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Evotaz: Uses, Dosage & Safety Information

Evotaz

Evotaz

Evotaz

Atazanavir sulfate + Cobicistat
Evotaz is atazanavir with cobicistat in one tablet: the protease inhibitor and its booster, fixed together. That removes a second prescription and adds a constraint, because the booster cannot be adjusted, swapped or dropped, and its interaction profile becomes the tablet's own.
  • ActiveIngredient: Atazanavir sulfate + Cobicistat
  • DosageForm: Tablet
  • Dosage: 300 mg atazanavir with 150 mg cobicistat
  • Indications: Treatment of HIV-1 infection in combination with other antiretroviral agents, in adults and children weighing at least 35 kg
  • Manufacturer: Bristol Myers Squibb
  • Storage: Room temperature, in the original container
  • Drug Status: Prescription Only
What this tablet is
A protease inhibitor and its booster fused into one tablet — convenient, and inseparable.
Cobicistat has no antiviral activity of its own. It is a CYP3A inhibitor included to raise atazanavir levels, and several drug combinations are contraindicated because of it.1

Evotaz is a prescription HIV-1 tablet fusing the protease inhibitor atazanavir with the booster cobicistat, which has no antiviral activity of its own. It is taken with other antiretrovirals, not as a complete regimen, and is licensed for adults and children weighing at least 35 kilograms.

Atazanavir has always needed a booster. On its own it does not reach useful concentrations, so for two decades it has been prescribed alongside ritonavir as a separate tablet — the arrangement described on our Reyataz page. Evotaz replaces that separate booster with cobicistat and puts both in one tablet.

The trade is worth stating plainly. One tablet instead of two is a real gain in a lifelong regimen. What it costs is flexibility: the booster cannot be dose-adjusted, cannot be switched for ritonavir when an interaction demands it, and cannot be stopped while the protease inhibitor continues. Whatever cobicistat does to another medicine, this tablet does.

The eligibility threshold moves with the format. Atazanavir alone is licensed from three months and 5 kg because an oral powder can deliver an infant dose; a fixed tablet of 300 mg and 150 mg begins at 35 kg.

The bilirubin effect belongs to the molecule and is unchanged here: most patients develop asymptomatic increases in indirect bilirubin, reversible on discontinuation.

Approved on 29 January 2015 under Bristol Myers Squibb.2

One tablet once daily with food.1 Atazanavir absorption depends on an acidic stomach, and food supports it.

Before starting and during treatment: renal laboratory testing in all patients, and hepatic testing in anyone with underlying liver disease.

Every new medicine is checked before it is started, including anything bought without a prescription. Cobicistat is a CYP3A inhibitor and some combinations are contraindicated because raised levels of the other drug can be life-threatening; others lose their effect entirely.

Acid-reducing medicines matter as much here as with atazanavir alone. Proton pump inhibitors, H2 blockers and antacids raise gastric pH and can reduce absorption enough to risk treatment failure; timing rules and dose limits come from the prescriber.

The tablet is not split, and the booster is not supplemented or replaced. If cobicistat has to change, the whole product changes.

The effects divide cleanly by component, and knowing which one is responsible determines what happens next.

Reported Side Effects by Source
SourceEffectWhat it means
AtazanavirYellowing of eyes or skin from raised indirect bilirubinExpected and usually harmless; the dose is not reduced for it
AtazanavirNephrolithiasis and cholelithiasisConsider temporary interruption or discontinuation
CobicistatRaised serum creatinine, lowered estimated clearanceWithout change in true glomerular filtration; a laboratory effect, not injury
Both, in hepatitis coinfectionRaised transaminases, hepatic decompensationHepatic monitoring; investigate rather than attribute to bilirubin
ClassNew onset or worsening diabetes, hyperglycaemia, immune reconstitution syndromeProtease inhibitor and regimen-level effects

Source: 1

Rows one and three are the reason this page separates them: one makes a patient look jaundiced without liver disease, the other makes their kidney numbers look worse without kidney disease. Neither is a reason to stop, and both are reasons to have been told in advance.

