When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to dolutegravir.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is less than 4 hours until your next dose, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use dofetilide while you are using this medicine.
• Some medicines can affect how dolutegravir works. Tell your doctor if you are also using St John's wort, carbamazepine, efavirenz, etravirine, fosamprenavir, metformin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifampin, ritonavir, or tipranavir.
• Take dolutegravir at least 2 hours before or 6 hours after you 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 dolutegravir 2 hours before or 6 hours after you take these supplements.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including hepatitis B or C), or other types of infection.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  
  • Serious allergic reaction
  • Liver problems
• Your immune system may get stronger when you start taking HIV medicines. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Tell your doctor right away if you notice any changes in your health.
• This medicine will not keep you from giving HIV to others. Always practice safe sex, even if your partner also has HIV. Do not share needles or other items that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or severe skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, joint or muscle aches, or unusual tiredness or weakness
• Redness, pain, or swelling of or around your eye or eyelid
• Sores on your lips or mouth

If you notice these less serious side effects, talk with your doctor:

• Weight gain around your neck, upper back, breast, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088