Isentress belongs to a group of antiretroviral drugs that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Isentress is medication used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.

Isentress is for use in adults and children who weigh at least 4.4 pounds (2 kilograms). Isentress HD 600mg tablets are for use in adults, and in children weighing at least 88 pounds (40 kg).

Isentress may cause a severe skin reaction that can be fatal. Stop taking this medicine and get emergency medical help if you have skin redness or a rash that spreads and causes blistering and peeling.

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.

Isentress may cause a severe skin reaction that can be fatal. Stop taking this medicine and get emergency medical help if you have skin redness or a rash that spreads and causes blistering and peeling.

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.

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.

Do not substitute Isentress chewable tablets or oral suspension for the Isentress 400 mg or Isentress HD 600 mg film-coated tablet.

Take Isentress exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Isentress with or without food.

Do not crush, chew, or break a regular tablet. Swallow it whole.

The Isentress chewable tablet may be chewed or swallowed whole.

Isentress oral suspension is a powder that must be mixed with water before you take it.

The smaller, 25-milligram chewable tablet may be crushed and mixed in a cup with a teaspoon of liquid such as water, juice, or breast milk.

Use mixed medicine right away. Do not save it for later use.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Raltegravir doses are based on weight in children, and any changes may affect your child's dose.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep the chewable tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for HIV Infection:

Therapy-naive patients or patients virologically-suppressed on an initial regimen of the 400 mg film-coated tablets twice a day:
600 mg film-coated tablets: 1200 mg orally once a day
400 mg film-coated tablets: 400 mg orally twice a day

Therapy-experienced patients:
400 mg film-coated tablets: 400 mg orally twice a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Occupational Exposure:

US Public Health Service Working Group Recommendations:
400 mg film-coated tablets: 400 mg orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-This drug plus emtricitabine-tenofovir disoproxil fumarate is recommended as the preferred regimen for HIV postexposure prophylaxis; this drug is also recommended as a component in various alternative regimens.
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure:

US CDC Recommendations:
400 mg film-coated tablets: 400 mg orally twice a day
Duration of therapy: 28 days

Comments:
-This drug is recommended as a component of a preferred 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection; if other alternatives are considered, this drug is recommended as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

ORAL SUSPENSION:
Full-Term Neonates (Birth to 4 Weeks [28 Days] of Age):
Birth to 1 week:
-Weight 2 to less than 3 kg: 4 mg orally once a day
-Weight 3 to less than 4 kg: 5 mg orally once a day
-Weight 4 to less than 5 kg: 7 mg orally once a day

1 to 4 weeks:
-Weight 2 to less than 3 kg: 8 mg orally twice a day
-Weight 3 to less than 4 kg: 10 mg orally twice a day
-Weight 4 to less than 5 kg: 15 mg orally twice a day

Pediatric Patients At Least 4 Weeks of Age:
-Weight 3 to less than 4 kg: 25 mg orally twice a day
-Weight 4 to less than 6 kg: 30 mg orally twice a day
-Weight 6 to less than 8 kg: 40 mg orally twice a day
-Weight 8 to less than 10 kg: 60 mg orally twice a day
-Weight 10 to less than 14 kg: 80 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day

CHEWABLE TABLETS:
Pediatric Patients At Least 4 Weeks of Age:
-Weight 3 to less than 6 kg: 25 mg orally twice a day
-Weight 6 to less than 10 kg: 50 mg orally twice a day
-Weight 10 to less than 14 kg: 75 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day
-Weight 20 to less than 28 kg: 150 mg orally twice a day
-Weight 28 to less than 40 kg: 200 mg orally twice a day
-Weight at least 40 kg: 300 mg orally twice a day

400 MG FILM-COATED TABLETS:
-Weight at least 25 kg: 400 mg orally twice a day

600 MG FILM-COATED TABLETS:
-Weight at least 40 kg and either therapy-naive or virologically-suppressed on an initial regimen of the 400 mg film-coated tablets twice a day: 1200 mg orally once a day

Maximum dose:
-Oral suspension: 100 mg twice a day
-Chewable tablets: 300 mg twice a day

