dolutegravir (Tivicay, Tivicay PD)

Brand Names: Tivicay, Tivicay PD

Generic Name: dolutegravir

• What is dolutegravir (Tivicay, Tivicay PD)?
• What are the possible side effects of dolutegravir (Tivicay, Tivicay PD)?
• What is the most important information I should know about dolutegravir (Tivicay, Tivicay PD)?
• What should I discuss with my healthcare provider before taking dolutegravir (Tivicay, Tivicay PD)?
• How should I take dolutegravir (Tivicay, Tivicay PD)?
• What happens if I miss a dose (Tivicay, Tivicay PD)?
• What happens if I overdose (Tivicay, Tivicay PD)?
• What should I avoid while taking dolutegravir (Tivicay, Tivicay PD)?
• What other drugs will affect dolutegravir (Tivicay, Tivicay PD)?
• Where can I get more information (Tivicay, Tivicay PD)?

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.

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Stop taking this medicine 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.

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 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.

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.

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 this medicine 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.

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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.

Using this medicine 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.

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.

Your pharmacist can provide more information about dolutegravir.

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