Reyataz
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Reyataz
Reyataz Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Reyataz (atazanavir sulfate) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is an antiviral medication in a group of HIV medicines called protease inhibitors. Common side effects include headache, nausea, vomiting, diarrhea, stomach pain, fatigue, fever, or trouble sleeping.
The recommended oral dosage of Reyataz depends on the treatment history of the patient and the use of other co-administered drugs. Reyataz should not be taken together with ritonavir if you are also using the steroid medicine fluticasone. Reyataz may interact with digoxin, antibiotics, antifungals, antidepressants, blood thinners, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, heart rhythm medications, insulin or oral diabetes medication, medicines to treat erectile dysfunction, other HIV /AIDS medicines, or stomach acid reducers. Many other medicines can interact with Reyataz. Tell your doctor all prescription and over-the-counter medications and supplements you use. Reyataz should be used only when prescribed during pregnancy. It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Our Reyataz (atazanavir sulfate) 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Reyataz in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking atazanavir and call your doctor at once if you have a serious side effect such as:
- severe dizziness, fast or pounding heartbeats, feeling like you might pass out;
- severe pain in your side or lower back, painful urination, blood in your urine;
- easy bruising or bleeding, signs of a new infection such as fever or chills, cough, or flu symptoms;
- jaundice (yellowing of the skin or eyes);
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- nausea, vomiting, diarrhea, stomach pain;
- headache, dizziness, depressed mood, sleep problems (insomnia);
- mild skin rash;
- numbness, burning pain, or tingly feeling in your hands or feet;
- muscle pain; 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 Reyataz (Atazanavir Sulfate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Reyataz Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Tell your doctor right away if you have any serious side effects, including: yellowing eyes/skin, increased thirst/urination, dizziness, lightheadedness, signs of a kidney stone (such as pain in side/back/abdomen, painful urination, blood in the urine).
Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.
Get medical help right away if you have any very serious side effects, including: signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).
Atazanavir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Reyataz (Atazanavir Sulfate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Reyataz FDA Prescribing Information: Side Effects
(Adverse Reactions)
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]
- hyperbilirubinemia [see WARNINGS AND PRECAUTIONS]
- nephrolithiasis [see WARNINGS AND PRECAUTIONS]
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.
Clinical Trial Experience in Adults
Treatment-Emergent Adverse Reactions in Treatment-Naive Patients
The safety profile of REYATAZ in treatment-naive adults is based on 1625 HIV-1 infected patients in clinical trials. 536 patients received REYATAZ 300 mg with ritonavir 100 mg and 1089 patients received REYATAZ 400 mg or higher (without ritonavir).
The most common adverse reactions are nausea, jaundice/scleral icterus, and rash.
Selected clinical adverse reactions of moderate or severe intensity reported in ≥ 2% of treatment-naive patients receiving combination therapy including REYATAZ 300 mg with ritonavir 100 mg and REYATAZ 400 mg (without ritonavir) are presented in Tables 4 and 5, respectively.
Table 4: Selected Treatment-Emergent Adverse Reactionsa
of Moderate or Severe Intensity Reported in ≥ 2% of Adult
Treatment-Naive Patients,b Study AI424-138
| 96 weeksc REYATAZ 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined (n=441) |
96 weeksc lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined (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 REYATAZ. c Median time on therapy. d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. |
||
Table 5: Selected
Treatment-Emergent Adverse Reactionsa of Moderate or Severe
Intensity Reported in ≥ 2% of Adult Treatment-Naive Patients,b Studies
AI424-034, AI424-007, and AI424-008
| Study AI424-034 | Studies AI424-007, -008 | |||
| 64 weeksc REYATAZ 400 mg once daily + lamivudine + zidovudinee (n=404) |
64 weeksc efavirenz 600 mg once daily + lamivudine + zidovudinee (n=401) |
120 weeksc REYATAZ 400 mg once daily + stavudine + lamivudine or didanosine (n=279) |
73 weeksc,d nelfinavir 750 mg TID or 1250 mg BID + stavudine + 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. bBased on regimens containing REYATAZ. c Median time on therapy. dIncludes long-term follow-up. e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. |
||||
Treatment-Emergent Adverse Reactions in Treatment-Experienced Patients
The safety profile of REYATAZ in treatment-experienced adults is based on 119 HIV-1 infected patients in clinical trials.
