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Atazanavir (Monograph)

Brand name: Reyataz [Web]
Drug class: HIV Protease Inhibitors

Medically reviewed by Drugs.com on Dec 11, 2023. Written by ASHP.

Introduction

Antiretroviral; HIV protease inhibitor (PI).

Uses for Atazanavir

Treatment of HIV Infection

Treatment of HIV-1 infection in adults, adolescents, and pediatric patients ≥3 months of age weighing ≥5 kg; used in conjunction with other antiretrovirals. Use of ritonavir-boosted atazanavir in antiretroviral-experienced patients should be guided by the number of baseline primary HIV protease inhibitor (PI) resistance substitutions. Atazanavir is not recommended for use in patients <3 months because of the risk of kernicterus.

Ritonavir-boosted or cobicistat-boosted atazanavir is used with a dual-nucleoside reverse transcriptase inhibitor (NRTI) “backbone” of a fully suppressive antiretroviral regimen; consult guidelines for the most current information on recommended regimens. 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.

Commercially available as a single-entity preparation and in a fixed-dose combination preparation that also contains cobicistat; refer to the full prescribing information for administration of the combination product.

Postexposure Prophylaxis following Occupational Exposure to HIV (PEP)

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.

USPHS recommends a 3-drug regimen of raltegravir and emtricitabine and tenofovir DF as preferred regimen for PEP following occupational exposure to HIV. Ritonavir-boosted atazanavir and 2 NRTIs is one of several alternative regimens. Preferred dual NRTI option for PEP regimens is emtricitabine and tenofovir DF; alternatives are tenofovir DF and lamivudine, zidovudine and lamivudine, or zidovudine and emtricitabine.

Management of occupational exposures to HIV is complex and evolving; 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. Do not delay initiation of PEP while waiting for expert consultation.

Atazanavir Dosage and Administration

General

Pretreatment Screening

Patient Monitoring

Dispensing and Administration Precautions

Other General Considerations

Administration

Oral Administration

Available as capsules or oral powder.

Administer in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Administer orally in conjunction with low-dose ritonavir (ritonavir-boosted atazanavir) or unboosted (without low-dose ritonavir) once daily with food.

If used concomitantly with certain drugs (e.g., antacids, buffered medications, didanosine, histamine H2-receptor antagonists), dosage adjustments may be needed and/or doses of atazanavir and the other drug may need to be given at separate times.

Capsules

Swallow capsules whole; do not open.

Used in adults, adolescents, and pediatric patients ≥6 years of age.

Usually administered with low-dose ritonavir (ritonavir-boosted atazanavir); may be used without low-dose ritonavir in adults and adolescents ≥13 years of age weighing ≥40 kg who are unable to tolerate ritonavir.

Oral Powder

Provided in single-use packets containing 50 mg of atazanavir as an oral powder; must be mixed with food or beverage prior to administration.

Used in pediatric patients ≥3 months of age weighing ≥5 kg.

Must be administered with low-dose ritonavir (ritonavir-boosted atazanavir). Administer low-dose ritonavir immediately following the atazanavir dose.

Store atazanavir powder in original packet; do not open until ready to use.

Prior to mixing the oral powder, determine the number of packets (3, 4, 5, or 6 packets) needed. Mixing the powder with food (e.g., applesauce, yogurt) is preferred; may mix with beverage (e.g., milk, infant formula, water) for infants able to drink from a cup. For infants <6 months of age not able to eat solid food or drink from a cup, mix with infant formula and administer using oral dosing syringe. Administration with infant bottle not recommended since full dose may not be delivered.

Mixing with food: Tap packet to settle powder; cut packet along dotted line with clean scissors. Using a spoon, mix contents of recommended number of packets with ≥1 tablespoon of food (e.g., applesauce, yogurt) in a small container (e.g., cup, bowl); feed mixture to patient. Add and mix additional 1 tablespoon of food to the small container; feed residual mixture to patient.

Mixing with a beverage: Tap packet to settle powder; cut packet along dotted line with clean scissors. Using a spoon, mix contents of recommended number of packets in a small drinking cup with ≥30 mL of beverage; give mixture to patient to drink. Add and mix additional 15 mL of beverage to drinking cup; give residual mixture to patient to drink. If water is used as the beverage, patient also should eat food at time of administration.

Mixing with liquid infant formula: Tap packet to settle powder; cut packet along dotted line with clean scissors. Using a spoon, mix contents of recommended number of packets in a small medicine cup with 10 mL of prepared liquid infant formula. Draw entire mixture into oral dosing syringe and administer into infant's right or left inner cheek. Pour and mix additional 10 mL of infant formula into medicine cup to rinse off any remaining powder. Draw residual mixture into oral dosing syringe and administer into infant's right or left inner cheek.

Administer entire dose within 1 hour after mixing with food or beverage; may be left at room temperature (20–30°C) for up to 1 hour after mixing. For additional information on mixing and administering the oral powder, refer to the full instructions for use provided by the manufacturer.

Fixed Combinations Containing Atazanavir

Atazanavir also commercially available in a fixed-combination preparation containing atazanavir and cobicistat (atazanavir/cobicistat; Evotaz). Refer to the full prescribing information for administration of the combination product.

Dosage

Available as capsules or oral powder containing atazanavir sulfate; dosage expressed in terms of atazanavir.

Pediatric Patients

Dosage change may be required when transitioning between formulations; refer to the dosage table for the specific formulation.

Treatment of HIV Infection
Antiretroviral-naïve or Antiretroviral-experienced Pediatric Patients
Oral

Pediatric patients ≥3 months of age weighing ≥5 kg (oral powder): Dosage is based on weight. (See Table 1.) Oral powder must be used with low-dose ritonavir (ritonavir-boosted atazanavir); administer ritonavir immediately after atazanavir powder.

Recommendations regarding the timing and maximum doses of concomitant proton pump inhibitors and histamine H2-receptor antagonists in adults also apply to pediatric patients In patients weighing 5 to <10 kg who do not tolerate 200 mg (4 packets) of atazanavir oral powder and have not previously received an HIV PI, atazanavir oral powder in a dosage of 150 mg (3 packets) once daily may be used with close HIV viral load monitoring.