Comments:
-Neonates: If the mother used this drug 2 to 24 hours before delivery, the neonate's first dose should be administered between 24 and 48 hours after birth.
-Neonates, birth to 1 week of age: The dosing recommendations are based on about 1.5 mg/kg/dose.
-Neonates, 1 to 4 weeks of age: The dosing recommendations are based on about 3 mg/kg/dose.
-Pediatric patients at least 4 weeks of age: The weight-based dosing recommendation for the oral suspension and chewable tablets is based on about 6 mg/kg/dose twice a day.
-The oral suspension can be used in patients who weigh 2 to less than 20 kg; the chewable tablets can be used in patients at least 4 weeks of age who weigh at least 3 kg.
-The 400 mg film-coated tablets may be used in pediatric patients who weigh at least 25 kg if able to swallow a tablet.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Nonoccupational Exposure:

US CDC Recommendations:
ORAL SUSPENSION:
Pediatric Patients At Least 4 Weeks of Age:
-Weight 3 to less than 4 kg: 25 mg orally twice a day
-Weight 4 to less than 6 kg: 30 mg orally twice a day
-Weight 6 to less than 8 kg: 40 mg orally twice a day
-Weight 8 to less than 10 kg: 60 mg orally twice a day
-Weight 10 to less than 14 kg: 80 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day

CHEWABLE TABLETS:
Pediatric Patients At Least 4 Weeks of Age:
-Weight 3 to less than 6 kg: 25 mg orally twice a day
-Weight 6 to less than 10 kg: 50 mg orally twice a day
-Weight 10 to less than 14 kg: 75 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day
-Weight 20 to less than 28 kg: 150 mg orally twice a day
-Weight 28 to less than 40 kg: 200 mg orally twice a day
-Weight at least 40 kg: 300 mg orally twice a day

400 MG FILM-COATED TABLETS:
-Weight at least 25 kg: 400 mg orally twice a day

Maximum dose:
-Oral suspension: 100 mg twice a day
-Chewable tablets: 300 mg twice a day

Duration of therapy: 28 days

Comments:
-This drug is recommended as a component of a preferred (or alternative) 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection in children at least 4 weeks of age (and a postmenstrual age of at least 42 weeks); if other alternatives are considered, this drug is recommended as a component in various regimens.
-A pediatric HIV-specialist should be consulted for neonates (aged 0 to 27 days).
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-The oral suspension can be used in patients who weigh less than 20 kg; the chewable tablets can be used in patients who weigh at least 3 kg.
-The 400 mg film-coated tablets may be used in pediatric patients who weigh at least 25 kg if able to swallow a tablet.
-Current guidelines should be consulted for additional information.

You should not take Isentress HD film-coated tablets if you weigh less than 88 pounds (40 kilograms).

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

To make sure Isentress is safe for you, tell your doctor if you have ever had:

• a muscle disorder or muscle damage;

• high blood levels of an enzyme called creatine kinase (a sign of muscle damage);

• kidney disease (or if you are on dialysis);

• liver disease; or

• mental illness or depression.

Isentress chewable tablets contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

It is not known whether raltegravir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

HIV can be passed to your baby if the virus is not controlled during pregnancy. If you are pregnant, your name may be listed on a registry to track any effects of antiviral medicine on the baby. Use your medications properly to control HIV.

Do not breastfeed while using this medicine. 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.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb raltegravir.

Using this medicine may not prevent your disease from spreading. Do not have unprotected sex or share 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.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Isentress: fever, general ill feeling, tiredness, joint or muscle pain, trouble breathing; upper stomach pain, vomiting, loss of appetite, dark urine, yellowing of the skin or eyes; burning eyes, blisters or mouth sores; rash, hives, blistering or peeling skin; 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, or dark colored urine.

Isentress affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Isentress side effects may include:

• nausea;

• headache, dizziness;

• tired feeling; or

• sleep problems (insomnia).

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect Isentress, especially:

• fenofibrate or gemfibrozil;

• rifampin;

• HIV or AIDS medicine - etravirine, ritonavir, tipranavir, zidovudine;

• seizure medicine - carbamazepine, phenobarbital, phenytoin; or

• a "statin" cholesterol-lowering medicine - Crestor, Lipitor, Pravachol, Vytorin, Zocor, and others.

This list is not complete and many other drugs may interact with raltegravir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.