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).

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.

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.

Usual Adult Dose for HIV Infection:

Therapy-naive or therapy-experienced integrase strand transfer inhibitor (INSTI)-naive patients or virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients switching to this drug plus rilpivirine: 50 mg orally once a day

Therapy-naive or therapy-experienced INSTI-naive patients when coadministered with certain UGT1A or CYP450 3A inducers: 50 mg orally twice a day

INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg orally twice a day

Comments:
-Rilpivirine dose is 25 mg orally once a day for patients switching to this drug plus rilpivirine.
-The manufacturer product information should be consulted for relevant UGT1A or CYP450 3A inducers.
-In INSTI-experienced patients, alternative combinations that do not include metabolic inducers should be considered where possible.

Uses:
-In combination with other antiretroviral agents, for the treatment of HIV-1 infection in therapy-naive or therapy-experienced adults
-In combination with rilpivirine, as a complete regimen, for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to either drug

Usual Adult Dose for Nonoccupational Exposure:

US CDC Recommendations: 50 mg orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (emtricitabine-tenofovir disoproxil fumarate [DF] or lamivudine/zidovudine) is recommended as a preferred regimen for nonoccupational postexposure prophylaxis of HIV infection.
---This drug should not be used in nonpregnant females of childbearing potential who are sexually active or have been sexually assaulted and who are not using effective contraception; and,
---This drug should not be used in pregnant women early in pregnancy as the risk of an unborn infant developing a neural tube defect is during the first 28 days.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

4 WEEKS OR OLDER:
Tablets for Oral Suspension:
-Weight 3 to less than 6 kg: 5 mg orally once a day
-Weight 6 to less than 10 kg: 15 mg orally once a day
-Weight 10 to less than 14 kg: 20 mg orally once a day
-Weight 14 to less than 20 kg: 25 mg orally once a day
-Weight at least 20 kg: 30 mg orally once a day

Tablets:
-Weight 14 to less than 20 kg: 40 mg orally once a day
-Weight at least 20 kg: 50 mg orally once a day

Comments:
-If switching from the tablet formulation to the tablets for oral suspension formulation, the recommended dosage for Tablets for Oral Suspension should be followed.
-If switching from the tablets for oral suspension formulation to the tablet formulation, the recommended dosage for Tablets should be followed.
-The tablet formulation should not be used in patients weighing 3 to 14 kg; the tablets for oral suspension formulation is preferred in patients weighing less than 20 kg.
-If certain UGT1A or CYP450 3A inducers are coadministered, the recommended dose should be administered twice a day; the manufacturer product information should be consulted for relevant inducers.
-Safety and efficacy not established in INSTI-experienced patients with documented/clinically suspected resistance to other INSTIs (e.g., raltegravir, elvitegravir).

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in therapy-naive or therapy-experienced but INSTI-naive pediatric patients

Usual Pediatric Dose for Nonoccupational Exposure:

US CDC Recommendations:
13 years or older and weighing at least 40 kg: 50 mg orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (emtricitabine-tenofovir DF or lamivudine/zidovudine) is recommended as a preferred regimen for nonoccupational postexposure prophylaxis of HIV infection.
---This drug should not be used in nonpregnant females of childbearing potential who are sexually active or have been sexually assaulted and who are not using effective contraception; and,
---This drug should not be used in pregnant women early in pregnancy as the risk of an unborn infant developing a neural tube defect is during the first 28 days.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

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.

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.

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).

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.

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.