Emergency – stop and seek care
  • A rash that spreads, blisters or peels, or sores in the mouth, eyes or genitals
  • Yellowing with dark urine, pale stools, abdominal pain or feeling generally unwell — a different picture from the expected bilirubin rise
  • Severe pain in the side or back, or under the right ribs, which can signal a kidney or gallbladder stone
  • Any severe reaction shortly after starting a new medicine, given the interaction profile of the booster

Evotaz is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, in adults and in children weighing at least 35 kg.1

It is not a complete regimen. Unlike a single-tablet product such as Genvoya, this tablet supplies the protease inhibitor and its booster and expects a nucleoside backbone to be prescribed alongside it.

Where it fits is a question of what else the person takes. A boosted protease inhibitor is a strong option, but cobicistat carries a substantial interaction load, and a regimen built on it must be checked against every other medicine in use. Where an interaction rules out cobicistat, the separate combination of atazanavir with ritonavir remains available and can be adjusted independently.

The molecule and everything that follows from it — the bilirubin effect, the need for stomach acid, the paediatric range down to three months — are on our Reyataz page. This page is about what changes when the booster is built in.

Interactions Alcohol:

Use with caution
Alcohol is not a listed interaction. It matters indirectly in hepatitis B or C coinfection, where transaminase rises and hepatic decompensation are already a concern.

Interactions Other Medications:

Consult your doctor
This is the defining caution for this tablet. Cobicistat inhibits CYP3A, several combinations are contraindicated, and some drugs lose their effect entirely. Acid-reducing medicines separately threaten absorption. Nothing new is started without a check.

Special Groups Pregnancy:

Consult your doctor
Antiretroviral treatment continues in pregnancy under specialist care. Booster-containing regimens are specifically reviewed, because exposure can change through pregnancy.

Special Groups Breastfeeding:

Consult your doctor
Infant feeding decisions in HIV depend on viral suppression and local guidance and belong to the HIV team.

Special Groups Elderly:

Use with caution
The number of concurrent medicines matters most, given the booster. Renal testing is required in all patients, and a creatinine rise needs interpreting rather than acting on.

Special Groups Children:

Consult your doctor
Licensed from 35 kilograms. Below that weight the components are prescribed separately, since a fixed tablet cannot deliver a smaller dose.

Effects on Activities Driving:

Use with caution
No direct effect on alertness is described. Depression appears among the most reported terms for this molecule and is worth raising with the treating team.

Effects on Activities Operating Machinery:

Use with caution
The same reasoning applies to machinery.

Evotaz is prescription-only, approved on 29 January 2015 under NDA 206353 and held by Bristol Myers Squibb.2

Because both components appear in other products, duplication is a real hazard: another atazanavir product, or another cobicistat-boosted regimen, means the same molecules twice. The ingredient list rather than the brand name is what prevents it.

Two things travel with this prescription regardless of who dispenses it: the interaction check against the contraindicated table, and pretreatment renal testing. Both are in Critical warnings for Evotaz use.

Interactions that can be fatal, and interactions that silently fail

Coadministration is contraindicated with a list of drugs in the label, either because raised levels can cause serious or life-threatening events, or because the combination causes loss of therapeutic effect.1 Both directions matter: a booster can make another medicine dangerous, and it can also make it useless.

The booster cannot be separated

Where an interaction would normally be handled by switching from cobicistat to ritonavir or by adjusting the booster, this tablet offers no such option. The response is to change the product rather than to modify it.

Kidney and gallbladder stones

Nephrolithiasis and cholelithiasis have been reported, and temporary interruption or discontinuation is considered when they occur. Renal laboratory testing is performed before treatment and continued during it.1

Progressive renal disease

Discontinuation is considered in patients with progressive renal disease.1 Interpreting renal numbers on this tablet requires knowing that cobicistat itself raises creatinine without harming filtration.

