Lexiva Side Effects
Please note - some side effects for Lexiva 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 Lexiva - for the consumer
Lexiva
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 Lexiva:
Seek medical attention right away if any of these SEVERE side effects occur when using Lexiva:Changes in body fat distribution; diarrhea; headache; nausea; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; signs of infection (eg, fever, chills, sore throat); swollen, reddened, or blistered skin; unusual increase in thirst or urination; weight loss; yellowing of skin or eyes.
Lexiva Suspension
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 Lexiva Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Lexiva Suspension:Changes in body fat distribution; diarrhea; headache; nausea; tiredness; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; signs of infection (eg, fever, chills, sore throat); swollen, reddened, or blistered skin; unusual increase in thirst or urination; weight loss; yellowing of skin or eyes.
For the professional
Lexiva
Lexiva was studied in 700 patients in Phase III controlled clinical studies. The most common treatment-emergent adverse events in clinical studies of Lexiva were diarrhea, nausea, vomiting, headache, and rash and were generally mild to moderate in severity. Treatment discontinuation due to adverse events occurred in 6.4% of patients receiving Lexiva and in 5.9% of patients receiving comparator treatments.
Severe or life-threatening skin reactions, including 1 case of Stevens-Johnson syndrome among 700 patients treated with Lexiva, were reported in <1% of patients treated with Lexiva in the clinical studies. Treatment with Lexiva should be discontinued for severe or life-threatening rashes and for moderate rashes accompanied by systemic symptoms.
Skin rash (without regard to causality) occurred in approximately 19% of patients treated with Lexiva in the pivotal efficacy studies. Rashes were usually maculopapular and of mild or moderate intensity, some with pruritus. Rash had a median onset of 11 days after initiation of Lexiva and had a median duration of 13 days. Skin rash led to discontinuation of Lexiva in <1% of patients. In some patients with mild or moderate rash, dosing with Lexiva was often continued without interruption; if interrupted, reintroduction of Lexiva generally did not result in rash recurrence.
Selected adverse events reported during the clinical efficacy studies of Lexiva are shown in Tables 14 and 15. Each table presents drug-related adverse events of moderate or severe intensity and adverse events of all grades regardless of causality in patients treated with combination therapy for up to 48 weeks.
APV30001* |
APV30002* |
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Lexiva 1,400 mg b.i.d. (n = 166) |
Nelfinavir 1,250 mg b.i.d. (n = 83) |
Lexiva 1,400 mg q.d./Ritonavir 200 mg q.d. (n = 322) |
Nelfinavir 1,250 mg b.i.d. (n = 327) |
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Adverse Event |
Moderate/ Severe Drug-Related |
All Grades† |
Moderate/ Severe Drug-Related |
All Grades† |
Moderate/ Severe Drug-Related |
All Grades† |
Moderate/ Severe Drug-Related |
All Grades† |
Gastrointestinal |
||||||||
Diarrhea |
5% |
34% |
18% |
63% |
10% |
52% |
18% |
72% |
Nausea |
7% |
39% |
4% |
24% |
7% |
37% |
5% |
27% |
Vomiting |
2% |
16% |
4% |
17% |
6% |
20% |
4% |
13% |
Abdominal pain |
1% |
5% |
0% |
8% |
2% |
11% |
2% |
11% |
Skin |
||||||||
Pruritus |
0% |
7% |
0% |
11% |
<1% |
7% |
1% |
9% |
Rash |
8% |
35% |
2% |
19% |
3% |
17% |
2% |
21% |
General disorders |
||||||||
Fatigue |
2% |
10% |
1% |
7% |
4% |
18% |
2% |
13% |
Nervous system |
||||||||
Depressive/ mood disorders |
1% |
8% |
0% |
8% |
<1% |
8% |
0% |
6% |
Headache |
2% |
19% |
4% |
20% |
3% |
21% |
3% |
27% |
Paresthesia, oral |
0% |
2% |
0% |
0% |
<1% |
10% |
0% |
<1% |
*All patients also received abacavir and lamivudine twice daily.
†Includes adverse events of all grades regardless of causality reported in >5% of patients.
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Lexiva 700 mg b.i.d./ Ritonavir 100 mg b.i.d.* (n = 106) |
Lopinavir 400 mg b.i.d./ Ritonavir 100 mg b.i.d.* (n = 103) |
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Adverse Event |
Moderate/Severe Drug-Related |
All Grades† |
Moderate/Severe Drug-Related |
All Grades† |
Gastrointestinal |
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Diarrhea |
13% |
38% |
11% |
47% |
Nausea |
3% |
20% |
9% |
31% |
Vomiting |
3% |
10% |
5% |
17% |
Abdominal pain |
<1% |
11% |
2% |
9% |
Skin |
||||
Pruritus |
<1% |
8% |
0% |
3% |
Rash |
3% |
9% |
0% |
22% |
General disorders |
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Fatigue |
<1% |
9% |
<1% |
14% |
Nervous system |
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Depressive/mood disorders |
<1% |
11% |
<1% |
10% |
Headache |
4% |
27% |
2% |
20% |
Paresthesia, oral |
0% |
<1% |
0% |
0% |
*All patients also received 2 reverse transcriptase inhibitors.
†Includes adverse events of all grades regardless of causality in >5% of patients.
The percentages of patients with Grade 3 or 4 laboratory abnormalities in the clinical efficacy studies of Lexiva are presented in Tables 16 and 17.
APV30001* |
APV30002* |
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Laboratory Abnormality |
Lexiva 1,400 mg b.i.d. (n = 166) |
Nelfinavir 1,250 mg b.i.d. (n = 83) |
Lexiva 1,400 mg q.d./ Ritonavir 200 mg q.d. (n = 322) |
Nelfinavir 1,250 mg b.i.d. (n = 327) |
ALT (>5 x ULN) |
6% |
5% |
8% |
8% |
AST (>5 x ULN) |
6% |
6% |
6% |
7% |
Serum lipase (>2 x ULN) |
8% |
4% |
6% |
4% |
Hypertriglyceridemia† (>750 mg/dL) |
0% |
1% |
6% |
2% |
Neutropenia (<750 cells/mm3) |
3% |
6% |
3% |
4% |
*All patients also received abacavir and lamivudine twice daily.
†Fasting specimens.
ULN = Upper limit of normal.
The incidence of Grade 3 or 4 hyperglycemia in antiretroviral-naive patients who received Lexiva in the pivotal studies was <1%.
Laboratory Abnormality |
Lexiva 700 mg b.i.d./ Ritonavir 100 mg b.i.d.* (n = 104) |
Lopinavir 400 mg b.i.d./ Ritonavir 100 mg b.i.d.* (n = 103) |
Hypertriglyceridemia† (>750 mg/dL) |
11%‡ |
6%‡ |
Serum lipase (>2 x ULN) |
5% |
12% |
ALT (>5 x ULN) |
4% |
4% |
AST (>5 x ULN) |
4% |
2% |
Hyperglycemia (>251 mg/dL) |
2%‡ |
2%‡ |
*All patients also received 2 reverse transcriptase inhibitors.
†Fasting specimens.
‡n = 100 for Lexiva/ritonavir, n = 98 for lopinavir/ritonavir.
ULN = Upper limit of normal.
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LEXIVA - Includes detailed dosage instructions.
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