Lexiva Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP

What Is Lexiva?

Lexiva (fosamprenavir calcium) is a type of antiviral medication called a protease inhibitor used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Lexiva is not a cure for HIV or AIDS.

What Are Side Effects of Lexiva?

What are the possible side effects of Lexiva?

Lexiva may cause serious side effects including:
hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
fever,
sore throat,
burning eyes,
skin pain,
red or purple skin rash with blistering and peeling,
pale or yellowed skin,
dark colored urine,
confusion,
weakness,
increased urination,
extreme thirst,
dry mouth,
fruity breath odor,
sudden and severe pain in your lower back or side,
blood in your urine,
pain or burning when you urinate,
night sweats,
swollen glands,
cold sores,
cough,
wheezing,
diarrhea,
weight loss,
trouble speaking or swallowing,
problems with balance or eye movement,
prickly feeling,
swelling in your neck or throat (enlarged thyroid),
menstrual changes, and
impotence

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Lexiva include:

diarrhea
nausea
vomiting
headache
fatigue
stomach or abdominal pain
numbness or tingling (especially around your mouth)
headache
mood changes, or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist)

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Lexiva

The dose of Lexiva for therapy-naïve adults is 1,400 mg twice daily. For protease inhibitor-experienced adults the dose is 700 mg twice daily plus ritonavir 100 mg twice daily. Pediatric dose is calculated based on the child's body weight.

What Drugs, Substances, or Supplements Interact with Lexiva?

Lexiva may interact with itraconazole, ketoconazole, heart rhythm medicines, antidepressants, rifampin, steroids, St. John's wort, blood thinners, calcium channel blockers, cholesterol-lowering medicines, drugs that weaken the immune system, other HIV /AIDS medicines, insulin or oral diabetes medications, medicines to treat erectile dysfunction, seizure medications, or stomach acid reducers. Tell your doctor all medications and supplements you use.

Lexiva During Pregnancy or Breastfeeding

Lexiva should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Lexiva (fosamprenavir calcium) 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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A Timeline of the HIV/AIDS Pandemic See Slideshow

Lexiva Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop taking fosamprenavir and call your doctor at once if you have:

pale or yellowed skin, dark colored urine, fever, confusion or weakness;
increased urination or extreme thirst; or
high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
symptoms of kidney stones--sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate.

Fosamprenavir 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 of fosamprenavir may include:

fever or other signs of infection;
nausea, vomiting, diarrhea;
rash;
headache; 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.

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Lexiva Professional Information

SIDE EFFECTS

Severe or life-threatening skin reactions have been reported with the use of LEXIVA [see WARNINGS AND PRECAUTIONS].
The most common moderate to severe adverse reactions in clinical trials of LEXIVA were diarrhea, rash, nausea, vomiting, and headache.
Treatment discontinuation due to adverse events occurred in 6.4% of subjects receiving LEXIVA and in 5.9% of subjects receiving comparator treatments. The most common adverse reactions leading to discontinuation of LEXIVA (incidence less than or equal to 1% of subjects) included diarrhea, nausea, vomiting, AST increased, ALT increased, and rash.

Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adult Trials

The data for the 3 active-controlled clinical trials described below reflect exposure of 700 HIV-1–infected subjects to LEXIVA tablets, including 599 subjects exposed to LEXIVA for greater than 24 weeks, and 409 subjects exposed for greater than 48 weeks. The population age ranged from 17 to 72 years. Of these subjects, 26% were female, 51% white, 31% black, 16% American Hispanic, and 70% were antiretroviral-naive. Sixty-one percent received LEXIVA 1,400 mg once daily plus ritonavir 200 mg once daily; 24% received LEXIVA 1,400 mg twice daily; and 15% received LEXIVA 700 mg twice daily plus ritonavir 100 mg twice daily.

Selected adverse reactions reported during the clinical efficacy trials of LEXIVA are shown in Tables 3 and 4. Each table presents adverse reactions of moderate or severe intensity in subjects treated with combination therapy for up to 48 weeks.

Table 3: Selected Moderate/Severe Clinical Adverse Reactions Reported in Greater than or Equal to 2% of Antiretroviral-Naive Adult Subjects

Adverse Reaction	APV300001^a		APV30002^a
Adverse Reaction	LEXIVA 1,400 mg b.i.d. (n=661)	Nelfinavir 1,250 mg b.i.d. (n=83)	LEXIVA 1,400 mg q.d./ Ritonavir200 mg q.d. (n = 322)	Nelfinavir 1,250 mg b.i.d. (n=327)
Gastrointestinal
Diarrhea	5%	18%	10%	18%
Nausea	7%	4%	7%	5%
Vomiting	2%	4%	6%	4%
Abdominal pain	1%	0%	2%	2%
Skin
Rash	8%	2%	3%	2%
General disorders
Fatigue	2%	1%	4%	2%
Nervous system
Headache	2%	4%	3%	3%
^a All subjects also received abacavir and lamivudine twice daily.

