Daurismo (Glasdegib) belongs to the class of medications called antineoplastic agents. It is used in addition to Cytarabine to treat newly diagnosed acute myeloid Leukemia (AML) that has not been treated with other medications. It is prescribed for adults 75 years of age and older, or for people who cannot receive other intensive chemotherapy.

Acute myeloid leukemia is a type of blood cancer that occurs when the bone marrow stops producing normal blood cells. Daurismo (Glasdegib) works by reducing the number of abnormal cells that are produced, allowing the bone marrow to produce more normal cells.

Daurismo (Glasdegib) may be available under multiple brand names and/or in several different forms. Any specific brand name of Daurismo (Glasdegib) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Daurismo (Glasdegib) may not be used for all of the conditions discussed here.

Your doctor may have suggested Daurismo (Glasdegib) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Daurismo (Glasdegib), speak to your doctor. Do not stop taking Daurismo (Glasdegib) without consulting your doctor.

Do not give Daurismo (Glasdegib) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Daurismo (Glasdegib) if their doctor has not prescribed it.

The recommended dose of Daurismo (Glasdegib) is 100 mg taken by mouth, once daily. Daurismo (Glasdegib) can be taken without food or on an empty stomach. Try to take it at the same time each day. If you vomit after taking a dose, do not take another dose to replace it, wait until it is time to take the next dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Daurismo (Glasdegib) exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .

Store Daurismo (Glasdegib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Daurismo (Glasdegib). If you are concerned about side effects, discuss the risks and benefits of Daurismo (Glasdegib) with your doctor.

The following side effects have been reported by at least 1% of people taking Daurismo (Glasdegib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changes in sense of taste
• decreased appetite
• fatigue
• hair loss
• headache
• muscle, joint, or bone pain
• muscle spasms or tightness
• nausea
• rash
• sores or pain in the mouth or throat
• stomach pain
• tooth ache or loose tooth
• weakness
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• irregular heart beat (e.g., fast, slow, or pounding heartbeat; shortness of breath; dizziness)
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of infection (symptoms may include Fever or chills, severe Diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney failure (e.g., decreased urine production, swelling, fatigue, abdominal pain)
• swelling arms, legs, face
• symptoms of low sodium levels in the blood (e.g., achy, stiff, or uncoordinated muscles; confusion; tiredness; weakness)
• symptoms of pneumonia (e.g., fever or chills, shortness of breath, fatigue, chest pain, cough)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• eye bleeding (e.g., blurred vision, pain when exposed to light, eye bruising)
• severe breathing problems (respiratory failure: blue colour to skin, lips, or fingernails; sleepiness; irregular heartbeat; shortness of breath; loss of consciousness)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of bleeding in the brain (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• signs of a Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Daurismo (Glasdegib).

25 mg
Each yellow, film-coated tablet, debossed with "Pfizer" on one side and "GLS 25" on the other side, contains 25 mg of Daurismo (Glasdegib) (as Daurismo (Glasdegib) maleate). Nonmedicinal ingredients: dibasic calcium phosphate anhydrous, Hypromellose, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.

100 mg
Each pale orange, film-coated tablet, debossed with "Pfizer" on one side and "GLS 100" on the other side contains 100 mg of Daurismo (Glasdegib) (as Daurismo (Glasdegib) maleate). Nonmedicinal ingredients: dibasic calcium phosphate anhydrous, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.

Do not take Daurismo (Glasdegib) if you:

• are allergic to Daurismo (Glasdegib) or any ingredients of the medication
• are male and are unwilling or unable to use effective birth control
• are female, may become pregnant and are unwilling or unable to use effective birth control
• are pregnant
• are breast feeding

Do not give Daurismo (Glasdegib) to children and adolescents under 18 years old.

There may be an interaction between Daurismo (Glasdegib) and any of the following:

• antiarrythmics (e.g., Amiodarone, Disopyramide, Dronedarone, procainamide, quinidine, Sotalol)
• Apalutamide
• Aprepitant
• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole, posaconazole)
• Bosentan
• Chlorpromazine
• Cobicistat
• conivaptan
• Deferasirox
• Diltiazem
• efavirenz
• Elagolix
• Eliglustat
• Estradiol
• Enzalutamide
• etravirine
• Haloperidol
• HIV protease inhibitors (e.g., atazanavir, darunavir, indinavir, ritonavir)
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• mifepristone
• Modafinil
• protein kinase inhibitors(e.g., Dabrafenib, imatinib, Idelalisib, Nilotinib, Palbociclib)
• quinine
• rifampin
• rifabutin
• St. John's wort
• Sarilumab
• seizure medications (e.g., Carbamazepine, Phenobarbital, Phenytoin, primidone)
• siltuximab
• Tetrabenazine
• Tocilizumab
• Verapamil
• Ziprasidone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Daurismo (Glasdegib).

Anemia: Daurismo (Glasdegib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: If you are male and have a partner who is or may become pregnant, it is important that you use effective birth control, including a condom, even if you have had a vasectomy. This should be continued while taking Daurismo (Glasdegib) and for 30 days after the last dose of medication.

Women who may become pregnant should use 2 methods of effective birth control while taking Daurismo (Glasdegib) and for 30 days after the last dose of Daurismo (Glasdegib).

Clotting problems: Daurismo (Glasdegib) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: Daurismo (Glasdegib) may cause fatigue, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you Daurismo (Glasdegib) affects you.

Heart rhythm: Daurismo (Glasdegib) can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Daurismo (Glasdegib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Daurismo (Glasdegib), and whether any special monitoring is needed.

Your doctor will monitor your heart rhythm regularly while you are taking Daurismo (Glasdegib) with a test called an electrocardiogram (ECG). You should not take Daurismo (Glasdegib) if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.

Infection: As well as killing cancer cells, Daurismo (Glasdegib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: If you have liver problems, discuss with your doctor how Daurismo (Glasdegib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Daurismo (Glasdegib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Daurismo (Glasdegib).

Pregnancy: Daurismo (Glasdegib) should not be used during pregnancy, as it may cause harm to the developing baby. If you become pregnant while taking Daurismo (Glasdegib), contact your doctor immediately.

Breast-feeding: It is not known if Daurismo (Glasdegib) passes into breast milk. Breast-feeding is not recommended while taking Daurismo (Glasdegib).

Children: The safety and effectiveness of using Daurismo (Glasdegib) have not been established for children.