripheral wasting, breast enlargement, and general cushingoid appearance. 1 230 232 233 244 245 Mechanisms and long-term consequences of adipogenic effects unknown; causal relationship not established. 1 230 232 233 244 245 Immune Reconstitution Syndrome During initial treatment, HIV-infected patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis , cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii ]); 1 230 232 233 244 245 this may necessitate further evaluation and treatment. 1 230 232 233 244 245 Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported in the setting of immune reconstitution; 1 230 232 233 244 245 time to onset is more variable and can occur many months after initiation of antiretroviral therapy. 1 230 232 233 244 245 Specific Populations Pregnancy Emtricitabine (Emtriva ): Category B. 1 230 233 Emtricitabine/tenofovir alafenamide (Descovy ): Insufficient human data to assess risk of birth defects and miscarriage if used in pregnant women. 245 Emtricitabine/tenofovir DF (Truvada ): Category B. 230 233 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Category D. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Insufficient human data to assess risk of birth defects and miscarriage if used in pregnant women. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Category B. 233 Antiretroviral Pregnancy Registry at 800-258-4263 or . 1 202 230 232 233 244 245 Experts state that emtricitabine and tenofovir DF is a preferred dual NRTI option for use in conjunction with an INSTI, NNRTI, or PI for initial treatment of HIV-1 infection in antiretroviral-naive pregnant women, and is a preferred dual NRTI option in pregnant HIV-infected women coinfected with HBV. 202 Experts state that the dual NRTI option of tenofovir DF and emtricitabine in conjunction with the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir) is a preferred regimen for treatment of HIV type 2 (HIV-2) infection † in pregnant women. 202 If HIV-negative woman receiving emtricitabine/tenofovir DF (Truvada ) for HIV-1 PrEP becomes pregnant, carefully consider whether PrEP regimen should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy. 230 Lactation Emtricitabine distributed into human milk in low concentrations. 1 34 Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant. 1 202 230 232 233 244 245 Pediatric Use Emtricitabine (Emtriva ): Safety and efficacy for treatment of HIV-1 infection in pediatric patients ≥3 months of age is supported by evidence from studies in pediatric patients. 1 Adverse effects reported in children similar to adults. 1 Pharmacokinetics evaluated in a limited number of neonates born to HIV-infected mothers; efficacy in preventing or treating HIV infection in these neonates not determined. 1 20 Emtricitabine/tenofovir alafenamide (Descovy ): Should not be used in pediatric patients> <12 years of age or weighing> <35 kg. 245 Emtricitabine/tenofovir DF (Truvada ): Safety and efficacy for treatment of HIV-1 infection not established in pediatric patients weighing> <17 kg; 230 safety and efficacy for HIV-1 PrEP not established in pediatric patients. 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Do not use in pediatric patients> <12 years of age or weighing> <40 kg. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Safety and efficacy not established in pediatric patients> <12 years of age or weighing> <35 kg. 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Safety and efficacy not established in pediatric patients> <12 years of age or weighing> <35 kg. 233 Geriatric Use Insufficient experience in those ≥65 years of age to determine whether they respond differently to emtricitabine (single-entity or fixed-combination preparations) than younger adults. 1 230 232 233 Hepatic Impairment Emtricitabine not metabolized by liver enzymes; any impact of hepatic impairment expected to be limited. 1 (See Hepatic Impairment under Dosage and Administration.) Emtricitabine/tenofovir alafenamide (Descovy ): Not studied in patients with severe hepatic impairment (Child-Pugh class C). 245 Emtricitabine/tenofovir DF (Truvada ): Not studied in patients with hepatic impairment. 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Not recommended in those with moderate or severe hepatic impairment. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Not studied in patients with severe hepatic impairment (Child-Pugh class C). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Not studied in patients with severe hepatic impairment (Child-Pugh class C). 233 Renal Impairment Dosage adjustment of emtricitabine (Emtriva ) necessary based on degree of renal impairment. 1 Monitor clinical response and renal function in patients with renal impairment. 1 (See Renal Impairment under Dosage and Administration.) Emtricitabine/tenofovir alafenamide (Descovy ): Not recommended in patients with severe renal impairment (estimated Cl cr> <30 mL/minute). 245 Emtricitabine/tenofovir DF (Truvada ): Do not use for treatment of HIV-1 in patients with Cl cr> <30 mL/minute or patients with end-stage renal disease requiring dialysis. 230 Do not use for PrEP in HIV-1 uninfected adults with Cl cr> <60 mL. 230 If Cl cr decreases during emtricitabine/tenofovir DF (Truvada ) PrEP, evaluate potential causes and reassess potential risks and benefits of continued use. 230 Efavirenz/emtricitabine/tenofovir DF (Atripla ): Do not use in those with estimated Cl cr> <50 mL/minute. 232 Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey ): Not recommended in those with severe renal impairment (estimated Cl cr> <30 mL/minute). 244 Emtricitabine/rilpivirine/tenofovir DF (Complera ): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Cl cr> <50 mL/minute) or if dialysis required. 233 Common Adverse Effects Mild to moderate headache, GI effects (diarrhea, nausea), rash. 1 Interactions for Emtriva Emtricitabine does not inhibit CYP1A2, 2A6,2B6, 2C9, 2C19, 2D6, or 3A4. 1 Interactions with drugs metabolized by these CYP isoenzymes unlikely. 1 Emtricitabine does not inhibit glucuronosyltransferase (uridine diphosphoglucuronosyltransferase, UDP-glucuronate β-d-glucuronosyltransferase [acceptor-unspecific]), an enzyme responsible for glucuronidation. 1 Pharmacokinetic interactions unlikely. 1 The following drug interactions are based on studies using emtricitabine. 1 Interaction studies also have been performed using emtricitabine/tenofovir alafenamide, emtricitabine/tenofovir DF, efavirenz/emtricitabine/tenofovir DF, emtricitabine/rilpivirine/tenofovir alafenamide, or emtricitabine/rilpivirine/tenofovir DF. 230 232 233 244 245 When a fixed combinations containing emtricitabine is used, consider interactions associated with each drug in the fixed combination. 230 232 233 244 245 Specific Drugs Drug Interaction Comments Abacavir In vitro evidence of additive or synergistic antiretroviral effects 1 Atazanavir No in vitro evidence of antagonistic antiretroviral effects 203 Darunavir Pharmacokinetic interaction unlikely 204 No in vitro evidence of antagonistic antiretroviral effects 204 Delavirdine In vitro evidence of additive or synergistic antiretroviral effects 1 Didanosine Concomitant use with emtricitabine not recommended in antiretroviral-naive adults (inferior virologic efficacy, limited clinical trial experience, didanosine toxicities); 200 considered alternative (not a preferred) dual NRTI in antiretroviral-naive children ≥2 weeks of age 201 Efavirenz In vitro evidence of additive or synergistic antiretroviral effects 1 Elbasvir and grazoprevir Fixed combination of elbasvir and grazoprevir (elbasvir/grazoprevir): Clinically important pha you got
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