Glasdegib must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that glasdegib will cause severe birth defects (physical problems that are present at birth) or death of the unborn baby.

If you are a female who can become pregnant, you must have a negative pregnancy test within 7 days before you start treatment with glasdegib. You will need to use effective birth control during you treatment with glasdegib and for at least 30 days after your final dose. Talk to your doctor about birth control options that will work for you.

If you are a male with a female partner who can become pregnant or who is pregnant, you should know glasdegib may be present in the semen and may cause harm to the unborn baby. Use a condom during your treatment with glasdegib and for at least 30 days after the final dose even if you have had a vasectomy (surgery to prevent sperm from leaving your body and causing pregnancy). Do not donate semen during your treatment and for at least 30 days after yourfinal dose.

If you have had unprotected sex, think that your birth control has failed, or think you or your female partner may be pregnant call your doctor right away.

Do not donate blood or blood products during your treatment with glasdegib and for at least 30 days after your last dose.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with glasdegib 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 the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Glasdegib is used along with cytarabine as a first treatment for acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) in people over 75 years of age, or in adults who have other medical conditions and can not be treated with other chemotherapy medications. Glasdegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Glasdegib comes as a tablet to take by mouth. It is usually given with or without food once a day for at least 6 months, or as long as your doctor recommends treatment. Take glasdegib 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 glasdegib 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.

If you vomit after taking glasdegib, do not take another dose. Continue your regular dosing schedule.

Your doctor may need to interrupt your treatment, reduce your dose, or stop your treatment depending on your response to the medication and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment with glasdegib.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking glasdegib,

• tell your doctor and pharmacist if you are allergic to glasdegib, any other medications, or any of the ingredients in glasdegib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone), carbamazepine (Carbatrol, Equetro, Tegretol, others), chlorpromazine, cilostazol, citalopram (Celexa), clarithromycin, disopyramide (Norpace), dofetilide, donepezil (Aricept), dronedarone (Multaq), efavirenz (Sustiva, in Atripla, Symfi), escitalopram (Lexapro), flecainide (Tambocor), fluconazole (Diflucan), haloperidol (Haldol), ibutilide (Corvert), indinavir (Crixivan), itraconazole (Sporanox, Onmel), ketaconazole, methadone (Dolophine, Methadose), nefazodone, nelfinavir (Viracept), nevirapine (Viramune), ondansetron (Zofran, Zuplenz), phenobarbital, phenytoin (Dilantin, Phenytek), pimozide (Orap), pioglitazone (Actos, in Oseni, Duetact, Actoplus Met), procainamide, quinidine (in Nuedexta), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifater, Rifamate), ritonavir (Norvir, in Viekira Pak, Kaletra, Technivie), sotalol (Betapace, Sorine, Sotylize), and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with glasdegib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor what herbal products you are taking, especially St. John’s wort.
• tell your doctor if you have or have ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), heart failure (condition in which the heart cannot pump enough blood to other parts of the body), or low levels of magnesium or potassium in your blood.
• tell your doctor if you are breast-feeding. You should not breast-feed during your treatment with glasdegib and for at least 30 days after your final dose.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking glasdegib.

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

Take the missed dose as soon as you remember it. However, if it less than 12 hours until your 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.

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

• muscle spasms
• muscle, bone or joint pain
• extreme tiredness
• nausea
• vomiting
• abdominal pain
• constipation
• pain or sores in your mouth or throat
• decreased appetite
• change in the way things taste
• weight loss
• headache
• rash
• swelling of hands or legs
• hair loss
• toothache

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

• feeling faint, lightheaded, or dizzy; fast or irregular heartbeat
• unusual bruising or bleeding
• fever alone or along with chills, weakness. or other signs of infection
• decreased urination
• chest pain

Glasdegib 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:

• nausea
• vomiting
• extreme tiredness
• dizziness

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests such as electrocardiograms (EKG, test that records the electrical activity of the heart) and blood tests before and during therapy to make sure it is safe for you to take glasdegib and to check your body’s response to the medication.

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

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.

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