• 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

Patients should be told 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. Patients should be advised 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.

Patients should be informed that APTIVUS is not a cure for HIV-1 infection and that they may continue to develop opportunistic infections and other complications associated with HIV-1 disease. The long-term effects of APTIVUS are unknown at this time. Patients should be told that there are currently no data demonstrating that therapy with APTIVUS can reduce the risk of transmitting HIV-1 to others through sexual contact.

FDA-Approved Patient Labeling

Patient information is supplied as a tear-off following the full prescribing information.

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 2010 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

OT2000ME0410
10003515/09

Patient Information

APTIVUS®
(tipranavir) capsules 250 mg

APTIVUS®
(tipranavir) oral solution 100 mg/mL

Read the Patient Information that comes with APTIVUS before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare professional about your medical condition or treatment. You should stay under a healthcare professional’s care while taking APTIVUS.

What is the most important information I should know about APTIVUS?

Patients taking APTIVUS, together with 200 mg NORVIR® (ritonavir), may develop severe liver disease that can cause death. If you develop any of the following symptoms of liver problems, you should stop taking APTIVUS and NORVIR® (ritonavir) and call your healthcare professional right away: tiredness, general ill feeling or "flu-like" symptoms, loss of appetite, nausea (feeling sick to your stomach), yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale stools (bowel movements), or pain, ache, or sensitivity on your right side below your ribs. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems.

Patients taking APTIVUS together with 200 mg NORVIR® (ritonavir) may develop bleeding in the brain that ca