Alert

dolutegravir

Pronunciation: DOE loo TEG ra vir

Brand: Tivicay

Tivicay

slide 1 of 1, Tivicay,

50 mg, round, yellow, imprinted with SV 572, 50

Image of Tivicay
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What is the most important information I should know about dolutegravir?

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.

What is dolutegravir?

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.

This medicine is for use in adults and children who weigh at least 66 pounds (30 kilograms).

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

What should I discuss with my healthcare provider before taking 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.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dolutegravir 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 dolutegravir?

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.

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.

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.

What happens if I overdose?

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

What should I avoid while taking dolutegravir?

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.

What are the possible side effects of dolutegravir?

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: fever, general ill feeling, trouble breathing, extreme tiredness; 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.

What other drugs will affect dolutegravir?

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; o
  • 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.

Where can I get more information?

Your pharmacist can provide more information about dolutegravir.

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

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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