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Aptivus (tipranavir) capsules

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  • Taking APTIVUS
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  • Full Prescribing Information
  • Side Effects with APTIVUS
    • When Should You Stop Taking APTIVUS
    • Possible Side Effects
  • Important Safety Information
    • Glossary

Glossary

Adherence: Taking your medications regularly as prescribed by a healthcare provider (HCP).

AIDS: Acquired Immune Deficiency Syndrome.

AIDS-defining infection or condition: Also known as opportunistic infections or conditions. These are usually illnesses that a person not infected with HIV normally wouldn’t get.

Antiretroviral drugs: Also referred to as ARVs. Antiretroviral drugs help to manage and control the virus by slowing down HIV’s ability to replicate.

APTIVUS/r: Combination of APTIVUS® (tipranavir) capsules taken with Norvir® (ritonavir).

CD4+ cells: Also known as T cells, CD4+ cells are part of your immune system. They identify and fight infections and other diseases that invade your body.

Chronic hepatitis B infection: A serious disease of the liver caused by the hepatitis B virus (HBV). It is mostly transmitted through contact with blood and other bodily fluids, including sexual contact.

Chronic hepatitis C infection: A serious disease of the liver caused by the hepatitis C virus (HCV). It mostly affects people who share needles, have been on dialysis, have liver disease, or go through frequent blood transfusions or sexual contact.

Combination therapy: APTIVUS/r must be used with at least 2 other anti-HIV medicines. This is referred to as combination therapy.

Genotypic test: A test to see if the HIV virus has developed mutations that may be resistant to certain medications.

HAART: Highly Active Anti-Retroviral Therapy. Three or four anti-HIV drugs with different methods of working are taken together to avoid resistance.

HCP: An HCP, or healthcare provider, is the doctor, nurse, pharmacist, or other healthcare professional that is responsible for your HIV care.

Hemophilia: An inherited disease that prevents the blood from clotting properly.

HIV: Human Immunodeficiency Virus. HIV infects healthy immune cells and prevents them from protecting the body from infection and disease.

Immune system: Defends your body from infection and disease. HIV and AIDS can harm the functioning of your immune system.

Lipid: Another word for cholesterol and/or triglycerides.

Phenotypic test: A test to see if a drug is effective against your virus by measuring the amount of a specific drug needed to keep the HIV virus from reproducing.

Protease inhibitor: A class of anti-HIV drugs that work by blocking protease, an enzyme in a virus that helps it make copies of itself.

Regimen: When used in the context of treatment, a regimen is a combination of medications taken together. It can also be called a “cocktail.”

Replicate: When used in the context of HIV, "replicate" is the word used to describe the action that HIV cells undergo when they make new copies of themselves.

Resistance: A change in the virus that makes HIV medications work less well.

Undetectable: Reducing the amount of HIV in your blood to a level so low that routine testing cannot detect it—a goal of anti-HIV treatment.

Viral load: The amount of HIV in a sample of blood.

Important Safety Information for APTIVUS

  • Patients taking APTIVUS 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 treatment and CALL your HCP 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 HCP should check your blood tests more often because you have an increased chance of developing liver problems. Tell your HCP if you have liver disease, are infected with hepatitis B or C infection, or reduced liver function because you may have increased chance of liver disease problems while taking APTIVUS.
  • Patients taking APTIVUS may develop severe bleeding in the brain that can cause death. You should report any unusual or unexplained bleeding to your HCP if you are taking APTIVUS.
  • APTIVUS capsules and oral solution are always taken with Norvir® (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
  • Your HCP will prescribe at least 2 other anti-HIV medicines with APTIVUS. This usually will increase the likelihood of treatment response.
  • Baseline HIV resistance may affect your response to APTIVUS. Therefore, your HCP should conduct resistance tests and know your treatment history before prescribing APTIVUS.
  • Tell your healthcare professional about all the medications you take. Taking APTIVUS with certain drugs can reduce the effectiveness of your treatment and can result in serious or life-threatening events.
  • Tell your HCP if you have hemophilia or other medical conditions that increase the chances of bleeding. Tell your HCP about medicines you are taking to find out if they may increase your chance of bleeding.
  • If you are taking APTIVUS oral solution, which contains vitamin E, you should not take additional vitamin E other than that contained in a standard multivitamin.
  • Tell your HCP immediately if you develop or if you suspect you have a skin rash. APTIVUS should be used with caution in patients with a known sulfa allergy.
  • Patients may develop new or worsening diabetes, high blood sugar (hyperglycemia), immune reconstitution syndrome, changes in body fat, and elevated lipids. Your HCP may monitor your cholesterol and triglycerides before starting APTIVUS and while on treatment.
  • Women taking APTIVUS and estrogen-based hormonal contraceptives are advised to use alternative methods of contraception during therapy with APTIVUS. Women using estrogens for birth control or hormone replacement have an increased chance of developing a skin rash while taking APTIVUS. If a rash occurs, it is usually mild to moderate, but you should call your HCP.
  • Tell your HCP if you are thinking about becoming pregnant, if you are pregnant, or are thinking about breast-feeding. Breastfeeding can result in passing the HIV virus to your baby.
  • The most common side effects of APTIVUS include diarrhea, nausea, fever, vomiting, tiredness, headache, and stomach pain. Rash was seen more frequently in children.
  • APTIVUS should not be used in children under 2 years of age.

Please consult full Prescribing Information as well as the Patient Package Insert (PPI) including boxed WARNINGS for APTIVUS.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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