Lexiva Generic Name & Formulations
Legal Class
Rx
General Description
Fosamprenavir (as calcium) 700mg; tabs; (prodrug of amprenavir).
Pharmacological Class
HIV-1 protease inhibitor.
See Also
How Supplied
Tabs—60; Susp—225mL
Manufacturer
Generic Availability
NO
Lexiva Indications
Indications
HIV-1 infection.
Lexiva Dosage and Administration
Adult
Oral susp: take without food; if emesis occurs within 30 minutes after dosing, re-dose. Therapy-naive: 1.4g twice daily; or fosamprenavir 1.4g + ritonavir 200mg once daily; or fosamprenavir 1.4g + ritonavir 100mg once daily; or fosamprenavir 700mg + ritonavir 100mg twice daily. Protease inhibitor-experienced: fosamprenavir 700mg + ritonavir 100mg twice daily. Hepatic impairment: see full labeling for dose adjustments.
Children
Protease inhibitor-naive (<4wks) or Protease inhibitor-experienced (<6mos): not recommended. Oral susp: take with food; if emesis occurs within 30 minutes after dosing, re-dose. Protease inhibitor-naive (≥4wks–18yrs) or Protease inhibitor-experienced (≥6mos): <11kg: fosamprenavir 45mg/kg + ritonavir 7mg/kg twice daily; 11–<15kg: fosamprenavir 30mg/kg + ritonavir 3mg/kg twice daily; 15–<20kg: fosamprenavir 23mg/kg + ritonavir 3mg/kg twice daily; ≥20kg: fosamprenavir 18mg/kg + ritonavir 3mg/kg twice daily. Alternatively, Protease inhibitor-naive (≥2yrs): fosamprenavir 30mg/kg twice daily. For all: do not exceed the adult dosage (see full labeling). Other dosing considerations: see full labeling.
Lexiva Contraindications
Contraindications
Concomitant alfuzosin, cisapride, lurasidone, pimozide, ergots, midazolam, triazolam, St. John's wort, rifampin, lovastatin, simvastatin, delavirdine, sildenafil (Revatio; when used for treating PAH). Concomitant flecainide, or propafenone with ritonavir-boosted fosamprenavir.
Lexiva Boxed Warnings
Not Applicable
Lexiva Warnings/Precautions
Warnings/Precautions
Sulfonamide allergy. Hepatic impairment: see full labeling. Do not exceed recommended dose. Discontinue if severe rash occurs. Monitor lipids, liver function, and for hyperglycemia, increase in body fat, immune reconstitution syndrome. Hemophilia: monitor for spontaneous bleeding. Interrupt or discontinue if nephrolithiasis occurs. Elderly. Pregnancy. Nursing mothers: not recommended.
Lexiva Pharmacokinetics
See Literature
Lexiva Interactions
Interactions
See Contraindications. Life-threatening arrhythmias possible with amiodarone, lidocaine (systemic), quinidine. Concomitant salmeterol, boceprevir, simeprevir, ketoconazole or itraconazole (doses >200mg/day), paritaprevir/ritonavir/ombitasvir/dasabuvir, or nevirapine without ritonavir: not recommended. Reduce rifabutin dose by at least ½ (or by 75% if with ritonavir) and monitor for neutropenia (do weekly CBCs). Potentiates atorvastatin (max atorvastatin 20mg/day), sildenafil, tadalafil, vardenafil; reduce doses of these. May potentiate fluticasone (consider alternative therapy), trazodone (reduce trazodone dose). Monitor with antiarrhythmics (eg, amiodarone), anticonvulsants (eg, phenytoin), H2 blockers, immunosuppressants, tricyclics, warfarin, drugs that affect or are affected by CYP3A4 (eg, azole antifungals, certain benzodiazepines, calcium channel blockers, NNRTIs, protease inhibitors, statins, steroids). May antagonize, or be antagonized by combined hormonal contraceptives (use alternative non-hormonal methods), methadone, paroxetine. Concomitant dolutegravir (with ritonavir-boosted fosamprenavir): give dolutegravir 50mg twice daily; use alternative if known or suspected integrase inhibitor resistance. Concomitant bosentan, colchicine, quetiapine, maraviroc (adjust doses; see full labeling).
Lexiva Adverse Reactions
Adverse Reactions
Diarrhea, nausea, headache, rash (may be serious, eg, Stevens-Johnson), fatigue, vomiting and neutropenia (esp. children); hypertriglyceridemia, elevated liver enzymes, increase in body fat, immune reconstitution syndrome, hemolytic anemia.
Lexiva Clinical Trials
See Literature
Lexiva Note
Notes
Register pregnant patients exposed to fosamprenavir by calling (800) 258-4263.
Lexiva Patient Counseling
See Literature