Table 1. Dosage of Ritonavir-boosted Atazanavir Oral Powder for Pediatric Patients ≥3 Months of Age Weighing ≥5 kga1

Body Weight

Atazanavir Dosage (Oral Powder)

Ritonavir Dosage (Oral Solution)

5 to <15 kg

200 mg (4 packets) once daily

80 mg once daily

15 to <25 kg

250 mg (5 packets) once daily

80 mg once daily

≥25 kg and not able to swallow capsules

300 mg (6 packets) once daily

100 mg once daily

Pediatric patients 6 to <18 years of age (capsules): Dosage is based on weight. (See Table 2.) Capsules usually used with low-dose ritonavir (ritonavir-boosted atazanavir); administer atazanavir capsules and ritonavir simultaneously with food.

Recommendations regarding the timing and maximum doses of concomitant proton pump inhibitors and histamine H2-receptor antagonists in adults also apply to pediatric patients.

In antiretroviral-experienced patients, administer atazanavir capsules with ritonavir.

Table 2. Dosage of Ritonavir-boosted Atazanavir Capsules for Antiretroviral-Naive and Antiretroviral-Experienced Pediatric Patients 6 to <18 Years of Age , 1

Body Weight

Atazanavir Dosage (Capsules)

Ritonavir Dosage

<15 kg

Capsules not recommended

≥15 to <35 kg

200 mg once daily

100 mg once daily

≥35 kg

300 mg once daily

100 mg once daily

Unboosted atazanavir (i.e., without low-dose ritonavir or cobicistat) in antiretroviral-naïve adolescents ≥13 years of age weighing ≥40 kg unable to tolerate ritonavir: 400 mg once daily.

The fixed-combination preparation containing atazanavir and cobicistat (atazanavir/cobicistat; Evotaz) is also used for the treatment of HIV-1 infection in pediatric patients; refer to the full prescribing information for dosage of atazanavir/cobicistat in pediatric patients.

Adults

Treatment of HIV Infection
Antiretroviral-naïve Adults
Oral

Ritonavir-boosted atazanavir: Atazanavir 300 mg once daily in conjunction with ritonavir 100 mg once daily.

Unboosted atazanavir (adults unable to tolerate ritonavir): 400 mg once daily.

Ritonavir-boosted atazanavir in combination with efavirenz: Atazanavir 400 mg once daily in conjunction with ritonavir 100 mg once daily.

Antiretroviral-experienced Adults
Oral

Ritonavir-boosted atazanavir: Atazanavir 300 mg once daily in conjunction with ritonavir 100 mg once daily.

Ritonavir-boosted atazanavir in combination with histamine H2-receptor antagonist and tenofovir disoproxil fumarate (tenofovir DF): Atazanavir 400 mg once daily given in conjunction with ritonavir 100 mg once daily.

Do not use atazanavir without ritonavir in treatment-experienced adults.

The fixed-combination preparation containing atazanavir and cobicistat (atazanavir/cobicistat; Evotaz) is also used for the treatment of HIV-1 infection in adults; refer to the full prescribing information for dosage of atazanavir/cobicistat in adults.

Postexposure Prophylaxis following Occupational Exposure to HIV (PEP)† [off-label]
Oral

Ritonavir-boosted atazanavir: Atazanavir 300 mg once daily in conjunction with ritonavir 100 mg once daily. Alternatively, atazanavir 400 mg once daily can be used without ritonavir, but not in combination with tenofovir DF.

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

Special Populations

Consult the product labeling of the combination preparation containing atazanavir and cobicistat (atazanavir/cobicistat; Evotaz) for specific dosage adjustments in renal impairment, hepatic impairment, pregnancy, or geriatric use.

Hepatic Impairment

Unboosted atazanavir in treatment-naïve adults with mild hepatic impairment (Child-Pugh class A): 400 mg once daily.

Unboosted atazanavir in treatment-naïve adults with moderate hepatic impairment (Child-Pugh class B): 300 mg once daily.

Unboosted atazanavir in patients with severe hepatic impairment (Child-Pugh class C): Do not use.

Ritonavir-boosted atazanavir: Do not use in patients with any degree of hepatic impairment.

Renal Impairment

Ritonavir-boosted or unboosted atazanavir in patients with renal impairment not undergoing hemodialysis: Dosage adjustments not needed.

Ritonavir-boosted atazanavir in antiretroviral-naïve adults with end-stage renal disease undergoing hemodialysis: 300 mg once daily with ritonavir 100 mg once daily.

Antiretroviral-experienced adults with end-stage renal disease undergoing hemodialysis: Do not use ritonavir-boosted or unboosted atazanavir.

Geriatric Use

No specific dosage recommendations at this time. Exercise caution in administration and monitoring because of age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Pregnant and Postpartum Women

Use ritonavir-boosted atazanavir; do not use unboosted atazanavir. No dosage adjustments are necessary for postpartum patients; monitor closely for adverse effects, especially during first 2 months after delivery.

Ritonavir-boosted atazanavir in antiretroviral-naïve or antiretroviral-experienced pregnant patients: recommended dosage is atazanavir 300 mg once daily given in conjunction with ritonavir 100 mg once daily.

Ritonavir-boosted atazanavir in antiretroviral-experienced pregnant women in second or third trimester also receiving either a histamine H2-receptor antagonist or tenofovir DF: Increase atazanavir dosage to 400 mg once daily with ritonavir 100 mg once daily. Not recommended in antiretroviral-experienced pregnant women receiving both a histamine H2-receptor antagonist and tenofovir DF.

Cautions for Atazanavir

Contraindications

Warnings/Precautions

Sensitivity Reactions

Dermatologic Reactions

Rash (all grades, regardless of causality) reported frequently. Median time to onset 7.3 weeks; median duration 1.4 weeks. Generally mild-to-moderate maculopapular skin eruptions. Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions, including drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, reported.

Discontinue in patients who develop severe rash.

