Monograph Details
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Infections & Infestations
> Viral infections
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LEXIVA |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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HIV-1 protease inhibitor. |
| Generic Name |
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Fosamprenavir (as calcium) 700mg; tabs; (prodrug of amprenavir). |
| Also |
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• LEXIVA ORAL SUSPENSION
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| Indications |
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HIV-1 infection. |
| Children |
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<2yrs: not recommended. Oral susp: take with food; if emesis occurs within 30 minutes after dosing, re-dose. Therapy-naive: 2–5yrs: 30mg/kg twice daily. ≥6yrs: fosamprenavir 30mg/kg twice daily; or fosamprenavir 18mg/kg + ritonavir 3mg/kg twice daily. Therapy-experienced: ≥6yrs: fosamprenavir 18mg/kg + ritonavir 3mg/kg twice daily. For all: do not exceed the adult dosage (see literature). Alternative oral tabs regimen: see literature. |
| Adults |
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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 dysfunction: see literature for dose adjustments. |
| Contraindications |
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Concomitant cisapride, pimozide, ergots, midazolam, triazolam, possibly others; see literature. Concomitant flecainide, propafenone, or oral contraceptives with ritonavir-boosted fosamprenavir. St. John's wort, rifampin, lovastatin, simvastatin, delavirdine: not recommended. |
| Precautions |
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Sulfonamide allergy. Hepatic impairment: see literature. Do not exceed recommended dose. Discontinue if severe rash occurs. Monitor lipids, liver function, and for fat redistribution and hyperglycemia. Hemophilia: monitor for spontaneous bleeding. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Life-threatening arrhythmias possible with bepridil. Concomitant 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 sildenafil, tadalafil, vardenafil; reduce doses of these. May potentiate fluticasone (consider alternative therapy), trazodone (reduce trazodone dose). Monitor amiodarone, anticonvulsants (eg, phenytoin), H2 blockers, immunosuppressants, lidocaine (systemic), quinidine, tricyclics, warfarin, drugs that affect or are affected by CYP3A4 (eg, azole antifungals, benzodiazepines, calcium channel blockers, macrolides, NNRTIs, protease inhibitors, statins, steroids). May antagonize, or be antagonized by antacids, hormonal contraceptives (use non-hormonal methods), methadone. |
| Adverse Reactions |
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GI upset, headache, rash (may be serious, eg, Stevens-Johnson), fat redistribution, depression, fatigue, hypertriglyceridemia, elevated liver enzymes, immune reconstitution syndrome, vomiting (esp. children). |
| Extra Text |
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Note: Register pregnant patients exposed to fosamprenavir by calling (800) 258-4263. |
| How Supplied |
Tabs—60
Susp—225mL |
| Additional Resources |
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• Related Prescribing Note |
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