Brand Name: Aptivus
Other Name(s): TPV
Drug Class: Protease Inhibitors
Approved Use: Treatment of HIV Infection
Molecular Weight: 602.671
Tipranavir can cause serious, life-threatening side effects. These include liver problems, severe rash, and bleeding in the brain.
Some people taking tipranavir have had liver problems. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking tipranavir. Liver problems have also occurred in people taking tipranavir who have no history of liver disease. Liver function tests may be done before and during treatment with tipranavir.
Stop taking tipranavir (and ritonavir, the HIV medicine always used with tipranavir) and contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- General ill feeling or "flu-like" symptoms.
- Loss of appetite.
- Yellowing of your skin or the whites of your eyes (jaundice).
- Dark-colored urine.
- Light-colored bowel movements.
- Pain, aching, or tenderness on the right side below your ribs.
Stop taking tipranavir and contact your health care provider right away if you develop a rash and one or more of the following symptoms:
- Joint pain or stiffness.
- Throat tightness.
- Generalized itching.
- Muscle aches.
- Redness, blisters, or peeling of your skin.
Report any unusual or unexplained bleeding to your health care provider.
While taking tipranavir, it is important to keep all of your appointments with your health care provider.
What Is Tipranavir?
Tipranavir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age and older. Tipranavir is always used with the HIV medicine ritonavir (brand name: Norvir) and at least two other HIV medicines.
Tipranavir belongs to a class (group) of HIV drugs called protease inhibitors (PIs). PIs block an HIV enzyme called protease. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking protease, PIs prevent HIV from multiplying and can reduce the amount of HIV in the body.
Tipranavir should be used only in people who have taken HIV medicines before and whose HIV is resistant to more than one PI.
HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.
What Should I Tell My Health Care Provider Before Taking Tipranavir?
Before taking tipranavir, tell your health care provider:
- If you are allergic to tipranavir or any other medicines, including sulfa medicines.
- If you have hemophilia or another medical condition that increases your chance of bleeding.
- If you are taking medicines that increase your chance of bleeding.
- If you have liver problems or have hepatitis B virus (HBV) infection infection or hepatitis c virus (HCV) infection.
- If you have diabetes.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether tipranavir can harm an unborn baby is unknown. Tipranavir should be used during pregnancy only if the potential benefits outweigh the risks. Talk to your health care provider about possible risks with taking tipranavir when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking tipranavir.
- If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Tipranavir may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking tipranavir. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tipranavir may affect the way other medicines or products work, and other medicines or products may affect how tipranavir works. Taking tipranavir together with certain medicines or products may cause serious side effects.
How Should I Take Tipranavir?
Tipranavir (brand name: Aptivus) comes in the following forms and strengths:
- 250-mg capsules.
- 100-mg/mL oral solution. (An oral solution is a mixture of a medicine and a liquid that can be taken by mouth.)
Take tipranavir according to your health care provider's instructions.
Tipranavir capsules should be swallowed whole. Do not chew the capsules.
Tipranavir is always used with the HIV medicine ritonavir (brand name: Norvir) and at least two other HIV medicines. Take tipranavir and ritonavir at the same time. If you are taking tipranavir with ritonavir capsules or oral solution, the medicines can be taken with or without meals. If you are taking tipranavir with ritonavir tablets, the medicines must be taken only with meals.
The oral solution of tipranavir contains vitamin E. If you are taking the oral solution, don't take additional vitamin E other than that contained in a standard multivitamin.
If you take too much tipranavir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take tipranavir, see the FDA drug label
from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What Should I Do if I Forget a Dose?
If you miss a dose of tipranavir, together with ritonavir, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What Side Effects Can Tipranavir Cause?
Tipranavir may cause side effects. Most side effects from tipranavir are manageable, but a few can be serious. Serious side effects of tipranavir include liver problems, severe rash, and bleeding in the brain. (See the WARNING box above.)
Other possible side effects of tipranavir include:
- Diabetes and high blood sugar (hyperglycemia).
- Changes in body fat (including gain or loss of fat).
- Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- Increases in certain fat levels (cholesterol> and triglyceride) in the blood (hyperlipidemia).
- Increased bleeding in people with hemophilia.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of tipranavir. To learn more about possible side effects of tipranavir, read the drug label or package insert or talk to your health care provider or pharmacist.
The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to tipranavir.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.
How Should Tipranavir Be Stored?
- Store tipranavir capsules in a refrigerator at about 36°F to 46°F (2°C to 8°C). You can take the container with you for use away from home as long as the container remains at a temperature of 59°F to 86°F (15°C to 30°C). Once the container is opened, the capsules must be used within 60 days.
- Store tipranavir oral solution at 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze the oral solution. Once the container is opened, the oral solution must be used within 60 days.
- Do not use tipranavir if the original seal over the container opening is broken or missing.
- Throw away tipranavir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep tipranavir and all medicines out of reach of children.
Where Can I Find More Information About Tipranavir?
More information about tipranavir is available:
The above Patient Version drug summary is based on the following FDA label(s): Capsule (liquid filled), solution.