Tipranavir

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Generic Name: Tipranavir Brand Name(s): Generics only. No brands available.

Uses

What is Tipranavir used for?

Tipranavir must be used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

Tipranavir belongs to a class of drugs known as protease inhibitors. It must be given with ritonavir, another protease inhibitor, to increase (“boost”) the levels of tipranavir. This helps tipranavir work better.

How should I take Tipranavir?

Take this medication by mouth with or without food, usually twice daily or as directed by your doctor. If you are using the capsule form of this medication, swallow whole. Do not crush or chew. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Tipranavir must be taken at the same times as ritonavir, another protease inhibitor.

Dosage is based on your medical condition and response to therapy. For children, dosage is also based on weight and body size.

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

Do not take more or less of this drug than prescribed, or stop taking it (or other HIV medicines) even for a short time, unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (develop resistance), or worsen side effects.

How do I store Tipranavir?

Store an unopened bottle of tipranavir capsules in the refrigerator. Do not freeze.

After opening the bottle of capsules for the first time, you may store the medicine at room temperature. Store tipranavir liquid at room temperature away from moisture and heat. Do not store the liquid in the refrigerator.

Throw away any capsules or liquid you have not used within 60 days after you first opened the medicine bottle.

There may be different brands of Tipranavir that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Tipranavir down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Tipranavir?

Before taking tipranavir, tell your doctor or pharmacist if you are allergic to it; or to sulfa drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), blood or bleeding disorders (e.g., hemophilia), other conditions causing an increased risk of bleeding (e.g., injury, surgery), high blood fat levels (cholesterol/triglyceride), other viral infections (chronic hepatitis B or hepatitis C), liver disease (including abnormal liver function tests).

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and tipranavir may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Tipranavir during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Tipranavir. Tipranavir is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Tipranavir?

Diarrhea, nausea, drowsiness, dizziness, headache or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if any of these unlikely but serious side effects occur: depression, increased thirst, signs of kidney problems (such as change in the amount of urine).

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).

Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Tipranavir can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop a rash. Taking estrogen (in birth control or hormone therapy) may increase your risk of developing this rash.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Tipranavir?

Some products that may interact with this drug include: antiplatelet drugs (e.g., clopidogrel), artemether, “blood thinners” (anticoagulants such as warfarin, heparins), NSAIDs (e.g., ibuprofen, naproxen, sulindac, indomethacin), disulfiram, estrogens (e.g., ethinyl estradiol), garlic supplements, vitamin E, lumefantrine, metronidazole, orlistat.

Other medications can affect the removal of tipranavir from your body, which may affect how tipranavir works. Examples include macrolide antibiotics (such as erythromycin), rifampin, St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Tipranavir with ritonavir can both speed up and slow down the removal of other drugs from your body, thereby affecting how they work. Examples of affected drugs include alfuzosin, certain benzodiazepines (e.g., midazolam, triazolam), certain heart rhythm drugs (amiodarone, bepridil, flecainide, propafenone, quinidine), cisapride, colchicine, eletriptan, eplerenone, ergot-containing drugs (e.g., ergotamine), fluticasone, other HIV medications (such as etravirine, other protease inhibitors including fosamprenavir, lopinavir, saquinavir), meperidine, pimozide, ranolazine, rifabutin, salmeterol, certain “statin” cholesterol drugs (such as atorvastatin, lovastatin, simvastatin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil), among others.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.

Tipranavir may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Tipranavir?

Tipranavir may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Tipranavir?

Tipranavir may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Tipranavir.

What is the dose of Tipranavir for an adult?

Usual Adult Dose for HIV Infection

Tipranavir 500 mg plus ritonavir 200 mg orally twice a day

Use: In combination with ritonavir and other antiretrovirals, for the treatment of HIV-1 infection in therapy-experienced patients infected with HIV-1 strains resistant to more than 1 protease inhibitor

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): Caution recommended.

Moderate or severe liver dysfunction (Child-Pugh B or C): Contraindicated

Comments:

-Levels of this drug may be increased in patients with mild liver dysfunction.

-This drug (plus ritonavir) should be used with caution in patients with elevated transaminases or coinfected with HBV or HCV.

Dose Adjustments

2 to 18 years:

-Based on weight: Tipranavir 12 mg/kg plus ritonavir 5 mg/kg orally twice a day

-Based on BSA: Tipranavir 290 mg/m2 plus ritonavir 115 mg/m2 orally twice a day

Comments:

-Dose reduction may be considered if intolerance or toxicity develops and patients cannot continue the usual dose, as long as their virus is not resistant to multiple protease inhibitors.

Other Comments

Administration advice:

-Must use in combination with ritonavir (to exert therapeutic effect); use with other active agents (to increase likelihood of treatment response).

-When coadministered with ritonavir capsules or solution: May administer without regard to meals

-When coadministered with ritonavir tablets: Must only administer with meals

-Swallow capsules whole and do not chew.

-If a patient is unable to reliably swallow a capsule, use the oral solution; administer the oral solution using a calibrated dosing syringe.

Storage requirements:

-Capsules: Store unopened bottle in a refrigerator at 2C to 8C (36F to 46F); after opening bottle, may store at 25C (77F), with excursions permitted to 15C to 30C (59F to 86F); once bottle opened, must use within 60 days.

-Oral solution: Store at 25C (77F), with excursions permitted to 15C to 30C (59F to 86F); do not refrigerate or freeze; once bottle opened, must use within 60 days.

General:

-Use of this drug (plus ritonavir) should be guided by genotypic/phenotypic testing and/or treatment history; virologic response to this drug (plus ritonavir) affected by the number of baseline primary protease inhibitor mutations.

-If this drug is not coadministered with ritonavir correctly, plasma tipranavir levels will not be adequate to achieve desired antiviral effect; some drug interactions will be altered.

-This drug (plus ritonavir) is not recommended for use in therapy-naive patients.

-The manufacturer product information for ritonavir should be consulted.

Monitoring:

-Hepatic: Signs/symptoms of hepatitis; clinical and laboratory monitoring in all patients, especially those coinfected with chronic HBV or HCV; liver function tests (before starting and frequently during therapy)

-Metabolic: Cholesterol and triglyceride levels (prior to therapy and periodically thereafter)

Patient advice:

-Read the US FDA-approved patient labeling (Patient Information).

-If signs/symptoms of clinical hepatitis develop, stop therapy and seek medical attention.

-Report any unusual/unexplained bleeding to physician.

-If symptoms of rash develop, stop therapy and contact physician.

-If using the oral solution, do not take supplemental vitamin E greater than a standard multivitamin.

What is the dose of Tipranavir for a child?

Usual Pediatric Dose for HIV Infection

2 to 18 years:

-Based on weight: Tipranavir 14 mg/kg plus ritonavir 6 mg/kg orally twice a day

-Based on BSA: Tipranavir 375 mg/m2 plus ritonavir 150 mg/m2 orally twice a day

Maximum dose: Tipranavir 500 mg/dose plus ritonavir 200 mg/dose

Comments:

-Special vigilance recommended during dose calculation, medication order transcription, dispensing information, and dosing instructions to reduce risk for medication errors, overdose, and underdose.

-Pediatric dose should not exceed the usual adult dose.

Use: In combination with ritonavir and other antiretrovirals, for the treatment of HIV-1 infection in therapy-experienced patients infected with HIV-1 strains resistant to more than 1 protease inhibitor

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

How is Tipranavir available?

Tipranavir is available in the following dosage forms and strengths:

  • Oral solution,
  • Oral capsule.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Tipranavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: June 2, 2018 | Last Modified: June 2, 2018

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