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DAURISMO- glasdegib tablet, film coated


  1. Patient Information
  2. Advise Patients Of The Risks Of Daurismo Treatment:
  3. Before You Take Daurismo, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. What Should I Avoid While Taking Daurismo?
  5. What Are The Possible Side Effects Of Daurismo?daurismo Can Cause Serious Side Effects, Including:
  6. What Are The Ingredients In Daurismo?active Ingredient:
  7. Inactive Ingredients:
  8. Film-coating:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Advise Patients Of The Risks Of Daurismo Treatment: 

Embryo-Fetal Toxicity

  • Advise female patients of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy[
    DAURISMO is a prescription medicine that is used with the medicine cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults who:
    • are 75 years of age or older,or
    • have other medical conditions that prevent the use of standard chemotherapy
    DAURISMO has not been studied in people with severe kidney problems or moderate-to-severe liver problems.
    It is not known if DAURISMO is safe and effective in children.

Before You Take Daurismo, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have heart problems, including a condition called long QT syndrome.
  • abnormal blood salt (electrolytes) levels.
  • are pregnant or plan to become pregnant.
    • Take DAURISMO with the medicine cytarabine exactly as your healthcare provider tells you.
    • Take DAURISMO 1 time each day, at about the same time each day.
    • Take DAURISMO with or without food.
    • Do not chew, split or crush DAURISMO tablets.
    • If you miss a dose, take it as soon as you remember. If it is less than 12 hours before your next dose, just skip the missed dose and take your next dose at your regular time. Do not take 2 doses of DAURISMO within 12 hours.
    • If you vomit after taking a dose of DAURISMO, do not take an extra dose, just take your next dose at your regular time.
    • Your healthcare provider will perform certain tests to check you for side effects before and during treatment with DAURISMO.
    • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with DAURISMO if you have certain side effects. Do not change your dose or stop taking DAURISMO unless your healthcare provider tells you.

What Should I Avoid While Taking Daurismo? 

  • Do not donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose.
  • Do not donate semen during treatment with DAURISMO and for at least 30 days after the last dose.

What Are The Possible Side Effects Of Daurismo?daurismo Can Cause Serious Side Effects, Including: 

    • Store DAURISMO at room temperature between 68 F to 77 F (20 C to 25 C).
    Keep DAURISMO and all medicines out of the reach of children.General information about the safe and effective use of DAURISMO.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DAURISMO for a condition for which it was not prescribed. Do not give DAURISMO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about DAURISMO that is written for health professionals.

What Are The Ingredients In Daurismo?active Ingredient: 

glasdegib

Inactive Ingredients: 

microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.

Film-coating: 


25 mg tablets: Opadry II Yellow (33G120011) containing hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, and iron oxide yellow.
100 mg tablets: Opadry II Beige (33G170003) containing hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, iron oxide yellow, and iron oxide red.

Logo

LAB-1285-1.0
For more information, go towww.DAURISMO.comor call 1-800-438-1985.



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