Dovato is a tablet containing a combination of two active ingredients: dolutegravir (as dolutegravir sodium), which is an integrase strand transfer inhibitor, and lamivudine, a nucleoside analogue reverse transcriptase inhibitor. It is available as a film-coated tablet for oral use, with each tablet containing 50 mg of dolutegravir and 300 mg of lamivudine. Some key inactive ingredients in the tablet include magnesium stearate, mannitol, and povidone K29/32.

How should I use this medication?

Take this medication by mouth with water. You can take it with or without food. If it upsets your stomach, take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop. Take sucralfate, buffered medications, and antacids or laxatives with aluminum or magnesium at a different time of day than this medication. Take this medication 2 hours before or 6 hours after these products. Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer wanted or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue -Infection—fever, chills, cough, or sore throat -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Diarrhea -Fatigue -Headache -Nausea -Trouble sleeping -Worsening mood, feelings of depression

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Kidney disease -Liver disease -An unusual or allergic reaction to dolutegravir, lamivudine, lactose, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following: -Dofetilide This medication may also interact with the following: -Antiviral medications for HIV or AIDS -Buffered medications, such as buffered aspirin -Calcium supplements -Certain antacids -Certain laxatives -Certain medications for seizures, such as carbamazepine, oxcarbazepine, phenytoin, phenobarbital -Iron supplements -Metformin -Rifampin -Sorbitol -St. John's wort -Sucralfate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while taking this medication. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms. HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV. If you have hepatitis B and HIV, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication. Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

What are the most serious risks of this medication?

Do not stop taking this medication without first talking to your care team. If you have both HIV and hepatitis B, the symptoms of hepatitis B may worsen when you stop taking this medication. Your care team will check your liver and general health after treatment is stopped. You may need to take other medications if your hepatitis flares or returns.