Daurismo

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



  
 

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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 25 mg film-coated tablets 
Daurismo 100 mg film-coated tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Daurismo 25 mg film-coated tablets 
 
Each film-coated tablet contains glasdegib maleate equivalent to 25 mg of glasdegib. 
 
Excipient with known effect 
Each film-coated tablet contains 1.3 mg of lactose monohydrate.  
 
Daurismo 100 mg film-coated tablets 
 
Each film-coated tablet contains glasdegib maleate equivalent to 100 mg of glasdegib. 
 
Excipient with known effect 
Each film-coated tablet contains 5.0 mg of lactose monohydrate. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet (tablet). 
 
Daurismo 25 mg film-coated tablets  
 
7 mm round, yellow film-coated tablet debossed with “Pfizer” on one side and “GLS 25” on the other 
side.  
 
Daurismo 100 mg film-coated tablets  
 
11 mm round, pale orange film-coated tablet debossed with “Pfizer” on one side and “GLS 100” on 
the other side.  
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed 
de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for 
standard induction chemotherapy.  
 



  
 

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4.2 Posology and method of administration 
 
Daurismo should only be prescribed by or under the supervision of a physician experienced in the use 
of anticancer medicinal products. 
 
Posology 
 
The recommended dose is 100 mg glasdegib once daily in combination with low-dose cytarabine (see 
section 5.1). Glasdegib should be continued as long as the patient is deriving clinical benefit.  
 
Delayed or missed doses of glasdegib 
If a dose is vomited, a replacement dose should not be administered; patients should wait until the next 
scheduled dose is due. If a dose is missed or not taken at the usual time, then it should be taken as soon 
as the patient remembers unless more than 10 hours have passed since the scheduled dosing time, in 
which case the patient should not take the missed dose. Patients should not take 2 doses at the same 
time to make up for a missed dose.  
 
Dose modifications 
Dose modifications may be required based on individual safety and tolerability. If dose reduction is 
necessary, then the dose of glasdegib should be reduced to 50 mg taken orally once daily.  
 
Dose modification and management guidelines for specific adverse reactions are provided in Tables 1, 
2, 3 and 4. 
 
No starting dose adjustments are required on the basis of patient age, race, gender, or body weight (see 
section 5.2). 
 
Assessment and monitoring of laboratory and QT abnormalities  
Complete blood counts, electrolytes, renal, and hepatic function should be assessed prior to the 
initiation of Daurismo and at least once weekly for the first month. Electrolytes and renal function 
should be monitored once monthly for the duration of therapy. Serum creatine kinase (CK) levels 
should be obtained prior to initiating Daurismo and as indicated clinically thereafter (e.g., if muscle 
signs and symptoms are reported). Electrocardiograms (ECGs) should be monitored prior to the 
initiation of Daurismo, approximately one week after initiation, and then once monthly for the next 
two months to assess for QT corrected for heart rate (QTc) prolongation. ECG should be repeated if 
abnormal. Certain patients may require more frequent and ongoing ECG monitoring (see section 4.4). 
Abnormalities should be managed promptly.  
  



  
 

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Table 1. Dose modification and management for adverse reactions – QT interval prolongation 
(corrected QT interval prolongation on at least 2 separate electrocardiograms (ECGs)) 

Adverse reaction: 
ECG QT 
Prolonged 

Dose modification and management recommendations 

Corrected QT 
interval 480 msec to 
500 msec 
 
 

Assess electrolyte levels and supplement as clinically indicated. 
 
Review and adjust concomitant medicinal products with known QT 
prolonging effects (see section 4.5). 
 
Monitor ECGs at least weekly for 2 weeks following resolution of QT 
prolongation to less than or equal to 480 msec.

Corrected QT 
interval greater than 
500 msec 

Assess electrolyte levels and supplement as clinically indicated. 
 
Review and adjust concomitant medicinal products with known QT 
prolonging effects (see section 4.5). 
 
Interrupt Daurismo.  
 
Resume Daurismo at a reduced dose of 50 mg once daily when corrected 
QT interval returns to within 30 msec of baseline or less than or equal to 
480 msec. 
 
Monitor ECGs at least weekly for 2 weeks following resolution of QT 
prolongation. 
 
Consider re-escalating the dose of Daurismo to 100 mg daily if an 
alternative aetiology for the QT prolongation can be identified. 