Hepatotoxicity in hepatitis coinfection

Patients with hepatitis B or C are at risk of increased transaminases or hepatic decompensation, and hepatic laboratory monitoring is part of their care.1

Jaundice that is not liver failure

Most patients develop asymptomatic increases in indirect bilirubin, reversible on discontinuation. If transaminases rise at the same time, alternative causes are evaluated.1

Immune reconstitution and metabolic effects

Immune reconstitution syndrome may occur, as may new onset or worsening of diabetes and hyperglycaemia.1

What Is in the Tablet
Component or ruleDetailConsequence
Atazanavir300 mgThe active antiretroviral; a protease inhibitor
Cobicistat150 mgNo antiviral activity; raises atazanavir levels by inhibiting CYP3A
DosingOne tablet once daily with foodAbsorption depends on gastric acidity
Eligible weightAt least 35 kgA fixed tablet cannot deliver a paediatric dose; below this weight the components are used separately
Before and during treatmentRenal testing in all patients; hepatic testing in liver diseaseNephrolithiasis and transaminase rises are labelled effects
Course lengthContinuous, with no end date in the labelHIV-1 treatment is lifelong; the tablet is taken daily for as long as it works and is tolerated

Source: 1

The fourth and fifth rows are the ones that decide whether this tablet is usable at all for a given person, and neither is about the antiviral component.

Clinical detailstechnical detail

Cobicistat also inhibits the tubular secretion of creatinine, which raises serum creatinine and lowers estimated clearance without changing the actual glomerular filtration rate. A creatinine rise after starting a cobicistat-containing product needs interpreting against a baseline rather than acting on directly — the same caution as on our Genvoya page.

Approved 29 January 2015 under NDA 206353, Bristol Myers Squibb.2

This is the defining section of the page. A booster exists to inhibit an enzyme, and everything that enzyme handles is affected.1

Significant Interactions
Interacting substanceEffect and riskSeverityDocumentation
Drugs in the label’s contraindicated tableSerious or life-threatening events from raised exposure, or loss of therapeutic effectContraindicatedExcellent
Strong CYP3A inducersReduced atazanavir exposure, with risk of virologic failure and resistanceContraindicatedExcellent
Proton pump inhibitors, H2 blockers, antacidsRaised gastric pH reduces atazanavir absorption; efficacy can be lostMajorExcellent
Other atazanavir- or cobicistat-containing productsDuplicate therapy with the same molecules under another nameContraindicatedExcellent
RitonavirA second booster is not added to a tablet that already contains oneMajorGood

Source:

This table is the only place on this page where interacting substances are listed. Because the contraindicated list is long and revised, it is read from the current prescribing information rather than reproduced here in a form that could go stale.

Nothing against HIV. It is a CYP3A inhibitor included only to raise atazanavir concentrations, because atazanavir does not reach useful levels on its own. Everything it does to other medicines is the price of that boost.
Reyataz is atazanavir alone, with a booster prescribed separately, usually ritonavir. Evotaz fixes atazanavir and cobicistat in one tablet. The convenience is one tablet instead of two; the cost is that the booster cannot be adjusted, swapped or stopped independently, and the eligible weight rises from 5 kg to 35 kg.
Not without checking. Atazanavir needs an acidic stomach to be absorbed, and proton pump inhibitors, H2 blockers and antacids can reduce its levels enough to risk treatment failure. Timing rules and dose limits apply and come from the prescriber.
Possibly not. Cobicistat blocks the tubular secretion of creatinine, which raises serum creatinine and lowers estimated clearance without changing actual filtration. Interpreting it needs a baseline taken before treatment and the trend over time rather than a single reading.
No. It supplies the protease inhibitor and its booster, and a nucleoside backbone is prescribed alongside. That is different from single-tablet complete regimens, which are taken alone.

Evidence scope

What we know
  • The tablet is a fixed pairing of an antiretroviral with a booster that has no antiviral activity of its own.
  • Contraindications are stated as a table of drugs, covering both dangerous exposure increases and loss of therapeutic effect.
  • Pretreatment renal testing is required in all patients, with hepatic testing added in underlying liver disease.
What remains uncertain
  • How cobicistat compares with ritonavir on long-term outcomes for this protease inhibitor is not addressed by this label, which describes the fixed pairing rather than comparing boosters.
  • Postmarketing reports are indexed on atazanavir, so nothing in them distinguishes the boosted tablet from the molecule prescribed with a separate booster.
  • How often a creatinine rise on a cobicistat product is misread as kidney injury is not measured, although the pharmacology makes the error predictable.