Cardiac Conduction Abnormalities

Abnormalities in AV conduction (including prolongation of PR interval) reported. Cardiac conduction abnormalities generally are asymptomatic and limited to first-degree AV block.

Because of limited clinical experience in patients with preexisting cardiac conduction abnormalities (e.g., marked first-degree AV block; second- or third-degree AV block), consider ECG monitoring in such patients.

Chronic Kidney Disease

Chronic kidney disease reported in postmarketing experience in patients with human immunodeficiency virus type 1 (HIV-1) infection treated with atazanavir (with or without ritonavir). Reports included granulomatous interstitial nephritis (proven by biopsy) associated with the deposition of atazanavir drug crystals in the renal parenchyma.

Consider alternatives in patients at high risk for renal disease or with preexisting renal disease. Perform renal laboratory testing (including Scr , estimated Clcr , and urinalysis with microscopic examination) in all patients prior to and during treatment. Expert consultation advised for patients with confirmed renal laboratory abnormalities during therapy. Consider discontinuation in patients with progressive kidney disease.

Hyperbilirubinemia

Reversible, asymptomatic elevations in indirect (unconjugated) bilirubin occur in most patients since atazanavir is a competitive inhibitor of UGT 1A1 (an enzyme that catalyzes glucuronidation of bilirubin).

Assess hepatic transaminase elevations that occur with hyperbilirubinemia for alternative etiologies.

Long-term safety data not available for patients with persistent elevations in total bilirubin >5 times ULN.

If jaundice or scleral icterus resulting from elevated bilirubin causes cosmetic concerns, can consider alternative antiretroviral; reduction of atazanavir dosage not recommended since efficacy data not available.

Phenylketonuria

Advise individuals with phenylketonuria that atazanavir oral powder contains phenylalanine (component of aspartame).

Each packet of oral powder (50 mg of atazanavir) contains 35 mg of phenylalanine. Atazanavir capsules do not contain phenylalanine.

Hepatotoxicity Effects

Risk of further transaminase elevations or hepatic decompensation in HIV-infected patients with HBV or HCV coinfection or elevated hepatic enzymes prior to initiation of atazanavir. Evaluate hepatic function prior to and during atazanavir treatment in these patients.

Nephrolithiasis and Cholelithiasis

Postmarketing reports of nephrolithiasis and cholelithiasis; some patients required hospitalization for additional management or experienced complications.

If nephrolithiasis or cholelithiasis occurs, consider temporary interruption or discontinuation of atazanavir.

Drug Interactions

When ritonavir-boosted atazanavir is used, consider the cautions, precautions, contraindications, and drug interactions associated with atazanavir and ritonavir.

Ritonavir is a CYP3A inhibitor; initiation of ritonavir-boosted atazanavir in patients receiving drugs metabolized by CYP3A or initiation of drugs metabolized by CYP3A in patients already receiving ritonavir-boosted atazanavir, may increase plasma concentrations of the drugs metabolized by CYP3A. Initiation of drugs that inhibit or induce CYP3A may increase or decrease concentrations of ritonavir-boosted atazanavir, respectively.

Interactions with ritonavir-boosted atazanavir resulting in greater exposures of concomitant medications may lead to clinically important adverse effects (including severe, life-threatening, or fatal events). Some interactions may result in clinically important adverse effects due to greater exposures to ritonavir-boosted atazanavir or loss of therapeutic effect of ritonavir-boosted atazanavir and development of resistance.

Consider potential drug interactions prior to and during use of ritonavir-boosted atazanavir. Monitor for adverse effects associated with drugs used concomitantly with ritonavir-boosted atazanavir.

Additional drug interactions may exist for the fixed-dose combination of atazanavir and cobicistat (Evotaz). See the full prescribing information for drug interactions of this combination product.

Hyperglycemic and Diabetogenic Effects

Hyperglycemia (potentially persistent), new-onset diabetes mellitus, or exacerbation of preexisting diabetes mellitus reported with HIV PIs; diabetic ketoacidosis has also occurred.

Initiate or adjust antidiabetic therapy (e.g., insulin, oral hypoglycemic agents) as needed. Causal relationship not established.

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, M. tuberculosis, cytomegalovirus, Pneumocystis jirovecii); this may necessitate further evaluation and treatment.

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

Fat Redistribution

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance.

Mechanisms and long-term consequences of adipogenic effects unknown; causal relationship not established.

Hemophilia A and B

Increased bleeding, including spontaneous hematomas and hemarthrosis, reported with HIV PIs; causal relationship not established.

Increased hemostatic (e.g., antihemophilic factor) therapy may be needed in some cases; causal relationship not established.

HIV Resistance

Possibility of HIV-1 resistant to atazanavir.

Varying degrees of cross-resistance occur among the various HIV PIs. Resistance to atazanavir may not preclude subsequent use of other HIV PIs.

Pharmacogenomics

In patients who are poor metabolizers of UGT1A1, consider an alternative agent to ritonavir-boosted atazanavir particularly if there are concerns of jaundice.

Specific Populations

Pregnancy

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

Available animal and human data to date indicate that atazanavir does not increase risk of major birth defects overall compared to background rate. No treatment-related malformations observed in rats and rabbits at atazanavir exposures 0.7–1.2 times those reported with usual human dosage of ritonavir-boosted atazanavir (300 mg of atazanavir once daily with ritonavir 100 mg once daily). Based on prospective reports from the APR of approximately 1600 live births following exposure to atazanavir, no difference observed in rate of overall birth defects in those exposed to atazanavir compared with the estimated background risk of major birth defects.

Lactic acidosis, sometimes fatal, and symptomatic hyperlactatemia reported in pregnant women patients receiving atazanavir in conjunction with NRTIs. Hyperbilirubinemia reported in pregnant women receiving atazanavir. Advise pregnant patients of potential risks of lactic acidosis syndrome and hyperbilirubinemia.

Monitor postpartum women closely for adverse effects during first 2 months after delivery; atazanavir concentrations and AUC may be increased during postpartum period.

