Evotaz

Last updated on RxList: 8/13/2020
Evotaz Side Effects Center

What Is Evotaz?

Evotaz (atazanavir and cobicistat) is a combination of an HIV-1 protease inhibitor and a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults.

What Are Side Effects of Evotaz?

Common side effects of Evotaz include:

  • yellowing of the skin or eyes (jaundice),
  • itching and rash,
  • hives,
  • nausea,
  • diarrhea,
  • vomiting,
  • abdominal pain,
  • fatigue,
  • muscle tissue breakdown (rhabdomyolysis),
  • headache,
  • depression,
  • abnormal or strange dreams,
  • insomnia, and
  • kidney disease.

Dosage for Evotaz

Evotaz is a fixed-dose combination product containing 300 mg of atazanavir and 150 mg of cobicistat.

What Drugs, Substances, or Supplements Interact with Evotaz?

Evotaz may interact with paclitaxel, repaglinide, proton-pump inhibitors, antacids, buffered medications, H2-receptor antagonists, and other medications. Tell your doctor all medications and supplements you use.

Evotaz During Pregnancy and Breastfeeding

During pregnancy, Evotaz should be used only when prescribed. However, HIV medicines are often given to pregnant women with HIV. Treatment decreases the risk of HIV transmission to the baby. This medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Evotaz (atazanavir and cobicistat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Evotaz Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe dizziness, irregular heartbeats;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • liver or gallbladder problems--upper stomach pain, nausea, vomiting, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • a severe skin reaction--fever, flu-like symptoms, mouth sores, muscle or joint pain, swelling in your face, burning eyes, skin pain, blistering, warmth or redness under your skin; or
  • signs of a kidney stone--pain in your side or lower back, painful or difficult urination, blood in your urine.

You may need to stop taking this medicine permanently if you have a severe skin reaction.

Atazanavir and cobicistat affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • rash;
  • jaundice; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Evotaz (Atazanavir and Cobicistat Tablets for Oral Administration)

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Evotaz Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • cardiac conduction abnormalities [see WARNINGS AND PRECAUTIONS]
  • rash [see WARNINGS AND PRECAUTIONS]
  • effects on serum creatinine [see WARNINGS AND PRECAUTIONS]
  • new onset or worsening renal impairment when used with tenofovir DF [see WARNINGS AND PRECAUTIONS]
  • chronic kidney disease [see WARNINGS AND PRECAUTIONS]
  • nephrolithiasis and cholelithiasis [see WARNINGS AND PRECAUTIONS]
  • hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • hyperbilirubinemia [see WARNINGS AND PRECAUTIONS]

For additional safety information about atazanavir and cobicistat, consult the full prescribing information for these individual products.

Clinical 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 From Clinical Trial Experience In Adult Subjects

The safety of atazanavir and cobicistat coadministered as single agents is based on Week 144 data from a Phase 3 trial, Study GS-US-216-0114, in which 692 antiretroviral treatment-naive subjects with HIV-1 infection received:

  • atazanavir coadministered with cobicistat and emtricitabine/tenofovir DF (N=344) or
  • atazanavir coadministered with ritonavir and emtricitabine/tenofovir DF (N=348).

The most common adverse reactions (Grades 2-4) and reported in ≥5% of subjects in the atazanavir coadministered with cobicistat group were jaundice (6%) and rash (5%). The proportion of subjects who discontinued study treatment due to adverse events regardless of severity, was 11% in both the atazanavir coadministered with cobicistat and atazanavir coadministered with ritonavir groups. Table 2 lists the frequency of adverse reactions (Grades 2-4) occurring in at least 2% of subjects in the atazanavir coadministered with cobicistat group in Study GS-US-216-0114.

Table 2: Selected Adverse Reactionsa (Grades 2-4) Reported in ≥2% of Treatment-Naive Adults with HIV-1 Infection in the Atazanavir Coadministered with Cobicistat Group in Study GS-US-216-0114 (Week 144 analysis)

Atazanavir coadministered with cobicistat and emtricitabine/ tenofovir DF
(n=344)
Atazanavir coadministered with ritonavir and emtricitabine/ tenofovir DF
(n=348)
Jaundice6%3%
Rashb5%4%
Ocular icterus4%2%
Nausea2%2%
Diarrhea2%1%
Headache2%1%
a Frequencies of adverse reactions are based on Grades 2-4 adverse events attributed to study drugs.
b Rash events include dermatitis allergic, drug hypersensitivity, pruritus generalized, eosinophilic pustular folliculitis, rash, rash generalized, rash macular, rash maculopapular, rash morbilliform, rash papular, and urticaria.

Less Common Adverse Reactions

Selected adverse reactions of at least moderate severity (≥ Grade 2) occurring in less than 2% of subjects receiving atazanavir coadministered with cobicistat and emtricitabine/tenofovir DF are listed below. These events have been included because of investigator’s assessment of potential causal relationship and were considered serious or have been reported in more than one subject treated with atazanavir coadministered with cobicistat, and reported with greater frequency compared with the atazanavir coadministered with ritonavir group.

