IMPORTANT SAFETY INFORMATION  Prescribing Information

Indication and Usage: LEXIVA is indicated in combination with other antiretroviral agents for the treatment of HIV 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 plus ritonavir is not recommended for PI-experienced patients or any pediatric patients. LEXIVA does not cure HIV 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). Tell your healthcare provider if you have liver or kidney problems, have diabetes or hemophilia, are allergic to sulfa medicines, or are pregnant, planning to become pregnant, or breastfeeding. CONTINUED BELOW

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About HIV

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Important Safety Information

LEXIVA is indicated in combination with other antiretroviral agents for the treatment of HIV 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 plus ritonavir is not recommended for PI-experienced patients or any pediatric patients

LEXIVA does not cure HIV 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).
  • Tell your healthcare provider if you have liver or kidney problems, have diabetes or hemophilia, are allergic to sulfa medicines, or are pregnant, planning to become pregnant, or breastfeeding.
  • 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.
  • 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.
  • Kidney stones have been reported in patients taking LEXIVA. Tell your healthcare provider if you have pain in your side, blood in your urine, or pain when you urinate.
  • Missing or skipping doses of your medicine may make it easier for the virus to mutate and multiply. Your medicines may not work as well against a mutated virus, and you may become cross-resistant to other HIV medicines. It’s important to take your medicine exactly as prescribed.

Most Common Side Effects

  • 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), Revatio® (sildenafil), Uroxatral® (alfuzosin), 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, Advair® (fluticasone propionate/salmeterol) and Serevent® (salmeterol), and Quinaglute® (quinidine).
  • Women who use birth control pills should choose a different kind of birth control. The use of LEXIVA with Norvir (ritonavir) in combination with birth control pills may hurt your liver. Also, birth control pills may not work if you take LEXIVA or LEXIVA with Norvir. Talk to your healthcare provider about choosing the right birth control for you.
  • Patients taking Viagra® (sildenafil citrate) or LEVITRA® (vardenafil HCl) with LEXIVA may be at 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.