Lactation

Distributed into human milk. Unknown whether atazanavir affects human milk production.

Distributed into milk in rats; associated with neonatal growth retardation that reversed after weaning.

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

Pediatric Use

Ritonavir-boosted or unboosted atazanavir: Do not use in neonates and infants <3 months of age because of risk of kernicterus. Safety, efficacy, and pharmacokinetic profile not established in infants <3 months of age. All contraindications, warnings, and precautions of atazanavir apply to pediatric patients.

Ritonavir-boosted or unboosted atazanavir: Safety, efficacy, and pharmacokinetic profile evaluated in pediatric patients ≥3 months of age weighing ≥5 kg. Adverse effects in children 6 years to <18 years of age receiving the capsules generally similar to those reported in adults; adverse effects in pediatric patients weighing ≥5 kg receiving the oral powder generally similar to those reported in pediatric patients receiving capsules.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. Use with caution and monitor because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Hepatic Impairment

Atazanavir principally metabolized and eliminated by the liver; increased plasma atazanavir concentrations expected in patients with moderate to severe hepatic impairment.

Unboosted atazanavir: Dosage adjustments recommended in those with mild or moderate hepatic impairment (Child-Pugh class A or B). Do not use in those with severe hepatic impairment (Child-Pugh class C).

Ritonavir-boosted atazanavir: Do not use in those with any degree of hepatic impairment.

HIV-infected patients with HBV or HCV coinfection and those with marked increases in AST or ALT prior to atazanavir therapy may be at increased risk for further elevations in hepatic enzymes or for hepatic decompensation.

Renal Impairment

Plasma concentrations of atazanavir in individuals with severe renal impairment not undergoing dialysis generally are similar to those in individuals with normal renal function. Dosage adjustments not needed.

Ritonavir-boosted atazanavir can be used in antiretroviral-naïve patients with end-stage renal disease who are undergoing hemodialysis.

Use of ritonavir-boosted or unboosted atazanavir is not recommended in antiretroviral-experienced patients with end-stage renal disease undergoing hemodialysis.

Common Adverse Effects

Most common adverse effects (≥2%): headache, nausea, jaundice/scleral icterus, abdominal pain, rash, vomiting, diarrhea, insomnia, peripheral neurologic symptoms, dizziness, myalgia, depression, fever.

Drug Interactions

When atazanavir is used with ritonavir, consider drug interactions associated with both atazanavir and ritonavir. The following drug interactions are based on studies using ritonavir-boosted or unboosted atazanavir.

Additional drug interactions may exist for the fixed-dose combination of atazanavir and cobicistat (Evotaz); see the full prescribing information for drug interactions of this combination product.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

CYP3A inducers: Potential pharmacokinetic interactions with ritonavir-boosted and unboosted atazanavir (increased clearance of atazanavir and ritonavir; possible loss of antiretroviral efficacy and development of resistance to atazanavir).

CYP3A inhibitors: Potential pharmacokinetic interactions with ritonavir-boosted and unboosted atazanavir (increased plasma concentrations of atazanavir or ritonavir).

CYP3A or 2C8 substrates: Potential pharmacokinetic interactions with ritonavir-boosted and unboosted atazanavir (altered metabolism of these substrates). Use of atazanavir without ritonavir is not recommended when coadministered with drugs that are highly dependent on CYP2C8 metabolism and have narrow therapeutic indices (e.g., paclitaxel, repaglinide). When ritonavir-boosted atazanavir is coadministered with substrates of CYP2C8, clinically significant interactions are not expected.

Atazanavir not expected to interact with CYP2C19, 2C9, 2D6, 2B6, 2A6, 1A2, or 2E1 substrates.

Drugs Metabolized by Uridine Diphosphate-glucoronosyltransferase 1A1

UGT1A1 substrates: Potential pharmacokinetic interactions with ritonavir-boosted and unboosted atazanavir.

Specific Drugs

Drug

Interaction

Comments

Abacavir

No in vitro evidence of antagonistic antiretroviral effects

Acetaminophen

Pharmacokinetic interactions unlikely

Alfuzosin

Possible increased alfuzosin concentrations; may result in hypotension

Concomitant use with atazanavir contraindicated

Amprenavir

No in vitro evidence of antagonistic antiretroviral effects

Antacids or buffered medications

Possible decreased atazanavir concentrations

Administer atazanavir 2 hours before or 1 hour after antacids or buffered medications

Antiarrhythmic agents (amiodarone, bepridil, systemic lidocaine, quinidine)

Possible increased antiarrhythmic agent concentrations

Potential for serious or life-threatening effects (e.g., cardiac arrhythmias)

Amiodarone, quinidine: Concomitant use with ritonavir-boosted atazanavir contraindicated

Bepridil, systemic lidocaine; exercise caution; monitor concentrations of the antiarrhythmic drug if used concomitantly with atazanavir

Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)

Apixaban, dabigatran, edoxaban, rivaroxaban: Increased exposure of the anticoagulant and increased risk of bleeding

Warfarin: Increased plasma concentrations of warfarin and potential for serious and/or life-threatening bleeding

Apixaban: Refer to the full prescribing information of apixaban for specific dosing recommendations if used concomitantly with ritonavir-boosted atazanavir; monitor closely when apixaban is used concomitantly with atazanavir without ritonavir

Dabigatran, edoxaban, rivaroxaban: Refer to the full prescribing information of the anticoagulant for specific dosing recommendations

Rivaroxaban: Concomitant use of ritonavir-boostedatazanavir and rivaroxaban not recommended; monitor patients closely when rivaroxaban is used concomitantly with atazanavir (without ritonavir)

Warfarin: Monitor INR

Anticonvulsants (carbamazepine, lamotrigine, phenobarbital, phenytoin)

Carbamazepine: Possible decreased atazanavir concentrations and increased carbamazepine concentrations if used with ritonavir-boosted atazanavir; decreased atazanavir concentrations if used with unboosted atazanavir

Lamotrigine: Concomitant use of ritonavir-boosted atazanavir and lamotrigine decreases lamotrigine plasma concentrations

