Dolutegravir Sodium (doe-loo-TEG-ra-vir SOE-dee-um)

Treats HIV infection. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Tivicay, Tivicay PD

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is low so you do not run out.
• This medicine is available in tablet or tablet for suspension forms. Do not switch medicines unless your doctor tells you to.
• Swallow the tablet or tablet for suspension whole. Do not crush, break, or chew it. If you need more than one dose of this medicine, swallow one medicine at a time to prevent the risk of choking.
• If you cannot swallow the tablet for suspension whole:
  • You may mix it in 5 milliliters (mL) of water (for 1 or 3 tablets for suspension) or 10 mL of water (for 4, 5, or 6 tablets for suspension) in the medicine cup.
  • Use drinking water only to prepare the dose. Do not use any other drink or food.
  • Swirl the cup gently for 1 to 2 minutes or until no lumps of tablet remain. Drink the oral liquid at least 30 minutes after mixing.
  • You may add another 5 mL of water to the cup and drink it to make sure you get the full dose.
• Use the supplied medicine cup to prepare and give the oral liquid to children. Use the oral syringe to give this medicine to infants.
• 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 almost time for your next dose, wait until then and take a regular dose. 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 together with this medicine.
• Some medicines can affect how dolutegravir works. Tell your doctor if you are also using carbamazepine, dalfampridine, efavirenz, etravirine, fosamprenavir, metformin, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifampin, ritonavir, St John's wort, or tipranavir.
• Take this medicine at least 2 hours before or 6 hours after you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines.
• You may take calcium or iron supplements together with this medicine if you take them with food. If not, take this medicine at least 2 hours before or 6 hours after you take these supplements.

Warnings While Using This Medicine:

• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• 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.
• This medicine may cause the following problems:
  • Serious skin reactions
  • Liver problems
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or 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, 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:

• Headache
• Trouble sleeping

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