Tipranavir
Pronunciation: tip-ra-NA-veer.
- Generic name
- Tipranavir
- Brand names
- Tipranavir Cipla, Tipranavir Hetero, Aptivus, Tipranavir Natco
- Drug class
- Antiretroviral, Protease Inhibitor
Availability and supply rules vary by country
Trade names by country: Canada
Australia: · Full directory
What Tipranavir is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Tipranavir works
Tipranavir is a non-peptidic protease inhibitor that binds to the active site of the HIV-1 protease enzyme, preventing the cleavage of viral polyproteins. This inhibition results in the production of immature, non-infectious viral particles, thereby reducing viral replication and viral load in the patient. (1)
What Tipranavir is used for
HIV-1 infection
HIV-1 infection (1)
Before taking Tipranavir
Do not take / not appropriate for
- Contraindicated in patients with moderate or severe hepatic impairment, known hypersensitivity to tipranavir or its components, and those taking medications highly dependent on CYP3A4 for clearance. (Contraindication) (1)
Tell your clinician about
(1)How to take Tipranavir
- General Instructions: Take tipranavir exactly as prescribed by your healthcare provider, always in combination with ritonavir. Do not change your dose or stop taking it without consulting your doctor.. Adult Dosing: The usual adult dose is 500 mg tipranavir (two 250 mg capsules) plus 200 mg ritonavir, both taken orally twice daily with food.. Pediatric Dosing: Dosing for children (aged 2 years and older) is based on body weight or body surface area and must be determined by a pediatric HIV specialist.. Administration: Take tipranavir with food to improve absorption. Swallow capsules whole; do not crush or chew. If using the oral solution, measure the dose carefully with a dosing syringe or cup.. When To Stop: Do not stop taking tipranavir unless instructed by your doctor. Stopping suddenly can cause the virus to become resistant.. Storage: Store unopened capsule bottles in the refrigerator (2-8°C/36-46°F); after opening, capsules may be kept at room temperature (20-25°C/68-77°F) and must be used within 60 days. The oral solution should be stored at room temperature and used within 60 days after opening.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention or contact your local poison control center immediately. Symptoms may include severe nausea, vomiting, abdominal pain, or signs of liver toxicity. Supportive care is the mainstay of treatment. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Abdominal pain
Incidence: Reported in the clinician-authored database; frequency not established
Rash
Incidence: Reported in the clinician-authored database; frequency not established
Hepatotoxicity
Incidence: Reported in the clinician-authored database; frequency not established
Intracranial hemorrhage
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
FDA BOXED WARNING — Hepatotoxicity — serious
Symptoms: FDA BOXED WARNING — Hepatotoxicity: clinical hepatitis and hepatic decompensation, including some fatalities, have been reported with tipranavir/ritonavir. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, who have an increased risk of hepatotoxicity. Intracranial Hemorrhage: both fatal and non-fatal intracranial hemorrhage have been reported with tipranavir/ritonavir use.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Tipranavir can cause severe liver toxicity, sometimes fatal (see FDA boxed warning above) — serious
Symptoms: Tipranavir can cause severe liver toxicity, sometimes fatal (see FDA boxed warning above). Increased risk of bleeding, especially in patients with hemophilia. May cause changes in cholesterol and triglyceride levels. Can interact with many other medications, leading to serious side effects. Not recommended for use in patients with moderate or severe hepatic impairment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with moderate or severe hepatic impairment, known hypersensitivity to tipranavir or its components, and those taking medications highly dependent on CYP3A4 for clearance. Use with caution in patients with pre-existing liver disease, bleeding disorders, or hyperlipidemia.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Tipranavir has significant interactions with many medications, including other antiretrovirals, anticoagulants, anticonvulsants, certain antibiotics, cholesterol-lowering drugs, and herbal supplements like St. John’s wort. Always inform your healthcare provider about all medicines and supplements you are taking. Some interactions can cause life-threatening side effects or reduce the effectiveness of HIV therapy. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
There is a pregnancy exposure registry that monitors outcomes in women exposed to Aptivus (tipranavir) during pregnancy (Antiretroviral Pregnancy Registry, 1-800-258-4263). Available data from the registry and an expanded-access program are not sufficient to fully assess the risk of major birth defects, miscarriage, or adverse maternal/fetal outcomes; no birth defects were seen among a limited number (13) of first-trimester exposures reported so far. Discuss any pregnancy or plans for pregnancy with your prescriber. (1)
Breastfeeding
There is no information on whether tipranavir passes into human breast milk or its effects on a breastfed infant or on milk production (it has been found in the milk of lactating rats). Breastfeeding while HIV-positive also carries a risk of transmitting HIV to the infant (in HIV-negative infants) or of the infant's HIV developing viral resistance. Discuss the safest feeding approach for your baby with your HIV care team. (1)
Children
Frequency: Twice daily, always together with ritonavir.. Weight Based: Approved for pediatric patients weighing 36 kg or more who are treatment-experienced with resistance to more than one protease inhibitor; dosing is set by a pediatric HIV specialist based on body surface area/weight.. Max Daily Dose: Not established on this page for pediatric use; follow the prescriber's specific regimen.. Max Single Dose: Not established on this page for pediatric use.. Age Restrictions: Approved from 2 years of age and 36 kg body weight; safety and effectiveness below this weight have not been established. (1)
Renal_impairment
Renal: tipranavir's pharmacokinetics have not been formally studied in renal dysfunction, but because its renal clearance is negligible, a decrease in total body clearance is not expected with renal insufficiency, and no dose adjustment is specified. Hepatic: tipranavir is contraindicated in moderate or severe hepatic impairment (Child-Pugh Class B or C) because its pharmacokinetics have not been evaluated in these groups, and the boxed-warning hepatotoxicity risk is a major concern. In mild hepatic impairment (Child-Pugh Class A), a study found higher tipranavir and ritonavir blood levels than in unimpaired subjects, but within the range seen in clinical trials, so no dosing adjustment is required. Liver function tests should be monitored before starting and regularly during treatment. (1)
Hepatic_impairment
Renal: tipranavir's pharmacokinetics have not been formally studied in renal dysfunction, but because its renal clearance is negligible, a decrease in total body clearance is not expected with renal insufficiency, and no dose adjustment is specified. Hepatic: tipranavir is contraindicated in moderate or severe hepatic impairment (Child-Pugh Class B or C) because its pharmacokinetics have not been evaluated in these groups, and the boxed-warning hepatotoxicity risk is a major concern. In mild hepatic impairment (Child-Pugh Class A), a study found higher tipranavir and ritonavir blood levels than in unimpaired subjects, but within the range seen in clinical trials, so no dosing adjustment is required. Liver function tests should be monitored before starting and regularly during treatment. (1)
Monitoring
(1)Storage
Store unopened bottles of tipranavir (Aptivus) capsules in the refrigerator at 2-8°C (36-46°F). After opening, capsules may be stored at 20-25°C (68-77°F), with excursions permitted between 15-30°C (59-86°F), and must be used within 60 days of first opening the bottle. Store in a safe place out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: HIV-1 infection
Dose summary: Tipranavir 500 mg orally twice daily, in combination with ritonavir 200 mg orally twice daily.
