Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate (Monograph)

Drug class: HIV Integrase Inhibitors

Medically reviewed by Drugs.com on Feb 10, 2024. Written by ASHP.

[Web]

Introduction

Antiretroviral; fixed combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/c/FTC/TDF). Elvitegravir (EVG) is an HIV integrase strand transfer inhibitor (INSTI); cobicistat is a pharmacokinetic enhancer used to decrease metabolism and increase plasma concentrations of EVG; emtricitabine (FTC) and tenofovir DF (TDF) are HIV nucleoside reverse transcriptase inhibitors (NRTIs).

Uses for Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate

Treatment of HIV Infection

Used as a complete regimen for treatment of HIV-1 infection in adults and pediatric patients ≥12 years of age weighing ≥35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of the fixed-combination drug.

Elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/c/FTC/TDF) is included among alternative regimens recommended in guidelines for treatment of HIV in adults and sexually mature adolescent patients, but is not recommended in pregnant patients.

Selection of an initial antiretroviral regimen should be individualized based on factors such as virologic efficacy, toxicity, pill burden, dosing frequency, drug-drug interaction potential, resistance test results, comorbid conditions, access, and cost.

Postexposure Prophylaxis following Nonoccupational Exposure to HIV

Used as a complete regimen for postexposure prophylaxis of HIV infection following nonoccupational exposure ^{† [off-label]} (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. Included among alternative regimen options in guidelines for nPEP.

Postexposure Prophylaxis following Occupational Exposure to HIV

Used as a complete regimen for postexposure prophylaxis of HIV infection following occupational exposure ^{† [off-label]} (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. Included among alternative regimen options in guidelines for PEP.

Related/similar drugs

Biktarvy, Descovy, Truvada, Atripla, Stribild, Complera, Epzicom

Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate Dosage and Administration

General

Pretreatment Screening

• Patients should be tested for HBV infection prior to initiation of EVG/c/FTC/TDF.

• Serum creatinine, estimated creatinine clearance, urine glucose, and urine protein should be determined prior to initiation of EVG/c/FTC/TDF.

• In patients with chronic kidney disease (CKD), serum phosphorus should be determined prior to initiation of EVG/c/FTC/TDF.

Patient Monitoring

• Routinely monitor serum creatinine, estimated creatinine clearance, urine glucose, and urine protein during treatment in all patients.

• Routinely monitor serum phosphorus during treatment in patients with CKD.

Administration

Oral Administration

Administer fixed combination of EVG/c/FTC/TDF orally once daily with food.

Dosage

Each fixed-combination tablet of EVG/c/FTC/TDF contains elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir DF 300 mg.

Pediatric Patients

Treatment of HIV Infection

Oral

Pediatric patients ≥12 years of age weighing ≥35 kg: 1 tablet of EVG/c/FTC/TDF (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir DF 300 mg) once daily.

Adults

Treatment of HIV Infection

Oral

1 tablet of EVG/c/FTC/TDF (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir DF 300 mg) once daily.

Postexposure Prophylaxis following Nonoccupational Exposure to HIV† [off-label]

Oral

1 tablet of EVG/c/FTC/TDF (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir DF 300 mg) once daily.

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. If the exposed individual seeks care more than 72 hours after the exposure, nPEP is not recommended.

Postexposure Prophylaxis following Occupational Exposure to HIV† [off-label]

Oral

1 tablet of EVG/c/FTC/TDF (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir DF 300 mg) once daily.

Initiate PEP as soon as possible following occupational exposure to HIV (preferably within hours); continue for 4 weeks, if tolerated.

Special Populations

Hepatic Impairment

Mild or moderate hepatic impairment (Child-Pugh class A or B): Dosage adjustments not needed.

Severe hepatic impairment (Child-Pugh class C): Do not use.

Renal Impairment

Adults: Do not initiate EVG/c/FTC/TDF if estimated Cl_cr <70 mL/minute. Discontinue if estimated Cl_cr decreases to <50 mL/minute, or there is evidence of clinically significant decreases in renal function or Fanconi syndrome during treatment.

Pediatric patients: Data insufficient to make dosage recommendations for those with renal impairment.

Geriatric Use

Dosage adjustments not needed; however, use with caution.

Cautions for Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate

Contraindications

• Concomitant use with drugs highly dependent on CYP3A for metabolism and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., alfuzosin, cisapride, ergot alkaloids, lovastatin, lurasidone, oral midazolam, pimozide, sildenafil used for treatment of pulmonary arterial hypertension [PAH], simvastatin, triazolam).

