August 28, 2015
Recommended Topic Related To:

Lexiva

"The US Food and Drug Administration (FDA) has approved atazanavir and cobicistat (Evotaz, Bristol-Myers Squibb) for treatment of adults with human immunodeficiency virus (HIV-1) infection.

Atazanavir/cobicistat is a fixed-dos"...

Lexiva




Lexiva Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lexiva (fosamprenavir calcium) is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS. It is a type of antiviral medication called a protease inhibitor. Common side effects include diarrhea, nausea, vomiting, headache, fatigue, and stomach/abdominal pain.

The dose of Lexiva for therapy-na´ve 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. 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 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.

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.

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.

Lexiva 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 fosamprenavir and call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • increased urination or extreme thirst;
  • sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • easy bruising or bleeding;
  • rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);
  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid);
  • muscle weakness, tired feeling, joint or muscle pain, feeling short of breath;
  • weakness or prickly feeling in your fingers or toes;
  • problems with walking, breathing, speech, swallowing, or eye movement;
  • severe lower back pain, loss of bladder or bowel control;
  • 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 of fosamprenavir may include:

  • mild nausea, vomiting, stomach 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).

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 Lexiva (Fosamprenavir Calcium)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lexiva Overview - Patient Information: Side Effects

SIDE EFFECTS: Diarrhea, nausea, vomiting, and headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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: increased thirst/urination, 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).

Fosamprenavir 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 Lexiva (Fosamprenavir Calcium)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lexiva FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 APV30001a APV30002a
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)
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 APV30001a APV30002a
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%
Triglyceridesb ( > 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)
Triglyceridesb ( > 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 less 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 less 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.

Cardiac Disorders

Myocardial infarction.

Metabolism and Nutrition Disorders

Hypercholesterolemia.

Nervous System Disorders

Oral paresthesia.

Skin and Subcutaneous Tissue Disorders

Angioedema.

Urogenital

Nephrolithiasis.

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

Lexiva - User Reviews

Lexiva User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lexiva sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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