tivicay

Tivicay (dolutegravir) is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Tivicay is used with other antiviral medications to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Tivicay is not a cure for HIV or AIDS.

This medicine is for use in adults and children who are at least 12 years old and weigh at least 88 pounds.

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

Important information

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

Before taking this medicine

You should not use Tivicay if you are allergic to dolutegravir or if you are also taking dofetilide (Tikosyn).

To make sure Tivicay is safe for you, tell your doctor if you have:

• liver disease, especially hepatitis B or C.

FDA pregnancy category B. Tivicay is not expected to harm an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant and take all of your HIV medicines as directed to control your infection.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Tivicay on the baby.

Women with HIV or AIDS should not breast feed 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. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Tivicay with or without food.

While using Tivicay, you may need frequent blood tests.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid?

Taking this medication will not prevent you from passing HIV to other people. 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.

Avoid taking the following medicines within 6 hours before or 2 hours after you take Tivicay:

• 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;

• vitamin or mineral supplements that contain calcium or iron.

Tivicay side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tivicay: fever, general ill feeling, extreme tiredness, body aches; mouth sores, discomfort 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

• nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Tivicay may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Tivicay. Tell your doctor if you have any signs of a new infection, such as fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, or weight loss.

Common Tivicay side effects may include:

• headache;

• sleep problems (insomnia); or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

See also: Side effects (in more detail)

Tivicay dosing information

Usual Adult Dose for HIV Infection:

Therapy-naive or therapy-experienced integrase strand transfer inhibitor (INSTI)-naive patients: 50 mg orally once a day

With concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin: 50 mg orally twice a day

Comments:
-Efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, and rifampin are potent UGT1A/CYP450 3A inducers.

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

Comments:
-Alternative combinations that do not include metabolic inducers should be considered where possible.

Usual Pediatric Dose for HIV Infection:

12 years or older, weighing at least 40 kg:
Therapy-naive or therapy-experienced INSTI-naive patients: 50 mg orally once a day

With concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin: 50 mg orally twice a day

Comments:
-Safety and efficacy not established in patients younger than 12 years or weighing less than 40 kg.
-Safety and efficacy not established in INSTI-experienced patients with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

What other drugs will affect Tivicay?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Tivicay, 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 interactions are listed in this medication guide.