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Atazanavir 150 mg Capsule, 1,000-count — NDC 31722-0653-31 package photo
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Atazanavir 150 mg Capsule, 1,000-count — NDC 31722-653-31 (Billing 31722-0653-31)

by Camber Pharmaceuticals, Inc. · 100 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

This is a package of 1,000 capsules of Atazanavir 150 mg Capsule from Camber Pharmaceuticals, Inc., marketed since Feb 2022 and currently FDA-listed.

NDC 31722-0653-31
🏷️ FDA NDC (as labeled) 31722-653-31 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes3 compare ↓
Product page 31722-0653-10 Also comes in: 60 capsules 31722-653-60 1000 capsules 31722-653-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 31722-653-31 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
31722 labeler · 653 product · 31 package
Package marketed since
Feb 7, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0331722654609, 0331722653602, 0331722655309
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-653-31
Product NDC 31722-653
11-digit billing NDC 31722065331
RxCUI 402246, 402247, 664741
UNII 4MT4VIE29P
UPC 0331722654609, 0331722653602, 0331722655309
Application # ANDA212278
SPL Set ID 8a0c609f-e296-4925-a35c-e93a04467655
Established class (EPC) Protease Inhibitor
Mechanism of action Cytochrome P450 2C8 Inhibitors; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; HIV Protease Inhibitors; UDP Glucuronosyltransferases Inhibitors; UGT1A1 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-02-07
Route ORAL
Dosage form CAPSULE
Substance ATAZANAVIR SULFATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 12104515200130
GPI class Atazanavir Sulfate
GCN Seq No 052747
GCN 19952
HICL code 025390
Ingredient (HICL) Atazanavir Sulfate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5C
Therapeutic class — specific (HIC3) Antivirals, Hiv-Specific, Protease Inhibitors
AHFS code 08:18.08.08
AHFS class Hiv Protease Inhibitor Antiretrovirals
FDB label name ATAZANAVIR SULFATE 150 MG CAP
FDB brand name Atazanavir Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 052747
  • GCN: 19952
  • GPI-14 (Medi-Span): 12104515200130
  • HICL (First Databank): 025390
  • AHFS class code: 08:18.08.08
  • RxCUI (RxNorm): 402246
Why two NDCs? The FDA registers this code as 31722-653-31 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 31722-0653-31. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Protease Inhibitor class.

Pharmacologic class Protease Inhibitor
Drug family (ATC) Protease inhibitors
How it works HIV Protease Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 2C8 Inhibitors, Cytochrome P450 3A Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ATAZANAVIR SULFATE 150 MG CAP Ingredient Atazanavir Sulfate
📗 Our plain-language guide HelloPharmacist
  • Food makes a real difference with atazanavir — it can increase how much of the drug your body actually absorbs by up to 70%. Taking it without food means lower and less predictable...
  • Why do I have to take this with food every time?
  • This is one of the most common things people notice on atazanavir, and in most cases it's not dangerous. The drug causes an increase in indirect bilirubin — a natural pigment — whi...
  • My skin and eyes look a little yellow. Should I be worried?
📖 Read our full Atazanavir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 capsules 1000 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
31722-0653-10 31722-653-10 Main listing 1000 CAPSULE in 1 BOTTLE 2022-02-07 — Active
31722-0653-31 You're viewing this 100 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK 2022-02-07 — Active
31722-0653-60 31722-653-60 60 CAPSULE in 1 BOTTLE 2022-02-07 — Active

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 100 blister pack in 1 carton / 10 capsule in 1 blister pack.
How does this package differ from NDC 31722-0653-60?
Both are Atazanavir 150 mg Capsule — the drug itself is identical. This page's package is the 1,000-count one, while NDC 31722-0653-60 is the 60 capsules package.
What NDC number is used to bill for this package of Atazanavir 150 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atazanavir Sulfate 150 mg 00093-5526-06 Teva 60 capsules — AB FDA listed —
Atazanavir 150 mgthis 31722-0653-31 Camber 1000 capsules — AB FDA listed —
Atazanavir 150 mg 42385-0920-48 Laurus 60 capsules — AB FDA listed —
Atazanavir Sulfate 150 mg 65862-0711-03 Aurobindo 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color green / orange
ShapeCapsule
ImprintH;A8
Size24 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Atazanavir inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCamber Pharmaceuticals, Inc.
Application holderHETERO LABS LTD UNIT III
FDA applicationANDA212278 (ANDA)
Labeler code31722
First marketedFeb 2022
Product typeHuman Prescription Drug
Portfolio603 products on file

More NDCs from Camber Pharmaceuticals, Inc. labeler code 31722

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 136 words ▾

1 INDICATIONS AND USAGE Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: • Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4 )] . • Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4 )] .

Atazanavir capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Pretreatment testing: Renal laboratory testing should be performed in all patients prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. Hepatic testing should be performed in patients with underlying liver disease prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. ( 2.2 ) • Treatment-naive adults: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food or atazanavir 400 mg once daily with food.

( 2.3 ) • Treatment-experienced adults: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food. ( 2.3 ) • Pediatric patients: Atazanavir capsule dosage is based on body weight not to exceed the adult dose and must be taken with food. ( 2.4 ) • Pregnancy: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food, with dosing modifications for some concomitant medications.

( 2.6 ) • Dosing modifications: may be required for concomitant therapy ( 2.3 , 2.4 , 2.6 ), renal impairment ( 2.7 ), and hepatic impairment. ( 2.8 )

2.1Overview • Atazanavir capsules must be taken with food. • Do not open the capsules. • The recommended oral dosage of atazanavir capsules depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H 2 -receptor antagonists or proton-pump inhibitors, dose separation may be required [see Dosage and Administration ( 2.3 , 2.4 , and 2.6 ) and Drug Interactions ( 7 )] . • Atazanavir capsules without ritonavir are not recommended for treatment-experienced adult or pediatric patients with prior virologic failure [see Clinical Studies ( 14 )] . • Efficacy and safety of atazanavir capsules with ritonavir when ritonavir is administered in doses greater than 100 mg once daily have not been established.

The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended. Prescribers should consult the complete prescribing information for ritonavir when using ritonavir.

2.2Testing Prior to Initiation and During Treatment with Atazanavir Capsules Renal laboratory testing should be performed in all patients prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination [see Warnings and Precautions ( 5.5 , 5.6 )] . Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules [see Warnings and Precautions ( 5.4 )] .

