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). You should not take LEXIVA with: AGENERASE® (amprenavir), Halcion® (triazolam), ergot medications (Cafergot®, Migranal®, D.H.E. 45®, and others), Propulsid® (cisapride), CONTINUED BELOW

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Information About LEXIVA: Frequently Asked Questions

HIV and AIDS first made headlines in the 1980s. Since then, there have been advances in treatment. Get the answers to your most common questions and the facts about treating HIV.

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What is LEXIVA?

LEXIVA is a medicine you take by mouth to treat HIV infection. HIV is the virus that causes AIDS (acquired immune deficiency syndrome). LEXIVA belongs to a class of anti-HIV medicines called protease inhibitors. LEXIVA is always used with other anti-HIV medicines. When used in combination therapy, LEXIVA may help lower the amount of HIV found in your blood, raise CD4+ (T) cell counts, and keep your immune system as healthy as possible, so it can help fight infection. However, LEXIVA does not work in all patients with HIV.

LEXIVA does not:
  • cure HIV infection or AIDS. We do not know if LEXIVA will help you live longer or have fewer of the medical problems (opportunistic infections) that people get with HIV or AIDS. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare provider regularly while you are taking LEXIVA. The long-term effects of LEXIVA are not known.
  • lower the risk of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles.

LEXIVA has not been fully studied in children under the age of 2 or in adults over the age of 65.

How should I take LEXIVA?

  • Take LEXIVA exactly as your healthcare provider prescribed.
  • Do not take more or less than your prescribed dose of LEXIVA at any one time. Do not change your dose or stop taking LEXIVA without talking with your healthcare provider.
  • You can take LEXIVA Tablets with or without food.
  • Adults should take LEXIVA Oral Suspension without food.
  • Pediatric patients should take LEXIVA Oral Suspension with food. If vomiting occurs within 30 minutes after dosing, the dose should be repeated.
  • Shake LEXIVA Oral Suspension vigorously before each use.
  • When your supply of LEXIVA or other anti-HIV medicine starts to run low, get more from your healthcare provider or pharmacy. The amount of HIV virus in your blood may increase if one or more of the medicines are stopped, even for a short time.
  • Stay under the care of a healthcare provider while using LEXIVA.
  • It is important that you do not miss any doses. If you miss a dose of LEXIVA by more than 4 hours, wait and take the next dose at the regular time. However, if you miss a dose by fewer than 4 hours, take your missed dose right away. Then take your next dose at the regular time.
  • If you take too much LEXIVA, call your healthcare provider or poison control center right away.

How should I store LEXIVA?

  • LEXIVA Tablets should be stored at room temperature between 59° and 86°F (15° to 30°C). Keep the container of LEXIVA Tablets tightly closed.
  • LEXIVA Oral Suspension may be stored at room temperature or refrigerated. Refrigeration of LEXIVA Oral Suspension may improve taste for some patients. Do not freeze.
  • Keep LEXIVA and all medicines out of the reach of children.
  • Do not keep medicine that is out of date or that you no longer need. Be sure that if you throw any medicine away, it is out of the reach of children.

What are the ingredients in LEXIVA?

Tablets:

Active Ingredient: fosamprenavir calcium.
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone K30. The tablet film coating contains the inactive ingredients hypromellose, iron oxide red, titanium dioxide, and triacetin.

LEXIVA Tablets, 700 mg, are pink in color and are capsule shaped, with the letters "GX LL7" printed on one side of the tablet.

Oral Suspension:

Active Ingredient: fosamprenavir calcium
Inactive ingredients: artificial grape bubblegum flavor, calcium chloride dihydrate, hypromellose, methylparaben, natural peppermint flavor, polysorbate 80, propylene glycol, propylparaben, purified water, and sucralose.


With the exception of LEXIVA, the products mentioned on this page are not trademarks of ViiV Healthcare.
The makers of these brands are not affiliated with and do not endorse ViiV Healthcare.

*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.

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INDICATION AND 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

  • The 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.
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