Tipranavir

What is Tipranavir?

• Tipranavir (Aptivus) a protease inhibitor, co-administered with ritonavir, used in the therapy and prevention of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS).

Tipranavir

Tipranavir 3D

What are the uses of this medicine?

Tipranavir (Aptivus) is a prescription medicine used with ritonavir and other anti-HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in people who:

• have taken anti-HIV-1 medicines in the past, and
• whose healthcare provider determines that they meet certain requirements.

• HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

How does this medicine work?

• Tipranavir is an antiretroviral drug.
• Tipranavir (tye pran' a vir) a nonpeptidic antiretroviral protease inhibitor that acts by binding to the catalytic site of the HIV protease, thereby preventing the cleavage of viral polyprotein precursors into mature, functional proteins that are necessary for viral replication.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have moderate to severe liver problems

take any of the following medicines:

• alfuzosin
• amiodarone
• atorvastatin or a product that contains atorvastatin
• bepridil
• cisapride

ergot-containing medicines:

• dihydroergotamine
• ergonovine
• ergotamine
• methylergonovine
• flecainide
• lovastatin or a product that contains lovastatin
• lurasidone
• midazolam, when taken by mouth
• pimozide
• propafenone
• quinidine
• rifampin
• sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)
• simvastatin or a product that contains simvastatin
• St. John's wort, or a product that contains St. John's wort
• triazolam

What drug interactions can this medicine cause?

Co-administration of APTIVUS can alter the concentrations of other drugs and other drugs may alter the concentration of tipranavir. The potential for drug-drug interactions must be considered prior to and during therapy.

APTIVUS cannot be used with the following medicines:

• alfuzosin
• amiodarone
• atorvastatin or a product that contains atorvastatin
• bepridil
• cisapride
• ergot-containing medicines:
• dihydroergotamine
• ergonovine
• ergotamine
• methylergonovine
• flecainide
• lovastatin or a product that contains lovastatin
• lurasidone
• midazolam, when taken by mouth
• pimozide
• propafenone
• quinidine
• rifampin
• sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)
• simvastatin or a product that contains simvastatin
• St. John's wort, or a product that contains St. John's wort
• triazolam

Is this medicine FDA approved?

• Tipranavir was approved for use in the United States in adults in 2005 and for children in 2008 for the therapy of HIV infection in combination with other antiretroviral agents.
• Tipranavir is typically used in combination with low “booster” doses of ritonavir, which inhibits its hepatic metabolism and improves its pharmacokinetics.

How should this medicine be used?

Recommended dosage:

• Adults: 500 mg APTIVUS, co-administered with 200 mg ritonavir, twice daily.
• Pediatric patients (age 2 to 18 years): Dosing is based on body weight or body surface area not to exceed adult dose.

Administration:

• APTIVUS comes in 2 forms: capsules and oral solution.
• You must take APTIVUS at the same time you take ritonavir.
• APTIVUS taken with ritonavir capsules or solution can be taken with or without meals.
• APTIVUS taken with ritonavir tablets must only be taken with meals.
• The adult dose is 2 APTIVUS capsules or 5 mL of APTIVUS oral solution taken together with ritonavir twice a day.
• APTIVUS taken with ritonavir must be used together with other anti-HIV-1 medicines.
• If your child is taking APTIVUS, your child's healthcare provider will decide the right dose based on the child's weight or size. The dose should not be more than the recommended adult dose.
• Your child will be checked to see if they can swallow capsules. If your child cannot swallow an APTIVUS capsule, your healthcare provider will prescribe APTIVUS oral solution.
• You should swallow APTIVUS capsules whole. Do not open or chew the capsules.
• Stay under the care of your healthcare provider during treatment with APTIVUS.
• Do not change your dose or stop taking APTIVUS without talking to your healthcare provider.
• If you forget to take APTIVUS, take the next dose of APTIVUS together with ritonavir as soon as you remember. Take your next dose of APTIVUS at your normal time. Do not take a double dose to make up for a missed dose.
• When your APTIVUS supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to APTIVUS and become harder to treat.
• If you take too much APTIVUS, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 250 mg
• Oral solution: 100 mg/mL

This medicine is available in fallowing brand namesː

• APTIVUS

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• fever
• vomiting
• tiredness
• headache
• stomach pain

APTIVUS may cause serious side effects, including:

• Liver problems
• intracranial hemorrhage, or ICH
• Rash
• hyperglycemia
• Immune Reconstitution Syndrome
• Changes in body fat
• Increased blood fat (lipid) levels
• Increased bleeding in patients with hemophilia

What special precautions should I follow?