Corrected QT 
interval 
prolongation and 
life-threatening 
arrhythmia 

Discontinue Daurismo permanently. 

 



  
 

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Table 2. Dose modification and management for CK elevations and muscle-related adverse 
events 

Adverse reaction: 
Severity of CK 
elevation 

Dose modification and management recommendations  

Grade 1 
[CK elevation 
>ULN - 2.5 x 
ULN] 

Continue Daurismo at the same dose and monitor CK levels weekly until 
resolution to baseline and then monthly. Monitor muscle symptoms for 
changes until resolution to baseline.  
 
Check renal function (serum creatinine) regularly and ensure that patient is 
adequately hydrated.  

Grade 2 without 
renal impairment  
(serum Cr ≤ ULN)  
[CK elevation >2.5 
x ULN - 5 x ULN] 

Interrupt Daurismo and monitor CK levels weekly until resolution to 
baseline.  
 
Monitor muscle symptoms for changes until resolution to baseline. Upon 
resolution, resume Daurismo at the same dose level and measure CK 
monthly thereafter.  
 
Check renal function (serum creatinine) regularly and ensure that patient is 
adequately hydrated. 
  
If symptoms re-occur, interrupt Daurismo until resolution to baseline. 
Re-introduce Daurismo at 50 mg daily and follow the same monitoring 
recommendations. If symptoms persist, consider discontinuing Daurismo.  

Grade 3 or 4 
without renal 
impairment  
(serum Cr ≤ ULN)  
[Grade 3 (CK 
elevation >5 x 
ULN - 10 x ULN)]  
[Grade 4 (CK 
elevation >10 x 
ULN)] 

Interrupt Daurismo and monitor CK levels weekly until resolution to 
baseline. Monitor muscle symptoms for changes until resolution to baseline.  
 
Check renal function (serum creatinine) regularly and ensure that patient is 
adequately hydrated.  
 
If renal function is not impaired and CK resolves to baseline, consider 
resuming Daurismo at 50 mg daily. CK levels should be measured weekly 
for 2 months after re-administration of Daurismo and monthly thereafter. 

Grade 2, 3 or 4 
with renal 
impairment  
(serum Cr > ULN 
per CTCAE 4.0) 

If renal function is impaired, interrupt Daurismo and ensure that the patient 
is adequately hydrated and evaluate other secondary causes of renal 
impairment.  
 
Monitor CK and serum creatinine levels weekly until resolution to baseline.  
 
Monitor muscle symptoms for changes until resolution to baseline.  
 
If CK and serum creatinine levels return to baseline consider resuming 
Daurismo at 50 mg daily and measure CK levels weekly for 2 months and 
monthly thereafter; otherwise discontinue treatment permanently.  

Abbreviations: CK=creatine kinase; Cr=creatinine; ULN=upper limit of normal; CTCAE=Common Terminology Criteria for 
Adverse Events. 
 



  
 

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Table 3. Dose modification and management for adverse reactions – Haematologic toxicity 
Adverse reaction:  
Haematologic 
toxicity 

Dose modification and management recommendations 

Platelets less than 
10 x 109/L for more 
than 42 days in the 
absence of disease 

Discontinue Daurismo and low-dose cytarabine permanently. 

Neutrophil count 
less than 
0.5 x 109/L for 
more than 42 days 
in the absence of 
disease 

Discontinue Daurismo and low-dose cytarabine permanently. 
 

 
Table 4. Dose modification and management for adverse reactions – Nonhaematologic toxicity 

Adverse reaction: 
Nonhaematologic 
toxicity  

Dose modification and management recommendations 
 
If adverse reaction is attributed to low-dose cytarabine and not to Daurismo, 
low-dose cytarabine may be modified while Daurismo dosing should be 
continued. 

Grade 3* Interrupt Daurismo and/or low-dose cytarabine until symptoms improve to 
Grade ≤ 1 or return to baseline.  
 
Resume Daurismo at the same dose level, or at a reduced dose of 50 mg. 
 
Resume low-dose cytarabine at the same dose level, or at a reduced dose of 
15 mg or 10 mg. 
 
If toxicity recurs, discontinue Daurismo and/or low-dose cytarabine.† 

Grade 4* Withhold Daurismo until symptoms improve to Grade ≤ 1 or return to 
baseline. 
 
