Dolutegravir is an antiviral medicine that is used with other medications to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). Dolutegravir is not a cure for HIV or AIDS.

Dolutegravir is for use in adults and children as young as 4 weeks old and weighing at least 6 pounds (3 kilograms).

Dolutegravir may also be used for purposes not listed in this medication guide.

You should not use dolutegravir if you are also taking dofetilide (Tikosyn).

Taking dolutegravir during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using dolutegravir.

Dolutegravir comes as a tablet and as a tablet for suspension (a tablet to dissolve in liquid) to take by mouth. It is usually taken once or twice a day with or without food. Take dolutegravir at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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. You can swallow the tablet whole, one at a time, or mix them with drinking water before use.

If you 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. When the tablet(s) for suspension completely dissolve, drink the mixture right after mixing it. If it has been more than 30 minutes after mixing the mixture, discard the mixture.

If giving the tablets for suspension mixture to a child, make sure that he or she 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, swirl, and give it all to the child to make sure the child gets the full dose.

If giving the tablets for suspension mixture to an infant, use the oral syringe provided to measure and give the dose. Place the tip of the syringe into the dosing cup with the prepared mixture to draw it up into the syringe. Place the tip of 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 in the syringe to make sure the infant gets the full dose. The mixture should be given to the baby within 30 minutes of mixing. After the dose, wash the cup and syringe parts separately with water. Allow parts to dry completely before reassembling and storing.

Do not switch from tablets to tablet(s) for suspension without first talking to your doctor.

Continue to take dolutegravir even if you feel well. Do not stop taking dolutegravir without talking to your doctor. When your supply of dolutegravir runs low, get more from your doctor or pharmacist. 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take dolutegravir with or without food.

Do not crush or chew a dispersible tablet whole. Swallow the tablet whole, or place it in a small amount of water. Allow the tablet to disperse (it will not dissolve completely). Stir and give the mixture to the child right away. The amount of water needed will depend on the number of tablets needed for your child's dose. Follow the instructions provided with your medicine.

The dolutegravir regular tablet and dispersible tablet cannot be used in the same dosages. Take only the pill form your doctor has prescribed. Avoid medication errors by always checking the medicine you receive at the pharmacy.

Dolutegravir doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

While using dolutegravir, you may need frequent blood tests.

If you've ever had hepatitis B, using dolutegravir can cause this virus to become active or get worse. You may need frequent liver function tests while using dolutegravir and for several months after you stop.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with any packet or canister of moisture-absorbing preservative.

You should not use dolutegravir if you are allergic to it, or if you are also taking dofetilide (Tikosyn).

Tell your doctor if you have ever had:

• liver disease, especially hepatitis B or C.

You may need to have a negative pregnancy test before starting this treatment.

Dolutegravir may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

HIV can be passed to your baby if the virus is not controlled during pregnancy. If you are pregnant, your name may be listed on a registry to track any effects of antiviral medicine on the baby. Use your medications properly to control HIV.

Women with HIV or AIDS should not breastfeed. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Using dolutegravir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Stop taking dolutegravir and get emergency medical help if you have signs of an allergic reaction: fever, general ill feeling, trouble breathing, tiredness; joint or muscle pain, blisters or mouth sores, redness or swelling in your eyes; blistering or peeling skin; swelling of your face, lips, tongue, or throat.

Dolutegravir may cause serious side effects. Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild; or

• liver problems--nausea, vomiting, loss of appetite, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of dolutegravir may include:

• headache;

• tiredness; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make dolutegravir much less effective when taken at the same time. If you take any of the following medicines, take your dolutegravir dose 2 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate);

• buffered medicine; or

• vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir with food, you can take these supplements at the same time).

Many drugs can affect dolutegravir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.