Reyataz Side Effects
Please note - some side effects for Reyataz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Reyataz - for the consumer
Reyataz
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Reyataz:
Seek medical attention right away if any of these SEVERE side effects occur when using Reyataz:Changes in body fat; cough; diarrhea; fatigue; headache; increased cough; nausea; pain; stomach pain; trouble sleeping; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; depression; dizziness; fever, chills, or sore throat; increased urination or thirst; irregular heartbeat; lightheadedness; numbness, tingling, or extreme weakness especially in the arms or legs; painful urination; red, blistered, or swollen skin; severe nausea or vomiting; severe stomach or side pain; trouble breathing; unusual bleeding or bruising; yellowing of skin or eyes.
For the professional
Reyataz
Adult Patients
Treatment-Emergent Adverse Events in Treatment-Naive PatientsSelected drug-related clinical adverse events of moderate or severe intensity reported in ≥2% of treatment-naive patients receiving combination therapy including Reyataz are presented in Table 12. For other information regarding observed or potentially serious adverse events, see WARNINGS and PRECAUTIONS.
| Phase III Study AI424-034 | Phase II Studies AI424-007, -008 | |||
|---|---|---|---|---|
| 64 weeksc Reyataz 400 mg once daily + lamivudine + zidovudinee |
64 weeksc efavirenz 600 mg once daily + lamivudine + zidovudinee |
120 weeksc,d Reyataz 400 mg once daily + stavudine + lamivudine or didanosine |
73 weeksc,dnelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or didanosine |
|
| (n=404) | (n=401) | (n=279) | (n=191) | |
| * None reported in this treatment arm. | ||||
| a Includes events of possible, probable, certain, or unknown relationship to treatment regimen. | ||||
| b Based on regimens containing Reyataz. | ||||
| c Median time on therapy. | ||||
| d Includes long-term follow-up. | ||||
| e As a fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. | ||||
| 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% |
| Diarrhea | 1% | 2% | 3% | 16% |
| Abdominal pain | 4% | 4% | 4% | 2% |
| Nervous System | ||||
| Dizziness | 2% | 7% | <1% | * |
| Insomnia | 3% | 3% | <1% | * |
| Peripheral neurologic symptoms |
<1% | 1% | 4% | 3% |
| Skin and Appendages | ||||
| Rash | 7% | 10% | 5% | 1% |
Selected drug-related clinical adverse events of moderate-severe intensity in ≥2% of treatment-experienced patients receiving Reyataz/ritonavir are presented in Table 13. For other information regarding observed or potentially serious adverse events, see WARNINGS and PRECAUTIONS.
| 48 weeksc Reyataz/ritonavir 300/100 mg once daily + tenofovir + NRTI |
48 weeksc lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI |
|
|---|---|---|
| (n=119) | (n=118) | |
| * 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. | ||
| 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% | * |
Postmarketing Experience
The following events have been identified during postapproval 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
Gastrointestinal System: pancreatitis
Hepatic System: hepatic function abnormalities
Metabolic System and Nutrition Disorders: hyperglycemia, diabetes mellitus
Musculoskeletal System: arthralgia
Renal System: nephrolithiasis
Skin and Appendages: pruritus, alopecia, maculopapular rash
Laboratory Abnormalities
Treatment-Naive PatientsThe percentages of adult treatment-naive patients treated with combination therapy including Reyataz (atazanavir sulfate) with Grade 3-4 laboratory abnormalities are presented in Table 14.
| Phase III Study AI424-034 | Phase II Studies AI424-007, -008 | ||||
|---|---|---|---|---|---|
| 64 weeksb | 64 weeksb | 120 weeksb,c | 73 weeksb,c | ||
| Reyataz 400 mg once daily + lamivudine + zidovudinee |
efavirenz 600 mg once daily + lamivudine + zidovudinee |
Reyataz 400 mg once daily + stavudine + lamivudine or + stavudine + didanosine |
nelfinavir 750 mg TID or 1250 mg BID + stavudine + lamivudine or + stavudine + didanosine |
||
| Variable | Limitd | (n=404) | (n=401) | (n=279) | (n=191) |
| * 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. | |||||
| 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% |
Lipids, Change from Baseline
For Study AI424-034, changes from baseline in fasting LDL-cholesterol, HDL-cholesterol, total cholesterol, and fasting triglycerides are shown in Table 15.
| Reyataza,b | efavirenzb,c | |||||
|---|---|---|---|---|---|---|
| Baseline | Week 48 | Baseline | Week 48 | |||
| mg/dL | mg/dL | Changed | mg/dL | mg/dL | Changed | |
| (n=383e) | (n=283e) | (n=272e) | (n=378e) | (n=264e) | (n=253e) | |
| 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. Use of serum lipid-reducing agents was more common in the efavirenz treatment arm (3%) than in the Reyataz arm (1%). | ||||||
| c Efavirenz 600 mg once daily with the fixed-dose combination: 150 mg lamivudine, 300 mg zidovudine twice daily. | ||||||
| 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. | ||||||
| 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% |
The percentages of adult treatment-experienced patients treated with combination therapy including Reyataz/ritonavir with Grade 3-4 laboratory abnormalities are presented in Table 16.
| 48 weeksb | 48 weeksb | ||
|---|---|---|---|
| Reyataz/ritonavir 300/100 mg once daily + tenofovir + NRTI |
lopinavir/ritonavir 400/100 mg twice dailyd + tenofovir + NRTI |
||
| Variable | Limitc | (n=119) | (n=118) |
| a Based on regimen(s) containing Reyataz. | |||
| b Median time on therapy. | |||
| c ULN = upper limit of normal. | |||
| d As a fixed-dose combination. | |||
| 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 | <750 cells/mm3 | 7% | 8% |
Lipids, Change from Baseline
For Study AI424-045, changes from baseline in fasting LDL-cholesterol, HDL-cholesterol, total cholesterol, and fasting triglycerides are shown in Table 17. 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.
| Reyataz/ritonavira,b | lopinavir/ritonavirb,c | |||||
|---|---|---|---|---|---|---|
| Baseline | Week 48 | Baseline | Week 48 | |||
| mg/dL | mg/dL | Changed | mg/dL | mg/dL | Changed | |
| (n=111e) | (n=75e) | (n=74e) | (n=108e) | (n=76e) | (n=73e) | |
| a Reyataz 300 mg once daily + ritonavir + tenofovir + 1 NRTI. | ||||||
| b Values obtained after initiation of serum lipid-reducing agents were not included in these analyses. Use of serum lipid-reducing agents was more common in the lopinavir/ritonavir treatment arm (19%) than in the Reyataz/ritonavir arm (8%). | ||||||
| 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. | ||||||
| LDL-Cholesterolf | 108 | 98 | -10% | 104 | 103 | +1% |
| HDL-Cholesterol | 40 | 39 | -7% | 39 | 41 | +2% |
| Total Cholesterol | 188 | 170 | -8% | 181 | 187 | +6% |
| Triglyceridesf | 215 | 161 | -4% | 196 | 224 | +30% |
Liver function tests should be monitored in patients with a history of hepatitis B or C. 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 nelfinavir-treated patients. Within atazanavir and control regimens, no difference in frequency of bilirubin elevations was noted between seropositive and seronegative 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.
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Reyataz - Includes detailed dosage instructions.
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