Isentress HD

Isentress HD is an antiviral medicine that stops the human immunodeficiency virus (HIV) from growing in your body.

Isentress HD is used to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). This medicine does not cure HIV or AIDS.

Isentress HD is for adults and children who weigh at least 4.4 pounds (2 kilograms).

Isentress HD may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Isentress HD with or without food.

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

The Isentress HD chewable tablet may be chewed or swallowed whole.

Isentress HD 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. Isentress HD 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.

Stop taking this medicine and get emergency medical help if you notice any signs of an allergic reaction: fever, joint or muscle pain, trouble breathing, stomach pain, vomiting, dark urine, yellowing of the skin or eyes, burning eyes, mouth sores, rash, blistering or peeling skin, or swelling in your face or throat.

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.

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

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

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 breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Stop taking Isentress HD and get emergency medical help if you have signs of an allergic reaction: fever, feeling generally unwell, 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 sores in the mouth; rash, hives, blistering or peeling skin; swelling of your face, lips, tongue, or throat.

In rare cases, Isentress HD can cause a condition that breaks down skeletal muscle tissue, which may lead 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 HD affects your immune system, which may lead to 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 a prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), changes in your menstrual cycle, impotence.

Common side effects of Isentress HD may include:

• nausea;
• headache, dizziness;
• feeling tired; 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.

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

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

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 Isentress HD.

Using Isentress HD may not prevent your disease from spreading. 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.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect Isentress HD, 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 affect Isentress HD. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.