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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Risks & Side Effects

Here are the answers to some common questions about the risks and side effects of LEXIVA. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Be sure to talk to your doctor or pharmacist if you have any questions about LEXIVA.

What is the most important information I should know about LEXIVA?

LEXIVA can cause dangerous and life-threatening interactions if taken with certain other medicines. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

  • Some medicines cannot be taken at all with LEXIVA.
  • Some medicines will require dose changes if taken with LEXIVA.
  • Some medicines will require close monitoring if you take them with LEXIVA.

Know all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Keep a list of the medicines you take. Show this list to all your healthcare providers and pharmacists anytime you get a new medicine or refill. Your healthcare providers and pharmacists must know all the medicines you take. They will tell you if you can take other medicines with LEXIVA. Do not start any new medicines while you are taking LEXIVA without talking with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that can interact with LEXIVA.

Who should not take LEXIVA?

Do not take LEXIVA if you:

  • are taking certain other medicines. Read the section "What is the most important information I should know about LEXIVA?" Do not take the following medicines* with LEXIVA. You could develop serious or life-threatening problems.
    • Halcion® (triazolam; used for insomnia)
    • Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others (used for migraine headaches)
    • Propulsid® (cisapride), used for certain stomach problems
    • Versed® (midazolam), used for sedation
    • Orap® (pimozide), used for Tourette’s disorder
    • Revatio® (sildenafil), used for treatment of pulmonary arterial hypertension
    • Uroxatral® (alfuzosin), used for benign prostatic hyperplasia (BPH)

    • The brands listed are registered trademarks of their respective owners and are not trademarks of ViiV Healthcare. The makers of these brands are not affiliated with and do not endorse ViiV Healthcare or its products.

  • are allergic to LEXIVA or any of its ingredients. The active ingredient is fosamprenavir calcium. See the end of this leaflet for a list of all the ingredients in LEXIVA.
  • are allergic to AGENERASE (amprenavir).

You should not take AGENERASE (amprenavir) and LEXIVA at the same time.

There are other medicines you should not take if you are taking LEXIVA and Norvir® (ritonavir) together. You could develop serious or life-threatening problems. Tell your healthcare provider about all medicines you are taking before you begin taking LEXIVA and Norvir (ritonavir) together.

What should I tell my healthcare provider before taking LEXIVA?

Before taking LEXIVA, tell your healthcare provider about all of your medical conditions including if you:

  • are pregnant or planning to become pregnant. It is not known if LEXIVA can harm your unborn baby. You and your healthcare provider will need to decide if LEXIVA is right for you. If you use LEXIVA while you are pregnant, talk to your healthcare provider about how you can be on the Antiretroviral Pregnancy Registry.
  • are breastfeeding. You should not breastfeed if you are HIV positive because of the chance of passing the HIV virus to your baby through your milk. Also, it is not known if LEXIVA can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.
  • have liver problems. You may be given a lower dose of LEXIVA or LEXIVA may not be right for you.
  • have kidney problems
  • have diabetes. You may need dose changes in your insulin or other diabetes medicines.
  • have hemophilia
  • are allergic to sulfa medicines

Before taking LEXIVA, tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. LEXIVA can cause dangerous and life-threatening interactions if taken with certain other medicines. You may need dose changes in some of your medicines or closer monitoring with some medicines if you also take LEXIVA (see "What is the most important information I should know about LEXIVA?"). Know all the medicines that you take and keep a list of them with you to show healthcare providers and pharmacists.

Women who use birth control pills should choose a different kind of contraception. The use of LEXIVA with Norvir (ritonavir) in combination with birth control pills may be harmful to your liver. The use of LEXIVA with or without Norvir may decrease the effectiveness of birth control pills. Talk to your healthcare provider about choosing an effective contraceptive.

What should I avoid while taking LEXIVA?

  • Do not use certain medicines while you are taking LEXIVA. See "What is the most important information I should know about LEXIVA?" and "Who should not take LEXIVA?"
  • Do not breastfeed. See "Before taking LEXIVA, tell your healthcare provider." Talk with your healthcare provider about the best way to feed your baby.
  • Avoid doing things that can spread HIV infection since LEXIVA doesn't stop you from passing the HIV infection to others.
  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
  • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

What are the possible side effects of LEXIVA?

LEXIVA may cause the following side effects:

  • Skin rash. Skin rashes, some with itching, have happened in patients taking LEXIVA. Swelling of the face, lips, and tongue (angioedema) has also been reported. Tell your healthcare provider if you get a rash or develop facial swelling after starting LEXIVA.
  • Diabetes and high blood sugar (hyperglycemia). Some patients had diabetes before taking LEXIVA while others did not. Some patients may need changes in their diabetes medicine. Others may need a new diabetes medicine.
  • Increased bleeding problems in some patients with hemophilia.
  • Worse liver disease. Patients with liver problems, including hepatitis B or C, are more likely to get worse liver disease when they take anti-HIV medicines like LEXIVA.
  • Changes in blood tests. Some people have changes in blood tests while taking LEXIVA. These include increases seen in liver function tests and blood fat levels, and decreases in white blood cells. Your healthcare provider may do regular blood tests to see if LEXIVA is affecting your body.
  • Changes in body fat. These changes have happened in patients taking antiretroviral medicines like LEXIVA. The changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.
  • Kidney stones have been reported in some patients taking LEXIVA. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), tell your healthcare provider right away.

Common side effects of LEXIVA are nausea, vomiting, and diarrhea. Tell your healthcare provider about any side effects that bother you or that won't go away.

This list of side effects of LEXIVA is not complete. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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*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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