Dolutegravir

Dolutegravir

Dolutegravir

What is dolutegravir?

Dolutegravir is intended for use in adults and children 4 weeks of age and older and weighing at least 6 pounds (3 kilograms).

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

Side effects of dolutegravir

Stop taking dolutegravir and get medical help if you notice signs of an allergic reaction:Fever, general malaise, difficulty breathing, tiredness; joint or muscle pain, blisters or sores in your mouth, redness or swelling of your eyes; blistering or peeling skin; Swelling of your face, lips, tongue, or throat.

Dolutegravir can cause serious side effects. Call your doctor immediately if you have:

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

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

Dolutegravir affects your immune system, which may cause certain side effects (including weeks or months after taking 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;

• difficulty speaking or swallowing, problems with balance or eye movement, weakness or tingling; or

• Swelling in the neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of dolutegravir may include:

• Headache;

• Fatigue; 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

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

Taking dolutegravir during the first trimester of pregnancy can cause birth defects. Use effective contraception to prevent pregnancy while using dolutegravir.

Before you take this medicine

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 contraception to prevent pregnancy and tell your doctor if you become pregnant.

HIV can be passed on 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 the effects of antiviral medicines on the baby. Use your medications correctly to control HIV.

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

How should I take dolutegravir?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

You can take dolutegravir with or without food.

Do not crush or chew a tablet for oral suspension whole. Swallow the tablet whole or add it to a small amount of water. Allow the tablet to disperse (it will not dissolve completely). Stir and give the mixture to the child immediately. The amount of water needed depends on the number of tablets required for your child's dose. Follow the instructions that come with your medicine.

The regular dolutegravir tablet and the oral suspension tablet cannot be used in the same dosages. Only take the pill form your doctor has prescribed for you. Avoid medication errors by always checking the medications you receive at the pharmacy.

The dosage of dolutegravir depends on the weight of children. Your child's dosage needs may change if the child gains or loses weight.

Frequent blood tests may be needed while using dolutegravir.

If you have ever had hepatitis B, using dolutegravir may cause this virus to become active or worsen. You may need to have frequent liver function tests while you are using dolutegravir and for several months after you stop using it.

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 continue to be cared for by a doctor.

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

What happens if I miss a dose?

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

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

What happens if I overdose?

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

What should I avoid while taking dolutegravir?

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

What other drugs will affect dolutegravir?

Some medicines can significantly affect the effectiveness of dolutegravir when taken together.If you are taking any of the following medicines, take your dose of dolutegravir 2 hours before or 6 hours after taking the other medicine.

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

• buffered medicine; or

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

Many medications can affect dolutegravir. This includes prescription and over-the-counter medications, vitamins and herbal products. Not all possible interactions are listed here. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

• Welche Medikamente sind in der HIV-Behandlung Juluca enthalten?

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.