Dolutegravir

WHY is this medicine prescribed?

Dolutegravir is used to treat human immunodeficiency virus (HIV) infection. Dolutegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body.

Although dolutegravir does not cure HIV, using it along with other medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifestyle changes may decrease the risk of giving the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dolutegravir comes as a tablet and as a tablet for suspension (a tablet to dissolve in liquid) to take by mouth. Take once or twice a day with or without food. Take dolutegravir at around the same time(s) every day.

Take dolutegravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not chew, cut, or crush the tablets for oral suspension. Swallow the tablet whole, one at a time, or mix them with drinking water before use.

To mix the tablets for oral suspension in drinking water, add the prescribed number of tablet(s) to a dosing cup. If taking 1 or 3 tablet(s) for oral suspension, add 1 teaspoon (5 mL) of drinking water to the cup. If taking 4, 5, or 6 tablets for oral suspension, add 2 teaspoons (10 mL) of drinking water to the cup. Do not use any other liquid to dissolve the tablet. Swirl the cup for 1 or 2 minutes or until the mixture is completely dissolved; the mixture will appear cloudy. Then drink the mixture right after mixing it. Discard the mixture if it has been more than 30 minutes after mixing.

Make sure that a child is upright when taking it. If there is remaining mixture in the cup, add another 1 teaspoon (5 mL) of drinking water to the cup and swirl. Give it all to the child to make sure the full dose is given.

Use the oral syringe provided to measure and give the dose to an infant. Place the tip of the syringe into the dosing cup with the prepared mixture to draw it up into the syringe. Insert the oral syringe into the child's mouth against the inside of the cheek. Gently push down on the plunger to give the dose slowly. Allow time for the infant to swallow the mixture. Add another 1 teaspoon (5 mL) of drinking water to the cup and swirl. Draw up the remaining mixture into the syringe and give it all to the infant. Repeat if any of the mixture remains to make sure the infant gets the full dose. Give the mixture within 30 minutes of mixing.

Continue to take dolutegravir even if you feel well. Do not stop taking dolutegravir without talking to your doctor. If you stop taking dolutegravir or miss doses, your condition may become worse and more difficult to treat with medication.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking dolutegravir,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking or plan to take while taking dolutegravir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• if you are taking antacids, laxatives, or multivitamins that contain aluminum, magnesium, or calcium; calcium supplements; iron supplements; sucralfate (Carafate); or buffered medications such as buffered aspirin, take them 2 hours after or 6 hours before you take dolutegravir. However, if you take dolutegravir with food, you may take these supplements at the same time that you take dolutegravir.

• the following herbal product may interact with dolutegravir: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking dolutegravir. Do not start this medication while taking dolutegravir without discussing with your healthcare provider.

• tell your doctor if you are receiving dialysis treatments or have or have ever had any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), or kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking dolutegravir, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking dolutegravir.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms after starting treatment with dolutegravir, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dolutegravir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep
• headache
• tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, stop taking dolutegravir and call your doctor immediately or get emergency medical attention:

• rash; fever; excessive tiredness; muscle or joint pain; blistering or peeling skin; blisters or sores in the mouth; red or swollen eyes; swelling of the eyes, face, lips, mouth, tongue, or throat; difficulty breathing or swallowing
• nausea, vomiting, loss of appetite, yellow of eyes or skin, dark urine, pale colored bowel movements, pain in the upper right part of the stomach

Dolutegravir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet that contains a substance that absorbs moisture to keep the medication dry) from the bottle.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dolutegravir.

Keep a supply of dolutegravir on hand. Do not wait until you run out of medication to refill your prescription.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.