Aptivus Solution

Generic Name: Tipranavir (tye-PRAN-a-vir)Brand Name: Aptivus

Aptivus Solution is used along with another HIV medicine (ritonavir). Serious and sometimes fatal bleeding in the brain has occurred with this combination. Contact your doctor right away if you develop symptoms of bleeding in the brain. These may include confusion, vision or speech problems, or one-sided weakness.

Serious and sometimes fatal liver problems have also been reported with this combination. Patients who have hepatitis B or C may be at greater risk. Contact your doctor at once if you develop symptoms of liver problems. Such symptoms may include yellowing of the eyes or skin, dark urine, pale stools, stomach pain or tenderness, severe or persistent nausea, or loss of appetite.

Discuss any questions or concerns with your doctor.

Aptivus Solution is used for:

Treating HIV infection. Aptivus Solution should be used with ritonavir.

Aptivus Solution 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 Solution if:

  • you are allergic to any ingredient in Aptivus Solution
  • you are taking certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, ergot derivatives (eg, ergonovine, ergotamine), other HIV protease inhibitors (eg, saquinavir), pimozide, rifampin, a serotonin 5-HT1 receptor antagonist (eg, eletriptan, sumatriptan), 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 Solution:

Some medical conditions may interact with Aptivus Solution. 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, liver problems (eg, hepatitis B or C), abnormal liver function tests, severe kidney problems, or bleeding problems (eg, hemophilia)
  • if you take vitamin E or 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 Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, ergot derivatives (eg, ergonovine, ergotamine), pimozide, serotonin 5-HT1 receptor antagonists (eg, eletriptan, sumatriptan), 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 Solution's effectiveness
  • Other HIV protease inhibitors (eg, saquinavir) because their effectiveness may be decreased by Aptivus Solution
  • Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), and many prescription and nonprescription medicines (eg, used for aches and pains, asthma, erectile dysfunction, diabetes, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat, nasal allergies, seizures), multivitamin products, and herbal or dietary supplements (eg, coenzyme Q10, garlic, ginkgo, ginseng, herbal teas, St. John's wort) may interact with Aptivus Solution, increasing the risk of side effects

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

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

  • An extra patient leaflet is available with Aptivus Solution. Talk to your pharmacist if you have questions about this information.
  • Take Aptivus Solution by mouth with or without food.
  • Aptivus Solution is administered along with another medicine called ritonavir. Be sure to follow your doctor's instructions for taking ritonavir along with Aptivus Solution.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you are also taking didanosine, do not take it within 2 hours of taking Aptivus Solution. Check with your doctor if you have questions.
  • Taking Aptivus Solution at the same time each day will help you remember to take it.
  • Take Aptivus Solution 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 Solution even if you feel well. Do not miss any doses. Failure to do so may decrease the effectiveness of Aptivus Solution and increase the risk that your HIV will no longer be sensitive to Aptivus Solution or to other similar medicines.
  • If you miss a dose of Aptivus Solution, 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 Solution.

Important safety information:

  • Aptivus Solution may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aptivus Solution 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 Solution 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 Solution. The cause and long-term effects of these changes are not known. Discuss any concerns with your doctor.
  • Aptivus Solution may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, cough, fever, shortness of breath, sore throat, weakness) after you start Aptivus Solution.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Aptivus Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Aptivus Solution 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 Solution 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 Solution 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 Solution 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.
  • Aptivus Solution may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Aptivus Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Aptivus Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).
  • Women who take estrogens for birth control or hormone replacement may have an increased risk of rash from Aptivus Solution. Contact your doctor if you develop a rash.
  • Lab tests, including viral load, CD4 count, triglyceride and lipid levels, and liver function, may be performed while you use Aptivus Solution. 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 Solution with caution in the ELDERLY; they may be more sensitive to its effects.
  • Use Aptivus Solution with extreme caution in CHILDREN younger than 2 years; 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 risk of using Aptivus Solution while you are pregnant. It is not known if Aptivus Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Aptivus Solution to the baby.

Possible side effects of Aptivus Solution:

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:

Cough; diarrhea; headache; nausea; tiredness; vomiting.

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

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 hunger, thirst, or urination; fast heartbeat; fever, chills, or sore throat; flu-like symptoms; fruity breath odor; itching; joint pain or stiffness; loss of appetite; mental or mood changes; mouth sores or ulcers; muscle pain; numbness or tingling; pale stools; red, blistered, swollen, or peeling skin; severe or persistent nausea; slurred speech or one-sided weakness; stomach pain or tenderness; throat tightness; unusual bruising or bleeding; unusual drowsiness or tiredness; unusual weakness; vision changes; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Proper storage of Aptivus Solution:

Store Aptivus Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate or freeze. Aptivus Solution must be used within 60 days after opening the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aptivus Solution out of the reach of children and away from pets.

General information:

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

  • Aptivus Prescribing Information (FDA)
  • Aptivus Consumer Overview
  • Aptivus Detailed Consumer Information (PDR)
  • Aptivus Advanced Consumer (Micromedex) - Includes Dosage Information
  • Tipranavir Professional Patient Advice (Wolters Kluwer)