Pronunciation:

doe-loo-TEG-ra-vir SOE-dee-um

Brand Names:

• Tivicay
• Tivicay PD

Dosage Forms:

• Tablet
• Tablet for Suspension

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Dolutegravir

Uses of This Medicine:

Dolutegravir is used together with other medicines for the treatment of the infection caused by human immunodeficiency virus (HIV) in patients who have not received anti-HIV medicines in the past or to replace their current anti-HIV medicines. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Dolutegravir tablets are also used together with rilpivirine in adults to replace their current anti-HIV medicines when their healthcare provider determines that they meet certain requirements.

Dolutegravir will not cure or prevent HIV infection or AIDS, however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Dolutegravir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dolutegravir in children younger than 4 weeks of age or weighing less than 3 kilograms (kg). Safety and efficacy have not been established. Use of dolutegravir tablet is not recommended in children weighing 3 to 14 kg.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dolutegravir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving dolutegravir.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aluminum
• Amprenavir
• Cabotegravir
• Calcium
• Carbamazepine
• Dabrafenib
• Dalfampridine
• Dasabuvir
• Efavirenz
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fosphenytoin
• Iron
• Itraconazole
• Magaldrate
• Magnesium
• Mavacamten
• Metformin
• Nevirapine
• Omaveloxolone
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort
• Sucralfate
• Tipranavir
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B or C, or history of—Use with caution. May make this condition worse.

• Infections—May decrease your body's ability to fight infection.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not take more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using dolutegravir for the full time of treatment, even if you begin to feel better. It is also important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

This medicine is available in tablet or tablet for suspension forms. Do not switch medicines unless your doctor tells you to.

Swallow the tablet or tablet for suspension whole. Do not crush, break, or chew it. If you need more than one dose of this medicine, swallow one medicine at a time to prevent the risk of choking.

If you are unable to swallow the tablet for suspension whole:

• You may mix it in 5 milliliters (mL) of water (for 1 or 3 tablets) or 10 mL of water (for 4, 5, or 6 tablets) in the medicine cup.
• Use drinking water only to prepare the dose. Do not use any other drink or food.
• Swirl the cup gently for 1 to 2 minutes or until no lumps of tablet remain. Drink the oral liquid at least 30 minutes after mixing.
• You may add another 5 mL of water to the cup and drink it to make sure you get the full dose.

Use the supplied medicine cup to prepare and give the oral liquid to children. Use the oral syringe to give this medicine to infants.

You may take this medicine with or without food.

If you are taking antacids or laxatives containing aluminum, calcium, or magnesium, sucralfate, calcium or iron supplements, or buffered medicines, take dolutegravir at least 2 hours before or 6 hours after you take these medicines.

You may also take calcium or iron supplements together with this medicine if you take them with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of HIV infection:
  • For oral dosage form (tablets):
    • Adults—50 milligrams (mg) 2 times a day. If you are switching to dolutegravir and rilpivirine treatment, take 50 mg of dolutegravir and 25 mg of rilpivirine once a day.
    • Children 4 weeks of age and older—Dose is based on body weight and must be determined by your doctor:
      • Children weighing 20 kilograms (kg) or more—50 mg once a day (one 50-mg tablet).
      • Children weighing 14 to less than 20 kg—40 mg once a day (four 10-mg tablet).
    • Children younger than 4 weeks of age or weighing less than 14 kg—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets for suspension):
    • Children 4 weeks of age and older—Dose is based on body weight and must be determined by your doctor:
      • Children weighing 20 kilograms (kg) or more—30 milligrams (mg) once a day (six 5-mg tablet).
      • Children weighing 14 to less than 20 kg—25 mg once a day (five 5-mg tablet).
      • Children weighing 10 to less than 14 kg—20 mg once a day (four 5-mg tablet).
      • Children weighing 6 to less than 10 kg—15 mg once a day (three 5-mg tablet).
      • Children weighing 3 to less than 6 kg—5 mg once a day (one 5-mg tablet).
    • Children younger than 4 weeks of age or weighing less than 3 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in its original bottle. Keep it tightly closed and protect from moisture.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not use this medicine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first part of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

Serious skin and allergic reactions may occur while taking this medicine. Check with your doctor right away if you or your child have a severe rash or rash with fever, blistering or peeling skin, joint or muscle pain, sores in the mouth, swelling of the face, trouble breathing, unusual tiredness or weakness, or yellow eyes or skin.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notices any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Black, tarry stools

blistering or peeling skin

bloody urine

burning, dry, or itching eyes

chest pain

chills

cough

dark urine

decreased frequency or amount of urine

discharge or excessive tearing

fever

general feeling of discomfort or illness

increased thirst

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of appetite

lower back or side pain

muscle or joint aches

nausea

painful or difficult urination

rash with fever

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

severe rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, fingers, feet, or lower legs

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

weight gain

yellow eyes and skin

Incidence not known

Clay-colored stools

decreased appetite

headache

stomach pain or tenderness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Itching skin

stomach discomfort

trouble sleeping

Rare

Abnormal dreams

diarrhea

dizziness

Incidence not known

Anxiety

difficulty in moving

joint pain or swelling

muscle cramp or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.