Isentress

Isentress is used for:

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Treating certain patients who have HIV infection. It is used along with other HIV medicines.

Isentress is an HIV-1 integrase strand transfer inhibitor. It works by blocking HIV-1 integrase, an enzyme needed for the HIV virus to replicate.

Do NOT use Isentress if:

• you are allergic to any ingredient in Isentress

Contact your doctor or health care provider right away if any of these apply to you.

Before using Isentress :

Some medical conditions may interact with Isentress . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances, including mouse or murine proteins
• if you have a history of liver problems or hepatitis B or C infection
• if you have a history of muscle problems or weakness (eg, myopathy, rhabdomyolysis)
• if you are on dialysis

Some MEDICINES MAY INTERACT with Isentress . Tell your health care provider if you are taking any other medicines, especially any of the following:

• HMG-CoA reductase inhibitors (eg, simvastatin) because the risk of muscle problems may be increased
• Atazanavir because it may increase the risk of Isentress 's side effects
• Phenobarbital, phenytoin, or rifampin because they may decrease Isentress 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Isentress may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Isentress :

Use Isentress as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Isentress . Talk to your pharmacist if you have questions about this information.
• Take Isentress by mouth with or without food.
• Take Isentress on a regular schedule to get the most benefit from it. Taking Isentress at the same time each day will help you remember to take it.
• Continue to take Isentress even if you feel well. Do not miss any doses.
• If you miss a dose of Isentress , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Isentress .

Important safety information:

• Isentress may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Isentress with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Isentress may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Isentress .
• Isentress is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Do not change your dose or stop taking Isentress or any other medicine for HIV without checking with your doctor.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Isentress , even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Isentress does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• The long-term effects of Isentress are not known at this time. Contact your doctor right away if you develop any unusual symptom or if any symptom persists or gets worse.
• Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Isentress . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Isentress should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Isentress while you are pregnant. It is not known if Isentress is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Isentress to the baby.

Possible side effects of Isentress :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; tiredness; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; dark urine; fainting; fever, chills, or sore throat; mental or mood changes (eg, anxiety, paranoia, depression); muscle pain, tenderness, or weakness; numbness of an arm or leg; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness or stomach pain; severe or persistent tiredness or weakness; shortness of breath; sudden, severe headache or vomiting; sudden vision changes; suicidal thoughts or actions; unusual lumps, skin growths, or skin changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Store Isentress at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isentress out of the reach of children and away from pets.

General information:

• If you have any questions about Isentress , please talk with your doctor, pharmacist, or other health care provider.
• Isentress is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Isentress . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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