Phenobarbital, phenytoin: Concomitant use of unboosted atazanavir and phenobarbital or phenytoin may decrease plasma concentrations of atazanavir; concomitant use of ritonavir-boosted atazanavir and phenobarbital or phenytoin may decrease plasma concentrations or atazanavir and the anticonvulsant

Carbamazepine: Concomitant use of unboosted atazanavir and carbamazepine not recommended; if ritonavir-boosted atazanavir is initiated in a patient already receiving a stable carbamazepine dosage, carbamazepine dosage reduction may be needed

Lamotrigine: Dosage adjustments not needed if lamotrigine is used concomitantly with unboosted atazanavir; concomitant use of ritonavir-boosted atazanavir and lamotrigine may require lamotrigine dosage adjustment

Phenobarbital, phenytoin: Concomitant use of unboosted atazanavir and phenobarbital or phenytoin not recommended; if ritonavir-boosted atazanavir is used concomitantly with phenobarbital or phenytoin, adjustment of the anticonvulsant dosage may be needed

Antifungals, azoles (fluconazole, itraconazole, ketoconazole, voriconazole)

Fluconazole: No clinically important pharmacokinetic interactions

Itraconazole, ketoconazole: Possible increased antifungal concentrations if concomitantly used with ritonavir-boosted atazanavir

Voriconazole: Use with ritonavir-boosted atazanavir results in decreased atazanavir and voriconazole plasma concentrations in patients with a functional CYP2C19 allele; decreased atazanavir concentrations and increased voriconazole concentrations in patients without a functional CYP2C19 allele. Coadministration of voriconazole and atazanavir without ritonavir may affect atazanavir concentrations; however, no data are available.

Itraconazole, ketoconazole: Caution advised if ketoconazole or itraconazole dosage >200 mg daily used with ritonavir-boosted atazanavir

Voriconazole: Do not use with ritonavir-boosted atazanavir unless potential benefits outweigh risks; monitor for voriconazole-associated adverse effects and loss of voriconazole or atazanavir efficacy

Antimycobacterials (rifabutin, rifampin)

Rifabutin: Increased concentrations of rifabutin if used with ritonavir-boosted or unboosted atazanavir

Rifampin: Substantially decreased atazanavir concentrations; possible decreased antiretroviral efficacy and increased risk of antiretroviral resistance

Rifabutin: May reduce rifabutin dosage up to 75% (e.g., 150 mg once every other day or 3 times weekly); increased monitoring for rifabutin-associated adverse effects (e.g., neutropenia) warranted

Rifampin: Concomitant use contraindicated

Antineoplastic agents (apalutamide, irinotecan, ivosidenib, paclitaxel)

Apalutamide: Potential for subsequent loss of virologic response and possible resistance to the class of protease inhibitors

Irinotecan: Atazanavir may interfere with metabolism of irinotecan leading to increased irinotecan toxicity

Ivosidenib: Potential loss of virologic response and serious adverse events such as QT prolongation

Paclitaxel: Possible increased paclitaxel concentrations if used with unboosted atazanavir; clinically important interactions not expected if used with ritonavir-boosted atazanavir

Apalutamide: Concomitant use contraindicated

Irinotecan: Concomitant use contraindicated

Ivosidenib: Concomitant use contraindicated

Paclitaxel: Concomitant use with unboosted atazanavir not recommended

Antiplatelet agents (clopidogrel, ticagrelor)

Clopidogrel: Potential reduction of antiplatelet activity of clopidogrel

Ticagrelor: Potential increase in risk of dyspnea, bleeding, and other adverse events associated with ticagrelor

Clopidogrel: Concomitant use not recommended

Ticagrelor: Concomitant use not recommended

Antipsychotics (lurasidone, pimozide, quetiapine)

Lurasidone: Possible increased lurasidone concentrations; potential for serious and/or life-threatening adverse effects if used concomitantly with ritonavir-boosted atazanavir

Pimozide: Increased pimozide concentrations; potential for serious and/or life-threatening effects (e.g., cardiac arrhythmias)

Quetiapine: Increased quetiapine concentrations expected

Lurasidone: Concomitant use with ritonavir-boosted atazanavir contraindicated; if concomitant use with unboosted atazanavir necessary, reduce lurasidone dosage

Pimozide: Concomitant use contraindicated

Quetiapine: If possible, consider alternative antiretroviral therapy to avoid increases in quetiapine exposures; if initiating ritonavir-boosted atazanavir in patient receiving quetiapine, reduce quetiapine to one-sixth of original dosage and monitor for adverse effects of quetiapine; if quetiapine is initiated in a patient receiving ritonavir-boosted atazanavir, refer to quetiapine prescribing information for initial dosage and titration

Atenolol

No clinically important pharmacokinetic interactions

Azithromycin

Clinically important interactions unlikely

Benzodiazepines (midazolam, triazolam)

Midazolam or triazolam: Possible increased concentrations of midazolam or triazolam and potential for serious and/or life- threatening effects (e.g., prolonged or increased sedation or respiratory depression)

Oral midazolam or triazolam: Concomitant use contraindicated

Parenteral midazolam: Use with caution and in a monitored setting where respiratory depression and/or prolonged sedation can be managed; consider reduced dosage of midazolam, especially if more than a single dose of midazolam given

Bosentan

Ritonavir-boosted or unboosted atazanavir: Possible decreased atazanavir concentrations

In patients already receiving ritonavir-boosted atazanavir for ≥10 days, initiate bosentan using a dosage of 62.5 mg once daily or every other day based on individual tolerability

In patients already receiving bosentan, discontinue bosentan for ≥36 hours prior to initiating ritonavir-boosted atazanavir; after ≥10 days of ritonavir-boosted atazanavir, resume bosentan at a dosage of 62.5 mg once daily or every other day based on individual tolerability

Unboosted atazanavir: concomitant use with bosentan is not recommended

Buprenorphine

Increased buprenorphine and norbuprenorphine concentrations; when used with unboosted atazanavir, decreased atazanavir concentrations also possible

