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Lexiva Side Effects

Generic Name: fosamprenavir

Note: This document contains side effect information about fosamprenavir. Some of the dosage forms listed on this page may not apply to the brand name Lexiva.

In Summary

Common side effects of Lexiva include: skin rash. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fosamprenavir: oral suspension, oral tablet

Along with its needed effects, fosamprenavir (the active ingredient contained in Lexiva) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fosamprenavir:

More Common

Less Common

  • Abdominal or stomach pain
  • blurred vision
  • depression
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • mood or mental changes
  • nausea
  • sweating
  • troubled breathing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting

Rare

  • Back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • chills
  • cough
  • dark urine
  • diarrhea
  • difficulty with breathing
  • fever
  • general body swelling
  • itching
  • joint or muscle pain
  • loss of appetite
  • nosebleeds
  • pale skin
  • red skin lesions often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • yellowing of the eyes or skin

Incidence Not Known

  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of fosamprenavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Mild or moderate rash

Less Common

  • Burning or prickling sensation around the mouth
  • headache

Incidence Not Known

  • Breast enlargement
  • buffalo hump
  • increased fat deposits on the face, neck, and trunk
  • obesity

For Healthcare Professionals

Applies to fosamprenavir: oral suspension, oral tablet

General

Diarrhea, rash, nausea, vomiting, and headache were the most frequent moderate to severe side effects in clinical trials. Discontinuations due to side effects were 6.4% in patients using this drug compared to 5.9% in those using comparator therapies; the most common side effects leading to discontinuation of this drug (incidence up to 1%) included diarrhea, nausea, vomiting, increased AST, increased ALT, and rash.[Ref]

Dermatologic

Very common (10% or more): Skin rash (up to 19%)

Common (1% to 10%): Rash/cutaneous reactions (including erythematous or maculopapular cutaneous eruptions [with or without pruritus])

Rare (0.01% to 0.1%): Severe and/or life-threatening skin reactions (including Stevens-Johnson syndrome)

Frequency not reported: Erythema multiforme, pruritus

Postmarketing reports: Angioedema

Protease inhibitors:

-Frequency not reported: Lipohypertrophy[Ref]

Skin rash (regardless of causality) was reported in about 19% of patients. Rashes were generally maculopapular and of mild or moderate intensity, some with pruritus. Rash had a median onset and duration of 11 and 13 days, respectively, and led to discontinuation of this drug in less than 1% of patients.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 13%)

Common (1% to 10%): Nausea, vomiting, abdominal pain, increased serum lipase, loose stools, gastritis, abdominal distension, upper abdominal pain, flatulence

Uncommon (0.1% to 1%): Gastroesophageal reflux disease

Frequency not reported: Increased amylase

Postmarketing reports: Oral paresthesia[Ref]

Increased serum lipase (greater than 2 times the upper limit of normal [2 x ULN]) has been reported in up to 8% of patients.

Vomiting was reported more often in pediatric patients than adult patients.[Ref]

Other

Very common (10% or more): Increased fasting triglycerides (up to 11%)

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Pyrexia, increased cholesterol

Antiretroviral therapy:

-Frequency not reported: Increased weight, increased blood lipids[Ref]

Increased fasting triglycerides (greater than 750 mg/dL) have been reported in up to 11% of patients.[Ref]

Hepatic

Elevated ALT (greater than 5 x ULN) and AST (greater than 5 x ULN) have been reported in up to 8% and up to 6% of patients, respectively.[Ref]

Common (1% to 10%): Elevated ALT, elevated AST

Frequency not reported: Liver toxicity[Ref]

Hematologic

Common (1% to 10%): Decreased absolute neutrophil count, neutropenia

Amprenavir:

-Frequency not reported: Acute hemolytic anemia

Protease inhibitors:

-Frequency not reported: Spontaneous bleeding in patients with hemophilia A and B[Ref]

Decreased absolute neutrophil count (less than 750 cells/mm3) has been reported in 3% of patients.

