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dolutegravir and lamivudine

Pronunciation: DOE loo TEG ra vir and la MIV ue deen

Brand: Dovato

What is the most important information I should know about dolutegravir and lamivudine?

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

Taking dolutegravir and lamivudine during the first trimester of pregnancy may cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

If you've ever had hepatitis B, it may become active or get worse during or after treatment with dolutegravir and lamivudine. You may need frequent liver function tests for several months.

What is dolutegravir and lamivudine?

Dolutegravir and lamivudine is a combination antiviral medicine used to treat HIV, the virus that can cause the acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Dolutegravir and lamivudine is for use only in adults who have not been treated with other antiviral medications in the past.

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

What should I discuss with my healthcare provider before taking dolutegravir and lamivudine?

You should not use this medicine if you are allergic to dolutegravir or lamivudine, 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 develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you are overweight, or if you are a woman. Ask your doctor about your risk.

You may need to have a negative pregnancy test before starting this treatment.

Dolutegravir and lamivudine 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 and lamivudine on the baby.

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 dolutegravir and lamivudine?

Before you start treatment with dolutegravir and lamivudine, your doctor may perform tests to make sure you do not have hepatitis B.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You will need frequent medical tests.

If you've ever had hepatitis B, this virus may become active or get worse during treatment with dolutegravir and lamivudine, or in the months after you stop using this medicine. You may need frequent liver function tests while using dolutegravir and lamivudine and for several months after your last dose.

Do not change your dose or stop using dolutegravir and lamivudine 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.

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 should I avoid while taking dolutegravir and lamivudine?

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.

Avoid taking an herbal supplement containing St. John's wort.

What are the possible side effects of dolutegravir and lamivudine?

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.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

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 and lamivudine 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;
  • nausea, diarrhea; 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 and lamivudine?

Some medicines can make dolutegravir and lamivudine much less effective when taken at the same time. If you take any of the following medicines, take your dolutegravir and lamivudine 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 and lamivudine. 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 and lamivudine.

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.

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