What are the most important things to know about raltegravir?
Raltegravir can cause serious, life-threatening side effects. These include severe skin reactions, allergic reactions, andproblems.
Stop taking raltegravir and contact your health care provider right away if you develop a rash with any of the following symptoms:
- General ill feeling
- Extreme tiredness
- Muscle or joint aches
- Blisters or sores in your mouth
- Blisters or peeling of your skin
- Redness or swelling of your eyes
- Swelling of your mouth or face
- Trouble breathing
An allergic reaction to raltegravir can cause liver problems. Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite
- Pain, aching, or tenderness on the right side of your stomach area
While taking raltegravir, it is important to keep all of your appointments with your health care provider.
What is raltegravir?
Raltegravir is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV in adults and children. One form of raltegravir, Isentress, is approved for adults and children weighing at least 4 lb and 4 oz (2 kg). Another form of raltegravir, Isentress HD, is approved for adults and children weighing at least 88 lb (40 kg). Raltegravir is always used in combination with other HIV medicines.
HIV medicines can’t cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV. If you are taking HIV medicines, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.
What should I tell my health care provider before taking raltegravir?
Before taking raltegravir, tell your health care provider:
- If you are allergic to raltegravir or any other medicines.
- If you have liver problems.
- If you have a history of a muscle disorder called or .
- If you have increased levels of creatine kinase (an found mainly in the heart, brain, and skeletal muscle) in your blood.
- If you have phenylketonuria (PKU). The artificial sweetener in raltegravir chewable tablets (aspartame) contains phenylalanine. Phenylalanine may be harmful to people with PKU.
- If you are on kidney dialysis treatment.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking raltegravir during pregnancy.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking raltegravir.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Raltegravir may affect the way other medicines or products work, and other medicines or products may affect how raltegravir works. Taking raltegravir together with certain medicines or products may cause serious side effects.
How should I take raltegravir?
Raltegravir comes in the following forms and strengths:
- 25-mg chewable tablets (brand name: Isentress)
- 100-mg chewable tablets (brand name: Isentress)
- 100-mg single-use packets for oral suspension (brand name: Isentress)
- 400-mg film-coated tablets (brand name: Isentress)
- 600-mg film-coated tablets (brand name: Isentress HD)
Take raltegravir according to your health care provider’s instructions.
Take raltegravir by mouth, with or without food. Always swallow the film-coated tablets whole. The chewable tablets may be chewed or swallowed whole.
Raltegravir for oral suspension must be mixed with water before use and given within 30 minutes of mixing. Raltegravir for oral suspension comes in a kit that contains the packets of raltegravir and reusable syringes and cups needed to mix and give the medicine. See the detailed instructions that come with the kit for information about the correct way to mix and give aof raltegravir for oral suspension. If you have questions about how to mix or give raltegravir for oral suspension, talk to your health care provider or pharmacist.
Do not switch between the film-coated tablets, the chewable tablets, or the oral suspension without talking with your health care provider first.
Always take raltegravir in combination with other HIV medicines.
If you take too much raltegravir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take raltegravir, see the FDA drug label.
What should I do if I forget a dose?
If you miss a dose of raltegravir, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What side effects can raltegravir cause?
Raltegravir may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the ClinicalInfo fact sheet on HIV Medicines and Side Effects for more information.
Some side effects of raltegravir can be serious. Serious side effects of raltegravir include severe skin reactions, allergic reactions, and liver problems. (See section above: What are the most important things to know about raltegravir?)
Other possible side effects of raltegravir include:
- Changes in your (called or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- Unexplained muscle pain, tenderness, or weakness. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of raltegravir. To learn more about possible side effects of raltegravir, read the drug label or or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should raltegravir be stored?
- Store raltegravir at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep raltegravir film-coated and chewable tablets in the container that they came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
- Keep raltegravir for oral suspension in the foil packets it came in. Do not open the packets until ready for use.
- Do not use raltegravir if the original seal over the container opening is broken or missing.
- Throw away raltegravir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep raltegravir and all medicines out of reach of children.
Where can I find more information about raltegravir?
More information about raltegravir is available:
Merck & Co., Inc.
Main number: 877-888-4231
Patient assistance: 800-727-5400
The above Patient Version drug summary is based on the following FDA label(s): Tablet (chewable), tablet (film coated), granule for oral suspension.
Last Reviewed: August 7, 2019