2.3Dosage of Atazanavir Capsules in Adult Patients Table 1 displays the recommended dosage of atazanavir capsules in treatment-naive and treatment-experienced adults. Table 1 also displays recommended dosage of atazanavir capsules and ritonavir when given concomitantly with other antiretroviral drugs and H 2 -receptor antagonists (H2RA). Ritonavir is required with several atazanavir capsule dosage regimens (see the ritonavir complete prescribing information about the safe and effective use of ritonavir).

The use of atazanavir capsules in treatment-experienced adult patients without ritonavir is not recommended. Table 1: Recommended Atazanavir Capsules and Ritonavir Dosage in Adults a Atazanavir Capsules Once Daily Dosage Ritonavir Once Daily Dosage Treatment-Naive Adult Patients recommended regimen 300 mg 100 mg unable to tolerate ritonavir 400 mg N/A in combination with efavirenz 400 mg 100 mg Treatment-Experienced Adult Patients recommended regimen 300 mg 100 mg in combination with both H2RA and tenofovir DF 400 mg 100 mg a See Drug Interactions ( 7 ) for instructions concerning coadministration of acid-reducing medications (eg, H2RA or proton pump inhibitors [PPIs]), and other antiretroviral drugs (eg, efavirenz, tenofovir DF… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 141 words ▾

3 DOSAGE FORMS AND STRENGTHS Atazanavir Capsules: • 150 mg capsule with off white to pale yellow colored granular powder filled in size 1 hard gelatin capsules with green opaque cap imprinted with "H" in black color and light green opaque body imprinted with "A6" in black color. • 200 mg capsule with off white to pale yellow colored granular powder filled in size 0 hard gelatin capsules with green opaque cap imprinted with "H" in black color and light green opaque body imprinted with "A7'' in black color. • 300 mg capsule with off white to pale yellow colored granular powder filled in size 00 hard gelatin capsules with orange opaque cap imprinted with "H" in black color and green opaque body imprinted with "A8" in black color. • Capsules: 150 mg, 200 mg, 300 mg.

( 3, 16 )

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Atazanavir capsules are contraindicated: • in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens- Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see Warnings and Precautions ( 5.2 )] . • when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see Table 6). • when coadministered with drugs that strong inducers of CYP3A due to the potential for loss of therapeutic effect and development of resistance.

Coadministration is contraindicated with, but not limited to, the following drugs listed in Table 6: Table 6: Drugs Contraindicated with Atazanavir (Information in the table applies to atazanavir with or without ritonavir, unless otherwise indicated) Drug Class Drugs within class that are contraindicated with Atazanavir capsules Alpha 1-adrenoreceptor antagonist Alfuzosin Antiarrhythmics Amiodarone (with ritonavir), quinidine (with ritonavir) Anticonvulsants Carbamazepine, phenobarbital, phenytoin Antimycobacterials Rifampin Antineoplastics Apalutamide, encorafenib, irinotecan, ivosidenib Antipsychotics Lurasidone (with ritonavir), pimozide Benzodiazepines Orally administered midazolam a , triazolam Ergot Derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine GI Motility Agent Cisapride Hepatitis C Direct-Acting Antivirals Elbasvir/grazoprevir; glecaprevir/pibrentasvir Herbal Products St.

John’s wort ( Hypericum perforatum ) Lipid-Modifying Agents: Lomitapide, lovastatin, simvastatin Phosphodiesterase-5 (PDE-5) Inhibitor Sildenafil b when dosed as REVATIO ® for the treatment of pulmonary arterial hypertension Protease Inhibitors Indinavir Non-nucleoside Reverse Transcriptase Inhibitors Nevirapine a See Drug Interactions, Table 16 ( 7 ) for parenterally administered midazolam. b See Drug Interactions, Table 16 ( 7 ) for sildenafil when dosed as VIAGRA ® for erectile dysfunction. • In patients with previously demonstrated hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components atazanavir capsules.

( 4 ) • Coadministration with drugs that are strong inducers of CYP3A, due to the potential for loss of therapeutic effect and development of resistance. (4) • Coadministration with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. ECG monitoring should be considered in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. ( 5.1 , 7.3 , 12.2 , 17 ) • Severe Skin Reactions: Discontinue if severe rash develops.

( 5.2 , 17 ) • Hyperbilirubinemia : Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. Do not dose reduce. If a concomitant transaminase increase occurs, evaluate for alternative etiologies.

( 5.8 ) • Hepatotoxicity: Patients with hepatitis B or C virus are at risk of increased transaminases or hepatic decompensation. Monitor hepatic laboratory tests prior to therapy and during treatment. ( 2.8 , 5.4 , 8.8 ) • Chronic kidney disease has been reported during postmarketing surveillance in patients with HIV-1 treated with atazanavir, with or without ritonavir.

Consider alternatives in patients at high risk for renal disease or with preexisting renal disease. Monitor renal laboratory tests prior to therapy and during treatment. Consider discontinuation of atazanavir in patients with progressive renal disease.

( 5.5 ) • Nephrolithiasis and cholelithiasis have been reported. Consider temporary interruption or discontinuation. ( 5.6 ) • The concomitant use of atazanavir with ritonavir and certain other medications may result in known or potentially significant drug interactions.

Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 5.7 , 7.3 ) • Patients receiving atazanavir may develop new onset or exacerbations of diabetes mellitus/hyperglycemia ( 5.9 ), immune reconstitution syndrome (5.10), and redistribution/accumulation of body fat. ( 5.11 ) • Hemophilia: Spontaneous bleeding may occur, and additional factor VIII may be required.

( 5.12 )

5.1Cardiac Conduction Abnormalities Atazanavir has been shown to prolong the PR interval of the electrocardiogram in some study participants. In healthy participants and in participants with HIV-1 treated with atazanavir, abnormalities in atrioventricular (AV) conduction were asymptomatic and generally limited to first-degree AV block. There have been reports of second-degree AV block and other conduction abnormalities [see Adverse Reactions ( 6.2 ) and Overdosage ( 10 )] .

In clinical trials that included electrocardiograms, asymptomatic first-degree AV block was observed in 5.9% of atazanavir-treated participants (n=920), 5.2% of lopinavir/ritonavir-treated participants (n=252), 10.4% of nelfinavir-treated participants (n=48), and 3.0% of efavirenz-treated participants (n=329). In Study AI424-045, asymptomatic first-degree AV block was observed in 5% (6/118) of atazanavir with ritonavir-treated participants and 5% (6/116) of lopinavir/ritonavir-treated participants who had on-study electrocardiogram measurements.

