Fosamprenavir

What it is used for

LEXIVA is a prescription anti-HIV medicine used with other anti-HIV medicines to treat human immunodeficiency (HIV-1) infections in adults and children 4 weeks of age and older. LEXIVA is a type of anti-HIV medicine called a protease inhibitor. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

When used with other anti-HIV medicines, LEXIVA may help:

• 1. Reduce the amount of HIV-1 in your blood. This is called “viral load”.
• 2. Increase the number of white blood cells called CD4 (T) cells, which help fight off other infections. Reducing the amount of HIV-1 and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

It is not known if LEXIVA is safe and effective in children less than 4 weeks of age.

LEXIVA does not cure HIV-1 infection or AIDS. People taking LEXIVA may develop infections or other conditions associated with HIV-1 infection, including opportunistic infections (for example, pneumonia and herpes virus infections).

You should remain under the care of your healthcare provider when using LEXIVA.

Avoid doing things that can spread HIV-1 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 and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

How to take it

• Stay under the care of a healthcare provider while taking LEXIVA.
• Take LEXIVA exactly as prescribed by your healthcare provider.
• Do not change your dose or stop taking LEXIVA without talking with your healthcare provider.
• If your child is taking LEXIVA, your child’s healthcare provider will decide the right dose based on your child’s weight.
• You can take LEXIVA Tablets with or without food.
• Adults should take LEXIVA Oral Suspension without food.
• Children should take LEXIVA Oral Suspension with food. If your child vomits within 30 minutes after taking a dose of LEXIVA, the dose should be repeated.
• Shake LEXIVA Oral Suspension well before each use.
• If you miss a dose of LEXIVA, take the next dose as soon as possible and then take your next dose at the regular time. Do not double the next dose. If you take too much LEXIVA, call your healthcare provider or go to the nearest hospital emergency room right away.

Side effects, and when to stop

LEXIVA may cause serious side effects including:

• Severe skin rash. LEXIVA may cause severe or life-threatening skin reactions or rash.

If you get a rash with any of the following symptoms, stop taking LEXIVA and call your healthcare provider or get medical help right away:

• • ∘ hives or sores in your mouth, or your skin blisters and peels
  • ∘ trouble swallowing or breathing
  • ∘ swelling of your face, eyes, lips, tongue, or throat
• Liver problems. Your healthcare provider should do blood tests before and during your treatment with LEXIVA to check your liver function. Some people with liver problems, including hepatitis B or C, may have an increased risk of developing worsening liver problem during treatment with LEXIVA.
• Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors, including LEXIVA, can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking LEXIVA.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine.
• Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Changes in blood tests. Some people have changes in blood tests while taking LEXIVA. These include increases seen in liver function tests, blood fat levels, and decreases in white blood cells. Your healthcare provider should do regular blood tests before and during your treatment with LEXIVA.
• Increased bleeding problems in some people with hemophilia. Some people with hemophilia have increased bleeding with protease inhibitors, including LEXIVA.
• Kidney stones. Some people have developed kidney stones while taking LEXIVA. Tell your healthcare provider right away if you develop signs or symptoms of kidney stones:
  • ∘ pain in your side
  • ∘ blood in your urine
  • ∘ pain when you urinate

The most common side effects of LEXIVA in adults include:

• nausea
• vomiting
• diarrhea
• headache

Vomiting is the most common side effect in children when taking LEXIVA.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of LEXIVA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take LEXIVA if you take any of the following medicines:

• alfuzosin (UROXATRAL ® )
• flecainide (TAMBOCOR™)
• propafenone (RYTHMOL SR ® )
• rifampin (RIFADIN ®, RIFAMATE ®, RIFATER ®, RIMACTANE ® )
• ergot including:
  • ∘ dihydroergotamine mesylate (D.H.E. 45 ®, MIGRANAL ® )
  • ∘ ergotamine tartrate (CAFERGOT ®, MIGERGOT ®, ERGOMAR ®, MEDIHALER ERGOTAMINE ® )
  • ∘ methylergonovine (METHERGINE ® )
• St. John’s wort ( Hypericum perforatum )
• lovastatin (ADVICOR ®, ALTOPREV ®, MEVACOR ® )
• simvastatin (ZOCOR ®, VYTORIN ®, SIMCOR ® )
• pimozide (ORAP ® )
• delavirdine mesylate (RESCRIPTOR ® )
• sildenafil (REVATIO ® ), for treatment of pulmonary arterial hypertension
• triazolam (HALCION ® )

Serious problems can happen if you or your child take any of the medicines listed above with LEXIVA.

Do not take LEXIVA if you are allergic to AGENERASE ® (amprenavir), fosamprenavir calcium, or any of the ingredients in LEXIVA. See the end of this leaflet for a complete list of ingredients in LEXIVA.

What to say before you start

Before taking LEXIVA, tell your healthcare provider if you:

• are allergic to medicines that contain sulfa
• have liver problems, including hepatitis B or C
• have kidney problems
• have high blood sugar (diabetes)
• have hemophilia
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if LEXIVA will harm your unborn baby.

Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

• Do not breastfeed. We do not know if LEXIVA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all prescription and non-prescription medicines you take. Also tell your healthcare provider about any vitamins, herbal supplements, and dietary supplements you are taking.

Taking LEXIVA with certain other medicines may cause serious side effects. LEXIVA may affect the way other medicines work, and other medicines may affect how LEXIVA works.

Especially tell your healthcare provider if you take estrogen-based contraceptives (birth control pills). LEXIVA may reduce effectiveness of estrogen-based contraceptives. During treatment with LEXIVA, you should use a different contraceptive method.

Know all the medicines that you take. Keep a list of them with you to show healthcare providers and pharmacists when you get a new medicine.

Storing it

• Store LEXIVA Tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the bottle of LEXIVA Tablets tightly closed.
• Store LEXIVA Oral Suspension between 41°F to 86°F (5°C to 30°C). Refrigeration of LEXIVA Oral Suspension may improve taste for some people.
• Do not freeze. Keep LEXIVA and all medicines out of the reach of children.

General information about LEXIVA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LEXIVA for a condition for which it was not prescribed. Do not give LEXIVA to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about LEXIVA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about LEXIVA that is written for health professionals.

For more information call 877-844-8872 or go to www.LEXIVA.com.