Dolutegravir

Generic Name: dolutegravir (DOE-loo-TEG-ra-vir)
Brand Name: Tivicay

Dolutegravir is used for:

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

Dolutegravir 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 dolutegravir if:

  • you are allergic to any ingredient in dolutegravir
  • you have severe liver problems
  • you are taking carbamazepine, dofetilide, fosphenytoin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, primidone, or St. John's wort

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

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Before using dolutegravir:

Some medical conditions may interact with dolutegravir. 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 substances
  • if you have a history of liver problems (eg, hepatitis B or C infection) or kidney problems

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

  • Dofetilide because the risk of serious and sometimes fatal side effects may be increased
  • Carbamazepine, efavirenz, etravirine, fosamprenavir, fosphenytoin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifamycins (eg, rifampin), ritonavir, St. John's wort, or tipranavir because they may decrease dolutegravir's effectiveness
  • Metformin because the risk of its side effects may be increased by dolutegravir.

This may not be a complete list of all interactions that may occur. Ask your health care provider if dolutegravir 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 dolutegravir:

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

  • An extra patient leaflet is available with dolutegravir. Talk to your pharmacist if you have questions about this information.
  • Take dolutegravir by mouth with or without food.
  • Do not take an antacid or product that has magnesium, aluminum, iron, or calcium in it; sucralfate; or buffered medicines within 6 hours before or 2 hours after you take dolutegravir.
  • Take dolutegravir on a regular schedule to get the most benefit from it. Taking dolutegravir at the same time each day will help you remember to take it.
  • Continue to take dolutegravir even if you feel well. Do not miss any doses.
  • If you miss a dose of dolutegravir, take it as soon as possible. If it is within 4 hours of 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 dolutegravir.

Important safety information:

  • Dolutegravir 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 dolutegravir.
  • Dolutegravir 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 dolutegravir or any other medicine for HIV without checking with your doctor.
  • Serious and sometimes fatal skin reactions and allergic reactions have been reported in some patients taking dolutegravir. 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).
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking dolutegravir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking dolutegravir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Dolutegravir 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 such as 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 dolutegravir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Dolutegravir should be used with extreme caution in CHILDREN younger than 12 years old and in those who weigh less than 88 pounds (40 kilograms); 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 dolutegravir while you are pregnant. It is not known if dolutegravir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or dolutegravir to the baby.

Possible side effects of dolutegravir:

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:

Headache; 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); change in the amount of urine produced; fever, chills, or persistent sore throat; general feeling of being unwell; mouth sores or blisters; muscle or joint aches; red, swollen, blistered, or peeling skin; redness or swelling of the eyes; severe or persistent tiredness or weakness; shortness of breath; 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).

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 dolutegravir:

Store dolutegravir 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 dolutegravir out of the reach of children and away from pets.

General information:

  • If you have any questions about dolutegravir, please talk with your doctor, pharmacist, or other health care provider.
  • Dolutegravir 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 dolutegravir 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 dolutegravir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dolutegravir. 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 dolutegravir.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
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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