Daurismo (glasdegib) belongs to a class of medications called hedgehog pathway inhibitors. Glasdegib works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Daurismo 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.

Daurismo use has not been studied in people with severe kidney problems or moderate-to-severe liver problems.

Daurismo 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 the mother or father is using this medicine. Use effective birth control.

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

Take Daurismo exactly as prescribed by your doctor Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Daurismo is given in a 28-day treatment cycle, usually for a total of 6 cycles. Daurismo is taken by mouth. Your doctor will determine how long to treat you with this medicine.

Take the medicine once a day at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Daurismo, do not take another dose. Take your next dose as scheduled.

Your heart function may need to be checked using an electrocardiogram or ECG (sometimes called an EKG).

You will need frequent medical tests and your cancer treatments may be delayed based on the results.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Daurismo for Acute Myeloid Leukemia:

100 mg orally once a day on days 1 to 28 in combination with cytarabine 20 mg subcutaneously 2 times a day on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control; for patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response

Use: This drug, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years old or older or who have comorbidities that preclude use of intensive induction chemotherapy

Usual Geriatric Dose of Daurismo for Acute Myeloid Leukemia:

75 years or older:
100 mg orally once a day on days 1 to 28 in combination with cytarabine 20 mg subcutaneously 2 times a day on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control; for patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response

Use: This drug, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years old or older or who have comorbidities that preclude use of intensive induction chemotherapy

To make sure Daurismo is safe for you, tell your doctor if you have ever had:

• heart problems;

• long QT syndrome (in you or a family member);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);

• muscle pain or muscle spasms;

• kidney disease; or

• liver disease.

You will need to take a pregnancy test within 7 days of starting treatment with Daurismo.

May harm an unborn baby. You will need a pregnancy test to make sure you are not pregnant. Use effective birth control while using Daurismo and for at least 30 days after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 30 days after your last dose.

Men using Daurismo should use condoms during treatment, even after a vasectomy and for at least 30 days after treatment ends.

It may be harder for you to get a woman pregnant while you are using this medicine.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses within 12 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tiredness, nausea, vomiting, dizziness, feeling like you might pass out, thirst, and little or no urination.

Do not donate blood while taking Daurismo, and for at least 30 days following your last dose.

Do not donate semen while you are taking Daurismo, and for at least 30 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction to Daurismo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Daurismo may cause serious side effects. Call your doctor at once if you have:

• irregular or fast heartbeats, shortness of breath, and sudden dizziness (like you might pass out);

• easy bruising, unusual bleeding, purple or red spots under your skin;

• any new or worsening muscle pain or muscle spasms; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Daurismo side effects may include:

• bleeding;

• fever, low blood cell counts;

• changes in your sense of taste;

• pain or sores in mouth or throat;

• loss of appetite, constipation, nausea;

• rash;

• muscle pain;

• swelling in your arms or legs;

• feeling tired; or

• trouble breathing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Daurismo can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with glasdegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.