Isentress

Pronunciation

Generic Name: raltegravir (ral TEG ra veer)
Brand Names: Isentress

What is Isentress?

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

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

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

Important information

In rare cases, Isentress 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 Isentress, tell your doctor if you are allergic to any drugs, or if you have a muscle disorder, kidney disease, or liver disease.

Slideshow: Flashback: FDA Drug Approvals 2013

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 Isentress 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.

Before taking this medicine

You should not use Isentress if you are allergic to raltegravir.

To make sure you can safely take Isentress, tell your doctor if you have any of these other conditions:

  • a muscle disorder;

  • kidney disease;
  • liver disease;
  • a history of mental illness or depression.

FDA pregnancy category C. It is not known whether Isentress will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Isentress. 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Isentress on the baby.

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.

The Isentress chewable tablet may contain phenylalanine. Talk to your doctor before using this form of Isentress if you have phenylketonuria (PKU).

How should I take Isentress?

Take Isentress exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

The Isentress chewable tablet must be chewed before you swallow it. Do not crush, chew, or break a regular Isentress tablet. Swallow it whole.

You may take Isentress with or without food.

Use Isentress regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store Isentress at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Taking Isentress 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.

Isentress side effects

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

In rare cases, Isentress 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 Isentress 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.

See also: Side effects (in more detail)

What other drugs will affect Isentress?

Tell your doctor about all other medicines you use, especially rifampin (Rifadin, Rifamate, Rimactane).

This list is not complete and other drugs may interact with Isentress. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Isentress.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Isentress only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 4.01. Revision Date: 2012-07-02, 3:52:21 PM.

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