which might be [50:<1% (Limited to important or life-threatening): Glycosuria ALERT: U.S. Boxed Warning Hepatitis B coinfection: Efavirenz/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 have discontinued emtricitabine or tenofovir disoproxil fumarate. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who discontinue therapy and are coinfected with HIV-1 and HBV. If appropriate, initiation of anti hepatitis B therapy may be warranted. Warnings/Precautions Concerns related to adverse effects: CNS effects: CNS symptoms (eg, insomnia, abnormal dreams, hallucinations) have been reported with efavirenz; symptoms usually start during first 1 to 2 days of treatment and generally resolve after 2 to 4 weeks; administration at bedtime may improve tolerability of CNS symptoms. May also cause CNS depression (eg, impaired concentration, dizziness or drowsiness); avoid potentially hazardous tasks such as driving or operating machinery. 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 to> <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. Fat redistribution: May cause redistribution/accumulation of body fat (eg, central obesity, dorsocervical fat enlargement [buffalo hump], peripheral wasting, facial wasting, breast enlargement, cushingoid appearance). Hepatotoxicity: Hepatic failure has been reported, including patients with no preexisting hepatic disease or other identifiable risk factors. Monitor liver function tests at baseline and during treatment in patients with underlying hepatic disease (including hepatitis B or C), marked transaminase elevations, or taking concomitant medications known to cause hepatotoxicity); consider monitoring in patients without preexisting hepatic dysfunction or other risk factors. Weigh risks/benefits in patients who have persistent elevations of serum transaminases >5 time ULN. 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 analogs, 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: Tenofovir disoproxil fumarate 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. Psychiatric effects: Serious psychiatric symptoms have been associated with efavirenz, including severe depression, suicide attempts and ideation, paranoia, aggression, and mania. Use with caution in patients with a history of mental illness/drug abuse. QT prolongation: QT prolongation has been reported with efavirenz; consider alternative therapy in patients at risk of torsades de pointes or when coadministered with medications with known risk of torsades de pointes. Rash: Rash, ranging from mild to moderate maculopapular skin eruptions to life-threatening cutaneous reactions (eg, Stevens-Johnson syndrome), may occur with efavirenz. Mild to moderate rashes occur within 2 weeks (median onset, 11 days) and resolve within 1 month in patients continuing treatment. Treatment may be reinitiated in patients interrupting therapy for mild to moderate rashes; discontinue use and consider alternative therapy if severe rash associated with blistering, desquamation, mucosal involvement, or fever develops. Pediatric patients are more susceptible to development of rash (median time to onset: 28 days); prophylactic antihistamines should be considered. 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 disoproxil fumarate regimen to which a high dose or multiple NSAID therapy was added. Consider alternatives to NSAIDS in patients taking tenofovir and at risk for renal impairment. Calculate estimated creatinine clearance (CrCl) 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, also assess serum phosphorus, urine glucose, and urine protein prior to and periodically during treatment. IDSA guidelines recommend discontinuing tenofovir disoproxil fumarate (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 indicated for treatment of chronic hepatitis B. 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. Hepatic impairment: Not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B, C). Use caution in patients with mild hepatic impairment (Child-Pugh class A). Monitor liver function tests before and during treatment. HIV-associated dementia: Avoid efavirenz based regimens if possible in patients with HIV-associated dementia; neuropsychiatric side effects of efavirenz may hinder assessment of the effects of antiretrovirals on the improvement of symptoms associated with HIV-associated dementia (HHS [adult] 2016). Renal impairment: Use is not recommended in patients with CrCl> <50 mL/minute. Seizure disorder: Use efavirenz with caution in patients with a history of seizure disorder; seizures have been associated with use. 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 other drugs containing efavirenz, emtricitabine, lamivudine, tenofovir disoproxil fumarate, or tenofovir alafenamide; however, coadministration with efavirenz may be required for dose-adjustment with concomitant rifampin therapy. Monitoring Parameters Testing for HBV is recommended prior to the initiation of antiretroviral therapy. CBC with differential, reticulocyte count, creatine kinase, CD4 count, HIV RNA plasma levels; serum creatinine (prior to initiation and as clinically indicated during therapy); serum phosphorus, urine glucose, and urine protein at baseline and periodically during therapy in patients at risk for renal impairment or who experienced renal impairment while taking adefovir; hepatic function tests (discontinuation of treatment should be considered for persistent serum transaminase elevations >5 times ULN); bone density (patients with a history of bone fracture or have risk factors for bone loss). Patients with HIV and HBV coinfection should have hepatic function monitored for several months following discontinuation. Pregnancy Risk Factor D Pregnancy Considerations Adverse events have been observed in some animal reproduction studies. The manufacturer's labeling of this combination product recommends pregnancy testing prior to therapy, and effective contraception in women of reproductive potential during treatment and for 12 weeks after therapy is discontinued. 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 efavirenz in combination with emtricitabine and tenofovir disoproxil fumarate as an alternative initial regimen in antiretroviral-naive pregnant women; it may be preferred in women who require co-administration of drugs without significant interactions with protease inhibitors, or for the convenience of once-daily dosing (HHS [perinatal] 2016). See individual agents. 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 headache, fatigue, nightmares, dizziness, difficulty focusing, nausea, vomiting, diarrhea, insomnia, loss of strength and energy, or skin discoloration. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), 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 depression (suicidal ideation, anxiety, emotional instability, confusion), tachycardia, abnormal heartbeat, passing out, bone pain, muscle pain, muscle weakness, painful extremities, seizures, change in body fat, signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), 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. Next Interactions Print this page Add to My Med List More about efavirenz/emtricitabine/tenofovir Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 102 Reviews Add your own review/rating Drug class: antiviral combinations Consumer resources Efavirenz, emtricitabine, and tenofovir Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Efavirenz, emtricitabine, and tenofovir (Advanced Reading) Professional resources Other brands: Atripla Related treatment guides HIV Infection Nonoccupational Exposure Occupational Exposure> ]} Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Efavirenz / emtricitabine / tenofovir Rating 102 User Reviews 9.0 /10 102 User Reviews 9.0 Rate it! Drug Class Antiviral combinations Related Drugs antiviral combinations Harvoni , Truvada , Atripla , Genvoya , Triumeq , Stribild HIV Infection Truvada , Atripla , Norvir , Viread , Isentress , Prezista , Stribild , lamivudine , More... Nonoccupational Exposure Truvada , Atripla , Viread , lamivudine , abacavir , tenofovir , Epzicom , Reyataz , More... Occupational Exposure Truvada , Atripla , Viread , Isentress , lamivudine , abacavir , tenofovir , Epzicom , More...} } is certain
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