GSK's commitment

GlaxoSmithKline's global community outreach efforts are dedicated to giving thousands of people in Africa and the developing world hope after HIV—through research and development of new HIV medicines and vaccines, preferential pricing for antiretrovirals community investments, and innovative partnerships. The following is a brief summary of some of the initiatives undertaken by GlaxoSmithKline.

Research & development of antiretrovirals

• Conducted first human trials of HIV vaccine
• Undertaking R&D for the prevention and treatment of HIV/AIDS, tuberculosis, and malaria
• Have supported more than 25 ongoing and past clinical trials in developing countries, including 19 in Africa
• Nurturing the broadest discovery and development pipeline of antiretrovirals, antimalarials, and vaccines

Community investment

• Positive Action, GlaxoSmithKline's program of HIV education, care, and community support, has been ongoing since 1992
• GlaxoSmithKline's France Foundation has supported 31 programs in 12 African countries focusing on HIV prevention, education training, and healthcare in developing countries
• GlaxoSmithKline funds community-led initiatives in more than 100 countries around the world

Innovative partnerships

• GlaxoSmithKline has extended voluntary licenses to several companies to produce GSK antiretrovirals for sale and use in developing countries

See the full Prescribing Information for LEXIVA

LEXIVA^® (fosamprenavir calcium)

Indication and Usage:

LEXIVA treats HIV infection in adults. It should always be used in combination with other HIV medicines. These medicines do not cure HIV infection/AIDS or prevent passing HIV to others.

Important Safety Information

• You should not take LEXIVA if you have had an allergic reaction to LEXIVA or AGENERASE^® (amprenavir)
• High blood sugar, diabetes or worsening of diabetes, and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors
• When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor
• Changes in body fat may occur in some patients taking antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time
• Skin rashes can occur in patients taking LEXIVA. Rarely, rashes were severe or life threatening
• Opportunistic infections can develop when you have HIV and your immune system is weak. It is very important that you see your healthcare provider regularly while you are taking LEXIVA to discuss any side effects or concerns
• Most common side effects in clinical studies were diarrhea, headache, nausea, rash, and vomiting. In most cases, these side effects did not cause people to stop taking their medicine

DRUG INTERACTIONS

• LEXIVA should not be taken with: AGENERASE^® (amprenavir), Halcion^® (triazolam), ergot medications (Cafergot^®, Migranal^®, D.H.E. 45^®, and others), Propulsid^® (cisapride), Versed^® (midazolam), Orap^® (pimozide), Zocor^® (simvastatin), Mevacor^® (lovastatin), Rifadin^® (rifampin), Rescriptor^® (delavirdine mesylate), or St. John's wort (Hypericum perforatum). If you are taking Norvir^® (ritonavir), you should not take Tambocor^® (flecainide), or Rythmol^® (propafenone hydrochloride)
• Serious and/or life-threatening events could occur between LEXIVA and other medications, including Cordarone^® (amiodarone), lidocaine (intravenous only), Elavil^® (amitriptyline HCl) and Tofranil^® (imipramine pamoate), tricyclic antidepressants, and Quinaglute^® (quinidine)
• Women who use birth control should choose a different kind of contraception. LEXIVA can affect the safety and effectiveness of birth control pills.
• Patients taking Viagra^® (sildenafil citrate) or LEVITRA^® (vardenafil HCl) with LEXIVA may be at an increased risk of side effects
• This list of drug interactions is not complete. Be sure to tell your healthcare provider about all medicines you are taking or plan to take, including over-the-counter drugs, vitamins, and herbals