Adult Dosing
Treatment of HIV infection
Treatment-naive patients
- 1400 mg PO bid without ritonavir
- 1400 mg PO daily with ritonavir 100 or 200 mg PO daily
- 700 mg PO bid with ritonavir 100 mg PO bid
Treatment-naive patients in combination with efavirenz
- 1400 mg PO daily with ritonavir 300 mg PO daily
- Note: Ritonavir dose increase not necessary when fosamprenavir/ritonavir is bid
Protease Inhibitor-Experienced Patients:
- 700 mg PO bid with ritonavir 100 mg PO bid
Pediatric Dosing
Treatment of HIV infection in patient >2 yrs old
Treatment-naive patients
- (2-5 yrs): Oral suspension: 30 mg/kg PO bid (not to exceed 1400 mg/dose)
- (
6 yrs): Oral suspension: 30 mg/kg PO bid (not to exceed 1400 mg/dose) OR combination of Oral suspension 18 mg/kg PO bid plus ritonavir 3 mg/kg PO bid (not to exceed 700 mg/dose for fosamprenavir and 100 mg/dose for ritonavir)
Treatment-experienced patients
- (6 yrs): Oral suspension: 18 mg/kg plus ritonavir 3 mg/kg PO bid (not to exceed 700 mg and ritonavir 100 mg PO bid )
Note: Calculate dose based on body weight (kg) and dosage should not exceed the recommended adult dose
[Outline]
See Supplemental Patient Information
- Use of alfuzosin, flecainide, propafenone, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, st. john’s wort (hypericum perforatum), lovastatin, simvastatin, pimozide, delavirdine, sildenafil, midazolam and triazolam are contraindicated with fosamprenavir due to potential life-threatening adverse events, significant drug interactions, or loss of virologic activity
- Discontinue treatment on occurrence of moderate rashes accompanied by systemic symptoms, severe or life-threatening rashes and for Stevens-Johnson syndrome
- Avoid use of fosamprenavir with ritonavir at unapproved dosages as elevations in transaminase have occurred. Patients with underlying hepatitis B or C or marked elevations in transaminases prior to therapy are highly susceptible for developing or worsening of transaminase elevations. Perform appropriate laboratory tests prior to initiating therapy and monitor patients closely during treatment
- New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, diabetic ketoacidosis and hyperglycemia may occur in HIV-infected patients receiving protease inhibitor. Persistent hyperglycemia have occurred even on discontinuation of therapy
- Immune reconstitution syndrome has occurred in patients treated with combination antiretroviral therapy. Further evaluation and treatment is necessary in patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections
- Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance, have occurred in patients receiving antiretroviral therapy
- Lipid elevations have occurred in patients receiving fosamprenavir. Perform triglyceride and cholesterol test prior to initiating therapy and at periodic intervals during therapy. Manage lipid disorders as clinically appropriate
- Acute hemolytic anemia has occurred in patients treated with amprenavir. Patients with hemophilia A and B treated with protease inhibitors are prone to spontaneous bleeding
- Nephrolithiasis have occurred during postmarketing surveillance in HIV-infected patients receiving therapy with this drug. On occurrence of signs or symptoms of nephrolithiasis temporarily consider interruption or discontinuation of therapy
- Potential for resistance/cross-resistance exists
Cautions: Use cautiously in
- Hepatic impairment
- Hypersensitivity to sulfonamides
- Hemophilia
- Diabetes mellitus
Supplemental Patient Information
- Advise patients to avoid use of fosamprenavir with triazolam, dihydroergotamine, ergonovine, ergotamine, and methylergonovine, ergotrate maleate, cisapride, midazolam, pimozide, sildenafil, alfuzosin
- Advise patients to inform health care provider if they are taking any concomitant medication
- Advise patients to inform health care provider if they are pregnant or planning to become pregnant
Pregnancy Category:C
Breastfeeding: HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral reduces the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Antiretroviral prophylaxis in breastfed infants with antiretroviral drugs has been successfully used as part of a regimen that decreases mother-to-child transmission about half, but the optimal regimen and duration of prophylaxis has not yet been defined. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 21 January 2011). Centers for disease control and prevention recommends mothers avoiding breast-feeding their infants as risk for postnatal transmission of HIV-1 infection exists. Manufacturer advises to instruct infected mothers to avoid breast-feeding during therapy because of both the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants.
Pricing data from www.DrugStore.com in U.S.A.
- Lexiva 700 MG TABS [Bottle] (VIIV HEALTHCARE)
30 mg = $439.98
90 mg = $1240.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Lexiva 700 MG Oral Tablet
Ingredient(s): Fosamprenavir
Imprint: GX;LL7
Color(s): Pink
Shape: Capsule
Size (mm): 21.00
Score: 1
Inactive Ingredient(s): colloidal silicon dioxide / croscarmellose sodium / magnesium stearate / cellulose, microcrystalline / povidone k30 / hypromellose / titanium dioxide / triacetin / ferric oxide red
Drug Label Author:
GlaxoSmithKline LLC
DEA Schedule:
Non-Scheduled
Drug Name: Lexiva 700 MG Oral Tablet
Ingredient(s): Fosamprenavir
Imprint: GX;LL7
Color(s): Pink
Shape: Capsule
Size (mm): 21.00
Score: 1
Inactive Ingredient(s): colloidal silicon dioxide / croscarmellose sodium / magnesium stearate / cellulose, microcrystalline / povidone k30 / hypromellose / titanium dioxide / triacetin / ferric oxide red
Drug Label Author:
State of Florida DOH Central Pharmacy
DEA Schedule:
Non-Scheduled
