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Fosamprenavir suspension

Generic Name: fosamprenavir (FOS-am-PREN-a-vir)
Brand Name: Lexiva

Fosamprenavir suspension is used for:

Treating HIV infection in some patients when used in combination with certain other medicines.

Fosamprenavir suspension is an HIV protease inhibitor. It works by slowing the growth of HIV, the virus that causes AIDS.

Do NOT use fosamprenavir suspension if:

  • you are allergic to any ingredient in fosamprenavir suspension or to amprenavir
  • you are taking alfuzosin, amprenavir, boceprevir, bosutinib, cabazitaxel, cisapride, conivaptan, delavirdine, dronedarone, erythromycin, an ergot medicine (eg, ergotamine), inhaled fluticasone, ivabradine, lomitapide, lovastatin, lurasidone, midazolam, pimozide, rifampin, salmeterol, silodosin, simvastatin, St. John's wort, tamsulosin, telaprevir, tolvaptan, or triazolam
  • you are taking sildenafil for pulmonary arterial hypertension (PAH)
  • you are taking flecainide or propafenone along with ritonavir

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using fosamprenavir suspension:

Some medical conditions may interact with fosamprenavir suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction (eg, a severe rash, hives, itching, breathing difficulties, or dizziness) to a sulfonamide ("sulfa") medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
  • if you have a history of liver problems (eg, hepatitis) or abnormal liver function tests
  • if you have a history of heart problems, high blood pressure, kidney problems, diabetes or high blood sugar, the bleeding problem hemophilia, high blood cholesterol or lipid levels, or a skin rash

Some MEDICINES MAY INTERACT with fosamprenavir suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for aches or pain, allergies, angina, asthma or other lung or breathing problems, birth control, blood clotting problems, blood flow problems, cancer, Cushing syndrome, cystic fibrosis, depression or other mental or mood problems, enlarged prostate, erectile dysfunction, gout, high blood pressure, high cholesterol, HIV infection, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, migraines, narcotic dependence, nausea or vomiting, PAH, seizures, sinus problems, sleeping problems, stomach problems or indigestion, overactive bladder), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) because they may interact with fosamprenavir suspension. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with fosamprenavir suspension.

This may not be a complete list of all interactions that may occur. Ask your health care provider if fosamprenavir suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use fosamprenavir suspension:

Use fosamprenavir suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with fosamprenavir suspension. Talk to your pharmacist if you have questions about this information.
  • Adults should take fosamprenavir suspension by mouth without food.
  • Children should take fosamprenavir suspension by mouth with food.
  • If vomiting occurs within 30 minutes after taking fosamprenavir suspension, the dose should be taken again.
  • Shake well before each use.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • You may refrigerate fosamprenavir suspension to help improve the taste. Do not freeze.
  • Do not change your dose or stop taking fosamprenavir suspension without talking with your doctor first. Continue to take fosamprenavir suspension even if you feel well. Do not miss any doses.
  • Taking fosamprenavir suspension at the same time(s) each day will help you remember to take it. It is important to not miss any doses of fosamprenavir suspension.
  • If you miss a dose of fosamprenavir suspension, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use fosamprenavir suspension.

Important safety information:

  • Do not take more than the recommended dose without checking with your doctor.
  • Fosamprenavir suspension is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Fosamprenavir suspension does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking fosamprenavir suspension, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Fosamprenavir suspension may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice signs or symptoms of an infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start fosamprenavir suspension.
  • Severe and sometimes life-threatening skin reactions have occurred in patients taking fosamprenavir suspension. Contact your doctor right away if you develop any type of skin reaction (eg, red, swollen, blistered, or peeling skin).
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk; loss of fat from the legs, arms, and face) may occur in some patients taking fosamprenavir suspension. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Fosamprenavir suspension may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Hemophilia patients - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as fosamprenavir suspension. Report all bleeding episodes to your doctor.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using fosamprenavir suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Lab tests, including liver function, cholesterol or triglyceride levels, white blood cell count, and blood sugar levels, may be performed while you use fosamprenavir suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Caution is advised when using fosamprenavir suspension in CHILDREN; they may be more sensitive to its effects, especially vomiting and low white blood cell levels (neutropenia).
  • Fosamprenavir suspension should be used with extreme caution in CHILDREN younger than 4 weeks old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using fosamprenavir suspension while you are pregnant. It is not known if fosamprenavir suspension is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or fosamprenavir suspension to the baby.

Possible side effects of fosamprenavir suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling of the mouth; chest, jaw, or arm pain; dark urine; fainting; loss of appetite; mouth sores; shortness of breath; signs of infection (eg, fever, chills, sore throat); swollen, reddened, peeling, or blistered skin; stomach or back pain; sudden, severe nausea or vomiting; symptoms of kidney stones (eg, lower back or side pain, blood in the urine, painful urination); unusual increase in thirst or urination; unusual sweating; unusual tiredness or weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of fosamprenavir suspension:

Store fosamprenavir suspension in the refrigerator or at room temperature, between 41 and 86 degrees F (5 and 30 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep the container tightly closed. Do not use after the expiration date. Keep fosamprenavir suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about fosamprenavir suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Fosamprenavir suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take fosamprenavir suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about fosamprenavir suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fosamprenavir suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using fosamprenavir suspension.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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