Unboosted atazanavir: Concomitant use with buprenorphine not recommended

Ritonavir-boosted atazanavir: Monitor for sedation and adverse cognitive effects; consider reduced buprenorphine dosage

Calcium-channel blocking agents (diltiazem, felodipine, nifedipine, nicardipine, verapamil)

Possible increased concentrations of calcium-channel blocking agent

Felodipine, nifedipine, nicardipine, verapamil: Use with caution; consider dose titration of calcium-channel blocking agent; ECG monitoring recommended

Diltiazem: Consider 50% reduction in diltiazem dosage; use concomitantly with caution; ECG monitoring recommended

Cisapride

Possible increased cisapride concentrations; potential for serious and/or life-threatening effects (e.g., cardiac arrhythmias)

Concomitant use contraindicated

Clarithromycin

Increased concentrations of atazanavir, increased clarithromycin concentrations, decreased 14-hydroxyclarithromycin concentrations; increased clarithromycin concentrations may cause QTc prolongation

Consider reducing clarithromycin dosage by 50%; consider alternative anti-infective for indications other than infections due to Mycobacterium avium complex

Colchicine

Increased colchicine concentrations

Patients with renal or hepatic impairment: Concomitant use of colchicine and atazanavir not recommended

Colchicine for treatment of gout flares: Use initial colchicine dose of 0.6 mg followed by 0.3 mg 1 hour later and repeat dose no earlier than 3 days later

Colchicine for prophylaxis of gout flares: In those receiving ritonavir-boostedatazanavir, decrease colchicine dosage to 0.3 mg once daily in those originally receiving 0.6 mg twice daily or decrease dosage to 0.3 mg once every other day in those originally receiving 0.6 once daily

Colchicine for treatment of familial Mediterranean fever (FMF): Use maximum colchicine dosage of 0.6 mg daily (may be given as 0.3 mg twice daily)

Corticosteroids

Coadministration with dexamethasone or other corticosteroids that induce CYP3A may result in loss of therapeutic effect of atazanavir and resistance development

Consider alternative corticosteroids; long-term concomitant use may increase risk of adverse effects including Cushing's syndrome and adrenal suppression

Co-trimoxazole

Clinically important interactions unlikely

Dapsone

Clinically important interactions unlikely

Delavirdine

No in vitro evidence of antagonistic antiretroviral effects

Didanosine

Buffered didanosine: Decreased atazanavir concentrations and AUC

Didanosine delayed-release capsules: Decreased didanosine concentrations and AUC if given with atazanavir and food

No in vitro evidence of antagonistic antiretroviral effects

Buffered didanosine: Administer atazanavir (with food) 2 hours before or 1 hour after buffered didanosine preparations

Didanosine delayed-release capsules: Administer didanosine capsules and atazanavir at different times

Efavirenz

Decreased atazanavir concentrations and AUC

No in vitro evidence of antagonistic antiretroviral effects with atazanavir

Ritonavir-boosted atazanavir in antiretroviral-naïve adults: Use atazanavir 400 mg and ritonavir 100 mg once daily (with food) and efavirenz 600 mg once daily (without food, preferably at bedtime)

Ritonavir-boosted atazanavir in antiretroviral-experienced adults: Concomitant use not recommended

Emtricitabine

No in vitro evidence of antagonistic antiretroviral effects

Enfuvirtide

No in vitro evidence of antagonistic antiretroviral effects

Ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine)

Possible increased concentrations of ergot derivatives and potential for serious and/or life-threatening effects such as ergot toxicity (e.g., peripheral vasospasm, ischemia of the extremities and other tissues)

Concomitant use contraindicated

Erythromycin

Clinically important interactions unlikely

Elbasvir and grazoprevir (elbasvir/grazoprevir)

Increased grazoprevir concentrations and thus increased risk of ALT elevations

Concomitant use contraindicated

Estrogens/progestins

Hormonal contraceptive containing ethinyl estradiol and norgestimate or norethindrone: Increased or decreased plasma concentrations of ethinyl estradiol; increased plasma concentrations of the progestin

Use with caution

Ritonavir-boosted atazanavir: Use an oral contraceptive containing ≥35 mcg of ethinyl estradiol

Unboosted atazanavir: Use an oral contraceptive containing no more than 30 mcg of ethinyl estradiol

Data not available for other hormonal contraceptives: Alternative methods of contraception recommended

Fluticasone (orally inhaled, intranasal)

Increased fluticasone concentrations; adrenal insufficiency and Cushing's syndrome reported

Ritonavir-boosted atazanavir: Do not use concomitantly unless potential benefits outweigh risks of systemic corticosteroid adverse effects; consider alternative especially when long-term corticosteroid use anticipated

Unboosted atazanavir: Use with caution; consider alternatives, especially when long-term use of the corticosteroid anticipated

Glecaprevir and pibrentasvir (glecaprevir/pibrentasvir)

Increased glecaprevir and pibrentasvir concentrations, and thus increased risk of ALT elevations

Concomitant use contraindicated

GnRH antagonists (elagolix)

Elagolix: Potential loss of virologic response and risk of adverse events such as bone loss and hepatic transaminase elevations

Elagolix: If necessary, limit concomitant use of elagolix 200 mg twice daily with atazanavir for up to 1 month or limit concomitant use of elagolix 150 mg once daily with atazanavir for up to 6 months and monitor virologic response

Histamine H2-receptor antagonists

Famotidine: Decrease in plasma concentrations of atazanavir; possible loss of the therapeutic effect of the antiretroviral agent and development of resistance

Ritonavir-boosted atazanavir in antiretroviral-naïve adults: Administer atazanavir 300 mg once daily with ritonavir 100 mg once daily with food simultaneously with and/or ≥10 hours after the histamine H2-receptor antagonist; dosage of histamine H2-receptor antagonist should not exceed famotidine 40 mg twice daily (or equivalent)

Unboosted atazanavir in antiretroviral-naïve adults: Administer atazanavir 400 mg once daily ≥2 hours before and ≥10 hours after the histamine H2-receptor antagonist; dosage of the histamine H2-receptor antagonist should not exceed famotidine 40 mg daily (or equivalent) and single doses should not exceed famotidine 20 mg (or equivalent)

