Dolutegravir tablets for oral suspension

What is this medication?

DOLUTEGRAVIR (doe loo teg ra veer) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tivicay PD

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• liver disease
• an unusual or allergic reaction to dolutegravir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this drug by mouth. You can take it with or without food. If it upsets your stomach, take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other drugs. Continue taking this therapy unless your health care provider tells you to stop.

When taking whole tablets: Do not cut, crush, or chew the tablets. If more than 1 tablet is required, swallow 1 tablet at a time to reduce the risk of choking.

When using tablets to make a suspension: Place the tablets in water in the supplied cup. For 1 to 3 tablets, use 5 mL of water. For 4 to 6 tablets, use 10 mL of water. Swirl the suspension so that no lumps remain. Take the dose within 30 minutes of mixing.

Take products with iron, aluminum, calcium, or magnesium in them at a different time of day than this drug. Talk to your health care provider if you have questions.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 weeks for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• dofetilide

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS like efavirenz, etravirine, nevirapine, fosamprenavir/ritonavir, tipranavir/ritonavir
• antacids, vitamins, or other products that contain aluminum, calcium, iron, or magnesium
• buffered medicines, like buffered aspirin
• certain medicines for seizures like carbamazepine, oxcarbazepine, phenytoin, phenobarbital
• metformin
• rifampin
• St. John's Wort; Hypericum perforatum
• sucralfate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care provider for regular check-ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• muscle or joint pain
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs of infection - fever or chills, cough, sore throat, pain or trouble passing urine

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• headache
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature below 86 degrees F (30 degrees C). Keep this medicine in the original container. Keep container tightly closed. Do not throw out the packet in the container. It keeps the medicine dry. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.