Because of limited clinical experience in those with preexisting conduction system disease (eg, marked first-degree AV block or second- or third-degree AV block), ECG monitoring should be considered in these patients [see Clinical Pharmacology ( 12.2 )] .

5.2Severe Skin Reactions In controlled clinical trials, rash (all grades, regardless of causality) occurred in approximately 20% of participants with HIV-1 treated with atazanavir. The median time to onset of rash in clinical studies was 7.3 weeks and the median duration of rash was 1.4 weeks. Rashes were generally mild-to-moderate maculopapular skin eruptions.

Treatment-emergent adverse reactions of moderate or severe rash (occurring at a rate of ≥2%) are presented for the individual clinical studies [see Adverse Reactions ( 6.1 )] . Dosing with atazanavir was often continued without interruption in patients who developed rash. The discontinuation rate for rash in clinical trials was <1%.

Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic ski… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • cardiac conduction abnormalities [see Warnings and Precautions ( 5.1 )] • rash [see Warnings and Precautions ( 5.2 )] • hyperbilirubinemia [see Warnings and Precautions ( 5.8 )] • chronic kidney disease [see Warnings and Precautions ( 5.5 )] • nephrolithiasis and cholelithiasis [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Treatment-Naive Adult Participants The safety profile of atazanavir in treatment-naive adults is based on 1625 participants with HIV-1 in clinical trials. 536 participants received atazanavir 300 mg with ritonavir 100 mg and 1089 participants received atazanavir 400 mg or higher (without ritonavir).

The most common adverse reactions were nausea, jaundice/scleral icterus, and rash. Selected clinical adverse reactions of moderate or severe intensity reported in > 2% of treatment- naive participants receiving combination therapy including atazanavir 300 mg with ritonavir 100 mg and atazanavir 400 mg (without ritonavir) are presented in Tables 7 and 8, respectively. Table 7: Selected Adverse Reactions a of Moderate or Severe Intensity Reported in >2% of Adult Treatment-Naive Participants with HIV-1, b Study AI424-138 96 weeks c 96 weeks c Atazanavir capsules 300 mg with ritonavir 100 mg (once daily) and tenofovir DF/emtricitabine d lopinavir/ritonavir d 400 mg/100 mg (twice daily) and tenofovir DF/emtricitabine e (n=441) (n=437) Digestive System Nausea 4% 8% Jaundice/scleral icterus 5% * Diarrhea 2% 12% Skin and Appendages Rash 3% 2% * None reported in this treatment arm. a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. b Based on the regimen containing atazanavir. c Median time on therapy. d Administered as a fixed-dose. e As a fixed-dose product: 300 mg tenofovir DF, 200 mg emtricitabine once daily.

Table 8: Selected Adverse Reactions a of Moderate or Severe Intensity Reported in ≥2% of Adult Treatment-Naive Participants with HIV-1, b Studies AI424-034, AI424-007, and AI424-008 Study AI424-034 Studies AI424-007, -008 64 weeks c 64 weeks c 120 weeks c,d 73 weeks c,d Atazanavir capsules 400 mg (once daily) with lamivudine/ Zidovudine e (n=404) efavirenz 600 mg (once daily) with lamivudine/ zidovudine e (n=401) Atazanavir capsules 400 mg (once daily) with stavudine and lamivudine or didanosine (n=279) nelfinavir 750 mg TID or 1250 mg BID with stavudine and lamivudine or didanosine (n=191) Body as a Whole Headache 6% 6% 1% 2% Digestive System Nausea 14% 12% 6% 4% Jaundice/scleral icterus 7% * 7% * Vomiting 4% 7% 3% 3 Abdominal pain 4% 4% 4% 2% Diarrhea 1% 2% 3% 16% Nervous System Insomnia 3% 3% <1% * Dizziness 2% 7% <1% * Peripheral neurologic symptoms <1% 1% 4% 3% Skin and Appendages Rash 7% 10% 5% 1% * None reported in this treatment arm. a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. b Based on regimens containing atazanavir. c Median time on therapy. d Includes long-term follow-up. e As a fixed-dose product: 150 mg lamivudine/300 mg zidovudine twice daily.

Adverse Reactions in Treatment-Experienced Adult Participants The safety profile of atazanavir in treatment-experienced adults with HIV-1 is based on 119 participants with HIV-1 in clinical trial… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Coadministration of atazanavir can alter the concentration of other drugs and other drugs may alter the concentration of atazanavir. The potential drug-drug interactions must be considered prior to and during therapy. ( 4 , 7 , 12.3 )

7.1Potential for Atazanavir to Affect Other Drugs Atazanavir is an inhibitor of CYP3A and UGT1A1. Coadministration of atazanavir and drugs primarily metabolized by CYP3A or UGT1A1 may result in increased plasma concentrations of the other drug that could increase or prolong its therapeutic and adverse effects. Atazanavir is a weak inhibitor of CYP2C8.

Use of atazanavir without ritonavir is not recommended when coadministered with drugs highly dependent on CYP2C8 with narrow therapeutic indices (eg, paclitaxel, repaglinide). When atazanavir with ritonavir is coadministered with substrates of CYP2C8, clinically significant interactions are not expected [see Clinical Pharmacology, Table 22 ( 12.3 )]. The magnitude of CYP3A-mediated drug interactions on coadministered drug may change when atazanavir is coadministered with ritonavir.

See the complete prescribing information for ritonavir for information on drug interactions with ritonavir.

7.2Potential for Other Drugs to Affect Atazanavir Atazanavir is a CYP3A4 substrate; therefore, drugs that induce CYP3A4 may decrease atazanavir plasma concentrations and reduce atazanavir therapeutic effect (see Table 16). Atazanavir solubility decreases as pH increases. Reduced plasma concentrations of atazanavir are expected if proton-pump inhibitors, antacids, buffered medications, or H 2 -receptor antagonists are administered with atazanavir [see Dosage and Administration ( 2.3 , 2.4 , and 2.6 )] .

