Raltegravir

Pronunciation

Generic Name: raltegravir (ral-TEG-ra-vir)
Brand Name: Isentress

Raltegravir is used for:

Treating HIV infection. It is used along with other HIV medicines.

Raltegravir is an HIV-1 integrase strand transfer inhibitor. It works by blocking HIV-1 integrase, an enzyme needed for the HIV virus to replicate.

Do NOT use raltegravir if:

  • you are allergic to any ingredient in raltegravir

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using raltegravir:

Some medical conditions may interact with raltegravir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substance
  • if you have a history of liver problems (eg, hepatitis B or C infection)
  • if you have a history of muscle problems or weakness (eg, myopathy, rhabdomyolysis), high creatine kinase blood levels, mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you are on dialysis

Some MEDICINES MAY INTERACT with raltegravir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Fenofibrate, gemfibrozil, statins (eg, simvastatin), or zidovudine because the risk of muscle problems may be increased
  • Darunavir/ritonavir because it may increase the risk of rash
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
  • Rifamycins (eg, rifampin) because it may decrease raltegravir's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if raltegravir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use raltegravir:

Use raltegravir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with raltegravir. Talk to your pharmacist if you have questions about this information.
  • Take raltegravir by mouth with or without food.
  • Swallow raltegravir whole. Do not break, crush, or chew before swallowing.
  • Certain antacids (eg, those that have aluminium or magnesium in them) should not be taken with raltegravir. Talk to your doctor about other antacids that you can take with raltegravir.
  • Take raltegravir on a regular schedule to get the most benefit from it. Taking raltegravir at the same time each day will help you remember to take it.
  • Continue to take raltegravir even if you feel well. Do not miss any doses.
  • If you miss a dose of raltegravir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use raltegravir.

Important safety information:

  • Raltegravir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use raltegravir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Raltegravir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start raltegravir.
  • Raltegravir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Do not change your dose or stop taking raltegravir or any other medicine for HIV without checking with your doctor.
  • Do not change between raltegravir and the chewable tablet or oral suspension doseforms without talking to your doctor.
  • Serious and sometimes fatal skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and allergic reactions have been reported in some patients taking raltegravir. Contact your doctor right away if you develop blisters or sores in the mouth; fever; general ill feeling; muscle or joint aches; rash, including red, swollen, blistered, or peeling skin; red or swollen eyes; severe tiredness; trouble breathing; swelling of the mouth or face; symptoms of kidney problems (eg, decreased urination); or symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or vomiting, stomach pain, yellowing of the eyes or skin).
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking raltegravir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Raltegravir does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • Lab tests, including complete blood cell counts and liver function, may be performed while you take raltegravir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Raltegravir should be used with extreme caution in CHILDREN younger than 4 weeks old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking raltegravir while you are pregnant. It is not known if raltegravir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or raltegravir to the baby.

Possible side effects of raltegravir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); back pain; blood in the urine; change in the amount of urine produced; decreased coordination; fever, chills, or persistent sore throat; general feeling of being unwell; mental or mood changes (eg, anxiety, paranoia, depression); mouth sores or blisters; muscle aches, pain, tenderness, or weakness; red, swollen, blistered, or peeling skin; redness or swelling of the eyes; severe or persistent dizziness; severe or persistent tiredness or weakness; shortness of breath; suicidal thoughts or actions; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or vomiting, stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of raltegravir:

Store raltegravir at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep raltegravir out of the reach of children and away from pets.

General information:

  • If you have any questions about raltegravir, please talk with your doctor, pharmacist, or other health care provider.
  • Raltegravir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take raltegravir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about raltegravir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to raltegravir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using raltegravir.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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