Lexiva (Fosamprenavir) - Side Effects and Adverse Reactions

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ADVERSE REACTIONS

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 interrup tion; if interrup ted, 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.

**Table 14. Selected Clinical Adverse Events Reported in Antiretroviral-Naive Patients**
	APV30001 *				APV30002 *
	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)
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.

**Table 15. Selected Clinical Adverse Events Reported in Protease Inhibitor-Experienced Patients (Study APV30003)**
Adverse Event	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)
Adverse Event	Moderate/Severe Drug-Related	All Grades ^*/	Moderate/Severe Drug-Related	All Grades ^*/
Gastrointestinal
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
Fatigue	<1%	9%	<1%	14%
Nervous system
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.

**Table 16. Grade 3/4 Laboratory Abnormalities Reported in >/=2% of Antiretroviral-Naive Adult Patients in Studies APV30001 and APV30002**
Laboratory Abnormality	APV30001 *		APV30002 *
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 × ULN)	6%	5%	8%	8%
AST (>5 × ULN)	6%	6%	6%	7%
Serum lipase (>2 × 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 = up per limit of normal.

The incidence of Grade 3 or 4 hyperglycemia in antiretroviral-naive patients who received LEXIVA in the pivotal studies was <1%.

**Table 17. Grade 3/4 Laboratory Abnormalities Reported in >/=2% of Protease Inhibitor-Experienced Adult Patients in Study APV30003**
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 × ULN)	5%	12%
ALT (>5 × ULN)	4%	4%
AST (>5 × 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 = up per limit of normal.

REPORTS OF SUSPECTED LEXIVA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Lexiva. The information is not vetted and should not be considered as verified clinical evidence.

Possible Lexiva side effects / adverse reactions in 30 year old male

Reported by a pharmacist from Japan on 2011-11-07

Patient: 30 year old male

Reactions: Hepatic Function Abnormal

Suspect drug(s):
Lexiva
    Dosage: 4iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-07-01
    End date: 2011-10-26

Truvada
    Dosage: 500mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-07-01
    End date: 2011-10-26

Possible Lexiva side effects / adverse reactions in male

Reported by a physician from Japan on 2011-12-05

Patient: male

Reactions: Abdominal Discomfort

Suspect drug(s):
Truvada
    Dosage: 1iuax per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-09-02

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Lexiva
    Dosage: 1400mg per day
    Administration route: Oral
    Start date: 2010-09-13
    End date: 2010-10-14

Prezista
    Dosage: 800mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-09-03
    End date: 2010-09-12

Possible Lexiva side effects / adverse reactions in 34 year old male

Reported by a physician from Japan on 2011-12-09

Patient: 34 year old male

Reactions: Gastrointestinal Disorder, Herpes Zoster

Adverse event resulted in: hospitalization

Suspect drug(s):
Lexiva
    Administration route: Oral
    Start date: 2010-09-13
    End date: 2010-10-14

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-10-14

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-09-03
    End date: 2010-09-12

Lexiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-05
    End date: 2010-09-02

Other drugs received by patient: Primperan TAB; Motilium; Loperamide HCL; Loxonin; Valtrex

See index of all Lexiva side effect reports >>

Drug label data at the top of this Page last updated: 2006-06-18

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ADVERSE REACTIONS

REPORTS OF SUSPECTED LEXIVA SIDE EFFECTS / ADVERSE REACTIONS

Possible Lexiva side effects / adverse reactions in 30 year old male

Possible Lexiva side effects / adverse reactions in male

Possible Lexiva side effects / adverse reactions in 34 year old male