7.3Established and Other Potentially Significant Drug Interactions Table 16 provides dosing recommendations in adults as a result of drug interactions with atazanavir. These recommendations are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious events or loss of efficacy. Table 16: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies a or Predicted Interactions (Information in the table applies to atazanavir with or without ritonavir, unless otherwise indicated) Concomitant Drug Class: Specific Drugs Effect on Concentration of Atazanavir or Concomitant Drug Clinical Comment HIV Antiviral Agents Nucleoside Reverse Transcriptase Inhibitors (NRTIs): didanosine buffered formulations enteric coated (EC) capsules ↓ atazanavir ↓ didanosine It is recommended that atazanavir be given (with food) 2 h before or 1 h after didanosine buffered formulations.

Simultaneous administration of didanosine EC and atazanavir with food results in a decrease in didanosine exposure. Thus, atazanavir and didanosine EC should be administered at different times. Nucleotide Reverse Transcriptase Inhibitors: tenofovir disoproxil fumarate (DF) ↓atazanavir ↑tenofovir When coadministered with tenofovir DF in adults, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg and tenofovir DF 300 mg (all as a single daily dose with food).

The mechanism of this interaction is unknown. Higher tenofovir concentrations could potentiate tenofovir-associated adverse reactions, including renal disorders. Patients receiving atazanavir and tenofovir DF should be monitored for tenofovir-associated adverse reactions.

For pregnant patients taking atazanavir with ritonavir and tenofovir DF, see Dosage and Administration (2.6) . Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs): efavirenz ↓atazanavir In HIV-treatment-naive adult patients: If atazanavir is combined with efavirenz, atazanavir 400 mg (two 200-mg capsules) should be administered with ritonavir 100 mg simultaneously once daily with food, and efavirenz 600 mg should be administered once daily on an empty stomach, preferably at bedtime.… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate. ( 8.1 ) • Hepatitis B or C co-infection: Monitor liver enzymes. ( 5.4 , 6.1 ) • Renal impairment: Atazanavir is not recommended for use in treatment- experienced patients with end-stage renal disease managed with hemodialysis.

( 2.7 , 8.7 ) • Hepatic impairment: Atazanavir is not recommended in patients with severe hepatic impairment. Atazanavir with ritonavir is not recommended in patients with any degree of hepatic impairment. ( 2.8 , 8.8 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to atazanavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Atazanavir has been evaluated in a limited number of women during pregnancy.

Available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. No treatment-related malformations were observed in rats and rabbits, for which the atazanavir exposures were 0.7 to 1.2 times of those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir).

When atazanavir was administered to rats during pregnancy and throughout lactation, reversible neonatal growth retardation was observed [see Data]. Clinical Considerations Dose Adjustments during Pregnancy and the Postpartum Period • Atazanavir must be administered with ritonavir in pregnant patients. • For pregnant patients, no dosage adjustment is required for atazanavir with the following exceptions: • For treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an H 2 -receptor antagonist or tenofovir DF, atazanavir 400 mg with ritonavir 100 mg once daily is recommended.

There are insufficient data to recommend a atazanavir dose for use with both an H 2 -receptor antagonist and tenofovir DF in treatment-experienced pregnant patients. • No dosage adjustment is required for postpartum patients. However, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery [see Dosage and Administration ( 2.6 ) and Clinical Pharmacology ( 12.3 )]. Maternal Adverse Reactions Cases of lactic acidosis syndrome, sometimes fatal, and symptomatic hyperlactatemia have occurred in pregnant women using atazanavir in combination with nucleoside analogues, which are associated with an increased risk of lactic acidosis syndrome.

Hyperbilirubinemia occurs frequently in patients who take atazanavir [see Warnings and Precautions ( 5.8 )] , including those who are pregnant [see Data]. Advise pregnant women of the potential risks of lactic acidosis syndrome and hyperbilirubinemia. Fetal/Neonatal Adverse Reactions All infants, including neonates exposed to atazanavir in utero , should be monitored for the development of severe hyperbilirubinemia during the first few days of life [see Data].

Data Human Data In Study AI424-182, atazanavir with ritonavir (300/100 mg or 400/100 mg) coadministered with lamivudine/zidovudine (150 mg/ 300 mg, as fixed-dose product) was administered to 41 pregnant women with HIV-1, during the second or third trimester. Among the 39 women who completed the study, 38 women achieved an HIV-1 RNA less than 50 copies/mL at time of delivery. Six of 20 (30%) women on atazanavir with ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir with ritonavir 400/100 mg experienced hyperbilirubinemia (total bilirubin greater than or equal to 2… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to atazanavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Atazanavir has been evaluated in a limited number of women during pregnancy.

Available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. No treatment-related malformations were observed in rats and rabbits, for which the atazanavir exposures were 0.7 to 1.2 times of those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir).

When atazanavir was administered to rats during pregnancy and throughout lactation, reversible neonatal growth retardation was observed [see Data]. Clinical Considerations Dose Adjustments during Pregnancy and the Postpartum Period • Atazanavir must be administered with ritonavir in pregnant patients. • For pregnant patients, no dosage adjustment is required for atazanavir with the following exceptions: • For treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an H 2 -receptor antagonist or tenofovir DF, atazanavir 400 mg with ritonavir 100 mg once daily is recommended.

There are insufficient data to recommend a atazanavir dose for use with both an H 2 -receptor antagonist and tenofovir DF in treatment-experienced pregnant patients. • No dosage adjustment is required for postpartum patients. However, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery [see Dosage and Administration ( 2.6 ) and Clinical Pharmacology ( 12.3 )]. Maternal Adverse Reactions Cases of lactic acidosis syndrome, sometimes fatal, and symptomatic hyperlactatemia have occurred in pregnant women using atazanavir in combination with nucleoside analogues, which are associated with an increased risk of lactic acidosis syndrome.

Hyperbilirubinemia occurs frequently in patients who take atazanavir [see Warnings and Precautions ( 5.8 )] , including those who are pregnant [see Data]. Advise pregnant women of the potential risks of lactic acidosis syndrome and hyperbilirubinemia. Fetal/Neonatal Adverse Reactions All infants, including neonates exposed to atazanavir in utero , should be monitored for the development of severe hyperbilirubinemia during the first few days of life [see Data].

Data Human Data In Study AI424-182, atazanavir with ritonavir (300/100 mg or 400/100 mg) coadministered with lamivudine/zidovudine (150 mg/ 300 mg, as fixed-dose product) was administered to 41 pregnant women with HIV-1, during the second or third trimester. Among the 39 women who completed the study, 38 women achieved an HIV-1 RNA less than 50 copies/mL at time of delivery. Six of 20 (30%) women on atazanavir with ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir with ritonavir 400/100 mg experienced hyperbilirubinemia (total bilirubin greater than or equal to 2.6 times ULN).