• Concomitant use with drugs that are potent inducers of CYP3A which may result in decreased elvitegravir and/or cobicistat concentrations and possible decreased antiretroviral efficacy and development of resistance (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s wort [Hypericum perforatum]).

Warnings/Precautions

Warnings

HIV-infected Individuals Coinfected with HBV

Test all HIV-infected patients for presence of HBV before initiating antiretroviral therapy.

EVG/c/FTC/TDF not indicated for treatment of chronic HBV infection. Safety and efficacy of EVG/c/FTC/TDF not established in patients coinfected with HIV and HBV.

Severe acute exacerbations of HBV reported following discontinuance of emtricitabine or tenofovir DF in HIV-infected patients with HBV infection. HBV exacerbations have been associated with hepatic decompensation and hepatic failure.

Closely monitor hepatic function (using both clinical and laboratory follow-up) for at least several months after EVG/c/FTC/TDF is discontinued in patients coinfected with HIV and HBV. If appropriate, initiation of HBV treatment may be warranted.

Other Warnings/Precautions

Renal Toxicity

Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with hypophosphatemia), reported with tenofovir DF (a component of EVG/c/FTC/TDF).

Cobicistat (a component of EVG/c/FTC/TDF) may cause modest increase in S_cr and modest decrease in estimated Cl_cr due to inhibition of tubular secretion of creatinine; glomerular function not affected.

Determine S_cr, estimated Cl_cr, serum phosphorus, urine glucose, and urine protein prior to initiation of EVG/c/FTC/TDF and routinely monitor during treatment in all patients. Assess serum phosphorus in patients with CKD. Discontinue EVG/c/FTC/TDF if clinically significant renal dysfunction develops or there is evidence of Fanconi syndrome.

Do not initiate EVG/c/FTC/TDF in patients with estimated Cl_cr <70 mL/minute; discontinue if estimated Cl_cr decreases to <50 mL/minute during therapy.

If a confirmed increase in S_cr of >0.4 mg/dL from baseline occurs during EVG/c/FTC/TDF treatment, closely monitor for renal toxicity.

Because persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy, promptly evaluate renal function in patients at risk for renal dysfunction who present with such symptoms.

Avoid EVG/c/FTC/TDF in patients who are receiving or have recently received a nephrotoxic drug (e.g., high-dose or multiple NSAIAs). Acute renal failure reported after initiation of high-dose or multiple NSAIAs in HIV-infected patients at risk for renal dysfunction who appeared stable while receiving tenofovir DF; hospitalization and renal replacement therapy required in some patients. Consider alternatives to NSAIAs in patients at risk for renal dysfunction.

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving NRTIs, including emtricitabine and tenofovir DF (components of EVG/c/FTC/TDF), in conjunction with other antiretrovirals.

Interrupt EVG/c/FTC/TDF treatment 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).

Bone Effects

Decreases in bone mineral density (BMD) from baseline at lumbar spine and hip, increases in several biochemical markers of bone metabolism, and increased serum parathyroid hormone and 1,25 vitamin D levels reported in patients receiving tenofovir DF (a component of EVG/c/FTC/TDF). Bone effects reported in pediatric patients are similar to those reported in adults. Effects of tenofovir-associated changes in BMD on long-term bone health and future fracture risk unknown.

Osteomalacia associated with proximal renal tubulopathy, which may contribute to fractures, reported in patients receiving tenofovir DF. Arthralgia and muscle pain or weakness also reported in cases of proximal renal tubulopathy. Consider hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving preparations containing tenofovir DF.

Consider BMD monitoring in adult and pediatric patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Effect of calcium and vitamin D supplementation not studied, but may be beneficial for all patients. If bone abnormalities suspected, obtain appropriate consultation.

Interactions

Concomitant use with certain drugs may result in decreased antiretroviral plasma concentrations leading to loss of therapeutic effect and possible development of resistance; concomitant use with certain other drugs may result in increased antiretroviral plasma concentrations and/or increased plasma concentrations of the concomitant drugs leading to clinically important adverse reactions, including potentially severe, life-threatening, or fatal events. Loss of therapeutic effect of concomitant drugs that utilize CYP3A to form active metabolites may also occur.

Consider potential drug interactions prior to and during therapy. Review drugs used concomitantly with EVG/c/FTC/TDF; monitor patient for adverse reactions associated with these drugs.

Use of Fixed Combinations

Consider cautions, precautions, and contraindications associated with each component of EVG/c/FTC/TDF. Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.