The most common adverse reactions are jaundice/scleral icterus and myalgia.
Selected clinical adverse reactions of moderate or severe intensity reported in ≥ 2% of treatment-experienced patients receiving REYATAZ/ritonavir are presented in Table 6.
Table 6: Selected Treatment-Emergent Adverse Reactionsa
of Moderate or Severe Intensity Reported in ≥ 2% of Adult
Treatment-Experienced Patients,b Study AI424-045
| 48 weeksc REYATAZ/ritonavir 300/100 mg once daily + tenofovir + NRTI (n=119) |
48 weeksc lopinavir/ritonavir 400/100 mg twice daily + tenofovir + NRTI (n=118) |
|
| Body as a Whole | ||
| Fever | 2% | * |
| Digestive System | ||
| Jaundice/scleral icterus | 9% | * |
| Diarrhea | 3% | 11% |
| Nausea | 3% | 2% |
| Nervous System | ||
| Depression | 2% | < 1% |
| Musculoskeletal System | ||
| Myalgia | 4% | * |
| * None reported in this treatment
arm. a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. bBased on the regimen containing REYATAZ. c Median time on therapy. d As a fixed-dose combination. |
||
Laboratory Abnormalities in Treatment-Naive Patients
The percentages of adult treatment-naive patients treated with combination therapy including REYATAZ (atazanavir sulfate) 300 mg with ritonavir 100 mg and REYATAZ 400 mg (without ritonavir) with Grade 3-4 laboratory abnormalities are presented in Tables 7 and 8, respectively.
Table 7: Grade 3-4 Laboratory Abnormalities Reported in ≥ 2%
of Adult Treatment-Naive Patients,a Study AI424-138
| Variable | Limitc | 96 weeksb REYATAZ 300 mg with ritonavir 100 mg (once daily) and tenofovir with emtricitabined (n=441) |
96 weeksb lopinavir 400 mg with ritonavir 100 mg (twice daily) and tenofovir with emtricitabined (n=437) |
| Chemistry | High | ||
| SGOT/AST | ≥ 5.1 x ULN | 3% | 1% |
| SGPT/ALT | ≥ 5.1 x ULN | 3% | 2% |
| Total Bilirubin | ≥ 2.6 x ULN | 44% | < 1% |
| Lipase | ≥ 2.1 x ULN | 2% | 2% |
| Creatine Kinase | ≥ 5.1 x ULN | 8% | 7% |
| Total Cholesterol | ≥ 240 mg/dL | 11% | 25% |
| Hematology | Low | ||
| Neutrophils | < 750 cells/mm³ | 5% | 2% |
| a Based on the regimen containing REYATAZ. b Median time on therapy. c ULN = upper limit of normal. d As a fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. |
|||
Table 8: Grade 3-4 Laboratory
Abnormalities Reported in ≥ 2% of Adult Treatment-Naive Patients,a Studies
AI424-034, AI424-007, and AI424-008
| Variable | Limitd | Study AI424-034 | Studies AI424-007, -008 | ||
| 64 weeksb REYATAZ 400 mg once daily + lamivudine+ zidovudinee (n=404) |
64 weeksb efavirenz 600 mg once daily + lamivudine + zidovudinee (n=401) |
120 weeksb,c REYATAZ 400 mg once daily + stavudine + lamivudine or + stavudine + didanosine (n=279) |
73 weeksb,c nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or + stavudine + didanosine (n=191) |
||
| Chemistry | High | ||||
| SGOT/AST | ≥ 5.1 x ULN | 2% | 2% | 7% | 5% |
| SGPT/ALT | ≥ 5.1 x ULN | 4% | 3% | 9% | 7% |
| Total Bilirubin | ≥ 2.6 x ULN | 35% | < 1% | 47% | 3% |
| Amylase | ≥ 2.1 x ULN | * | * | 14% | 10% |
| Lipase | ≥ 2.1 x ULN | <1% | 1% | 4% | 5% |
| Creatine Kinase | ≥ 5.1 x ULN | 6% | 6% | 11% | 9% |
| Total Cholesterol | ≥ 240 mg/dL | 6% | 24% | 19% | 48% |
| Triglycerides | ≥ 751 mg/dL | < 1% | 3% | 4% | 2% |
| Hematology | Low | ||||
| Hemoglobin | < 8.0 g/dL | 5% | 3% | < 1% | 4% |
| Neutrophils | < 750 cells/mm³ | 7% | 9% | 3% | 7% |
| * None reported in this treatment
arm. a Based on regimen(s) containing REYATAZ. b Median time on therapy. c Includes long-term follow-up. d ULN = upper limit of normal. e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. |
|||||
Laboratory Abnormalities in Treatment-Experienced Patients
The percentages of adult treatment-experienced patients treated with combination therapy including REYATAZ/ritonavir with Grade 3-4 laboratory abnormalities are presented in Table 9.
