Isentress

Pronunciation

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

What is Isentress?

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

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

Important information

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, 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.

Slideshow: Flashback: FDA Drug Approvals 2013

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.

Before taking this medicine

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

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

  • a muscle disorder;

  • liver disease; or

  • 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 this medicine.

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

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.

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.

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

How should I take Isentress?

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

You may take Isentress with or without food.

The Isentress chewable tablet may be chewed or swallowed whole.

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

Isentress oral suspension is a powder that must be mixed with water before you take it. Mix 1 packet of this powder with 1 teaspoon (5 milliliters) of water. Measure this mixture with the dosing syringe provided, and give the medicine by mouth within 30 minutes after mixing. Do not save any of the mixed medicine for later use.

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.

If your doctor changes your brand, strength, or type of raltegravir, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of raltegravir you receive at the pharmacy.

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 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.

Isentress dosing information

Usual Adult Dose of Isentress for HIV Infection:

Film-coated tablets: 400 mg orally twice a day

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

Usual Adult Dose of Isentress for Occupational Exposure:

(Not approved by FDA)

US Public Health Service working group recommendations:
Film-coated tablets: 400 mg orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Raltegravir plus tenofovir plus emtricitabine is recommended as the preferred regimen for HIV postexposure prophylaxis; raltegravir 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 the institution's protocol.
-The most current therapeutic guidelines should be consulted for more information.

Usual Pediatric Dose of Isentress for HIV Infection:

At least 4 weeks of age:
Oral suspension:
3 to less than 4 kg: 20 mg orally twice a day
4 to less than 6 kg: 30 mg orally twice a day
6 to less than 8 kg: 40 mg orally twice a day
8 to less than 11 kg: 60 mg orally twice a day
11 to less than 14 kg: 80 mg orally twice a day
14 to less than 20 kg: 100 mg orally twice a day

Chewable tablets:
11 to less than 14 kg: 75 mg orally twice a day
14 to less than 20 kg: 100 mg orally twice a day
20 to less than 28 kg: 150 mg orally twice a day
28 to less than 40 kg: 200 mg orally twice a day
At least 40 kg: 300 mg orally twice a day

Film-coated tablets:
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

Comments:
-The weight-based dosing recommendation for the oral suspension and chewable tablets is based on approximately 6 mg/kg/dose twice a day.
-After mixing a single-use packet for oral suspension with 5 mL water, the final concentration is 20 mg/mL; the oral suspension can be used as long as weight is less than 20 kg.
-Either the oral suspension or the chewable tablet formulation can be used when weight is between 11 and 20 kg.
-The film-coated tablet is the recommended formulation for patients weighing at least 25 kg; if unable to swallow a tablet, the chewable tablet regimen should be considered.

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

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 while taking Isentress?

Avoid taking an antacid that contains aluminum or magnesium within 2 hours before or 2 hours after you take Isentress. This includes antacids such as Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. Aluminum or magnesium antacids can make it harder for your body to absorb raltegravir.

Taking this medicine will not prevent you from passing HIV to other people. 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.

Isentress side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Isentress: hives; difficult breathing; upper stomach pain, vomiting, loss of appetite; dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); swelling of your face, lips, tongue, or throat.

Isentress may cause a severe skin reaction that can be fatal. Stop taking this medicine and get emergency medical help if you have a fever, general ill feeling, muscle or joint pain, extreme tiredness, trouble breathing, 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.

Isentress may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Isentress. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

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

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.

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.

See also: Side effects (in more detail)

What other drugs will affect Isentress?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Isentress, especially:

  • fenofibrate (Antara, Lipogen, Tricor, Trilipix);

  • gemfibrozil (Lopid);

  • rifampin (Rifadin, Rifamate, Rimactane);

  • a "statin" cholesterol-lowering medicine (Crestor, Lipitor, Pravachol, Vytorin, Zocor, and others); or

  • zidovudine (Combivir, Retrovir, Trizivir).

This list is not complete. Other drugs may interact with raltegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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 by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 5.02. Revision Date: 2014-07-28, 10:13:53 AM.

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