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tipranavir (Rx)Brand and Other Names:Aptivus

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 250mg

oral solution

  • 100mg/mL
more...

HIV Infection

500 mg PO BID; coadministration with ritonavir 200 mg PO BID is required (boosted therapy)

Administration with ritonavir essential to achieve correct dosing and adequate blood levels

Other Information

Administration

  • If taken with ritonavir tablets: Take with food
  • If taken with ritonavir capsules and oral solution: Take with food if possible (may improve tolerability)

Monitor: LFTs

Dosage Forms & Strengths

capsule

  • 250mg

oral solution

  • 100mg/mL
more...

HIV Infection

Neonates and infants: Safety and efficacy not established

2-18 years: 14 mg/kg (tipranavir) coadministered with 6 mg/kg (ritonavir) PO BID, OR  

375 mg/sq.meter (tipranavir) coadministered with 150 mg/sq.meter (ritonavir) PO BID 

Do not exceed adult dose of 500 mg (tipranavir) coadministered with 200 mg (ritonavir) PO BID

Administration with ritonavir essential to achieve correct dosing and adequate blood levels

Dose reduction

  • May reduce dose if not tolerated if patient does not have virus resistant to more than one PI
  • 12 mg/kg (tipranavir) coadministered with 5 mg/kg (ritonavir) PO BID, OR
  • 290 mg/sq.meter (tipranavir) coadministered with 115 mg/sq.meter (ritonavir) PO BID

Other Information

Administration

  • If taken with ritonavir tablets: Take with food
  • If taken with ritonavir capsules and oral solution: Take with food if possible (may improve tolerability)

Monitor: LFTs

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Interactions

Interaction Checker

tipranavir and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Diarrhea

            1-10%

            Abdominal pain

            Asthenia

            Bronchitis

            Cough

            Depression

            Fatigue

            Headache

            Insomnia

            Nausea

            Pyrexia

            Rash

            Vomiting

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            Warnings

            Black Box Warnings

            Hepatitis and hepatic decompensation, including some fatalities, reported; extra vigilance warranted with chronic hepatitis B or hepatitis C coinfection because of increased risk of hepatotoxicity

            Intracranial hemorrhage, both fatal and nonfatal, reported

            Contraindications

            Hypersensitivity

            Mod-severe hepatic impairment (Child-Pugh Class B & C)

            Drugs that are contraindicated with tipranavir (when coadministered 'boosted' with ritonavir) include alpha1-adrenoreptor agonists (eg, alfuzosin), antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, quinidine), rifampin, voriconazole, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, St. John’s wort, lovastatin, simvastatin, pimozide, sildenafil (when used for PAH), midazolam, and triazolam

            Cautions

            Mild hepatic impairment

            Risk of severe, potentially fatal hepatotoxicity

            Not recommended in Tx-naive patients

            May have antiplatelet/anticoagulant action

            Risk of potentially fatal intracranial hemorrhage

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

            Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment

            Must be coadministered with ritonavir

            Sulfonamide allergy

            Coadministration with other CYP3A4 substrates (ritonavir inhibits CYP3A4 and increases toxicity risk for drugs metabolized by CYP3A4)

            Increased risk of rash, especially with hormonal contraceptives

            Risk of large incr in total cholesterol and triglycerides

            Contains 116 IU/mL vitamin E (>RDA); limit supplemented vitamin E

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: do not nurse (HIV-infected mothers shouldn't nurse anyway)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Bioavailability: incr by food

            Protein Bound: 99.9%

            Half-Life: 5.5-6 hr

            Metabolism: primarily by liver CYP3A4

            Excretion: 82.3% (feces); 4% (urine)

            Mechanism of Action

            Protease Inhibitor

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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