Table 9: Grade 3-4 Laboratory
Abnormalities Reported in ≥ 2% of Adult Treatment-Experienced Patients, Study AI424-045a
| Variable | Limitc | 48 weeksb REYATAZ/ritonavir 300/100 mg once daily + tenofovir + NRTI (n=119) |
48 weeksb lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI (n=118) |
| Chemistry | High | ||
| SGOT/AST | ≥ 5.1 x ULN | 3% | 3% |
| SGPT/ALT | ≥ 5.1 x ULN | 4% | 3% |
| Total Bilirubin | ≥ 2.6 x ULN | 49% | < 1% |
| Lipase | ≥ 2.1 x ULN | 5% | 6% |
| Creatine Kinase | ≥ 5.1 x ULN | 8% | 8% |
| Total Cholesterol | ≥ 240 mg/dL | 25% | 26% |
| Triglycerides | ≥ 751 mg/dL | 8% | 12% |
| Glucose | ≥ 251 mg/dL | 5% | < 1% |
| Hematology | Low | ||
| Platelets | < 50,000 cells/mm³ | 2% | 3% |
| Neutrophils | 3 < 750 cells/mm³ | 7% | 8% |
| a Based on regimen(s) containing REYATAZ. b Median time on therapy. c ULN = upper limit of normal. d As a fixed-dose combination. |
|||
Lipids, Change from Baseline in Treatment-Naive Patients
For Study AI424-138 and Study AI424-034, changes from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides are shown in Tables 10 and 11, respectively.
Table 10: Lipid Values, Mean Change from Baseline, Study
AI424-138
| REYATAZ/ritonav a,b | lopinavir/ritonavirb,c | |||||||||
| Baseline mg/dL (n=428e) |
Week 48 | Week 96 | Baseline mg/dL (n=424e) |
Week 48 | Week 96 | |||||
| mg/dL (n=372e) |
Changed (n=372e) |
mg/dL (n=342e) |
Changed (n=342e) |
mg/dL (n=335e) |
Changed (n=335e) |
mg/dL (n=291e) |
Changed (n=291e) |
|||
| LDL-Cholesterolf | 92 | 105 | +14% | 105 | +14% | 93 | 111 | +19% | 110 | +17% |
| HDL-Cholesterolf | 37 | 46 | +29% | 44 | +21% | 36 | 48 | +37% | 46 | +29% |
| Total Cholesterolf | 149 | 169 | +13% | 169 | +13% | 150 | 187 | +25% | 186 | +25% |
| Triglyceridesf | 126 | 145 | +15% | 140 | +13% | 129 | 194 | +52% | 184 | +50% |
| a REYATAZ 300 mg with ritonavir 100 mg once daily with the
fixed-dose combination: 300 mg tenofovir, 200 mg emtricitabine once daily. bValues obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 1% in the lopinavir/ritonavir treatment arm and 1% in the REYATAZ/ritonavir arm. Through Week 48, serum lipid-reducing agents were used in 8% in the lopinavir/ritonavir treatment arm and 2% in the REYATAZ/ritonavir arm. Through Week 96, serum lipid-reducing agents were used in 10% in the lopinavir/ritonavir treatment arm and 3% in the REYATAZ/ritonavir arm. c Lopinavir 400 mg with ritonavir 100 mg twice daily with the fixed-dose combination 300 mg tenofovir, 200 mg emtricitabine once daily. d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 or Week 96 values and is not a simple difference of the baseline and Week 48 or Week 96 mean values, respectively. e Number of patients with LDL-cholesterol measured. f Fasting. |
||||||||||
Table 11: Lipid Values, Mean
Change from Baseline, Study AI424-034
| REYATAZa,b | etavirenzb,c | |||||
| Baseline mg/dL (n=383e) |
Week 48 mg/dL (n=283e) |
Week 48 Changed (n=272e) |
