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See the full Prescribing Information for LEXIVA

LEXIVA® (fosamprenavir calcium)

Indication and Usage:

LEXIVA is indicated in combination with other antiretroviral agents for the treatment of HIV infection in adults.

For PI-experienced patients, the following points should be considered:

• The protease inhibitor-experienced patient study was not large enough to reach a definitive conclusion that LEXIVA/ritonavir and lopinavir/ritonavir are clinically equivalent
• Once-daily administration of LEXIVA plus ritonavir is not recommended for protease inhibitor-experienced patients

Important Safety Information

• LEXIVA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of this product or to amprenavir
• Hyperglycemia, new onset or exacerbations of diabetes mellitus, and spontaneous bleeding in hemophiliacs have been reported with protease inhibitors
• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including LEXIVA. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment
• Redistribution/accumulation of body fat have been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism, and long-term consequences of these events are currently unknown
• LEXIVA should be used with caution in patients with a known sulfonamide allergy
• Severe or life-threatening skin reactions were reported in <1% of 700 patients treated with LEXIVA in clinical studies, including one case of Stevens-Johnson syndrome
• Skin rash (all grades, without regard to causality) occurred in approximately 19% of patients treated with LEXIVA in the pivotal efficacy studies. This led to the discontinuation of LEXIVA in <1% of patients
• Treatment with LEXIVA/r has resulted in increases in the concentration of triglycerides. Triglyceride and cholesterol testing should be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy
• Caution should be exercised when administering LEXIVA to patients with hepatic impairment, including those with hepatitis B or C or marked elevation in transaminases prior to treatment. Increased AST/ALT monitoring should be considered in these patients
• The most common grade 2-4 drug-related adverse events were diarrhea, nausea, vomiting, headache, and rash

DRUG INTERACTIONS

• LEXIVA is contraindicated with ergot derivatives, cisapride, pimozide, midazolam, and triazolam. If LEXIVA is coadministered with ritonavir, flecainide and propafenone are also contraindicated
• Caution should be used when coadministering medications that are substrates, inhibitors, or inducers of CYP3A4, or potentially toxic medications that are metabolized by CYP3A4
• Serious and/or life-threatening drug interactions could occur between LEXIVA and amiodarone, lidocaine (systemic), tricyclic antidepressants, and quinidine. Concentration monitoring of these agents is recommended if these agents are used concomitantly with LEXIVA
• LEXIVA should not be coadministered with rifampin, St. John's wort, lovastatin, simvastatin, or delavirdine
• Particular caution should be used when prescribing phosphodiesterase (PDE-5) inhibitors for erectile dysfunction (eg, sildenafil or vardenafil) in patients receiving LEXIVA
• This list of potential drug interactions is not complete
• Concomitant use of LEXIVA and oral contraceptives is not recommended. LEXIVA taken with oral contraceptives may alter hormonal levels. LEXIVA plus ritonavir taken with oral contraceptives may result in clinically-significant hepatic transaminase elevations. Therefore, alternative methods of non-hormonal contraception are recommended