Renal context: Tipranavir's pharmacokinetics have not been formally studied in patients with renal dysfunction. Because renal clearance of tipranavir is negligible, a decrease in total body clearance is not expected with renal insufficiency, so no dose adjustment is specified. (1)
Hepatic guidance
Tipranavir is contraindicated in moderate or severe hepatic impairment (Child-Pugh Class B or C), since its pharmacokinetics have not been evaluated in those groups. In mild hepatic impairment (Child-Pugh Class A), a controlled study found higher tipranavir and ritonavir plasma concentrations than in unimpaired subjects, but within the range observed in clinical trials, so no dosing adjustment is required. Liver function tests should be monitored before and regularly during therapy; discontinue for clinical hepatitis or marked transaminase elevations (see boxed warning).
Frequently asked questions
What is tipranavir used for?
Tipranavir is used in combination with other antiretroviral medicines to treat HIV-1 infection in adults and children aged 2 years and older, especially in patients who are resistant to other HIV medications.
How does tipranavir work?
Tipranavir is a protease inhibitor that blocks an enzyme HIV needs to multiply, helping to reduce the amount of virus in the body and maintain immune function.
What are the most common side effects?
Common side effects include diarrhea, nausea, vomiting, abdominal pain, headache, and rash. Some people may also experience changes in liver enzymes or cholesterol levels.
Can tipranavir cure HIV?
No, tipranavir does not cure HIV or AIDS. It helps control the infection and reduces the risk of HIV-related complications when taken as prescribed.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double up doses. Continue with your regular dosing schedule.
Are there any foods or drinks I should avoid?
Avoid alcohol, as it may increase the risk of liver problems. Always take tipranavir with food for best absorption.
Is tipranavir safe during pregnancy or breastfeeding?
Tipranavir should be used during pregnancy only if clearly needed and prescribed by your doctor. It is not recommended during breastfeeding, as HIV can be passed to the baby through breast milk.
What happens if I take too much Tipranavir?
Taking too much Tipranavir can lead to an overdose, potentially causing severe side effects such as liver problems, gastrointestinal distress, and neurological symptoms. If you suspect an overdose, seek immediate emergency medical attention. Do not attempt to induce vomiting or self-treat. Prompt medical evaluation is crucial for managing potential complications.
Can I drink alcohol while taking Tipranavir?
It is generally advisable to avoid or limit alcohol consumption while taking Tipranavir. Alcohol can increase the risk of liver damage, a known side effect of protease inhibitors. Combining alcohol with Tipranavir may exacerbate liver toxicity and other adverse effects. Always consult your healthcare provider regarding alcohol intake during your treatment.
Is Tipranavir safe during pregnancy?
Tipranavir's safety during pregnancy is not fully established, and it falls under a pregnancy category that requires careful consideration. It is crucial to consult your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. They can assess the potential risks and benefits, and discuss alternative treatment options to ensure the best outcome for both you and your baby.
What is the mechanism of action of Tipranavir?
Tipranavir is a non-peptidic protease inhibitor that binds to the active site of the HIV-1 protease enzyme, preventing the cleavage of viral polyproteins. This inhibition results in the production of immature, non-infectious viral particles, thereby reducing viral replication and viral load in the patient. (1)
What is the generic name of Tipranavir?
The generic name is Tipranavir. It is sold under brand names including Tipranavir Cipla, Tipranavir Hetero, Aptivus, Tipranavir Natco.
What class of drug is Tipranavir?
Tipranavir is classed as: Antiretroviral, Protease Inhibitor.
References
- Tipranavir — Prescribing Informationunresolved — authority not stated in research notes · unresolved — country/region not stated in research notes · dated unresolved — not supplied in research notes · accessed 2026-08-07 · source 1
- Tipranavir — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 2
- Tipranavir — RxNorm normalized drug concept (RXCUI 190548)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 3
Brand names by country
Single-ingredient Tipranavir names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
Canada
- APTIVUS