Lusutrombopag

Lusutrombopag is used treat thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) in patients with chronic (ongoing) liver disease who are scheduled to have a medical or dental procedure to help prevent bleeding complications. Lusutrombopag is in a class of medications called thrombopoietin (TPO) receptor agonists. It works by causing the body to produce more platelets.

Lusutrombopag comes as a tablet to take by mouth. It is usually taken with or without food once a day for 7 days, starting 8 to 14 days before the scheduled procedure. Take lusutrombopag 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 lusutrombopag exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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 lusutrombopag,

• tell your doctor and pharmacist if you are allergic to lusutrombopag, any other medications, or any of the ingredients in lusutrombopag tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had a blood clot or a genetic condition that could lead to blood clots.

• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking lusutrombopag, call your doctor.

• tell your doctor if you are breastfeeding. Your doctor will probably tell you not to breastfeed during your treatment and for 4 weeks after your final dose.

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

Take the missed dose as soon as you remember it on the same day. 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.

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

  • headache

• Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

  • swollen, painful, red, or tender leg

  • shortness of breath, cough, chest pain, fast heartbeat

  • stomach pain or tenderness

• Lusutrombopag 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.

Symptoms of overdose may include the following:

• swollen, painful, red or tender leg

• shortness of breath, cough, chest pain, fast heartbeat

• stomach pain or tenderness

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

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.