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
Helpful Links
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.
Here is a list of helpful web sites that provide more information about HIV and its treatment. Some sites offer stories and tips about living with HIV:
APositiveLife.com—This site features real people telling their stories about HIV. It also provides information on HIV treatment, living with HIV, and more.
AIDSmeds.com—This site provides information on HIV treatment options.
FreeHIVinfo.com—This site helps improve communication between HIV-positive consumers and their healthcare providers.
HIVandHepatitis.com—This site provides clear information about treatment for HIV/AIDS. It also covers other conditions: chronic hepatitis B (HBV) and hepatitis C (HCV), and co-infection with HIV/HCV and HIV/HBV.
ProjectInform.org—This nonprofit group has been educating people about HIV since 1985. This Web site features information on HIV. It offers tips on how to pick a healthcare provider and information about treatment options.
TheBody.com—This is the most-visited site about HIV on the Internet. This Positive Life, the Body's Podcast Central, is a library of podcast topics and shows. You'll find interviews with HIV-positive people and HIV in the news.
TheWellProject.org—This site addresses HIV-related needs that are unique to women.
POZ.com—This is a popular site from the publishers of Poz magazine. It provides valuable information for people with HIV and AIDS. The site also offers tips for their families, friends, and caregivers.
*Individual experiences may vary. By prescription only.
Talk to your doctor to see if LEXIVA is right for you.
Please see the full Prescribing Information for LEXIVA
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.