Lexiva

Pregnancy Category: C

Lactation: excreted in milk unknown; contraindicated

Pregnancy Registry: to monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral medications call 1-800-258-4263 or visit www.APRegistry.com

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Fosamprenavir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Fosamprenavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Fosamprenavir is not a cure for HIV or AIDS.

Fosamprenavir may also be used for purposes not listed in this medication guide.

• ViiV Healthcare Company

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.

Do not take Lexiva if you:

• are allergic to Lexiva or any of its ingredients. 
• are allergic to Agenerase (amprenavir).

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.

• Lexiva 1400 mg twice daily (without Norvir)
• Lexiva 1400 mg once daily and Norvir 200 mg once daily
• Lexiva 1400 mg once daily and Norvir 100 mg once daily
• Lexiva 700 mg twice daily and Norvir 100 mg twice daily. 

Some medicines can cause unwanted or dangerous effects when used with fosamprenavir. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Fosamprenavir is used in combination with other medicines to treat patients who are infected with the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Fosamprenavir may slow down the destruction of the immune system caused by HIV. This may help delay problems that are usually related to AIDS or HIV disease from occurring. However, this medicine will not cure or prevent HIV infection, and it will not keep you from spreading the virus to other people. Patients who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Lexiva tablets, 700 mg, are pink, film-coated, capsule-shaped, biconvex tablets with “GX LL7” debossed on one face.

Lexiva oral suspension, 50 mg per mL, is a white to off-white suspension that has a characteristic grape-bubblegum-peppermint flavor.

Lexiva tablets, 700 mg, are pink, film-coated, capsule-shaped, biconvex tablets, with “GX LL7” debossed on one face.

Bottle of 60 with child-resistant closure (NDC 49702-207-18).

Store at controlled room temperature of 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Keep container tightly closed.

Lexiva oral suspension, a white to off-white grape-bubblegum-peppermint–flavored suspension, contains 50 mg of fosamprenavir as fosamprenavir calcium equivalent to approximately 43 mg of amprenavir in each 1 mL.

Bottle of 225 mL with child-resistant closure (NDC 49702-208-53).

This product does not require reconstitution.

Store in refrigerator or at room temperature (5° to 30°C; 41° to 86°F). Shake vigorously before using. Do not freeze.

Lexiva (fosamprenavir) is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Lexiva is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Lexiva is for use in adults and children who are at least 4 weeks old. This medicine is not a cure for HIV or AIDS.

Get emergency medical help if you have signs of an allergic reaction to Lexiva: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking Lexiva and call your doctor at once if you have:

• chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;

• pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• increased urination or extreme thirst;

• sudden and severe pain in your lower back or side, blood in your urine, pain or burning when you urinate; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Lexiva may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Lexiva. Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Lexiva side effects may include:

• fever or other signs of infection;

• nausea, vomiting, diarrhea;

• rash;

• headache; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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