EVG/c/FTC/TDF is used alone as a complete regimen for treatment of HIV-1 infection; do not use in conjunction with other antiretrovirals.

Do not use EVG/c/FTC/TDF concomitantly with any preparation that contains any of its components (elvitegravir, cobicistat, emtricitabine, tenofovir DF). In addition, do not use EVG/c/FTC/TDF concomitantly with any preparation containing lamivudine, adefovir dipivoxil, or ritonavir.

Immune Reconstitution Syndrome

During initial treatment, 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]); this may necessitate further evaluation and treatment.

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) also reported in the setting of immune reconstitution; time to onset is more variable and can occur many months after initiation of antiretroviral therapy.

Specific Populations

Pregnancy

Antiretroviral Pregnancy Registry at 800-258-4263 or [Web].

Use of EVG/c/FTC/TDF not recommended due to substantially lower elvitegravir and cobicistat exposures in the second and third trimesters; use alternative regimen.

Experts state data insufficient to recommend routine use of EVG/c/FTC/TDF for initial treatment in antiretroviral-naïve pregnant women.

Lactation

Elvitegravir and cobicistat distributed into milk in rats; not known whether these drugs distributed into human milk. Emtricitabine and tenofovir DF are distributed into human milk.

Not known whether EVG/c/FTC/TDF affects human milk production or affects the breast-fed infant.

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.

Pediatric Use

Safety and efficacy of EVG/c/FTC/TDF not established in pediatric patients <12 years of age or in those weighing <35 kg.

Clinical trial data indicate that safety profile of EVG/c/FTC/TDF in HIV-1-infected, treatment-naïve pediatric patients 12 to <18 years of age is similar to that reported in adults.

Bone effects reported when tenofovir DF is used in pediatric and adolescent patients are similar to those reported in adults. In clinical studies, total body BMD gain in tenofovir DF-treated pediatric patients was less than that reported in control groups; skeletal growth appeared to be unaffected. Effects of tenofovir DF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk unknown.

Geriatric Use

Insufficient experience in adults ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Use with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Hepatic Impairment

Moderate hepatic impairment (Child-Pugh class B): No clinically important effect on pharmacokinetics of elvitegravir, cobicistat, or tenofovir; not expected to affect emtricitabine pharmacokinetics.

Severe hepatic impairment (Child-Pugh class C): EVG/c/FTC/TDF not recommended; data not available to date regarding pharmacokinetics or safety in such patients.

Renal Impairment

Determine S_cr, estimated Cl_cr, urine glucose, and urine protein prior to and routinely monitor during EVG/c/FTC/TDF treatment in all patients. Assess serum phosphorous in patients with CKD.

Adults: Do not initiate EVG/c/FTC/TDF in patients with estimated Cl_cr <70 mL/minute. Discontinue if estimated Cl_cr decreases to <50 mL/minute, or there is evidence of clinically significant decreases in renal function or Fanconi syndrome during treatment.

Pediatric patients: Data insufficient to make dosage recommendations for those with renal impairment.

Common Adverse Effects

Most common (≥10%) adverse effects include nausea and diarrhea.

Drug Interactions

Elvitegravir: Substrate of CYP3A; weak inducer and weak inhibitor of CYP3A. Induces CYP2C9. Does not inhibit CYP1A, 2A6, 2C9, 2C19, 2D6, or 2E1 in vitro. Inhibits organic anion transport polypeptides (OATP) 1B1 and 1B3.

Cobicistat: Substrate and inhibitor of CYP3A and 2D6; also inhibits CYP3A and 2D6. Inhibits p-glycoprotein (P-gp) transport, breast cancer resistance protein (BCRP), and OATP1B1 and 1B3.

Emtricitabine: Not a substrate of CYP enzymes; does not inhibit CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, or 3A4.

Tenofovir DF and tenofovir: Not substrates of CYP enzymes; tenofovir does not inhibit CYP3A4, 2D6, 2C9, or 2E1, but may have a slight inhibitory effect on CYP1A.

The following interactions are based on studies using elvitegravir, elvitegravir administered with cobicistat (cobicistat-boosted elvitegravir), elvitegravir administered with low-dose ritonavir (ritonavir-boosted elvitegravir), cobicistat, or EVG/c/FTC/TDF or are predicted to occur.

Consider potential interactions associated with each drug in the fixed combination.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

CYP3A or 2D6 substrates: Potential increased plasma concentrations of such substrates.