What has been reported to the FDA

As of the FAERS data cut of 30 July 2026, the FDA Adverse Event Reporting System held 2,956 reports naming atazanavir, 2,809 of them coded serious. Reports for this fixed combination are pooled with those for the molecule.3

Most Reported Terms, FAERS
Coded termReports
Drug interaction946
Depression787
Maternal exposure during pregnancy419
Foetal exposure during pregnancy326
Loss of personal independence in daily activities226
Spontaneous abortion192
Premature baby132
Anxiety126
How to read this table

FAERS records what was reported, not what the medicine caused, and has no denominator – no count can become a rate.

Drug interaction leading the list is the single most relevant fact here, and it is exactly what a boosted regimen would be expected to generate. Four of the eight remaining terms concern pregnancy and come from structured registry reporting rather than from a cluster of harms. The database indexes atazanavir as a substance, so nothing here separates this fixed tablet from the molecule taken with a separate booster — which is the comparison a reader would most want and the one FAERS cannot supply.

Who was this medicine studied in?

Evotaz was approved on 29 January 2015, which places it just inside the window for FDA Drug Trials Snapshots.2 Where one exists it reports the demographic composition of the trial population and is worth reading alongside the label.

The evidence for a fixed-dose booster combination has a particular shape: efficacy is inherited from the boosted protease inhibitor as already established, and the new work is pharmacokinetic, showing that cobicistat delivers atazanavir exposure comparable to the older arrangement. That is why the label reads as a description of a pairing rather than as a fresh trial programme.1

Who this is and is not appropriate for

Typically considered for: an adult or child of at least 35 kg with HIV-1, taking a nucleoside backbone alongside it, whose full medication list has been checked against the contraindicated table and whose renal function has been tested.

Not appropriate for: anyone taking a drug in the contraindicated table or a strong CYP3A inducer; anyone weighing under 35 kg, where the components are used separately; and anyone already taking another atazanavir or cobicistat product.1

Needs a conversation first: anyone on acid-reducing medicines, including ones bought without a prescription; anyone with hepatitis B or C; and anyone whose regimen may need the booster changed, since that cannot be done inside this tablet.

Where to go next

  • Report a side effect: FDA MedWatch, or MHRA Yellow Card in the UK
  • Full prescribing information, including the contraindicated drug table: DailyMed
  • Pregnancy-specific enquiries: MotherToBaby, or Bumps in the UK
  • The molecule with a separately prescribed booster: our Reyataz page
  1. FDA Prescribing Information — EVOTAZ (atazanavir and cobicistat) tablets, Bristol Myers Squibb. Indications and Usage; Dosage and Administration including pretreatment testing; Contraindications; Warnings and Precautions, including nephrolithiasis and cholelithiasis, hepatotoxicity, hyperbilirubinaemia, immune reconstitution and hyperglycaemia.
    Label revised 2025-05 · Accessed 2026-08-30
    Used for: composition and strengths, weight threshold, administration with food, renal and hepatic pretreatment testing, contraindicated interactions in both directions, bilirubin effect
    DailyMed SPL 83db29d7-5d85-49d6-8cb6-740473365cf8
  2. Drugs@FDA via openFDA — NDA 206353, EVOTAZ, approved 2015-01-29, Bristol Myers Squibb, Prescription.
    Accessed 2026-08-30
    Used for: approval date, sponsor and the single application behind the product
    Drugs@FDA, products.brand_name EVOTAZ
  3. FDA Adverse Event Reporting System via openFDA, query on atazanavir sulfate.
    Data cut 2026-07-30 · Accessed 2026-08-30
    Used for: report counts and most frequently coded terms, and the limitation that reports for the fixed combination cannot be separated from those for the molecule
    openFDA FAERS

This page is medical information, not medical advice. It describes a boosted protease inhibitor with a substantial interaction profile and does not replace the judgement of the clinical team managing your treatment and your other medicines.