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

Useful links

Useful Web sites about HIV

The following is a list of helpful Web sites that provide additional information about HIV, its treatment, and tips on living with the condition:

For additional information, please visit these sites or contact these organizations. The web sites listed are external to ViiV Healthcare. ViiV Healthcare does not have control over the content of the information provided on these web sites and therefore does not warrant their accuracy and completeness.

APositiveLife.com -this Web site features real people telling their stories about HIV. It also provides patient-friendly information on living with HIV, conditions related to HIV infection, HIV treatment, and more
TreatHIV.com -this Web site provides information about HIV treatments
AIDSmeds.com -this Web site is designed to provide information on HIV treatment options
FreeHIVinfo.com -their goal is to facilitate empowered and informed interactions between HIV-infected consumers and their healthcare providers about pharmaceutical and complementary treatments that can increase the length and quality of their lives
HIVandHepatitis.com -this site strives to create a quality online publication that provides accurate, timely, and cutting-edge information about treatment for HIV/AIDS, chronic hepatitis B and hepatitis C, and co-infection with HIV/HCV and HIV/HBV
ProjectInform.org -this national, non-profit organization has been educating people about HIV since 1985. This Web site has information on a variety of topics related to HIV, including everything from how to pick a healthcare provider, to treatment options
TheBody.com -the most-visited site about HIV on the Internet
TheWellProject.org -this Web site was created to address the HIV-related needs that are unique to women

NOTE: The Web sites above are external to ViiV Healthcare. ViiV Healthcare does not possess editorial control over the content of the information provided in the Web sites above and therefore does not warrant their accuracy and completeness.

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

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