Neutropenia was reported more often in pediatric patients than adult patients.[Ref]

Metabolic

Increased glucose (greater than 251 mg/dL) has been reported in 2% of patients.[Ref]

Common (1% to 10%): Increased glucose, hyperlipidemia, hypertriglyceridemia

Uncommon (0.1% to 1%): Anorexia

Frequency not reported: Hyperglycemia, increased body fat

Postmarketing reports: Hypercholesterolemia

Protease inhibitors:

-Frequency not reported: Hypertriglyceridemia, hypercholesterolemia, resistance to insulin

-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis

Antiretroviral therapy:

-Frequency not reported: Increased glucose[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness[Ref]

Hypersensitivity

Common (1% to 10%): Drug hypersensitivity[Ref]

Cardiovascular

Postmarketing reports: Myocardial infarction[Ref]

Renal

Postmarketing reports: Nephrolithiasis[Ref]

Musculoskeletal

Frequency not reported: Elevated creatine kinase, osteonecrosis

Protease inhibitors:

-Rare (0.01% to 0.1%): Rhabdomyolysis

-Frequency not reported: Increased creatine phosphokinase, myalgia, myositis[Ref]

Psychiatric

Frequency not reported: Depressive/mood disorders[Ref]

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)[Ref]

References

1. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV "Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf." ([2018, May 22):

2. "Drugs for HIV infection." Treat Guidel Med Lett 7 (2009): 11-22

3. Warnke D, Barreto J, Temesgen Z "Antiretroviral drugs." J Clin Pharmacol 47 (2007): 1570-9

4. Panel on Antiretroviral Guidelines for Adults and Adolescents "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf." ([2018, May 30]):

5. Borras-Blasco J, Navarro-Ruiz A, Borras C, Castera E "Adverse cutaneous reactions associated with the newest antiretroviral drugs in patients with human immunodeficiency virus infection." J Antimicrob Chemother 62 (2008): 879-88

6. Hester EK, Chandler HV, Sims KM "Fosamprenavir: drug development for adherence." Ann Pharmacother 40 (2006): 1301-10

7. Eron J Jr, Yeni P, Gathe J Jr, et al. "The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial." Lancet 368 (2006): 476-82

8. Shelton MJ, Wire MB, Lou Y, Adamkiewicz B, Min SS "Pharmacokinetic and safety evaluation of high-dose combinations of fosamprenavir and ritonavir." Antimicrob Agents Chemother 50 (2006): 928-34

9. "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline, Research Triangle Park, NC.

10. Ruane PJ, Luber AD, Wire MB, et al. "Plasma amprenavir pharmacokinetics and tolerability following administration of 1,400 milligrams fosamprenavir once daily in combination with either 100 OR 200 milligrams of ritonavir in healthy volunteers." Antimicrob Agents Chemother 51 (2006): 560-5

11. Gathe JC Jr, Ive P, Wood R, et al. "SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients." AIDS 18 (2004): 1529-1537

12. Piacenti FJ "An update and review of antiretroviral therapy." Pharmacotherapy 26 (2006): 1111-33

13. Wire MB, Baker KL, Jones LS, et al. "Ritonavir Increases Plasma Amprenavir (APV) Exposure to a Similar Extent when Coadministered with either Fosamprenavir or APV." Antimicrob Agents Chemother 50 (2006): 1578-80

14. Pavel S, Burty C, Alcaraz I, et al. "Severe liver toxicity in postexposure prophylaxis for HIV infection with a zidovudine, lamivudine and fosamprenavir/ritonavir regimen." AIDS 21 (2007): 268-269

15. Gathe JC Jr, Wood R, Sanne I, et al. "Long-Term (120-Week) antiviral efficacy and tolerability of fosamprenavir/ritonavir once daily in therapy-naive patients with HIV-1 infection: An uncontrolled, open-label, single-arm follow-on study." Clin Ther 28 (2006): 745-54

16. Arvieux C, Tribut O "Amprenavir or Fosamprenavir plus Ritonavir in HIV Infection: Pharmacology, Efficacy and Tolerability Profile." Drugs 65 (2005): 633-59

17. Soriano V, Puoti M, Sulkowski M, et al. "Care of patients coinfected with HIV and hepatitis C virus: 2007 updated recommendations from the HCV-HIV International Panel." AIDS 21 (2007): 1073-89

18. Bergersen BM "Cardiovascular Risk in Patients with HIV Infection : Impact of Antiretroviral Therapy." Drugs 66 (2006): 1971-87

19. Calza L, Manfredi R, Verucchi G "Myocardial infarction risk in HIV-infected patients: epidemiology, pathogenesis, and clinical management." AIDS 24 (2010): 789-802

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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