Dolutegravir and Lamivudine

Tell your doctor if you have or think you may have hepatitis B virus infection (HBV; an ongoing liver infection). Your doctor may test you to see if you have HBV before you begin your treatment with dolutegravir and lamivudine. If you have HBV and you take dolutegravir and lamivudine, your condition may suddenly worsen when you stop taking dolutegravir and lamivudine. Your doctor will examine you and order lab tests regularly for several months after you stop taking dolutegravir and lamivudine to see if your HBV has worsened.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to dolutegravir and lamivudine.

Talk to your doctor about the risks of taking dolutegravir and lamivudine.

The combination of dolutegravir and lamivudine is used alone to treat human immunodeficiency virus (HIV) infection in certain people who have never been treated with any HIV medications before. Lamivudine is in a class of medications called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and dolutegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). They work by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body. Although dolutegravir and lamivudine will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of getting or transmitting the HIV virus to other people.

The combination of dolutegravir and lamivudine comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take dolutegravir and lamivudine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dolutegravir and lamivudine exactly as directed. Do not take more or less of it, or take it more often than prescribed by your doctor.

Dolutegravir and lamivudine help to control HIV infection but do not cure it. Continue to take dolutegravir and lamivudine even if you feel well. Do not stop taking dolutegravir, and lamivudine without talking to your doctor. If you stop taking dolutegravir and lamivudine or miss doses, your condition may become more difficult to treat. When your supply of dolutegravir and lamivudine starts to run low, get more from your doctor or pharmacist.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking dolutegravir and lamivudine,

• tell your doctor and pharmacist if you are allergic to dolutegravir, lamivudine, any other medications, or any of the ingredients in the dolutegravir and lamivudine tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking dofetilide (Tikosyn). Your doctor will probably tell you not to take dolutegravir and lamivudine if you are taking this medication.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Equetro, Tegretol, others), dalfampridine (Ampyra), metformin (Glumetza, Glucophage, Riomet, in Invokamet, in Janumet, others), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and sorbitol or medications that contain sorbitol. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids or laxatives that contain aluminum or magnesium; sucralfate (Carafate); or buffered medications such as buffered aspirin, take them at least 2 hours after or 6 hours before you take dolutegravir and lamivudine.
• if you are taking iron or calcium supplements, or multivitamins that contain iron or calcium, take them at the same time that you take dolutegravir and lamivudine along with food, or take them at least 2 hours after or 6 hours before you take dolutegravir and lamivudine.
• tell your doctor what herbal products you are taking, especially St. John's wort.
• tell your doctor if have or have ever had hepatitis C virus infection (HCV; an ongoing liver infection) or other liver disease, or kidney disease.
• tell your doctor if you are pregnant, or plan to become pregnant. You will need to take a pregnancy test before you start treatment. You should not become pregnant while you are taking dolutegravir and lamivudine. Talk to your doctor about effective birth control methods that you can use during your treatment. If you become pregnant while taking dolutegravir and lamivudine, call your doctor immediately.
• tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking dolutegravir and lamivudine.
• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms during your treatment with dolutegravir and lamivudine, be sure to tell your doctor.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Dolutegravir and lamivudine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• diarrhea
• gas
• difficulty falling asleep or staying asleep
• tiredness
• muscle weakness

Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• yellowing of eyes or skin, abdominal pain, light colored stools, dark colored urine, nausea, vomiting, loss of appetite
• extreme tiredness or weakness, muscle pain, difficulty breathing, abdominal pain, nausea, vomiting, feeling cold especially in your arms and legs, dizziness, fast or irregular heartbeat
• rash (without any other symptoms)

Some side effects can be serious. If you experience any of these symptoms, stop taking dolutegravir and lamivudine and call your doctor immediately or get emergency medical treatment:

• hives, swelling of the face, throat, tongue, or lips, red or swollen eyes, difficulty swallowing or breathing
• rash along with any of the following symptoms; fever; flu-like symptoms; extreme tiredness; muscle or joint aches; peeling or blistering skin; sores or blisters in mouth; or red, itchy, watery eyes,

Dolutegravir and lamivudine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

• Dovato^® (as a combination product containing Dolutegravir, Lamivudine)

• dolutegravir and 3TC