tipranavir (Oral route)

tye-PRAN-a-vir

Oral route(Capsule;Solution)

Clinical hepatitis and hepatic decompensation, including some fatalities, have been reported. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection. Fatal and nonfatal intracranial hemorrhage have also been reported .

Commonly used brand name(s)

In the U.S.

  • Aptivus

Available Dosage Forms:

  • Solution
  • Capsule, Liquid Filled

Therapeutic Class: Antiviral

Pharmacologic Class: Protease Inhibitor

Uses For tipranavir

Tipranavir is used in combination with ritonavir (Norvir®) to treat an infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). tipranavir is usually given to patients who have received HIV treatment in the past.

Slideshow: Flashback: FDA Drug Approvals 2013

Tipranavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease from occurring. Tipranavir will not keep you from spreading HIV to other people. People who receive tipranavir may continue to have the problems usually related to AIDS or HIV disease.

tipranavir is available only with your doctor's prescription.

Before Using tipranavir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tipranavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tipranavir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tipranavir in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of tipranavir have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tipranavir.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tipranavir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tipranavir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Alfuzosin
  • Amiodarone
  • Astemizole
  • Bepridil
  • Cisapride
  • Colchicine
  • Conivaptan
  • Dabrafenib
  • Dihydroergotamine
  • Eletriptan
  • Ergonovine
  • Ergotamine
  • Eszopiclone
  • Fentanyl
  • Flecainide
  • Ibrutinib
  • Ivabradine
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Methylergonovine
  • Midazolam
  • Pazopanib
  • Pimozide
  • Primidone
  • Propafenone
  • Quetiapine
  • Quinidine
  • Rifampin
  • Romidepsin
  • Sildenafil
  • Simvastatin
  • St John's Wort
  • Terfenadine
  • Tolvaptan
  • Trabectedin
  • Triazolam
  • Vemurafenib
  • Vilazodone
  • Vorapaxar

Using tipranavir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ado-Trastuzumab Emtansine
  • Afatinib
  • Artemether
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Boceprevir
  • Bosentan
  • Buprenorphine
  • Carbamazepine
  • Ceritinib
  • Clozapine
  • Cyclophosphamide
  • Dabigatran Etexilate
  • Delamanid
  • Dolutegravir
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Eslicarbazepine Acetate
  • Etravirine
  • Everolimus
  • Fluticasone
  • Fosamprenavir
  • Garlic
  • Indinavir
  • Ketoconazole
  • Levomilnacipran
  • Lomitapide
  • Lopinavir
  • Lumefantrine
  • Macitentan
  • Mitotane
  • Nelfinavir
  • Nilotinib
  • Piperaquine
  • Pixantrone
  • Pomalidomide
  • Ponatinib
  • Retapamulin
  • Rifabutin
  • Rifapentine
  • Rilpivirine
  • Rivaroxaban
  • Salmeterol
  • Saquinavir
  • Siltuximab
  • Simeprevir
  • Sofosbuvir
  • Tadalafil
  • Telaprevir
  • Tocophersolan
  • Vilanterol
  • Vinflunine

Using tipranavir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abacavir
  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Bupropion
  • Calcium Carbonate
  • Clarithromycin
  • Cobicistat
  • Conjugated Estrogens
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Enfuvirtide
  • Esterified Estrogens
  • Estradiol
  • Estriol
  • Estrone
  • Estropipate
  • Ethinyl Estradiol
  • Fluconazole
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Methadone
  • Omeprazole
  • Phenobarbital
  • Rosuvastatin
  • Tenofovir Disoproxil Fumarate
  • Trazodone
  • Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of tipranavir. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems (e.g., hemophilia)—Use with caution. May increase the chance of bleeding.
  • Diabetes mellitus or
  • Hyperglycemia (high blood sugar)—May increase the amount of sugar in your blood.
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Liver problems (including hepatitis B or C)—Use with caution. May make these conditions worse. .
  • Liver disease, moderate or severe—Should not be used in patients with this condition.
  • Sulfa allergy, known or suspected—Use with caution. May cause side effects to be worse.