CYP3A inducers: Potential decreased plasma concentrations of elvitegravir and cobicistat; possible decreased antiretroviral efficacy and development of resistance.

CYP3A inhibitors: Potential increased plasma concentrations of cobicistat.

Drugs Affected by P-glycoprotein Transport

P-gp substrates: Potential increased plasma concentrations of such substrates.

Drugs Affected by Breast Cancer Resistance Protein

BCRP substrates: Potential increased plasma concentrations of such substrates.

Drugs Affected by Organic Anion Transport Polypeptides

OATP1B1 or 1B3 substrates: Potential increased plasma concentrations of such substrates.

Drugs Affecting Renal Function

Drugs that reduce renal function or compete for active tubular secretion: Potential increased concentrations of emtricitabine, tenofovir, and/or concomitant drug.

Specific Drugs

Elvitegravir, Cobicistat, Emtricitabine, and tenofovir Disoproxil Fumarate Pharmacokinetics

Absorption

Bioavailability

Following an oral dose of EVG/c/FTC/TDF with food, peak plasma concentrations of elvitegravir and cobicistat occur at 4 and 3 hours, respectively, and peak plasma concentrations of emtricitabine and tenofovir occur at 3 and 2 hours, respectively.

Cobicistat component of EVG/c/FTC/TDF increases plasma concentrations of elvitegravir.

Food

Relative to fasting, administration of EVG/c/FTC/TDF with high-fat meal (approximately 800 kcal, 50% fat) increases mean systemic exposures of elvitegravir and tenofovir by 87 and 23%, respectively, and decreases mean systemic exposures of cobicistat and emtricitabine by 17 and 4%, respectively.

Distribution

Extent

Elvitegravir and cobicistat: Distributed into milk in rats; not known whether distributed into human milk.

Emtricitabine and tenofovir: Distributed into human milk.

Plasma Protein Binding

Elvitegravir: Approximately 99%.

Cobicistat: Approximately 98%.

Emtricitabine: <4%.

Tenofovir: <0.7%.

Elimination

Metabolism

Elvitegravir: Metabolized principally by CYP3A to produce inactive M1 metabolite, also undergoes glucuronidation via UGT1A1/3 to produce inactive M4 metabolite. Cobicistat, a CYP3A inhibitor, is included in fixed combination of EVG/c/FTC/TDF to inhibit metabolism of and increase plasma concentrations of elvitegravir.

Cobicistat: Metabolized principally by CYP3A and, to a lesser extent, by CYP2D6. Does not undergo glucuronidation.

Emtricitabine: Undergoes oxidation and conjugation with glucuronic acid. Phosphorylated intracellularly and converted by cellular enzymes to the active emtricitabine 5′-triphosphate.

Tenofovir DF: Prodrug of tenofovir; undergoes initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylation by cellular enzymes to form the active tenofovir diphosphate.

Elimination Route

Elvitegravir: 94.8% in feces, 6.7% in urine. Unlikely to be removed by hemodialysis or peritoneal dialysis.

Cobicistat: 86.2% in feces, 8.2% in urine. Unlikely to be removed by hemodialysis or peritoneal dialysis.

Emtricitabine: 70% in urine (glomerular filtration and active tubular secretion), 13.7% in feces. Removed by hemodialysis; not known whether removed by peritoneal dialysis.

Tenofovir: 70–80% in urine (glomerular filtration and active tubular secretion). Removed by hemodialysis.

Half-life

Elvitegravir: 12.9 hours.

Cobicistat: 3.5 hours.

Emtricitabine: 10 hours.

Tenofovir: 12–18 hours.

Special Populations

Children and adolescents 12 to <18 years of age: Following oral administration of EVG/c/FTC/TDF, elvitegravir and tenofovir exposures 30 and 37% higher, respectively, than those observed in adults; difference not considered clinically important based on exposure-response relationships. Cobicistat and emtricitabine exposures similar to those observed in adults.

Mild or moderate hepatic impairment (Child-Pugh class A or B): No clinically important effect on pharmacokinetics of elvitegravir or cobicistat. Pharmacokinetics of emtricitabine and tenofovir unlikely to be affected.

Severe hepatic impairment (Child-Pugh class C): Pharmacokinetics of EVG/c/FTC/TDF not studied.

Renal impairment: No clinically important effects on pharmacokinetics of elvitegravir or cobicistat. Pharmacokinetics of emtricitabine and tenofovir altered (decreased clearance resulting in increased plasma concentrations and AUC).

