Is ISENTRESS Right For You?

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ISENTRESS is an HIV medicine that, when used with other HIV medicines,
may reduce the amount of HIV in your blood and help increase
the number of CD4 (T) cells.


ISENTRESS is a prescription
HIV-1 medicine used with other
HIV medicines to treat adults with
human immunodeficiency virus (HIV-1)
infection. HIV is the virus that causes
AIDS (Acquired Immune Deficiency
Syndrome).

The use of other medicines active
against HIV-1 in combination with
ISENTRESS may increase your
ability to fight HIV.

ISENTRESS does not cure HIV
infection or AIDS.

Patients must stay on continuous
HIV therapy to control infection and
decrease HIV-related illnesses.

IMPORTANT RISK
INFORMATION:

Severe, potentially life-threatening, and
fatal skin reactions and allergic
reactions have been reported in some
patients taking ISENTRESS. (cont'd
below)

Click here for more important risk information about ISENTRESS

ISENTRESS is a prescription HIV-1 medicine used with other HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV.

ISENTRESS does not cure HIV infection or AIDS.

Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.

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IMPORTANT RISK INFORMATION:

Severe, potentially life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing.

Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV medicine.

People taking ISENTRESS may still develop infections or other conditions associated with HIV infections.

The most common side effects of ISENTRESS include: dizziness, headache, nausea, tiredness and trouble sleeping. Less common side effects include: allergic reaction, depression, hepatitis, genital herpes, herpes zoster including shingles, kidney failure, kidney stones, stomach pain, suicidal thoughts and actions, vomiting and weakness.

Tell your doctor before beginning ISENTRESS if you have a history of muscle disorders (rhabdomyolysis or myopathy) or increased creatine kinase or if you are taking medications known to cause these conditions such as statins, fenofibrate, gemfibrozil or zidovudine.

Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.

Rash occurred more often in patients taking ISENTRESS and darunavir/ritonavir (Prezista) together, than with either drug separately, but was generally mild.

These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacist. Tell your doctor if you have any side effect that bothers you or that does not go away.

Tell your doctor about all your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk.

Tell your doctor about all the medicines you take, including: prescription medicines like rifampin (a medicine commonly used to treat tuberculosis), non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take antacids, as certain antacids (those containing aluminum and/or magnesium) are not recommended to be taken with ISENTRESS.

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.

Please read the Patient Information , for ISENTRESS and discuss it with your doctor. The physician Prescribing Information also is available.

Brands mentioned are the trademarks of their respective owners.


INFC-1066246-0000 08/13