Antiretroviral-experienced patients receiving ritonavir-boosted atazanavir: Administer atazanavir 300 mg once daily with ritonavir 100 mg once daily with food simultaneously with and/or ≥10 hours after the histamine H2-receptor antagonist; dosage of histamine H2-receptor antagonist should not exceed famotidine 20 mg twice daily (or equivalent)

Antiretroviral-experienced patients receiving tenofovir disoproxil fumarate (DF) and a histamine H2-receptor antagonist: Regimen of atazanavir 400 mg, tenofovir DF 300 mg, and ritonavir 100 mg once daily with food recommended

Antiretroviral-experienced pregnant patients in second or third trimester receiving ritonavir-boosted atazanavir and a histamine H2-receptor antagonist: Adjust dosage of atazanavir to 400 mg once daily with ritonavir 100 mg once daily; dosage recommendations not available for antiretroviral-experienced pregnant patients receiving atazanavir and both tenofovir DF and a histamine H2-receptor antagonist

HMG-CoA reductase inhibitors (statins)

Atorvastatin, lovastatin, rosuvastatin, simvastatin: Increased concentrations of the statin; increased risk of statin-associated adverse effects, including myopathy and rhabdomyolysis

Atorvastatin: Carefully titrate atorvastatin dosage; use lowest necessary dosage

Lovastatin: Concomitant use contraindicated

Rosuvastatin: Rosuvastatin dosage should not exceed 10 mg daily; titrate rosuvastatin dosage carefully and use the lowest necessary dosage

Simvastatin: Concomitant use contraindicated

Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)

Increased concentrations of immunosuppressive agent

Monitor immunosuppressive agent concentrations

Indinavir

Potential for additive hyperbilirubinemia

No in vitro evidence of antagonistic antiretroviral effects

Concomitant use contraindicated

Kinase inhibitors (fostamatinib)

Fostamatinib: Monitor for R406 exposure resulting in dose-related adverse events such as hepatotoxicity and neutropenia

Fostamatinib: Dose reduction may be required

Lamivudine

No clinically important interactions

No in vitro evidence of antagonistic antiretroviral effects

Lomitapide

Increased lomitapide concentrations

Concomitant use contraindicated (potential for hepatotoxicity and significantly increased transaminases)

Lopinavir

No in vitro evidence of antagonistic antiretroviral effects

Methadone

Clinically significant pharmacokinetic interactions unlikely

Nelfinavir

No in vitro evidence of antagonistic antiretroviral effects

Nevirapine

Substantially decreased atazanavir plasma concentrations and AUC with possible loss of therapeutic effect and development of resistance; increased nevirapine plasma concentrations and AUC and increased risk of nevirapine-associated adverse effects

No in vitro evidence of antagonistic antiretroviral effects

Concomitant use contraindicated

Proton-pump inhibitors (PPIs)

Omeprazole: Substantially decreased atazanavir concentrations and possible loss of virologic response and development of atazanavir resistance

Concomitant use with PPIs not recommended in antiretroviral-experienced patients

Ritonavir-boosted atazanavir in antiretroviral-naïve adults receiving a PPI: Use regimen of atazanavir 300 mg once daily with ritonavir 100 mg once daily with food; administer the PPI approximately 12 hours before ritonavir-boosted atazanavir; dosage of PPI should not exceed omeprazole 20 mg daily (or equivalent)

Repaglinide

Possible increased repaglinide concentrations if used with unboosted atazanavir; clinically important interactions not expected if used with ritonavir-boosted atazanavir

Concomitant use with unboosted atazanavir not recommended

Ritonavir

Increased atazanavir concentrations and AUC; low-dose ritonavir (100 mg once daily) used as a pharmacokinetic enhancer (pharmacokinetic booster) for therapeutic advantage (ritonavir-boosted atazanavir)

No in vitro evidence of antagonistic antiretroviral effects

Safety and efficacy of concomitant use of ritonavir dosages >100 mg once daily with atazanavir not established; such dosages not recommended

Ritonavir-boosted atazanavir: Concomitant use with other HIV PIs not recommended

Salmeterol

Possible increased salmeterol concentrations and increased risk of salmeterol-associated adverse cardiovascular effects (e.g., QT interval prolongation, palpitations, and sinus tachycardia)

Concomitant use not recommended

Saquinavir

Increased plasma concentrations of saquinavir possible

No in vitro evidence of antagonistic antiretroviral effects

Appropriate dosage for concomitant use with respect to safety and efficacy not established

Sildenafil

Possible increased sildenafil concentrations and increased risk of sildenafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)

Sildenafil (Revatio) for treatment of pulmonary arterial hypertension (PAH): Concomitant use contraindicated; safe and effective dose for concomitant use not established

Sildenafil for treatment of erectile dysfunction: Use a reduced sildenafil dosage of 25 mg once every 48 hours and closely monitor for sildenafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)

St. John’s wort (Hypericum perforatum)

Possible decreased atazanavir concentrations; possible decreased antiretroviral efficacy and increased risk of antiretroviral resistance

Concomitant use contraindicated

Tadalafil

Possible increased tadalafil concentrations and increased risk of tadalafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)

If tadalafil (Adcirca) is indicated for treatment of PAH in patients who have been receiving atazanavir (with or without ritonavir) for ≥1 week, use initial tadalafil dosage of 20 mg once daily and, if tolerated, increase dosage to 40 mg once daily

Avoid use of tadalafil (Adcirca) for treatment of PAH when starting atazanavir with or without ritonavir; discontinue tadalafil for ≥24 hours prior to initiating atazanavir; after ≥1 week of the antiretroviral agent, resume tadalafil at dosage of 20 mg once daily and, if tolerated, increase dosage to 40 mg once daily

If tadalafil is used for treatment of erectile dysfunction in patients already receiving atazanavir, do not exceed tadalafil dosage of 10 mg once every 72 hours and closely monitor for tadalafil-related adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection, syncope)

