Diazoxide Choline

WHY is this medicine prescribed?

Diazoxide choline is used to treat hyperphagia (the feeling of being hungry all the time) in people with Prader-Willi syndrome (an inherited condition that can cause physical, mental, and behavioral problems). Diazoxide choline is in a class of medications called anorexigenic agents. It works by reducing certain natural substances in brain and pancreas that can increase appetite and the feeling of being hungry.

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?

Diazoxide choline comes as an extended-release tablet to take by mouth. Take with or without food once a day. Take diazoxide choline at around the same time every day.

Take diazoxide choline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of diazoxide choline and gradually increase your dose, not more than once every 2 weeks.

Diazoxide choline controls hyperphagia but does not cure it. Continue to take diazoxide choline even if you feel well. Do not stop taking diazoxide choline without talking to your doctor.

You will be given the Medication Guide when you begin treatment with diazoxide choline and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking diazoxide choline,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking diazoxide choline. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you think you are dehydrated or if you have nausea, vomiting, or diarrhea or if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking). Also, tell your doctor if you have or have ever had high blood sugar or diabetes, swelling in your legs or other parts of your body, heart failure or other heart problems, or liver or kidney problems.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking diazoxide choline, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking diazoxide choline.

• talk to your doctor about the safe use of alcoholic beverages while you are taking diazoxide choline.

• you should know that diazoxide choline may cause an increase in blood sugar. Your doctor will check your blood sugar and glycosylated hemoglobin (HbA1c) before starting treatment and regularly while you are taking diazoxide choline. Tell your doctor immediately if you have any of the following symptoms: extreme thirst, frequent or increased urination, extreme hunger, weight loss, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, stomach pain, unusual tiredness or weakness, shortness of breath, breath that smells fruity, and decreased consciousness. Call your doctor if you are unable to eat or drink normally due to nausea, vomiting, or diarrhea while you are taking diazoxide choline. Your doctor may lower your dose, interrupt or stop your treatment, or treat with other medications to help control your blood sugar while you are taking diazoxide choline.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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?

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

• unusual hair growth
• joint pain
• runny nose or sore throat
• fever
• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, your doctor immediately:

• dry mouth, dark urine, decreased sweating, dry skin, or other signs of dehydration
• swelling of the face, hands, arms, feet, ankles, or lower legs
• shortness of breath or difficulty breathing, cough, fast or irregular heartbeat, or chest pain

Diazoxide choline 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). Do not remove the desiccant (drying agent) from the container.

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.

Symptoms of overdose may include:

• extreme thirst, frequent or increased urination, unusual hunger, weight loss
• nausea, vomiting, stomach pain, unusual tiredness or weakness, shortness of breath, breath that smells fruity, and decreased consciousness

What OTHER INFORMATION should I know?

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

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling 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.