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

Dolutegravir and lamivudine is sometimes used in adults who have never been treated with other HIV medications.

Dolutegravir and lamivudine is also used to replace other HIV medications in adults with suppressed viral loads. Your doctor will determine which medication is best for you.

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

You should not use dolutegravir and lamivudine 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 and resistant to medication while you are taking dolutegravir and lamivudine. Hepatitis B may also get worse after you stop using this medicine. You may need frequent liver function tests for several months.

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 may take dolutegravir and lamivudine with or without food.

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 dolutegravir and lamivudine. 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.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Uses: As a complete regimen, for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) with no history of treatment failure and no known substitutions associated with resistance to the individual components

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:

• kidney problems; or

• 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.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed. 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Using dolutegravir and lamivudine 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.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: 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.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, fast or irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Dolutegravir and lamivudine may cause serious side effects. 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 of dolutegravir and lamivudine 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.

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; or

• 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.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dolutegravir and lamivudine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of dolutegravir and lamivudine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.