• Clinical hepatitis and hepatic decompensation, including some fatalities, were reported with APTIVUS. Discontinue for signs and symptoms of clinical hepatitis or asymptomatic increases in ALT/AST >10 times ULN or asymptomatic increases in ALT/AST 5-10 times ULN with concomitant increases in total bilirubin. Monitor liver function tests prior to therapy and frequently thereafter.
• APTIVUS, co-administered with 200 mg of ritonavir, has been associated with reports of both fatal and non-fatal intracranial hemorrhage (ICH). Use with caution in patients at risk for increased bleeding or who are receiving medications that increase the risk of bleeding.
• The concomitant use of APTIVUS/ritonavir and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions.
• Rash, including urticarial rash, maculopapular rash, and possible photosensitivity, has been reported in subjects receiving APTIVUS/ritonavir. Discontinue and initiate appropriate treatment if severe skin reaction occurs or is suspected. Use with caution in patients with a known sulfonamide allergy.
• Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia , immune reconstitution syndrome , redistribution/accumulation of body fat , and elevated lipids. Monitor cholesterol and triglycerides prior to therapy and periodically thereafter.
• There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis in patients with hemophilia type A and B treated with protease inhibitors. Spontaneous bleeding may occur, and additional factor VIII may be required.
• Patients taking APTIVUS oral solution should be advised not to take supplemental vitamin E greater than a standard multivitamin as APTIVUS oral solution contains 116 IU/mL of vitamin E which is higher than the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU).
• APTIVUS should be used with caution in patients with a known sulfonamide allergy. Tipranavir contains a sulfonamide moiety.
• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including APTIVUS.
• Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy.
• Tipranavir can cause transient and usually asymptomatic elevations in serum aminotransferase levels and is a rare cause of clinically apparent, acute liver injury. In coinfected patients, hepatic injury during highly active antiretroviral therapy including tipranavir may be a result of exacerbation of the underlying chronic hepatitis B or C, rather than a direct effect of the medication.

What to do in case of emergency/overdose?

Management of overdosage:

• There is no known antidote for APTIVUS overdose.
• Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
• If indicated, elimination of unabsorbed tipranavir should be achieved by emesis or gastric lavage.
• Administration of activated charcoal may also be used to aid in removal of unabsorbed drug.
• Since tipranavir is highly protein bound, dialysis is unlikely to provide significant removal of the drug.

Can this medicine be used in pregnancy?

• It is not known if APTIVUS can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with APTIVUS.
• There is a pregnancy registry for women who take APTIVUS during pregnancy.
• The purpose of this registry is to collect information about the health of you and your baby.
• Talk to your healthcare provider about how you can take part in this registry.

Can this medicine be used in children?

• It is not known if APTIVUS is safe and effective in children under 2 years of age.

What are the active and inactive ingredients in this medicine?

Capsules:

• Active Ingredient: tipranavir
• Major Inactive Ingredients: dehydrated alcohol, polyoxyl 35 castor oil, propylene glycol, mono/diglycerides of caprylic/capric acid, and gelatin.

Oral Solution:

• Active Ingredient: tipranavir
• Major Inactive Ingredients: polyethylene glycol 400, vitamin E polyethylene glycol succinate, purified water, and propylene glycol.

Who manufactures and distributes this medicine?

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

• APTIVUS® is a registered trademark used under license from Boehringer Ingelheim International GmbH.

What should I know about storage and disposal of this medication?

Capsules:

• Store unopened bottles of APTIVUS capsules in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Once the bottle of APTIVUS capsules is opened, the capsules may be stored at room temperature 68°F to 77°F (20°C to 25°C) and must be used within 60 days after first opening of the bottle.

Oral Solution:

• Store APTIVUS oral solution at 59°F to 77°F (15°C to 25°C).
• Do not refrigerate or freeze APTIVUS oral solution.
• APTIVUS oral solution must be used within 60 days after first opening of the bottle.

Antiviral agents

Drugs for HIV Infection, in the Subclass Antiretroviral Agents

• Fusion Inhibitors (HIV)
  • Enfuvirtide, Maraviroc

• Integrase Inhibitors (HIV)
  • Dolutegravir, Elvitegravir, Raltegravir

• Monoclonal Antibodies
  • Ibalizumab

• Nonnucleoside Reverse Transcriptase Inhibitors (HIV)
  • Delavirdine, Efavirenz, Etravirine, Nevirapine, Rilpivirine

• Nucleoside Analogues (HIV)
  • Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Tenofovir, Zidovudine

• Protease Inhibitors (HIV)
  • Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir,Ritonavir, Saquinavir, Tipranavir

Drugs for Hepatitis B

• • Alpha Interferon, Adefovir, Emtricitabine, Entecavir, Lamivudine, Telbivudine, Tenofovir

Drugs for Hepatitis C

• Interferon Based Therapies
  • Alpha Interferon and Peginterferon, Ribavirin

HCV NS5A Inhibitors

• Daclatasvir, Elbasvir, Ledipasvir, Ombitasvir, Pibrentasvir, Velpatasvir

HCV NS5B (Polymerase) Inhibitors

• Dasabuvir, Sofosbuvir

HCV Protease Inhibitors

• Asunaprevir, Boceprevir, Glecaprevir, Grazoprevir, Paritaprevir, Simeprevir, Telaprevir, Voxilaprevir

Combination Therapies

• Epclusa, Harvoni, Mavyret, Technive, Viekira Pak, Vosevi, Zepatier

Drugs for Herpes Virus Infections (HSV, CMV, others)

• Acyclovir, Cidofovir, Famciclovir, Foscarnet, Ganciclovir, Valacyclovir, Valganciclovir

Drugs for Influenza

• Amantadine, Oseltamivir, Peramivir, Rimantadine, Zanamivir

• Dailymed label info on Tipranavir
• FDA Tipranavir

Tipranavir Resources
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