Table 4: Selected Moderate/Severe Clinical Adverse Reactions Reported in Greater than or Equal to 2% of Protease Inhibitor-Experienced Adult Subjects (Trial APV30003)

Adverse Reaction	LEXIVA 700 mg b.i.d./ Ritonavir 100 mg b.i.d.^a (n = 106)	Lopinavir 400 mg b.i.d./ Ritonavir 100 mg b.i.d.^a (n = 103)
Gastrointestinal
Diarrhea	13%	11%
Nausea	3%	9%
Vomiting	3%	5%
Abdominal pain	<1%	2%
Skin
Rash	3%	0%
Nervous system
Headache	4%	2%
^a All subjects also received 2 reverse transcriptase inhibitors.

Skin rash (without regard to causality) occurred in approximately 19% of subjects treated with LEXIVA in the pivotal efficacy trials. 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 less than 1% of subjects. In some subjects 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.

The percentages of subjects with Grade 3 or 4 laboratory abnormalities in the clinical efficacy trials of LEXIVA are presented in Tables 5 and 6.

Table 5: Grade 3/4 Laboratory Abnormalities Reported in Greater than or Equal to 2% of Antiretroviral-Naive Adult Subjects in Trials APV30001 and APV30002

Laboratory Abnormality	APV30001^a		APV30002^a
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%
Triglycerides^b(>750 mg/dL)	0%	1%	6%	2%
Neutrophil count, absolute (<750 cells/mm³)	3%	6%	3%	4%
^a All subjects also received abacavir and lamivudine twice daily. ^b Fasting specimens. ULN = Upper limit of normal.

The incidence of Grade 3 or 4 hyperglycemia in antiretroviral-naive subjects who received LEXIVA in the pivotal trials was less than 1%.

Table 6: Grade 3/4 Laboratory Abnormalities Reported in Greater than or Equal to 2% of Protease Inhibitor-Experienced Adult Subjects in Trial APV30003

Laboratory Abnormality	LEXIVA 700 mg b.i.d./ Ritonavir 100 mg b.i.d.^a (n = 104)	Lopinavir 400 mg b.i.d./ Ritonavir 100 mg b.i.d.^a (n = 103)
Triglycerides^b (>750 mg/dL)	11%^c	6%^c
Serum lipase (>2 x ULN)	5%	12%
ALT (>5 x ULN)	4%	4%
AST (>5 x ULN)	4%	2%
Glucose (>251 mg/dL)	2%^c	2%^c
^a All subjects also received 2 reverse transcriptase inhibitors. ^b Fasting specimens. ^c n = 100 for LEXIVA plus ritonavir, n = 98 for lopinavir plus ritonavir. ULN = Upper limit of normal.

Pediatric Trials

LEXIVA with and without ritonavir was studied in 237 HIV-1–infected pediatric subjects aged at least 4 weeks to 18 years in 3 open-label trials; APV20002, APV20003, and APV29005 [see Clinical Studies]. Vomiting and neutropenia occurred more frequently in pediatric subjects compared with adults. Other adverse events occurred with similar frequency in pediatric subjects compared with adults.

The frequency of vomiting among pediatric subjects receiving LEXIVA twice daily with ritonavir was 20% in subjects aged at least 4 weeks to younger than 2 years and 36% in subjects aged 2 to 18 years compared with 10% in adults. The frequency of vomiting among pediatric subjects receiving LEXIVA twice daily without ritonavir was 60% in subjects aged 2 to 5 years compared with 16% in adults.

The median duration of drug-related vomiting episodes in APV29005 was 1 day (range: 1 to 3 days), in APV20003 was 16 days (range: 1 to 38 days), and in APV20002 was 9 days (range: 4 to 13 days). Vomiting was treatment limiting in 4 pediatric subjects across all 3 trials.

The incidence of Grade 3 or 4 neutropenia (neutrophils less than 750 cells per mm³) seen in pediatric subjects treated with LEXIVA with and without ritonavir was higher (15%) than the incidence seen in adult subjects (3%). Grade 3/4 neutropenia occurred in 10% (5 of 51) of subjects aged at least 4 weeks to younger than 2 years and 16% (28 of 170) of subjects aged 2 to 18 years.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LEXIVA. 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. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to LEXIVA.

Read the entire FDA prescribing information for Lexiva (Fosamprenavir Calcium)