Tenofovir DF

Decreased atazanavir concentrations and AUC; increased tenofovir concentrations and AUC and possible increased risk of tenofovir-associated adverse effects, including renal disorders

No in vitro evidence of antagonistic antiretroviral effects

Unboosted atazanavir: Do not use concomitantly with tenofovir DF

Ritonavir-boosted atazanavir: Use atazanavir 300 mg, ritonavir 100 mg, and tenofovir DF 300 mg once daily with food; monitor for tenofovir toxicity

Ritonavir-boosted atazanavir used concomitantly with tenofovir and a histamine H2- receptor antagonist in antiretroviral-experienced adults: Use atazanavir 400 mg and ritonavir 100 mg, and tenofovir DF 300 mg once daily with food

Antiretroviral-experienced pregnant women in second or third trimester receiving ritonavir-boosted atazanavir and either a histamine H2-receptor antagonist or tenofovir: Use atazanavir 400 mg and ritonavir 100 mg once daily with food

Dosage recommendations not available for antiretroviral- experienced pregnant women receiving ritonavir-boosted atazanavir and both tenofovir DF and a histamine H2-receptor antagonist

Trazodone

Possible increased trazodone concentrations; adverse effects (nausea, dizziness, hypotension, syncope) reported when trazodone and ritonavir used concomitantly

Use concomitantly with caution; consider using decreased trazodone dosage

Tricyclic antidepressants

Possible increased concentrations of the tricyclic antidepressant and potential for serious and/or life-threatening effects

Monitor plasma concentrations of the tricyclic antidepressant

Vardenafil

Possible increased vardenafil concentrations and increased risk of vardenafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)

If ritonavir-boosted atazanavir is used in patients receiving vardenafil for treatment of erectile dysfunction, do not exceed vardenafil dosage of 2.5 mg once every 72 hours; if unboosted atazanavir is used in patients receiving vardenafil for treatment of erectile dysfunction, do not exceed vardenafil dosage of 2.5 mg once every 24 hours

Use with caution; closely monitor for vardenafil-related adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection, syncope)

Voxilaprevir, sofosbuvir, and velpatasvir (voxilaprevir/sofosbuvir/velpatasvir)

Increased voxilaprevir concentrations

Concomitant use contraindicated

Zidovudine

No clinically important interactions

No in vitro evidence of antagonistic antiretroviral effects

Atazanavir Pharmacokinetics

Absorption

Bioavailability

Unboosted atazanavir: Rapidly absorbed following oral administration; peak plasma concentrations attained approximately 2–2.5 hours after a dose.

Ritonavir-boosted atazanavir: Peak plasma concentrations attained approximately 2.7–3 hours after a dose.

Food

Food increases bioavailability and reduces pharmacokinetic variability.

Administration of unboosted atazanavir with a light meal increases peak plasma concentration by 57% and AUC by 70% compared with fasting. A high-fat meal increases AUC by 35% with no increase in peak plasma concentration.

Administration of ritonavir-boosted atazanavir with a light meal increases atazanavir peak plasma concentrations by 40% and AUC by 33% compared with fasting. A high-fat meal does not affect AUC compared with fasting.

Plasma Concentrations

Nonlinear pharmacokinetics with greater than dose-proportional increases in plasma concentrations and AUC.

Unboosted atazanavir: Steady-state concentrations attained between days 4–8 with an accumulation of approximately 2.3-fold.

Special Populations

Unboosted atazanavir in hepatic impairment: Following a single 400-mg dose of atazanavir, AUC increased 42% in adults with moderate to severe hepatic impairment (Child-Pugh class B and C) compared with healthy adults.

Unboosted atazanavir in renal impairment: Plasma concentrations in adults with severe renal impairment not undergoing dialysis generally are similar to those in adults with normal renal function. When administered before or after dialysis, plasma concentrations are lower than those in adults with normal renal function (mechanism of this change unknown).

Ritonavir-boosted atazanavir in postpartum women: Atazanavir steady-state peak plasma concentrations and AUC are approximately 28–43% higher during postpartum period (4–12 weeks) compared with historical data in HIV-infected, nonpregnant patients.

Distribution

Extent

Low concentrations of atazanavir attained in CSF and semen after oral administration.

Atazanavir distributed into fetal umbilical cord blood in low concentrations. When ritonavir-boosted atazanavir used in pregnant women, atazanavir concentrations in cord blood approximately 12–19% of maternal plasma concentrations at delivery.

Distributed into human milk.

Plasma Protein Binding

86% bound to serum proteins; binding independent of concentration.

Binds to both α-1-acid glycoprotein (89%) and albumin (86%).

Elimination

Metabolism

Extensively metabolized and eliminated in liver. CYP3A involved in metabolism of the drug.

Elimination Route

Approximately 79% of a dose eliminated in feces and 13% eliminated in urine as metabolites and unchanged drug.

In patients with severe renal impairment on hemodialysis, 2.1% of the administered dose of atazanavir was removed in a 4-hour dialysis session.

Half-life

Unboosted atazanavir: 6.5–7.9 hours.

Ritonavir-boosted atazanavir: 8.6–18.1 hours.

Special Populations

No clinically important differences in pharmacokinetics in those >65 years of age compared with younger adults.

Atazanavir: Half-life is 12.1 hours in those with moderate to severe hepatic impairment.

Stability

Storage

Oral

Capsules

25°C (excursions permitted between 15–30°C) in tightly closed container.

Powder

20-30°C in original packet. After mixing with food or beverage, may store for up to 1 hour at room temperature (20–30°C).

Actions and Spectrum

Advice to Patients

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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Atazanavir Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Powder

50 mg (of atazanavir) per packet

Reyataz

Bristol-Myers Squibb

Capsules

150 mg (of atazanavir)*

Reyataz

Bristol-Myers Squibb

200 mg (of atazanavir)

Reyataz

Bristol-Myers Squibb

300 mg (of atazanavir)

Reyataz

Bristol-Myers Squibb

AHFS DI Essentials™. © Copyright 2024, Selected Revisions December 11, 2023. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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