ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults, and in children weighing at least 4.4 pounds (2 kg).
ISENTRESS HD is a prescription HIV medicine used with other antiretroviral medicines to treat HIV-1 infection in adults, and in children weighing at least 88 pounds (40 kg).
ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults, and in children weighing at least 4.4 pounds (2 kg).
ISENTRESS HD is a prescription HIV medicine used with other antiretroviral medicines to treat HIV-1 infection in adults, and in children weighing at least 88 pounds (40 kg). HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
ISENTRESS should not be used in children weighing less than 4.4 pounds (2 kg).
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Some people who take ISENTRESS or ISENTRESS HD develop severe skin reactions and allergic reactions that can be serious, and may be life-threatening or lead to death. If you develop a rash, call your doctor right away. If you develop a rash with any of the following symptoms, stop using ISENTRESS or ISENTRESS HD and call your doctor or get medical help 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, lips, or face; problems breathing.
Some people who take ISENTRESS or ISENTRESS HD develop severe skin reactions and allergic reactions that can be serious, and may be life-threatening or lead to death. If you develop a rash, call your doctor right away. If you develop a rash with any of the following symptoms, stop using ISENTRESS or ISENTRESS HD and call your doctor or get medical help 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, lips, or face; problems breathing.
Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of your skin or whites of your eyes; dark or tea-colored urine; pale-colored stools (bowel movements); nausea or vomiting; loss of appetite; pain, aching, or tenderness on the right side of your stomach area.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 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-1 medicine.
People taking ISENTRESS or ISENTRESS HD may still develop infections or other conditions associated with HIV-1 infections.
The most common side effects of ISENTRESS or ISENTRESS HD include: trouble sleeping, headache, dizziness, nausea, and tiredness. Less common side effects include: depression, hepatitis, genital herpes, herpes zoster including shingles, kidney failure, kidney stones, indigestion or stomach area pain, vomiting, suicidal thoughts and actions, and weakness.
Tell your doctor before you take ISENTRESS or ISENTRESS HD if you have a history of a muscle disorder called rhabdomyolysis or myopathy or increased levels of creatine kinase in your blood.
Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS or ISENTRESS HD. These may be signs of a rare serious muscle problem that can lead to kidney problems.
These are not all the possible side effects of ISENTRESS or ISENTRESS HD. 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. Do not breastfeed if you take ISENTRESS or ISENTRESS HD. 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 and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with ISENTRESS or ISENTRESS HD. Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take ISENTRESS or ISENTRESS HD with those other medicines.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call FDA at 1-800-FDA-1088.
Please read the accompanying Patient Information and Instructions for Use for ISENTRESS and ISENTRESS HD and discuss them with your doctor. The physician Prescribing Information also is available.
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