Dolutegravir

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

Dolutegravir is for adults and infants who weigh at least 4.4 pounds (2 kilograms).

Dolutegravir may also be used for reasons not mentioned in this medication guide.

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 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.

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.

Stop taking dolutegravir and seek emergency medical help if you notice signs of an allergic reaction, such as fever, feeling generally unwell, difficulty breathing, tiredness; joint or muscle pain, blisters or sores in your mouth, redness or swelling in your eyes; skin that is blistering or peeling; or swelling of your face, lips, tongue, or throat.

Dolutegravir can cause serious side effects. Contact your doctor immediately if you experience:

• the first sign of any skin rash, no matter how mild; or
• liver issues, which may include nausea, vomiting, loss of appetite, pain in the upper stomach, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Dolutegravir impacts your immune system and may lead to certain side effects, even weeks or months after taking the medicine. Inform your doctor if you have:

• signs of a new infection, like fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, or weight loss;
• difficulty speaking or swallowing, issues with balance or eye movement, weakness, or a prickly sensation; or
• swelling in your neck or throat (enlarged thyroid), changes in your menstrual cycle, or impotence.

Common side effects of dolutegravir may include:

• headache;
• tiredness; or
• problems sleeping (insomnia).

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

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

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

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

Using dolutegravir will not prevent your disease from spreading. 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.

Some medicines can make dolutegravir much less effective when taken together. 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 new medicine you start or stop using.