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DAURISMO is a brand name for Glasdegib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DAURISMO (glasdegib) is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy. Distribution Restrictions DAURISMO is only…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dose Adjustment 10/2022 7 WARNINGS AND PRECAUTIONS 10/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment..................................................... 4 Administration...................................................................................................
5 Missed Dose .................................................................................................... 10 5 OVERDOSAGE ...........................................................................................................
10
). 2 Clinical Trial Adverse Reactions). Inform all patients starting treatment with DAURISMO of the risk of muscle-related adverse reactions. Instruct them to report promptly any unexplained muscle pain, tenderness or weakness occurring during treatment with DAURISMO or if symptoms persist after discontinuing treatment.
Monitor serum CK levels prior to and during treatment with DAURISMO (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). Management of high-grade CK elevation based on current standards of medical practice and following appropriate treatment guidelines is recommended.
2 Recommended Dose and Dosage Adjustment).
Reproductive Health:
Female and Male Potential Contraception in Men and Women Based on its mechanism of action and findings from animal embryo-fetal developmental studies, DAURISMO can cause fetal harm when administered to a pregnant woman. 1 WARNINGS AND PRECAUTIONS, Special Populations, Females of Childbearing Potential).
It is not known whether DAURISMO is present in semen. 1 WARNINGS AND PRECAUTIONS, Special Populations, Male Patients). Fertility Based on nonclinical safety findings, DAURISMO has the potential to impair reproductive function in males.
Some effects on male reproductive organs did not recover (see 16 NON-CLINICAL TOXICOLOGY). Men should seek advice on effective fertility preservation before treatment. Based on its mechanism of action, DAURISMO may impair female fertility.
In repeat-dose toxicity studies in rats, findings observed in the male reproductive tract included adverse testicular changes with DAURISMO at doses ≥50 mg/kg/day, and consisted of minimal to severe hypospermatogenesis characterized by partial to complete loss of spermatogonia, spermatocytes and spermatids and testicular degeneration.
10/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS ..............................................................................................................
1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION.................................................................................
1 Dosing Considerations ....................................................................................... 2 Recommended Dose and Dosage Adjustment..................................................... 4 Administration...................................................................................................
5 Missed Dose .................................................................................................... 10 5 OVERDOSAGE ...........................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ..........................................................................................
DAURISMO (glasdegib) is contraindicated in: • Female patients who are pregnant (see
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Hypospermatogenesis did not recover whereas testicular degeneration did recover. The dose at which adverse testicular effects were observed in male rats was identified as 50 mg/kg/day with corresponding systemic exposures that were approximately 8-times those associated with the observed human exposure at the 100 mg once daily dose (based on unbound AUC in respective species).
1 Special Populations Females of Childbearing Potential Females of childbearing potential must comply with effective contraceptive measures (see 2 CONTRAINDICATIONS) to avoid becoming pregnant, as per the DAURISMO Pregnancy Prevention Program (DPPP).
A FCBP must not be given DAURISMO until pregnancy is excluded. Verify the pregnancy status of female patients of reproductive potential prior to initiating treatment. I f the patient becomes pregnant while taking DAURISMO, the patient should be apprised of the potential hazard to the fetus.
Criteria for FCBP A FCBP is defined in the DPPP as a female patient who meets at least one of the following criteria: - is menstruating, - is amenorrhoeic and has not entered menopause (menopause should be clinically confirmed), - is perimenopausal.
A female patient who does not meet one of the above criteria, has a XY genotype, Turner’s syndrome, or uterine agenesis is defined as a Female of Non-Childbearing Potential. For FCBP, DAURISMO is contraindicated unless ALL of the following conditions are met: The patient is willing and able to comply with the DPPP and all the conditions of use.
If the patient is biologically capable of having children and is sexually active, the patient must agree to use two (2) highly effective methods of contraception consistently and correctly or to commit to continually abstaining from heterosexual contact.
The patient has a consultation with a health care professional to discuss the two most appropriate simultaneous contraceptive methods to be used, and to instruct the patient in their consistent and correct use. The patient must be willing and able to comply with the pregnancy testing requirements noted in detail below; which includes a negative pregnancy test (blood or urine) within 7 days prior to DAURISMO (glasdegib) Product Monograph Page 14 of 38 initiating DAURISMO treatment, as well as on-going monthly pregnancy tests throughout treatment.
The patient is informed of the potential risk to a fetus. The patient understands the need to consult the health care professional immediately if the selected birth control methods are discontinued or if pregnancy is known or suspected.
Contraception FCBP (including those who normally do not use contraception due to a history of infertility and those who have amenorrhoea and have not entered menopause) must agree to use 2 highly effective methods of contraception consistently and correctly for the duration of the treatment period and for at least 30 days following discontinuation of DAURISMO.
FCBP who chooses to abstain from heterosexual contact as a contraceptive measure must commit to using two methods of contraception at the same time if abstinence is no longer practiced. A FCBP who has amenorrhoea or has become amenorrhoeic must also use two effective methods of contraception simultaneously as outlined above.
Female patients with a previous hysterectomy or bilateral oophorectomy are exempt from contraception use […]
1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................ 3 Pediatrics ...................................................................................................
4 Geriatrics ................................................................................................... 16 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview.............................................................................. 2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Reactions ..................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...................................................................................................... 19 9 DRUG INTERACTIONS................................................................................................
4 Drug-Drug Interactions .................................................................................... 5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions ....................................................................................
7 Drug-Laboratory Test Interactions .................................................................... 23 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics....................................................................................... 23 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
25 PART II: SCIENTIFIC INFORMATION ...................................................................................... 26 13 PHARMACEUTICAL INFORMATION............................................................................ 26 14 CLINICAL TRIALS........................................................................................................
1 Trial Design and Study Demographics ......................................................... 2 Study Results ............................................................................................. 27 16 NON-CLINICAL TOXICOLOGY .....................................................................................
28 PATIENT MEDICATION INFORMATION ................................................................................. 30 DAURISMO (glasdegib) Product Monograph Page 4 of 38 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS DAURISMO (glasdegib) is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.
Distribution Restrictions DAURISMO is only available through a control distribution program called the DAURISMO Pregnancy Prevention Program (DPPP). Under this program, only prescribers and pharmacies registered with the program are able to prescribe and dispense the product, respectively.
In addition, DAURISMO can only be dispensed to patients who are registered and meet all the conditions of the DPPP. For more information, please contact the DPPP at 1 844 616-6888. 1 Pediatrics Pediatrics (˂18 years of […]