raltegravir

Pronunciation

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

What is raltegravir?

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

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

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

What is the most important information I should know about raltegravir?

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.

Before using raltegravir, 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 this medication 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.

What should I discuss with my health care provider before taking raltegravir?

You should not use this medication if you are allergic to raltegravir.

To make sure you can safely take raltegravir, 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 raltegravir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. 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 raltegravir 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 chewable tablet may contain phenylalanine. Talk to your doctor before using this form of raltegravir if you have phenylketonuria (PKU).

How should I take raltegravir?

Take 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.

You may take raltegravir with or without food.

The raltegravir chewable tablet must be chewed before you swallow it.

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

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

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.

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.

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 raltegravir?

Taking this medication 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.

Raltegravir side effects

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

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.

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 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)

Raltegravir Dosing Information

Usual Adult Dose 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 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 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 other drugs will affect raltegravir?

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 raltegravir. 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 raltegravir.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication 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 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2012-07-02, 3:52:21 PM.

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