Race or gender: No clinically important effects on pharmacokinetics of EVG/c/FTC/TDF.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).

Store in original container; keep tightly closed.

Actions and Spectrum

• EVG/c/FTC/TDF is a fixed-combination antiretroviral containing elvitegravir, cobicistat, emtricitabine, and tenofovir DF.

• Elvitegravir (EVG) is an HIV integrase strand transfer inhibitor antiretroviral. Inhibits activity of HIV-1 integrase, an enzyme that integrates HIV DNA into the host cell genome. Active against HIV-1 and also has some in vitro activity against HIV type 2 (HIV-2); inactive against HBV and HCV.

• Cobicistat is a mechanism-based CYP3A inhibitor and is included in EVG/c/FTC/TDF as a pharmacokinetic enhancer to decrease elvitegravir metabolism and increase plasma concentrations of the drug, resulting in systemic exposure of elvitegravir sufficient to allow for once-daily dosing (cobicistat-boosted elvitegravir). Has no antiretroviral or antiviral activity and is not active against HIV-1, HBV, or HCV. Does not antagonize the antiretroviral activity of elvitegravir, emtricitabine, or tenofovir.

• Emtricitabine (FTC) is an HIV NRTI. Prodrug that is inactive until converted intracellularly to an active 5′-triphosphate metabolite. Active against HIV-1 and also has some in vitro activity against HIV-2.

• Tenofovir DF (TDF) is a nucleotide reverse transcriptase inhibitor antiretroviral classified as an HIV NRTI. Prodrug that is inactive until it undergoes diester hydrolysis in vivo to tenofovir and is subsequently metabolized to the active metabolite (tenofovir diphosphate). Active against HIV-1 and also has some in vitro activity against HIV-2; also active against HBV.

• HIV-1 resistant to elvitegravir, emtricitabine, and tenofovir has been produced in vitro and has emerged during EVG/c/FTC/TDF therapy. One or more primary mutations associated with resistance to elvitegravir, emtricitabine, and/or tenofovir have been identified in HIV-1 isolates from patients who received EVG/c/FTC/TDF and were considered to be virologic treatment failures.

• Cross-resistance between elvitegravir and other HIV integrase inhibitors (e.g., dolutegravir, raltegravir) reported. Cross-resistance also occurs among the HIV NRTIs.

Advice to Patients

• Advise patients of the critical nature of compliance with HIV therapy and the importance of remaining under the care of a clinician. Importance of taking EVG/c/FTC/TDF as prescribed; do not alter or discontinue antiretroviral regimen without consulting clinician.

• Advise patients that EVG/c/FTC/TDF is a complete regimen for treatment of HIV-1 infection and should not be used in conjunction with other antiretroviral agents.

• Advise patients on the importance of taking EVG/c/FTC/TDF with food.

• If a dose is missed, take the dose as soon as it is remembered and take next dose at regularly scheduled time. If a dose is skipped, do not take a double dose to make up for the missed dose.

• Inform patients that testing for HBV infection is recommended before antiretroviral therapy is initiated. Also advise patients that severe acute exacerbations of HBV infection have been reported following discontinuance of emtricitabine or tenofovir DF in HIV-infected patients coinfected with HBV.

• Advise patients that renal impairment, including cases of acute renal failure or Fanconi syndrome, has occurred. Advise patients on the importance of not using EVG/c/FTC/TDF concomitantly with or shortly after nephrotoxic agents (e.g., high-dose or multiple NSAIAs).

• Advise patients of reproductive potential that additional or nonhormal methods of contraception should be used when estrogen-based contraceptives are used concomitantly with EVG/c/FTC/TDF.

• Advise patients that lactic acidosis and severe hepatomegaly with steatosis, including fatalities, have occurred with emtricitabine and tenofovir DF (components of EVG/c/FTC/TDF). Advise patients on the importance of contacting a clinician if symptoms suggestive of lactic acidosis or hepatotoxicity (e.g., nausea, vomiting, unusual/unexpected stomach discomfort, weakness) occur.

• Advise patients that decreased bone mineral density (BMD) has occurred and that assessment of BMD should be considered in those with a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss.

• Advise patients that signs and symptoms of inflammation from previous infections may occur soon after initiation of antiretroviral therapy in some individuals with advanced HIV infection (AIDS). These symptoms may be due to an improvement in immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients on the importance of immediately informing a healthcare provider if any symptoms of infection occur.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products (e.g., St. John's wort), as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Due to the risk of HIV transmission, HIV-infected women should not breast-feed infants.

• Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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