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Medications and Drugs

Brand Names: Isentress

Generic Name: raltegravir (Pronunciation: ral TEG ra veer)

What is raltegravir (Isentress)?

Raltegravir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Raltegravir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.

Raltegravir may also be used for purposes not listed in this medication guide.

Isentress

oval, pink, imprinted with 227

What are the possible side effects of raltegravir (Isentress)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, raltegravir can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • drowsiness, confusion, increased thirst, lower back pain, urinating less than usual or not at all;
  • depressed mood, unusual thoughts about hurting yourself;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • headache; sleep problems (insomnia);
  • mild stomach pain, vomiting, diarrhea;
  • tired feeling;
  • dizziness; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about raltegravir (Isentress)?

In rare cases, raltegravir can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Before using raltegravir, tell your doctor if you are allergic to any drugs, or if you have a muscle disorder, kidney disease, or liver disease.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Call your doctor at once if you have serious side effects such as easy bruising or bleeding, signs of a new infection, jaundice (yellowing of the skin or eyes), muscle weakness with fever and dark colored urine, or if you urinate less than usual or not at all.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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