Aptivus

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

Aptivus is used along with another HIV medicine (ritonavir). Serious and sometimes fatal bleeding in the brain has occurred with this combination. Contact your doctor immediately 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 tiredness, or loss of appetite.

Discuss any questions or concerns with your doctor.


Aptivus is used for:

Treating HIV infection. Aptivus should be used with ritonavir.

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 have moderate to severe liver problems
  • you are taking alfuzosin, certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, oral midazolam, triazolam), certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin), cisapride, conivaptan, dronedarone, ergot derivatives (eg, ergonovine, ergotamine), erythromycin, etravirine, fluticasone, ivabradine, other HIV protease inhibitors (eg, saquinavir), pimozide, rifampin, salmeterol, a serotonin 5-HT1 receptor antagonist (eg, eletriptan, sumatriptan), silodosin, St. John's wort, tamsulosin, terfenadine, or tolvaptan
  • you are taking sildenafil for pulmonary arterial hypertension (PAH)

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

Slideshow: Flashback: FDA Drug Approvals 2013

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, liver problems (eg, hepatitis B or C), abnormal liver function tests, 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 of bleeding or serious bruising
  • if you will be having or have recently had surgery
  • if you have never taken another medicine for HIV infection

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

  • Many other prescription and nonprescription medicines (eg, used for aches or pain, allergies, asthma or other lung or breathing problems, blood thinning, blood vessel problems, cancer, Cushing syndrome, cystic fibrosis, depression or other mental or mood problems, diabetes, erectile dysfunction, gout, high blood pressure, high cholesterol, HIV infection, immune suppression, infections, inflammation, irregular heartbeat or other heart problems, migraine headaches, narcotic addiction, nausea or vomiting, overactive bladder, seizures, stomach or bowel problems, trouble sleeping), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Aptivus. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Aptivus.

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.
  • Aptivus is taken at the same time with another medicine called ritonavir. If you are taking Aptivus with ritonavir capsules or solution, it can be taken with or without meals. If you are taking Aptivus with ritonavir tablets, it must be taken with meals.
  • Swallow Aptivus 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.
  • 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.
  • 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 drowsiness or dizziness. 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.
  • Aptivus 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, fever, sore throat, weakness, cough, shortness of breath) after you start Aptivus.
  • 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.
  • Do NOT take more than the recommended dose, change the dose, or stop taking Aptivus without checking with your doctor.
  • 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 - Some people with hemophilia have developed increased bleeding while taking protease inhibitors, such as Aptivus. 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.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Aptivus may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Aptivus. 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. 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. Contact your doctor if you develop a rash.
  • Lab tests, including viral load, CD4 count, complete blood cell counts, 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.
  • Caution is advised when using Aptivus in CHILDREN; they may be more sensitive to its effects, especially rash.
  • Use Aptivus with extreme caution in CHILDREN younger than 2 years 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 Aptivus 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; mild stomach pain; 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; fruit-like breath odor; itching; joint pain or stiffness; loss of appetite; mental or mood changes; mouth sores or ulcers; muscle aches or pain; numbness or tingling; pale stools; red, blistered, swollen, or peeling skin; severe or persistent nausea; shortness of breath; 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. 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 Aptivus:

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, store Aptivus 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aptivus 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 Aptivus. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aptivus. 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 Aptivus.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
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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