Proper Use of tipranavir

Take tipranavir exactly as directed by your doctor. Do not change your dose or stop using tipranavir without checking first with your doctor. When your supply of tipranavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of tipranavir.

tipranavir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Tipranavir is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.

If you are using tipranavir with ritonavir capsules or oral liquid, you may take it with or without food. However, you should take tipranavir with food if you are using it with ritonavir tablets.

Swallow the capsule whole. Do not break, crush, or chew it.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of tipranavir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tipranavir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of HIV infection:
    • For oral dosage forms (capsules or oral liquid):
      • Adults—500 milligrams (mg) or 5 milliliters (mL) of tipranavir and 200 mg of ritonavir (Norvir®) two times per day.
      • Children 2 to 18 years of age—Dose is based on body weight or body size and must be determined by your doctor. The dose is usually 14 milligrams (mg) per kilogram (kg) of body weight of tipranavir plus 6 mg per kg of body weight of ritonavir (Norvir®), or 375 mg/m(2) of body size of tipranavir plus 150 mg/m(2) of body size of ritonavir two times per day. Your doctor may adjust your dose if needed. However, the dose should not be more than the recommended adult dose.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed 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 go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules in the refrigerator until you are ready to open the bottle. Once you have opened the medicine bottle, you may store it at room temperature, away from heat, light, or moisture. The medicine is good for up to 60 days after you open the bottle. Throw away any unused capsules after 60 days and get a new bottle of medicine. .

Store the oral liquid at room temperature. Do not refrigerate or freeze it. The liquid must be used within 60 days after you open the bottle.

Precautions While Using tipranavir

It is very important that your doctor check the progress of you or your child at regular visits to make sure that tipranavir is working properly. Blood tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

You should not use any of the following medicines while you or your child are taking tipranavir. Using these medicines together with tipranavir may increase your chance of having serious medical problems:

  • Alfuzosin (Uroxatral®) or
  • Amiodarone (Cordarone®, Pacenone®) or
  • Bepridil (Vascor®) or
  • Cisapride (Propulsid®) or
  • Ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Methergine®, or Migranal®) or
  • Flecainide (Tambocor®) or
  • Lovastatin (Altocor®, Mevacor®) or
  • Oral midazolam (Versed®) or
  • Pimozide (Orap®) or
  • Propafenone (Rythmol®) or
  • Quinidine (Cardioquin®, Quinaglute dura®) or
  • Rifampin (Rifadin®, Rimactane®) or
  • Sildenafil (Revatio®) or
  • Simvastatin (Simcor®, Vytorin®, Zocor®) or
  • Triazolam (Halcion®).

tipranavir may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, diaphragms, or contraceptive foams or jellies.

tipranavir may cause intracranial hemorrhage (bleeding in the brain). Make sure your doctor knows if you or your child have a bleeding disorder, or any medical condition that increases your chance of bleeding. Call your doctor right away if you have any unusual or unexplained bleeding.

Stop using tipranavir and check with your doctor right away if you or your child have pain in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

When you start taking HIV medicines, your immune system may get stronger. If you have certain infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

tipranavir will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.

Serious skin reactions can occur with tipranavir. Stop using tipranavir and check with your doctor right away if you or your child have more than one of the following symptoms while using tipranavir: blistering, peeling, or loosening of the skin; fever or chills; itching; joint or muscle pain; severe rash; red skin lesions; sunburn; throat tightness; or sores, ulcers, or white spots in the mouth or on the lips.

tipranavir may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

tipranavir may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

tipranavir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Bleeding gums
  • confusion
  • cough producing mucus
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • fever
  • general feeling of tiredness or weakness
  • headache
  • increased menstrual flow or vaginal bleeding
  • loss of appetite
  • nausea or vomiting
  • nosebleeds
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry, or light-colored stools
  • red or dark brown urine
  • shortness of breath
  • sudden severe weakness
  • tightness in the chest
  • unusual bleeding
  • upper right abdominal or stomach pain
  • wheezing
  • yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
Less common
  • Abdominal or stomach pain
  • cough
  • discouragement
  • fat redistribution
  • feeling sad or empty
  • irritability
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • rash
  • sleeplessness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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