Dolutegravir and Lamivudine

IMPORTANT WARNING:

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 this medication. Your doctor will examine you and order lab tests regularly for several months after you stop taking dolutegravir and lamivudine.

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.

WHY is this medicine prescribed?

The combination of dolutegravir and lamivudine is used to treat human immunodeficiency virus (HIV) infection in certain people. 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 together to decrease the amount of HIV in your blood.

Although dolutegravir and lamivudine will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other lifestyle changes may also decrease the risk of giving the HIV virus to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

The combination of dolutegravir and lamivudine comes as a tablet to take by mouth. Take with or without food once a day. Take dolutegravir and lamivudine at around the same time every day.

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.

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 even for a short time, or if you skip doses, the virus may become resistant to medications and may be harder to treat.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking dolutegravir and lamivudine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with dolutegravir and lamivudine. Other medications may cause dosing changes or extra monitoring when taken with dolutegravir and lamivudine. Make sure you have discussed any medications you are currently taking or plan to take before starting dolutegravir and lamivudine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dolutegravir and lamivudine, please get the advice of your doctor or pharmacist.

• 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.

• the following herbal product may interact with dolutegravir and lamivudine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking dolutegravir and lamivudine. Do not start this medication while taking dolutegravir and lamivudine without discussing with your healthcare provider.

• 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. If you become pregnant while taking dolutegravir and lamivudine, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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
• dizziness
• anxiety

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.