DOVATO

Uses of DOVATO

Dovato is an oral, once-daily, antiviral medicine containing dolutegravir 50 mg with lamivudine 300 mg that may be used to treat HIV-1 infection in adults and adolescents aged 12 years and older and weighing at least 55 pounds (25kg):

• who have not received HIV-1 medicines in the past, or
• to replace a person’s current HIV-1 medication when their healthcare provider determines that they meet certain requirements (virologically suppressed, no history of treatment failure, no known substitutions associated with resistance).

Dovato combines 2 medications in 1 pill and is a complete regimen for HIV-1 treatment. No other HIV-1 medications are needed.

Dovato works in two different ways to kill the HIV-1 virus. Dolutegravir blocks an enzyme called HIV integrase that is essential for the entry of HIV into DNA and is an integrase strand transfer inhibitor (INSTI). Lamivudine blocks an enzyme called reverse transcriptase that prevents HIV from replicating and is a nucleoside analog reverse transcriptase inhibitor (NRTI).

Precautions and Warnings

People who are allergic to any of the following should not take Dovato.

• Dovato
• Dolutegravir
• Lamivudine
• Any of the ingredients in the specific product dispensed

Dovato should not be taken while you are using certain other medicines. Before taking Dovato, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Dovato is right for you.

Tell your healthcare provider if you have a condition called hepatitis B, which causes inflammation (swelling) in the liver. If you have hepatitis B and HIV-1, taking Dovato may cause the hepatitis B virus to become more difficult to treat (resistance). Stopping Dovato, if you have hepatitis B and HIV-1, may also worsen hepatitis B. For a few months after stopping Dovato, your healthcare provider may do blood tests to check how well your liver is working.

Tell your healthcare provider if you have any of the following.

• Liver problems, including hepatitis C
• Kidney problems

It is not known if or how Dovato could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.

Dovato passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

Dosage

The usual dosage of Dovato is one tablet of Dovato (dolutegravir 50 mg/lamivudine 300 mg) once a day. You may take Dovato with or without food.

Additional dosage information:

Your healthcare provider may give you an additional 50mg of dolutegravir if you also take carbamazepine or rifampin. Take this separated from this combination product by 12 hours.

If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, you should take Dovato at least 2 hours before or 6 hours after you take these medicines.

Do not change your dose or stop using Dovato without your doctor’s advice. Every person with HIV should remain under the care of a doctor.

Side Effects

Common side effects:

• headache
• tiredness
• nausea
• diarrhea
• anxiety
• sleep problems (insomnia).