Pronunciation:

doe-loo-TEG-ra-vir, la-MIV-ue-deen

Brand Names:

• Dovato

Dosage Forms:

• Tablet

Warnings:

Warning: Patients Co-Infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV-1): Emergence of Lamivudine-Resistant HBV and Exacerbations of HBVAll patients with HIV-1 should be tested for the presence of HBV prior to or when initiating dolutegravir/lamivudine. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If dolutegravir/lamivudine is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of dolutegravir/lamivudine. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Integrase Inhibitor

Uses of This Medicine:

Dolutegravir and lamivudine combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Dolutegravir and lamivudine combination will not cure or prevent HIV infection or AIDS. It works by lowering the amount of HIV in the blood and will also help your immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. Dolutegravir and lamivudine combination will not keep you from spreading HIV to other people.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dolutegravir and lamivudine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dolutegravir and lamivudine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aluminum
• Amprenavir
• Cabotegravir
• Calcium
• Carbamazepine
• Dabrafenib
• Dalfampridine
• Dasabuvir
• Efavirenz
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fosphenytoin
• Horsetail
• Iron
• Itraconazole
• Magaldrate
• Magnesium
• Mavacamten
• Metformin
• Nevirapine
• Omaveloxolone
• Orlistat
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Sorbitol
• St John's Wort
• Sucralfate
• Tacrolimus
• Tipranavir
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B or C infection—Use with caution. May make this condition worse.

• Kidney disease or
• Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for the full time of treatment, even if you begin to feel better. It is also important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

Dolutegravir and lamivudine combination contains a fixed amount of each medicine in the tablet.

You may take this medicine with or without food.

Take this medicine at least 2 hours before or 6 hours after take sucralfate, an antacid or laxative that contains aluminum, calcium, or magnesium, or a buffered medicine.

You may take calcium or iron supplements together with this medicine if you take them with food. If not, take this medicine 2 hours before or 6 hours after you take these supplements.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For HIV infection:
    • Adults—One tablet once a day. Each tablet contains 50 milligrams (mg) dolutegravir and 300 mg lamivudine.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine together with dofetilide (Tikosyn®). Using these medicines together may cause serious or life-threatening side effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first part of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

Serious allergic reactions may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: a severe rash or rash with fever, blistering or peeling skin, diarrhea, nausea, vomiting, joint or muscle pain, sores in the mouth, swelling of the face, trouble breathing, unusual tiredness or weakness, or yellow eyes or skin.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Black, tarry stools

bleeding gums

bloody urine

chills

cough

dark urine

decreased frequency or amount of urine

fast heartbeat

fever

hives, itching, skin rash

hoarseness

increased blood pressure

increased thirst

irritation

joint pain, stiffness, or swelling

light-colored stools

loss of appetite

lower back or side pain

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

redness of the skin

sore throat

stomach discomfort or pain

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble breathing or swallowing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

weight gain

yellow eyes and skin

Incidence not known

Blurred vision

diarrhea

dry mouth

fast, shallow breathing

flushed, dry skin

fruit-like breath odor

headache

increased hunger

increased urination

light-colored stools

muscle cramps, pain, stiffness, or spasms

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sleepiness

stomach pain, continuing

sweating

unexplained weight loss

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abnormal dreams

anxiety

bloated or full feeling

discouragement

dizziness

excess air or gas in the stomach or bowels

feeling sad or empty

headache

loss of interest or pleasure

passing gas

thoughts or attempts at killing oneself

trouble concentrating

trouble sleeping

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty in moving

hair loss or thinning of hair

redistribution of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.