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APTIVUS- tipranavir capsule, liquid filledAPTIVUS- tipranavir solution

Patient Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Hepatic Impairment and Toxicity

    Inform patients that APTIVUS co-administered with 200 mg of ritonavir, has been associated with severe liver disease, including some deaths. Patients with signs or symptoms of clinical hepatitis should discontinue APTIVUS/ritonavir treatment and seek medical evaluation. Symptoms of hepatitis include fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. Extra vigilance is needed for patients with chronic hepatitis B or C co-infection, as these patients have an increased risk of developing hepatotoxicity.

    Liver function tests should be performed prior to initiating therapy with APTIVUS and 200 mg of ritonavir, and frequently throughout the duration of treatment. Patients with chronic hepatitis B or C co-infection or elevations in liver enzymes prior to treatment are at increased risk (approximately 2-fold) for developing further liver enzyme elevations or severe liver disease. Caution should be exercised when administering APTIVUS/ritonavir to patients with liver enzyme abnormalities or history of chronic liver disease. Increased liver function testing is warranted in these patients. APTIVUS should not be given to patients with moderate to severe hepatic impairment.

  • Intracranial Hemorrhage

    Inform patients that APTIVUS co-administered with 200 mg of ritonavir has been associated with reports of both fatal and non-fatal intracranial hemorrhage. Patients should report any unusual or unexplained bleeding to their physician.

  • Drug Interactions

    APTIVUS may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or non-prescription medications or herbal products, particularly St. John s wort.

  • Use of Vitamin E

    Advise patients taking APTIVUS oral solution not to take supplemental vitamin E greater than a standard multivitamin as APTIVUS oral solution contains 116 IU/mL of vitamin E and when taken at the recommended maximum dose of 500 mg/200 mg tipranavir/ritonavir BID, results in a daily dose of 1160 IU. This intake is higher than the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU).

  • Rash

    Rash, including flat or raised rashes or sensitivity to the sun, have been reported in approximately 10% of subjects receiving APTIVUS. Some patients who developed rash also had one or more of the following symptoms: joint pain or stiffness, throat tightness, generalized itching, muscle aches, fever, redness, blisters, or peeling of the skin. Women taking birth control pills may get a skin rash. Tell patients to discontinue use of APTIVUS and call their physician right away if any of these symptoms develop.

  • Sulfa Allergy

    Tell patients to report any history of sulfonamide allergy to the physician.

  • Contraceptives

    Instruct women receiving estrogen-based hormonal contraceptives that additional or alternative contraceptive measures should be used during therapy with APTIVUS. There may be an increased risk of rash when APTIVUS is given with hormonal contraceptives [see Use in Specific Populations(8.3)].

  • Fat Redistribution

    Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time.

  • Administration

    Inform patients that APTIVUS must be co-administered with ritonavir to ensure its therapeutic effect. Failure to correctly co-administer APTIVUS with ritonavir will result in reduced plasma levels of tipranavir that may be insufficient to achieve the desired antiviral effect.

    • APTIVUS co-administered with ritonavir capsules or solution can be taken with or without meals
    • APTIVUS co-administered with ritonavir tablets must only be taken with meals

    Instruct patients to swallow APTIVUS capsules whole. They must not be opened or chewed.

    Tell patients that sustained decreases in plasma HIV-1 RNA have been associated with a reduced risk of progression to AIDS and death. Patients should remain under the care of a physician while using APTIVUS. Advise patients to take APTIVUS and other concomitant antiretroviral therapy every day as prescribed. APTIVUS, co-administered with ritonavir, must be given in combination with other antiretroviral drugs. Patients should not alter the dose or discontinue therapy without consulting with their healthcare professional. If a dose of APTIVUS is missed, patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped the patient should not double the next dose.

  • Pregnancy Registry

    Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to APTIVUS during pregnancy [see Use in Specific Populations(8.1)].

  • Lactation

    Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations(8.2)].

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

Address medical inquiries to: (800) 542-6257 or (800) 459-9906 TTY.

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

Copyright 2018 Boehringer Ingelheim International GmbH


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