IMPORTANT SAFETY INFORMATION Prescribing Information
Indication: LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The PI-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/ritonavir is not recommended for adult PI-experienced patients or any pediatric 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. LEXIVA is contraindicated with ergot derivatives, PROPULSID®*(cisapride), ORAP®* (pimozide), VERSED®* (midazolam), HALCION®*(triazolam), rifampin, MEVACOR®* (lovastatin), ZOCOR®* (simvastatin),RESCRIPTOR®* (delavirdine), or St. John’s wort (Hypericum perforatum). If LEXIVA is coadministered with ritonavir, TAMBOCOR®* (flecainide) and RYTHMOL®* (propafenone) are also contraindicated. CONTINUED BELOW
Important Safety Information
Indication
LEXIVA is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
- The PI-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/ritonavir is not recommended for adult PI-experienced patients or any pediatric 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
- LEXIVA is contraindicated with ergot derivatives, PROPULSID® (cisapride), ORAP® (pimozide), VERSED® (midazolam), HALCION® (triazolam), rifampin, MEVACOR® (lovastatin), ZOCOR® (simvastatin), RESCRIPTOR® (delavirdine), or St. John's wort (Hypericum perforatum). If LEXIVA is coadministered with ritonavir, TAMBOCOR® (flecainide) and RYTHMOL® (propafenone) are also contraindicated
- Hyperglycemia, new onset or exacerbations of diabetes mellitus, and spontaneous bleeding in hemophiliacs have been reported with protease inhibitors
- Treatment with LEXIVA/r has resulted in increases in the concentration of triglycerides and cholesterol. 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 elevations in transaminases prior to treatment. Increased AST/ALT monitoring should be considered in these patients
- 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, alternate methods of non-hormonal contraception are recommended
- 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, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance," 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
- Cases of nephrolithiasis were reported during post-marketing surveillance in HIV-infected patients receiving fosamprenavir calcium. If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of therapy may be considered.
- Severe or life-threatening skin reactions were reported in <1% of 700 patients treated with LEXIVA in clinical studies, including 1 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
Other Drug Interactions
- 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 CORDARONE® (amiodarone), lidocaine (systemic), tricyclic antidepressants, and quinidine. Concentration monitoring of these agents is recommended if these agents are used concomitantly with LEXIVA
- 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
Resistance
- Because the potential for HIV cross-resistance among protease inhibitors has not been fully explored, it is unknown what effect therapy with LEXIVA will have on the activity of subsequently administered protease inhibitors
- Clinical relevance of resistance data is unknown