Dolutegravir, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV infection. Take it exactly as directed. Do not run out of or stop taking this medicine without your healthcare provider's approval. The amount of virus in your blood may increase and become harder to treat.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: dolutegravir, oral; Tivicay

What is this medicine used for?

This medicine is taken by mouth along with other medicines to treat HIV infection. It will not cure HIV or AIDS but may slow the progression of the disease. It is used along with other anti-HIV medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease such as hepatitis B or hepatitis C
• Kidney disease

Tell your healthcare provider if you take dofetilide (Tikosyn). Taking this medicine and dofetilide can cause side effects that may be life-threatening.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Do not run out of this medicine. The amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to this medicine and become harder to treat.

Check with your healthcare provider before using this medicine in children under age 12 or anyone who weighs less than 66 lbs (30 kg).

You may take this medicine with or without food. Taking it with meals may lessen the chance the medicine will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

If you are also infected with hepatitis B or C, you need blood tests and checkups for several months after you stop taking this medicine. This medicine may cause flare-ups of hepatitis.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

This medicine may cause dizziness or drowsiness. Do not drive or operate machinery unless you are fully alert.

Your body fat may change as a result of taking this medicine. Your legs and arms may be thin but your chest, belly, back and face may have more fat. Discuss this with your healthcare provider.

You need to have lab tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex and do not share needles.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing).

Serious (Report these to your healthcare provider right away.): serious rash with a fever; blistering; mouth sores; red eyes; swelling; unusual muscle pain or joint pain; feeling cold, especially in your arms or legs; decreased urination; dark urine; yellowing of your eyes or skin; light-colored bowel movements; unexplained loss of appetite; fever; unusual tiredness or weakness; trouble breathing; severe dizziness or fainting; severe stomach pain; severe nausea or vomiting.

Other: Diarrhea, nausea, trouble sleeping, headache, dizziness, changes in body fat.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antacids or laxatives that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take dolutegravir at least 2 hours before or 6 hours after these antacids or laxatives.)
• Antibiotics such as rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Diabetes medicines that contain metformin such as alogliptin/metformin (Kazano), glipizide/metformin, glyburide/metformin (Glucovance), linagliptin/metformin (Jentadueto), metformin (Fortamet, Glucophage, Riomet), pioglitazone/metformin (Actoplus Met), repaglinide/metformin (PrandiMet), rosiglitazone/metformin (Avandamet), saxagliptin/metformin (Kombiglyze), and sitagliptin/metformin (Janumet)
• Dofetilide (Tikosyn)
• Other HIV medicines such as abacavir/dolutegravir/lamivudine (Triumeq), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), etravirine (Intelence), fosamprenavir (Lexiva), lopinavir/ritonavir (Kaletra), nevirapine (Viramune), ritonavir (Norvir), and tipranavir (Aptivus)
• St. John’s wort
• Sucralfate (Carafate) (Take this medicine at least 2 hours before or 6 hours after you take sucralfate.)
• Supplements or multivitamins that contain calcium or iron. You may take this medicine, calcium, and iron products at the same time IF you take them with food. Otherwise, take this medicine at least 2 hours before or 6 hours after you take medicines that calcium or iron.
• Supplements or multivitamins that contain selenium or zinc

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.