Gastrointestinal Disorders: vomiting, upper abdominal pain

General Disorders and Administration Site Conditions: fatigue

Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis

Psychiatric Disorders: depression, abnormal dreams, insomnia

Renal and Urinary Disorders: nephropathy, Fanconi syndrome acquired, nephrolithiasis

Laboratory Abnormalities

The frequency of laboratory abnormalities (Grades 3-4) occurring in at least 2% of subjects in the atazanavir coadministered with cobicistat group in Study GS-US-216-0114 is presented in Table 3.

Table 3: Laboratory Abnormalities (Grades 3-4) Reported in ≥2% of HIV-1-Infected Treatment-Naive Adults in the Atazanavir Coadministered with Cobicistat Group in Study GS-US-216-0114 (Week 144 analysis)

Laboratory Parameter Abnormality144 weeks Atazanavir coadministered with cobicistat and emtricitabine/ tenofovir DF
(n=344)
144 weeks Atazanavir coadministered with ritonavir and emtricitabine/ tenofovir DF
(n=348)
Total Bilirubin (>2.5 × ULN)73%66%
Creatine Kinase (≥10.0 × ULN)8%9%
Urine RBC (Hematuria) (>75 RBC/HPF)6%3%
ALT (>5.0 × ULN)6%3%
AST (>5.0 × ULN)4%3%
GGT (>5.0 × ULN)4%2%
Serum Amylasea (>2.0 × ULN)4%2%
Urine Glucose (Glycosuria ≥1000 mg/dL)3%3%
Neutrophils (<750/mm3)3%2%
Serum Glucose (Hyperglycemia) (≥250 mg/dL)2%2%
a For subjects with serum amylase >1.5 × upper limit of normal, lipase test was also performed. The frequency of increased lipase (Grades 3-4) occurring in the atazanavir coadministered with cobicistat group (N=46) and atazanavir coadministered with ritonavir group (N=35) was 7% and 3%, respectively.

Increase in Serum Creatinine

Cobicistat, a component of EVOTAZ, has been shown to increase serum creatinine and decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. In Study GS-US-216-0114, increases in serum creatinine and decreases in estimated creatinine clearance occurred early in treatment in the atazanavir coadministered with cobicistat group, after which they stabilized. The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was −15.1 ± 16.5 mL/min in the atazanavir coadministered with cobicistat group and −8.0 ± 16.8 mL/min in the atazanavir coadministered with ritonavir group.

Serum Lipids

Changes from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides are presented in Table 4. In both groups, mean values for serum lipids remained within the normal range for each laboratory test. The clinical significance of these changes is unknown.

Table 4: Lipid Values, Mean Change from Baseline, Reported in Treatment-Naive Adults with HIV-1 Infection Receiving Atazanavir Coadministered with Cobicistat and Emtricitabine/Tenofovir DF or Atazanavir Coadministered with Ritonavir and Emtricitabine/Tenofovir DF in Study GS-US-216-0114 (Week 144 analysis)

Atazanavir coadministered with cobicistat and emtricitabine/ tenofovir DFAtazanavir coadministered with ritonavir and emtricitabine/ tenofovir DF
Baseline mg/dLWeek 144 change from baselineaBaseline mg/dLWeek 144 change from baselinea
Total Cholesterol (fasted)163 [N=219]+11 [N=219]165 [N=227]+13 [N=227]
HDL-cholesterol (fasted)43 [N=218]+7 [N=218]43 [N=228]+6 [N=228]
LDL-cholesterol (fasted)102 [N=218]+11 [N=218]104 [N=228]+16 [N=228]
Triglycerides (fasted)130 [N=219]+14 [N=219]131 [N=227]+14 [N=227]
a The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 144 values and excludes subjects receiving an HMG-CoA reductase inhibitor drug.

Adverse Reactions From Clinical Trial Experience In Pediatric Subjects

Although no clinical trial with EVOTAZ as the fixed-dose tablet was conducted in a pediatric population, the safety of atazanavir coadministered with cobicistat plus two nucleoside reverse transcriptase inhibitors was evaluated in treatment-experienced virologically suppressed subjects with HIV-1 infection between the ages of 12 to less than 18 years (N=14) through Week 48 in an open-label clinical trial (Study GS-US-216-0128) [see Clinical Studies]. Results from this study showed that the safety profile of atazanavir and cobicistat coadministered with a background regimen was similar to that in adults.

Postmarketing Experience

See the full prescribing information for atazanavir for postmarketing information on atazanavir.

Read the entire FDA prescribing information for Evotaz (Atazanavir and Cobicistat Tablets for Oral Administration)

© Evotaz Patient Information is supplied by Cerner Multum, Inc. and Evotaz Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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