There were no cases of lactic acidosis observed in clinical trial AI424-182. Atazanavir drug concentrations in fetal umbilical cord blood were approximately 12% to 19% of maternal concentrations. Among the 40 infants born to 40 pregnant women with HIV-1, all had test results that were negative for HIV-1 DNA at the time of delivery and/or during the first 6 months postpartum.

All 40 infants received antiretroviral prophylactic treatment containing zidovudine. No evidence of severe hyperbilirubinemia (total bilirubin levels greater than 20 mg/dL) or acute or chronic bilirubin encephalopathy was observed among neonate… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 168 words ▾

8.4Pediatric Use Atazanavir is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1, 6 years of age and older weighing at least 15 kg. Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Indications and Usage ( 1 )]. All atazanavir contraindications, warnings, and precautions apply to pediatric patients [see Contraindications ( 4 ) and Warnings and Precautions ( 5 )].

The safety, pharmacokinetic profile, and virologic response of atazanavir in pediatric patients at least 6 years of age and older weighing at least 15 kg were established in three open-label, multicenter clinical trial: PACTG 1020A, AI424-451, and AI424-397 [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.3 )]. The safety profile in pediatric patients was generally similar to that observed in adults [see Adverse Reactions ( 6.1 )] . See Dosage and Administration ( 2.4 ) for dosing recommendations for the use of atazanavir capsules.

🧓 Geriatric Use 86 words ▾

8.5Geriatric Use Clinical studies of atazanavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Based on a comparison of mean single-dose pharmacokinetic values for C max and AUC, a dose adjustment based upon age is not recommended. In general, appropriate caution should be exercised in the administration and monitoring of atazanavir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 198 words ▾

10 OVERDOSAGE Human experience of acute overdose with atazanavir is limited. Single doses up to 1200 mg (three times the 400 mg maximum recommended dose) have been taken by healthy participants without symptomatic untoward effects. A single self-administered overdose of 29.2 g of atazanavir in a patient with HIV-1 (73 times the 400-mg recommended dose) was associated with asymptomatic bifascicular block and PR interval prolongation.

These events resolved spontaneously. At atazanavir doses resulting in high atazanavir exposures, jaundice due to indirect (unconjugated) hyperbilirubinemia (without associated liver function test changes) or PR interval prolongation may be observed [see Warnings and Precautions ( 5.1 , 5.8 ) and Clinical Pharmacology ( 12.2 )]. Treatment of overdosage with atazanavir should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patient’s clinical status.

If indicated, elimination of unabsorbed atazanavir should be achieved by emesis or gastric lavage. Administration of activated charcoal may also be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with atazanavir.

Since atazanavir is extensively metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicine.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atazanavir is an HIV-1 antiretroviral drug [see Microbiology ( 12.4 )].

12.2Pharmacodynamics Cardiac Electrophysiology Concentration- and dose-dependent prolongation of the PR interval in the electrocardiogram has been observed in healthy participants receiving atazanavir. In placebo-controlled Study AI424-076, the mean (±SD) maximum change in PR interval from the predose value was 24 (±15) msec following oral dosing with 400 mg of atazanavir (n=65) compared to 13 (±11) msec following dosing with placebo (n=67). The PR interval prolongations in this study were asymptomatic.

There is limited information on the potential for a pharmacodynamic interaction in humans between atazanavir and other drugs that prolong the PR interval of the electrocardiogram [see Warnings and Precautions ( 5.1 )]. Electrocardiographic effects of atazanavir were determined in a clinical pharmacology study of 72 healthy participants. Oral doses of 400 mg (maximum recommended dosage) and 800 mg (twice the maximum recommended dosage) were compared with placebo; there was no concentration- dependent effect of atazanavir on the QTc interval (using Fridericia’s correction).

In 1793 participants with HIV-1, receiving antiretroviral regimens, QTc prolongation was comparable in the atazanavir and comparator regimens. No atazanavir-treated healthy participant or participant with HIV-1 in clinical trials had a QTc interval >500 msec [see Warnings and Precautions ( 5.1 )].

12.3Pharmacokinetics The pharmacokinetics of atazanavir were evaluated in adult participants who either were healthy, or with HIV, after administration of atazanavir 400 mg once daily and after administration of atazanavir 300 mg with ritonavir 100 mg once daily (see Table 17). Table 17: Steady-State Pharmacokinetics of Atazanavir in Healthy Participants or Participants with HIV-1 in the Fed State 400 mg once daily 300 mg with ritonavir 100 mg once daily H ealthy Participants Participants with HIV-1 Healthy Participants Participants with HIV-1 Parameter (n=14) (n=13) (n=28) (n=10) C max (ng/mL) Geometric mean 5199 (26) 2298 (71) 6129 (31) 4422 (58) (CV%) Mean (SD) 5358 (1371) 3152 (2231) 6450 (2031) 5233 (3033) T max (h) Median 2.5 2.0 2.7

3.0AUC (ng•h/mL) Geometric mean 28132 (28) 14874 (91) 57039 (37) 46073 (66) (CV%) Mean (SD) 29303 (8263) 22262 (20159) 61435 (22911) 53761 (35294) T-half (h) Mean (SD) 7.9 (2.9) 6.5 (2.6) 18.1 (6.2) a 8.6 (2.3) C min (ng/mL) Geometric mean 159 (88) 120 (109) 1227 (53) 636 (97) (CV%) Mean (SD) 218 (191) 273 (298) b 1441 (757) 862 (838) a n=26. b n=12. Figure 1 displays the mean plasma concentrations of atazanavir at steady state after atazanavir 400 mg once daily (as two 200 mg capsules) with a light meal and after atazanavir 300 mg (as two 150 mg capsules) with ritonavir 100 mg once daily with a light meal in adult participants with HIV-1.

Figure 1: Mean (SD) Steady-State Plasma Concentrations of Atazanavir 400 mg (n=13) and 300 mg with Ritonavir (n=10) for Adult Participants with HIV-1 Absorption Atazanavir is rapidly absorbed with a T max of approximately 2.5 hours. Atazanavir demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in AUC and C max values over the dose range of 200 to 800 mg once daily. Steady state is achieved between Days 4 and 8, with an accumulation of approximately 2.3 fold.

