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Tivicay ( Dolutegravir )

HIV

Dolutegravir is an antiviral medicine that is used with other medications to treat HIV, the virus that can cause 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 whose weight is at least 6 pounds (3 kilograms).


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50mg × 120 tablets
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50mg × 90 tablets
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50mg × 60 tablets
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50mg × 30 tablets
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Tivicay

What is Tivicay?

Tivicay is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.
Tivicay is used with other antiviral medications to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS).
Tivicay is not a cure for HIV or AIDS.
Tivicay tablets are for use in adults and children who can swallow tablets.
Tivicay PD tablets for oral suspension are for use in children and infants aged at least four weeks and weighing at least 6 pounds (3 kilograms).

Warnings

You should not use Tivicay if you are also taking dofetilide (Tikosyn).
Taking Tivicay during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using dolutegravir.

Before taking this medicine

You should not use Tivicay if you are allergic to dolutegravir, 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 treatment with Tivicay.
Tivicay 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 a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Tivicay?

Take Tivicay exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
You may take Tivicay with or without food.
Do not crush or chew a Tivicay PD 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.
Dolutegravir doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.
For children taking Tivicay PD tablets for oral suspension, read the Instructions for Use that come with the medicine for detailed instructions on how to prepare a dose.
Tivicay PD may be swallowed whole or dispersed in drinking water and should not be chewed, cut, or crushed.
Tivicay tablets are not the same as Tivicay PD tablets for oral suspension and cannot be substituted for each other. Check to make sure you receive the correct form of Tivicay each time you or your child’s prescription is filled to avoid using the wrong medicine.
While using Tivicay, 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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What to avoid

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.

Tivicay side effects

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Tivicay: 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 Tivicay side effects may include:
• headache;

• tiredness; or

• sleep problems (insomnia).


What other drugs will affect Tivicay?

Some medicines can make dolutegravir much less effective when taken at the same time. If you take any of the following medicines, take your Tivicay 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 Tivicay with food, you can take these supplements at the same time).

Tell your doctor about all your other medicines, especially:
• oral diabetes medication that contains metformin;

• tuberculosis medication that contains rifampin;

• St. John's wort;

• other HIV or AIDS medicines - efavirenz, etravirine, fosamprenavir/ritonavir, nevirapine, tipranavir/ritonavir; or

• seizure medication - carbamazepine, oxcarbazepine, phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with dolutegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.


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