Dovato

What is Dovato?

Dovato, a combination of antiviral medicines, prevents the HIV virus from multiplying within your body. Dovato treats HIV, the virus that can lead to acquired immune deficiency syndrome. This medication is not a cure or treatment for HIV/AIDS.

Dovato can be used alone to treat HIV-1 in adults without the need for other HIV-1 medications.

• Who have not previously received HIV-1 medications
• If your healthcare provider determines you meet certain criteria, then it is time to replace your current HIV-1 medicine.

Warnings

Dovato should not be used if you also take dofetilide or Tikosyn. Dovato taken during the first three months of pregnancy can cause birth defects. While taking this medication, use effective birth control methods to avoid pregnancy. Dovato can make hepatitis B more active and resistant. Hepatitis B can also worsen after stopping this medication. You may require frequent liver function testing for several months.

Before you take this drug

Do not take Dovato if you are allergic to lamivudine or dolutegravir, or if you are taking Tikosyn (dofetalide).

Tell your doctor about any of the following to ensure that Dovato will be safe for you:

• Kidney problems;
• Hepatitis b and c are liver diseases.

You can develop lactic acidosis. This is a dangerous buildup of lactic acid in your blood. It may be more common if there are other medical conditions or if the person is obese. Consult your doctor to determine your risk. Dovato may require a negative pregnancy check before you begin treatment. Dolutegravir or lamivudine can harm an unborn child if taken at the time conception occurs or in the first 12 weeks after conception. Tell your doctor immediately if you are pregnant. You may find your name on a registry for pregnant women to monitor the effects of Dovato. Breastfeeding is not recommended for women with HIV/AIDS. Even if the baby was born HIV-free, the virus can be transmitted to the infant through your breast milk.

How to take Dovato?

Your doctor may run tests before you begin treatment with Dovato to ensure that you don't have hepatitis B. Read and carefully follow all instructions or guides provided with your medication, such as labels. Follow all directions as stated therein. Dovato can be taken both with and without food. Medical tests will be required frequently. If you have ever had the hepatitis B virus, it may become active during the treatment with Dovato or worsen in the months following your last dose. Dovato may require frequent liver function testing during treatment and for several weeks after the last dose. Do not stop using Dovato or change your dosage without consulting your doctor. Each person living with HIV should be under the care and supervision of a physician. Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for HIV infection:
Take 1 tablet once daily, orally.
Use: To treat HIV-1 infection as a complete regimen for patients who have no prior antiretroviral history and with no substitutions known to be associated with resistance. Or to replace an antiretroviral regime in those who are virologically suppressed (HIV-1RNA less than 50 copies/mL) on a stable regimen that has no history of failure.
Renal Dose Adjustments
If you are using less than 50 mL/min, it is not recommended.
Liver Dose Reductions:
If you have mild or moderate liver disease (Child Pugh A or B), no adjustment is recommended.
Severe liver disease (Child Pugh C) is not recommended.
Dose Adjustments
Dolutegravir should be administered in conjunction with carbamazepine and rifampin at a dose of 50 mg/day, separated by 12 hours.
Precautions:
US BOXED WARNINGS
Patients with HBV and HIV-1 co-infected:
Emergence of lamivudine-resistant HBV: Before or when starting the drug, all patients with HIV-1 must be tested for HBV. Theemergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If HBV/HIV-1 co-infected patients are treated with this drug, it is important to consider additional treatment for chronic HBV. Otherwise, an alternative regimen may be appropriate.
Exacerbations severe and acute of HBV have been reported in patients with HBV/HIV-1 who stopped taking lamivudine. HBV/HIV-1 co-infected patients' hepatic function should be closely monitored; anti-HBV treatment should be initiated if necessary.
CONTRAINDICATIONS:
Coadministration of dofetilide with a history of hypersensitivity to the active component
Patients younger than 18 have not yet been evaluated for safety and efficacy.

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once. Refill your prescription before you run out.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Dovato reduces the risk of HIV infection, but there is still the possibility that the disease could spread. Share razors and toothbrushes. Do not engage in unprotected sexual activity. Speak to your doctor about the best ways to prevent HIV from being transmitted during sex. Even healthy people should never share syringes for drugs or medicines. St. John's wort is a dangerous herb. John's wort.

Side effects of Dovato

If you experience any of the following symptoms, stop taking Dovato and seek emergency medical attention: Fever, general malaise, difficulty breathing, fatigue; joint or muscular pain; blisters or sores on your mouth; redness or swelling around your eyes; blistering, peeling, or blistering skin; swelling or redness of your face or lips; swelling or blistering of your tongue or throat The mild symptoms of lactic acidosis can worsen over time, and the condition is fatal. If you experience unusual muscle pains, difficulty breathing, stomach pains, vomiting, a fast or irregular heartbeat, dizziness, or fatigue, get emergency medical attention.

If you experience:

• The first sign of any skin reaction, however mild,
• Liver disease: nausea; vomiting; loss of appetite; upper abdominal pain; dark urine; and clay-colored stool. Jaundice.

Dolutegravir, lamivudine, and other antiviral drugs can affect your immune system. This may lead to certain side effects for weeks or even months after taking the medicine. You should tell your doctor if:

• Signs and symptoms of an infection: fever, sweats at night, swollen lymph glands, cold sores, coughing, wheezing, diarrhea, and weight loss.
• Problems with balance, eye movements, or speech, or even a prickly sensation;
• Impotence, menstrual changes, swelling of the neck or throat (enlarged thyroid)

Dovato can cause a variety of side effects.

• Headache;
• Tiredness;
• Nausea, diarrhea;
• Sleep problems (insomnia).

There may be other side effects. For medical advice on side effects, call your doctor.Contacting the FDA directly in regards to side effects is easy at 1-800-FDA-1088.

Interaction with other drug

Dovato can be less effective if taken with certain medicines. Take your Dovato 2 hours before or 6 hours after taking any of the medicines listed below.

• Antiacids and laxatives containing calcium, magnesium, or aluminum, such as Amphojel (Di-Gel Maalox), Mylanta (Milk of Magnesia), Pepcid Complete (Rolaids), Rulox (Rulox), Tums (Tums), or sucralfate, a medicine for ulcers (Carafate);
• Buffered medication
• Vitamin or mineral supplements containing calcium or iron

Dolutegravir and lamivudine interact with numerous drugs, from prescription to over-the-counter products and vitamins/herbal remedies. Below is only an incomplete list; be sure to inform your healthcare provider of all medications currently taken or those you intend to discontinue/start taking in order to ensure best possible care for you and for everyone in the household.