Food Effect Administration of atazanavir with food enhances bioavailability and reduces pharmacokinetic variability. Administration of a single 400 mg dose of atazanavir with a light meal (357 kcal, 8.2 g fat, 10.6 g protein) resulted in a 70% increase in AUC and 57% increase in C max relative to the fasting state. Administration of a single 400 mg dose of atazanavir with a high-fat meal (721 kcal, 37.3 g fat, 29.4 g protein) resulted in a mean increase in AUC of 35% with no change in C max relative to the fasting state.

Administration of atazanavir with either a light meal or high-fat… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Atazanavir is an HIV-1 antiretroviral drug [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atazanavir Capsules 150 mg are off white to pale yellow colored granular powder filled in size "1" hard gelatin capsules with green opaque cap imprinted with "H" in black color and light green opaque body imprinted with "A6" in black color. Bottles of 60 with child-resistant closure NDC 31722-653-60 Bottles of 1000 with child-resistant closure NDC 31722-653-10 Carton of 100 (10×10) unit-dose capsules NDC 31722-653-31 150 mg atazanavir equivalent to 170.854 mg atazanavir sulfate. Atazanavir Capsules 200 mg are off white to pale yellow colored granular powder filled in size "0" hard gelatin capsules with green opaque cap imprinted with "H" in black color and light green opaque body imprinted with "A7'' in black color.

Bottles of 60 with child-resistant closure NDC 31722-654-60 Bottles of 1000 with CT closure NDC 31722-654-10 Carton of 100 (10×10) unit-dose capsules NDC 31722-654-31 200 mg atazanavir equivalent to 227.805 mg atazanavir sulfate. Atazanavir Capsules 300 mg are off white to pale yellow colored granular powder filled in size "00" hard gelatin capsules with orange opaque cap imprinted with "H" in black color and green opaque body imprinted with "A8" in black color. Bottles of 30 with child-resistant closure NDC 31722-655-30 Bottles of 500 with child-resistant closure NDC 31722-655-05 Carton of 100 (10×10) unit-dose capsules NDC 31722-655-31 300 mg atazanavir equivalent to 341.708 mg atazanavir sulfate.

Keep capsules in a tightly closed container. Store atazanavir capsules at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 220 words ▾

11 DESCRIPTION The active ingredient in atazanavir capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is ((3 S ,8 S ,9 S ,12 S )-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl] 2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate. Its molecular formula is C 38 H 52 N 6 O 7 .H 2 SO 4 which corresponds to a molecular weight of 802.9 (sulphuric acid salt).

The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula: Atazanavir sulfate is an off white to pale yellow coloured crystalline powder. It is slightly soluble in water at acidic pH, freely soluble in methanol, soluble in dimethylformamide and dimethylsulfoxide.

Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.854 mg, 227.805 mg, or 341.708 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue 1, iron oxide yellow, titanium dioxide, In addition 150 mg capsule shell contains iron oxide black, 200 mg and 300 mg contains FD&C Yellow 6, 300 mg also contains FD&C Red 3.

The capsules are printed with black ink containing iron oxide black, potassium hydroxide, propylene glycol, shellac, strong ammonia solution. atazanavircapsulestructure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Atazanavir capsules are not a cure for HIV-1 infection. Advise patients to remain under the care of a healthcare provider while using atazanavir capsules. Cardiac Conduction Abnormalities Inform patients that atazanavir may produce changes in the electrocardiogram (eg, PR prolongation).

Tell patients to consult their healthcare provider if they are experiencing symptoms such as dizziness or lightheadedness [see Warnings and Precautions ( 5.1 )]. Severe Skin Reaction Inform patients that there have been reports of severe skin reactions (eg, Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions) with atazanavir capsules use. Advise patients that if signs or symptoms of severe skin reactions or hypersensitivity reactions develop, they must discontinue atazanavir capsules and seek medical evaluation immediately [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )].

Hyperbilirubinemia Inform patients that asymptomatic elevations in indirect bilirubin have occurred in patients receiving atazanavir capsules. This may be accompanied by yellowing of the skin or whites of the eyes and alternative antiretroviral therapy may be considered if the patient has cosmetic concerns [see Warnings and Precautions ( 5.8 )]. Chronic Kidney Disease Inform patients that treatment with atazanavir capsules may lead to the development of chronic kidney disease, and to maintain adequate hydration while taking atazanavir capsules [see Warnings and Precautions ( 5.5 )].

Nephrolithiasis and Cholelithiasis Inform patients that kidney stones and/or gallstones have been reported with atazanavir capsules use. Some patients with kidney stones and/or gallstones required hospitalization for additional management, and some had complications. Discontinuation of atazanavir capsules may be necessary as part of the medical management of these adverse events [see Warnings and Precautions ( 5.6 )] .

Drug Interactions Atazanavir capsules may lead to significant interaction with some drugs; therefore, advise patients to report the use of any other prescription, nonprescription medication, or herbal products, particularly St. John’s wort, to their healthcare provider prior to use [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 )]. Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV-1, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV-1 treatment is started [see Warnings and Precautions ( 5.10 )].

Fat Redistribution Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy including protease inhibitors and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions ( 5.11 )]. Dosing Instructions Advise patients to take atazanavir capsules with food every day and take other concomitant antiretroviral therapy as prescribed. Atazanavir capsules must always be used in combination with other antiretroviral drugs.

Advise patients that they should not alter the dose or discontinue therapy without consulting with their healthcare provider. Tell patients if a dose of atazanavir capsules are missed, they should take the dose as soon as possible and then return to their normal schedule; however, if a dose is skipped the patient should not double the next dose. Pregnancy Inform pregnant patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in pregnant patients exposed to atazanavir capsules during pregnancy.

Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry [see Use in Specific Populations ( 8.1 )]. Lactation Instruct patients with HIV-1 HIV-1 transmission to infants withou… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of atazanavir were evaluated in adult participants who either were healthy, or with HIV, after administration of atazanavir 400 mg once daily and after administration of atazanavir 300 mg with ritonavir 100 mg once daily (see Table 17). Table 17: Steady-State Pharmacokinetics of Atazanavir in Healthy Participants or Participants with HIV-1 in the Fed State 400 mg once daily 300 mg with ritonavir 100 mg once daily H ealthy Participants Participants with HIV-1 Healthy Participants Participants with HIV-1 Parameter (n=14) (n=13) (n=28) (n=10) C max (ng/mL) Geometric mean 5199 (26) 2298 (71) 6129 (31) 4422 (58) (CV%) Mean (SD) 5358 (1371) 3152 (2231) 6450 (2031) 5233 (3033) T max (h) Median 2.5 2.0 2.7

3.0AUC (ng•h/mL) Geometric mean 28132 (28) 14874 (91) 57039 (37) 46073 (66) (CV%) Mean (SD) 29303 (8263) 22262 (20159) 61435 (22911) 53761 (35294) T-half (h) Mean (SD) 7.9 (2.9) 6.5 (2.6) 18.1 (6.2) a 8.6 (2.3) C min (ng/mL) Geometric mean 159 (88) 120 (109) 1227 (53) 636 (97) (CV%) Mean (SD) 218 (191) 273 (298) b 1441 (757) 862 (838) a n=26. b n=12. Figure 1 displays the mean plasma concentrations of atazanavir at steady state after atazanavir 400 mg once daily (as two 200 mg capsules) with a light meal and after atazanavir 300 mg (as two 150 mg capsules) with ritonavir 100 mg once daily with a light meal in adult participants with HIV-1.

Figure 1: Mean (SD) Steady-State Plasma Concentrations of Atazanavir 400 mg (n=13) and 300 mg with Ritonavir (n=10) for Adult Participants with HIV-1 Absorption Atazanavir is rapidly absorbed with a T max of approximately 2.5 hours. Atazanavir demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in AUC and C max values over the dose range of 200 to 800 mg once daily. Steady state is achieved between Days 4 and 8, with an accumulation of approximately 2.3 fold.

Food Effect Administration of atazanavir with food enhances bioavailability and reduces pharmacokinetic variability. Administration of a single 400 mg dose of atazanavir with a light meal (357 kcal, 8.2 g fat, 10.6 g protein) resulted in a 70% increase in AUC and 57% increase in C max relative to the fasting state. Administration of a single 400 mg dose of atazanavir with a high-fat meal (721 kcal, 37.3 g fat, 29.4 g protein) resulted in a mean increase in AUC of 35% with no change in C max relative to the fasting state.

Administration of atazanavir with either a light meal or high-fat meal decreased the coefficient of variation of AUC and C max by approximately one-half compared to the fasting state. Coadministration of a single 300 mg dose of atazanavir and a 100 mg dose of ritonavir with a light meal (336 kcal, 5.1 g fat, 9.3 g protein) resulted in a 33% increase in the AUC and a 40% increase in both the C max and the 24-hour concentration of atazanavir relative to the fasting state. Coadministration with a high-fat meal (951 kcal, 54.7 g fat, 35.9 g protein) did not affect the AUC of atazanavir relative to fasting conditions and the C max was within 11% of fasting values.

The 24-hour concentration following a high-fat meal was increased by approximately 33% due to delayed absorption; the median T max increased from 2.0 to 5.0 hours. Coadministration of atazanavir with ritonavir with either a light or a high-fat meal decreased the coefficient of variation of AUC and C max by approximately 25% compared to the fasting state. Distribution Atazanavir is 86% bound to human serum proteins and protein binding is independent of concentration.

Atazanavir binds to both alpha-1-acid glycoprotein (AAG) and albumin to a similar extent (89% and 86%, respectively). In a multiple-dose study in participants with HIV-1 dosed with atazanavir 400 mg once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen. The cerebrospinal fluid/plasma ratio for atazanavir (n=4) ranged between 0.0021 and 0.0226 and seminal fluid/plasma ratio (n=5) rang… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 196 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology Concentration- and dose-dependent prolongation of the PR interval in the electrocardiogram has been observed in healthy participants receiving atazanavir. In placebo-controlled Study AI424-076, the mean (±SD) maximum change in PR interval from the predose value was 24 (±15) msec following oral dosing with 400 mg of atazanavir (n=65) compared to 13 (±11) msec following dosing with placebo (n=67). The PR interval prolongations in this study were asymptomatic.

There is limited information on the potential for a pharmacodynamic interaction in humans between atazanavir and other drugs that prolong the PR interval of the electrocardiogram [see Warnings and Precautions ( 5.1 )]. Electrocardiographic effects of atazanavir were determined in a clinical pharmacology study of 72 healthy participants. Oral doses of 400 mg (maximum recommended dosage) and 800 mg (twice the maximum recommended dosage) were compared with placebo; there was no concentration- dependent effect of atazanavir on the QTc interval (using Fridericia’s correction).

In 1793 participants with HIV-1, receiving antiretroviral regimens, QTc prolongation was comparable in the atazanavir and comparator regimens. No atazanavir-treated healthy participant or participant with HIV-1 in clinical trials had a QTc interval >500 msec [see Warnings and Precautions ( 5.1 )].

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Participants without Prior Antiretroviral Therapy Study AI424-138: a 96-week study comparing the antiviral efficacy and safety of either atazanavir or lopinavir/ritonavir, each in combination with fixed-dose tenofovir DF-emtricitabine in treatment-naive participants with HIV-1. Study AI424-138 (NCT00272779) was a 96-week, open-label, randomized, multicenter study, comparing atazanavir (300 mg once daily) with ritonavir (100 mg once daily) to lopinavir/ritonavir (400/100 mg twice daily as fixed-dose product), each in combination with the fixed-dose product, tenofovir DF/emtricitabine (300/200 mg once daily), in 878 antiretroviral treatment-naive participants.

Participants had a mean age of 36 years (range: 19 to 72), 49% were Caucasian, 18% Black, 9% Asian, 23% Hispanic/Mestizo/mixed race, and 68% were male. The median baseline plasma CD4+ cell count was 204 cells/mm 3 (range: 2 to 810 cells/mm 3 ) and the mean baseline plasma HIV-1 RNA level was 4.94 log 10 copies/mL (range: 2.60 to 5.88 log 10 copies/mL). Treatment response and outcomes through Week 96 are presented in Table 26.

