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|Aptivus

Aptivus

Aptivus is used for:

Treating HIV infection. Aptivus should be used with other antiretroviral agents.

Aptivus is a protease inhibitor. It works by blocking the growth of an enzyme (HIV protease) that the HIV virus needs to reproduce in the body.

Do NOT use Aptivus if:

• you are allergic to any ingredient in Aptivus
• you are taking an antiarrhythmic (eg, amiodarone, flecainide, propafenone, bepridil, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), certain cholesterol medicines (eg, simvastatin, lovastatin), cisapride, an ergot derivative (eg, ergotamine, ergonovine), pimozide, rifampin, a serotonin 5-HT₁ receptor antagonist (eg, sumatriptan, eletriptan), St. John"s wort, or terfenadine
• you have moderate to severe liver disease

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

Before using Aptivus :

Some medical conditions may interact with Aptivus . 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, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
• if you have cholesterol or lipid problems, diabetes or a family history of diabetes, hepatitis or other liver problems, severe kidney problems, or bleeding problems (eg, hemophilia)
• if you have a recent injury or other medical condition that may increase your risk for bleeding or serious bruising
• if you will be having or have recently had surgery

Some MEDICINES MAY INTERACT with Aptivus . 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 infections, inflammation, aches and pains, high blood pressure, high cholesterol, seizures), anticoagulants, antiplatelet medicines, (eg, warfarin) multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John"s wort) may interact with Aptivus , increasing the risk of side effects
• Antiarrhythmics (eg, amiodarone, flecainide, propafenone, bepridil, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), certain cholesterol medicines (eg, simvastatin, lovastatin), cisapride, ergot derivatives (eg, ergotamine, ergonovine), pimozide, serotonin 5-HT₁ receptor antagonists (eg, sumatriptan, eletriptan), or terfenadine because the risk of side effects, including heart or blood vessel problems, muscle problems, or severe breathing problems, may be increased
• Rifampin or St. John"s wort because they may decrease Aptivus "s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aptivus 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 Aptivus :

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

• An extra patient leaflet is available with Aptivus . Talk to your pharmacist if you have questions about this information.
• Take Aptivus by mouth with food.
• Aptivus is administered along with another medicine called ritonavir. Be sure to follow your doctor"s instructions for taking ritonavir along with Aptivus .
• Swallow this medicine whole. Do not break, crush, or chew before swallowing.
• If you are also taking didanosine, do not take it within 2 hours of taking Aptivus . Check with your doctor if you have questions.
• Taking Aptivus at the same time each day will help you remember to take it.
• Take Aptivus on a regular schedule to get the most benefit from it.
• Consult your doctor before including grapefruit or grapefruit juice in your diet.
• Continue to use Aptivus even if you feel well. Do not miss any doses. Failure to do so may decrease the effectiveness of Aptivus and increase the risk that your HIV will no longer be sensitive to Aptivus or to other similar medicines.
• Do not miss any doses. If you miss a dose of Aptivus , take it as soon as possible. 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 Aptivus .

Important safety information:

• Aptivus may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aptivus with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tell your doctor or dentist that you take Aptivus before you receive any medical or dental care, emergency care, or surgery.
• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Aptivus . The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Aptivus , even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Aptivus is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Aptivus does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Aptivus may increase triglyceride and lipid levels. The long-term chance of complications from these increased triglyceride and lipid levels, such as heart attack and stroke, are not known at this time.
• Hemophilia patients - Report all bleeding episodes to your doctor.
• Aptivus 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.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Aptivus . To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Lab tests, including viral load, CD4 count, triglyceride and lipid levels, and liver function, may be performed while you use Aptivus . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Aptivus with caution in the ELDERLY; they may be more sensitive to its effects.
• Use Aptivus with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risk of using this medicine during while you are pregnant. It is not known if Aptivus is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Aptivus to the baby.

Possible side effects of Aptivus :

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; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body fat changes; confusion; dark urine; depression; difficulty urinating; dizziness; excessive thirst, hunger, or urination; fast heartbeat; fever, chills, or sore throat; flu-like symptoms; fruity breath odor; itching; loss of appetite; joint pain or stiffness; mental or mood changes; muscle pain; numbness or tingling; pale stools; severe or persistent nausea; stomach pain or tenderness; throat tightness; unusual bruising or bleeding; unusual drowsiness or tiredness; unusual weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Before opening the bottle, store Aptivus in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. After opening the bottle, Aptivus may be stored at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Aptivus must be used within 60 days after opening the bottle. Keep the bottle tightly closed. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aptivus out of the reach of children and away from pets.

General information:

• If you have any questions about Aptivus , please talk with your doctor, pharmacist, or other health care provider.
• Aptivus 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.

This information is a summary only. It does not contain all information about Aptivus . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.