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LEXIVA ORAL SUSPENSION
Viral infections
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Drug Name:

LEXIVA ORAL SUSPENSION Rx

Generic Name and Formulations:
Fosamprenavir (as calcium) 50mg/mL; grape-bubblegum-peppermint flavor; (prodrug of amprenavir).

Company:
GlaxoSmithKline

Therapeutic Use:

Indications for LEXIVA ORAL SUSPENSION:

HIV-1 infection.

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.

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.

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, fat redistribution, immune reconstitution syndrome. Hemophilia: monitor for spontaneous bleeding. Interrupt or discontinue if nephrolithiasis occurs. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

See Contraindications. Life-threatening arrhythmias possible with amiodarone, lidocaine (systemic), quinidine. Concomitant salmeterol, boceprevir, simeprevir, 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 sildenafil, tadalafil, vardenafil; reduce doses of these. May potentiate fluticasone (consider alternative therapy), trazodone (reduce trazodone dose). Monitor antiarrhythmics (eg, amiodarone), anticonvulsants (eg, phenytoin), H2 blockers, immunosuppressants, tricyclics, warfarin, drugs that affect or are affected by CYP3A4 (eg, azole antifungals, benzodiazepines, calcium channel blockers, NNRTIs, protease inhibitors, statins, steroids). May antagonize, or be antagonized by hormonal contraceptives (use 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).

See Also:

LEXIVA

Pharmacological Class:

HIV-1 protease inhibitor.

Adverse Reactions:

Diarrhea, nausea, headache, rash (may be serious, eg, Stevens-Johnson), fatigue, vomiting and neutropenia (esp. children); hypertriglyceridemia, elevated liver enzymes, fat redistribution, immune reconstitution syndrome, hemolytic anemia.

Note:

Register pregnant patients exposed to fosamprenavir by calling (800) 258-4263.

Generic Availability:

NO

How Supplied:

Tabs—60; Susp—225mL

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