Baseline mg/dL (n=378e) |
Week 48 mg/dL (n=264e) |
Week 48 Changed (n=253e) |
|
| LDL-Cholesterolf | 98 | 98 | +1% | 98 | 114 | +18% |
| HDL-Cholesterol | 39 | 43 | +13% | 38 | 46 | +24% |
| Total Cholesterol | 164 | 168 | +2% | 162 | 195 | +21% |
| Triglyceridesf | 138 | 124 | -9% | 129 | 168 | +23% |
| a REYATAZ 400 mg once daily with the fixed-dose combination:
150 mg lamivudine, 300 mg zidovudine twice daily. b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 0% in the efavirenz treatment arm and < 1% in the REYATAZ arm. Through Week 48, serum lipid-reducing agents were used in 3% in the efavirenz treatment arm and 1% in the REYATAZ arm. c Efavirenz 600 mg once daily with the fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. dThe change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 values and is not a simple difference of the baseline and Week 48 mean values. e Number of patients with LDL-cholesterol measured. fFasting. |
||||||
Lipids, Change from Baseline in Treatment-Experienced Patients
For Study AI424-045, changes from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and triglycerides are shown in Table 12. The observed magnitude of dyslipidemia was less with REYATAZ/ritonavir than with lopinavir/ritonavir. However, the clinical impact of such findings has not been demonstrated.
Table 12: Lipid Values, Mean Change from Baseline, Study
AI424-045
| REYATAZ/ritonavira,b | lopinavir/ritonavirb,c | |||||
| Baseline mg/dL (n=111e) |
Week 48 mg/dL (n=75e) |
Week 48 Changed (n=74e) |
Baseline mg/dL (n=108e) |
Week 48 mg/dL (n=76e) |
Week 48 Changed (n=73e) |
|
| LDL-Cholesterolf | 108 | 98 | -10% | 104 | 103 | +1% |
| HDL-Cholesterol | 40 | 39 | % % 7 - | 39 | 41 | +2% |
| Total Cholesterol | 188 | 170 | - 00 0s | 181 | 187 | +6% |
| Triglyceridesf | 215 | 161 | % % 4 - | 196 | 224 | +30% |
| a REYATAZ 300 mg once daily + ritonavir + tenofovir + 1 NRTI. bValues obtained after initiation of serum lipid-reducing agents were not included in these analyses. At baseline, serum lipid-reducing agents were used in 4% in the lopinavir/ritonavir treatment arm and 4% in the REYATAZ/ritonavir arm. Through Week 48, serum lipid-reducing agents were used in 19% in the lopinavir/ritonavir treatment arm and 8% in the REYATAZ/ritonavir arm. c Lopinavir/ritonavir (400/100 mg) BID + tenofovir + 1 NRTI. d The change from baseline is the mean of within-patient changes from baseline for patients with both baseline and Week 48 values and is not a simple difference of the baseline and Week 48 mean values. e Number of patients with LDL-cholesterol measured. f Fasting. |
||||||
Clinical Trial Experience in Pediatric Patients
The safety and tolerability of REYATAZ Capsules with and without ritonavir have been established in pediatric patients at least 6 years of age from the open-label, multicenter clinical trial PACTG 1020A. Use of REYATAZ in pediatric patients less than 6 years of age is under investigation.