Table 26: Outcomes of Treatment Through Week 96 in Treatment-Naive Adults (Study AI424-138) Outcome Atazanavir 30 0 mg with ritonavir 100 mg (once daily) and tenofovir DF/emtricitabine (once daily)a (n=441) 9 6 Weeks lopinavir / ritonavir b 400 mg/100 mg (twice daily) with tenofovir DF/emtricitabine (once daily)a (n=437) 9 6 Weeks Responder c ,d,e 75% 68% Virologic failure f 17% 19% Rebound 8% 10% Never suppressed through Week 96 9% 9% Death 1% 1% Discontinued due to adverse event 3% 5% Discontinued for other reasons g 4% 7% a As a fixed-dose product: 300 mg tenofovir DF/200 mg emtricitabine once daily. b As a fixed-dose product: 400 mg lopinavir/100 mg ritonavir (twice daily). c Participants achieved HIV-1 RNA <50 copies/mL at Week 96.

Roche Amplicor®, v1.5 ultra-sensitive assay. d Pre-specified ITT analysis at Week 48 using as-randomized cohort: atazanavir with ritonavir 78% and lopinavir/ritonavir 76% (difference estimate: 1.7% [95% confidence interval: −3.8%, 7.1%]). e Pre-specified ITT analysis at Week 96 using as-randomized cohort: atazanavir with ritonavir 74% and lopinavir/ritonavir 68% (difference estimate: 6.1% [95% confidence interval: 0.3%, 12.0%]). f Includes viral rebound and failure to achieve confirmed HIV-1 RNA <50 copies/mL through Week 96. g Includes lost to follow-up, participant's withdrawal, noncompliance, protocol violation, and other reasons.

Through 96 weeks of therapy, the proportion of responders among participants with high viral loads (ie, baseline HIV-1 RNA > 100,000 copies/mL) was comparable for the atazanavir with ritonavir (165 of 223 participants, 74%) and lopinavir/ritonavir (148 of 222 participants, 67%) arms. At 96 weeks, the median increase from baseline in CD4+ cell count was 261 cells/mm3 for the atazanavir with ritonavir arm and 273 cells/mm 3 for the lopinavir/ritonavir arm. Study AI424-034: Atazanavir once daily compared to efavirenz once daily, each in combination with fixed-dose lamivudine/zidovudine twice daily.

Study AI424-034 (NCT00013897) was a randomized, double-blind, multicenter trial comparing atazanavir (400 mg once daily) to efavirenz (600 mg once daily), each in combination with the fixed-dose product of lamivudine/zidovudine (150 mg/300 mg) given twice daily, in 810 antiretroviral treatment-naive participants. Participants had a mean age of 34 years (range: 18 to 73), 36% were Hispanic, 33% were Caucasian, and 65% were male. The mean baseline CD4+ cell count was 321 cells/mm 3 (range: 64 to 1424 cells/mm 3 ) and the mean baseline plasma HIV-1 RNA level was 4.8 log 10 copies/mL (range: 2.2 to 5.9 log 10 copies/mL).

Treatment response and outcomes through Week 48 are presented in Table 27. Table 27: Outcomes of Randomized Treatment Through Week 48 in Treatment-Naive Adults (Study AI424-034) Outcome Atazanavir 400 mg once daily and lamivudine/zidovudine d (n=405) efav… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in mice and rats were carried out with atazanavir for two years. In the mouse study, drug-related increases in hepatocellular adenomas were found in females at 360 mg/kg/day. The systemic drug exposure (AUC) at the NOAEL (no observable adverse effect level) in females, (120 mg/kg/day) was 2.8 times and in males (80 mg/kg/day) was 2.9 times higher than those in humans at the clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir, non-pregnant patients).

In the rat study, no drug-related increases in tumor incidence were observed at doses up to 1200 mg/kg/day, for which AUCs were 1.1 (males) or 3.9 (females) times those measured in humans at the clinical dose. Mutagenesis Atazanavir tested positive in an in vitro clastogenicity test using primary human lymphocytes, in the absence and presence of metabolic activation. Atazanavir tested negative in the in vitro Ames reverse-mutation assay, in vivo micronucleus and DNA repair tests in rats, and in vivo DNA damage test in rat duodenum (comet assay).

Impairment of Fertility At the systemic drug exposure levels (AUC) 0.9 (in male rats) or 2.3 (in female rats) times that of the human clinical dose, (300 mg/day atazanavir boosted with 100 mg/day ritonavir) significant effects on mating, fertility, or early embryonic development were not observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 219 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies in mice and rats were carried out with atazanavir for two years. In the mouse study, drug-related increases in hepatocellular adenomas were found in females at 360 mg/kg/day. The systemic drug exposure (AUC) at the NOAEL (no observable adverse effect level) in females, (120 mg/kg/day) was 2.8 times and in males (80 mg/kg/day) was 2.9 times higher than those in humans at the clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir, non-pregnant patients).

In the rat study, no drug-related increases in tumor incidence were observed at doses up to 1200 mg/kg/day, for which AUCs were 1.1 (males) or 3.9 (females) times those measured in humans at the clinical dose. Mutagenesis Atazanavir tested positive in an in vitro clastogenicity test using primary human lymphocytes, in the absence and presence of metabolic activation. Atazanavir tested negative in the in vitro Ames reverse-mutation assay, in vivo micronucleus and DNA repair tests in rats, and in vivo DNA damage test in rat duodenum (comet assay).

Impairment of Fertility At the systemic drug exposure levels (AUC) 0.9 (in male rats) or 2.3 (in female rats) times that of the human clinical dose, (300 mg/day atazanavir boosted with 100 mg/day ritonavir) significant effects on mating, fertility, or early embryonic development were not observed.

📄 Recent Major Changes 5 words ▾

Contraindications ( 4 ) 12/2024

📄 Package Label / Principal Display Panel 25 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL atazanavir capsule 150 mg 60's count atazanavir capsule 200 mg 60's count atazanavir capsule 300 mg 30's count atazanavircapsule150mg60scount atazanavircapsule200mg60scount atazanavircapsule300mg30scount

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Atazanavir — the ingredient across all brands.

Top reported reactions

Drug Interaction1,792
Depression1,318
Foetal Exposure During Pregnancy1,048
Anxiety878
Pain755
Emotional Distress660
Anhedonia601

Age at onset

Neonate169
Infant40
Child10
Adolescent9
Adult1,653
Elderly68

Reporter sex

0 reports

Serious outcomes

Hospitalization4,221
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 881 30
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Camber Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 capsules (31722-0653-60), 1000 capsules (31722-0653-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Camber Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 31722-0647-30 · Camber 31722-0654-10 · Camber →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.