The safety profile of REYATAZ in pediatric patients (6 to less than 18 years of age) was generally similar to that observed in clinical studies of REYATAZ in adults. The most common Grade 2-4 adverse events ( ≥ 5%, regardless of causality) reported in pediatric patients were cough (21%), fever (18%), jaundice/scleral icterus (15%), rash (14%), vomiting (12%), diarrhea (9%), headache (8%), peripheral edema (7%), extremity pain (6%), nasal congestion (6%), oropharyngeal pain (6%), wheezing (6%), and rhinorrhea (6%). Asymptomatic second-degree atrioventricular block was reported in < 2% of patients. The most common Grade 3-4 laboratory abnormalities occurring in pediatric patients were elevation of total bilirubin ( ≥ 3.2 mg/dL, 58%), neutropenia (9%), and hypoglycemia (4%). All other Grade 3-4 laboratory abnormalities occurred with a frequency of less than 3%.
Patients Co-infected With Hepatitis B and/or Hepatitis C Virus
Liver function tests should be monitored in patients with a history of hepatitis B or C.
In study AI424-138, 60 patients treated with REYATAZ/ritonavir 300 mg/100 mg once daily, and 51 patients treated with lopinavir/ritonavir 400 mg/100 mg twice daily, each with fixed dose tenofovir-emtricitabine, were seropositive for hepatitis B and/or C at study entry. ALT levels > 5 times ULN developed in 10% (6/60) of the REYATAZ/ritonavir-treated patients and 8% (4/50) of the lopinavir/ritonavir-treated patients. AST levels > 5 times ULN developed in 10% (6/60) of the REYATAZ/ritonavir-treated patients and none (0/50) of the lopinavir/ritonavirtreated patients.
In study AI424-045, 20 patients treated with REYATAZ/ritonavir 300 mg/100 mg once daily, and 18 patients treated with lopinavir/ritonavir 400 mg/100 mg twice daily, were seropositive for hepatitis B and/or C at study entry. ALT levels > 5 times ULN developed in 25% (5/20) of the REYATAZ/ritonavir-treated patients and 6% (1/18) of the lopinavir/ritonavir-treated patients. AST levels > 5 times ULN developed in 10% (2/20) of the REYATAZ/ritonavir-treated patients and 6% (1/18) of the lopinavir/ritonavir-treated patients.
In studies AI424-008 and AI424-034, 74 patients treated with 400 mg of REYATAZ (atazanavir sulfate) once daily, 58 who received efavirenz, and 12 who received nelfinavir were seropositive for hepatitis B and/or C at study entry. ALT levels > 5 times the upper limit of normal (ULN) developed in 15% of the REYATAZ-treated patients, 14% of the efavirenz-treated patients, and 17% of the nelfinavir-treated patients. AST levels > 5 times ULN developed in 9% of the REYATAZ-treated patients, 5% of the efavirenz-treated patients, and 17% of the nelfinavirtreated patients. Within atazanavir and control regimens, no difference in frequency of bilirubin elevations was noted between seropositive and seronegative patients. [See WARNINGS AND PRECAUTIONS.]
Postmarketing Experience
The following events have been identified during postmarketing use of REYATAZ. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: edema
Cardiovascular System: second-degree AV block, third-degree AV block, left bundle branch block, QTc prolongation [see WARNINGS AND PRECAUTIONS]
Gastrointestinal System: pancreatitis
Hepatic System: hepatic function abnormalities
Hepatobiliary Disorders: cholelithiasis, cholecystitis, cholestasis
Metabolic System and Nutrition Disorders: diabetes mellitus, hyperglycemia [see WARNINGS AND PRECAUTIONS]
Musculoskeletal System: arthralgia
Renal System: nephrolithiasis [see WARNINGS AND PRECAUTIONS]
Skin and Appendages: alopecia, maculopapular rash [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], pruritus
Read the entire FDA prescribing information for Reyataz (Atazanavir Sulfate) »
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