Upon recovery, resume Daurismo at a dose of 50 mg or discontinue treatment 
at the discretion of the prescriber. 

* Grading according to CTCAE 4.0: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. 
† If a decision is made to permanently discontinue low-dose cytarabine, Daurismo should also be discontinued, unless the 
individual patient is deriving clinical benefit and is tolerating treatment with Daurismo. 
Abbreviations: CTCAE=Common Terminology Criteria for Adverse Events. 
 
Dose modification for concomitant use with moderate CYP3A4 inducers 
Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use 
of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as 
tolerated as shown in Table 5. After the moderate CYP3A4 inducer has been discontinued for 7 days, 
the Daurismo dose taken prior to initiating the moderate CYP3A4 inducer should be resumed (see 
section 4.5). 
 
Table 5. Dose modification recommendations for Daurismo with concomitant use of moderate 
CYP3A4 inducers 

Current dose Adjusted dose 
100 mg orally once daily 200 mg orally once daily 
50 mg orally once daily 100 mg orally once daily 



  
 

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Special populations 
 
Hepatic impairment 
No dose adjustments are recommended in patients with mild, moderate, or severe hepatic impairment 
(see section 5.2). 
 
Renal impairment 
No dose adjustments are recommended for patients with mild, moderate, or severe renal impairment. 
No data are available in patients requiring haemodialysis (see section 5.2). 
 
Elderly (≥ 65 years of age) 
No dose adjustment in elderly patients is required (see section 5.2). 
 
Paediatric population  
The safety and efficacy of Daurismo in the paediatric population (< 18 years of age) have not been 
established. Daurismo should not be used in the paediatric population because there is no expected 
significant therapeutic benefit over existing treatments for paediatric patients (see section 5.1). 
 
Method of administration  
 
Daurismo is for oral use. It may be taken with or without food. 
 
Patients should be encouraged to take their dose at approximately the same time each day. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Embryo-foetal toxicity 
 
Based on its mechanism of action and findings from animal embryo-foetal developmental toxicity 
studies, Daurismo can cause embryo-foetal death or severe birth defects when administered to a 
pregnant woman. Pregnant women should be advised of the potential risk to the foetus (see section 
4.6).  
 
Daurismo should not be used during pregnancy and in women of childbearing potential not using 
contraception. The pregnancy status of female patients of childbearing potential should be verified 
prior to initiating treatment with Daurismo. Women of childbearing potential should be advised to 
always use effective contraception during treatment with Daurismo and for at least 30 days after the 
last dose (see section 4.6). 
 
Males 
Glasdegib may be present in semen. Male patients with female partners should be advised of the 
potential risk of exposure through semen and to always use effective contraception, including a 
condom (with spermicide, if available), even after vasectomy, to avoid exposure of a pregnant partner 
or a female partner of childbearing potential during treatment with Daurismo and for at least 30 days 
after the last dose (see section 4.6).  
 
If a female patient or female partner of a male patient becomes pregnant, or suspects a pregnancy 
during treatment with Daurismo or during the 30 days after the last dose, they must inform their 
healthcare provider immediately (see section 4.6). 
 



  
 

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Based on non-clinical safety findings, glasdegib has the potential to impair reproductive function in 
males. Men should seek advice on effective fertility preservation prior to initiating treatment with 
Daurismo (see section 4.6). 
 
QT interval prolongation  
 
In a randomised study (Study 1) of patients with AML and high-risk MDS (myelodysplastic 
syndrome) treated with Daurismo with low-dose cytarabine vs. low-dose cytarabine alone, Grade 3/4 
ECG QT prolonged was reported in 3.5% of patients treated with Daurismo with low-dose cytarabine 
compared to 2.4% of the patients treated with low-dose cytarabine alone. 
 
Electrolytes should be assessed prior to initiation of Daurismo, at least once weekly for the first 
month, and then once monthly for the duration of therapy. Electrolyte abnormalities should be 
corrected. 
 
Concomitant medicinal products should be assessed. For medicinal products that have known 
QT prolonging effects and/or strong CYP3A4 inhibitor potential, alternatives should be considered. 
 
ECGs should be monitored prior to the initiation of Daurismo, approximately one week after initiation, 
and then once monthly for the next two months to assess for QTc prolongation. In patients with 
congenital long QT syndrome, congestive heart failure, electrolyte abnormalities, or those who are 
taking medicinal products with known QT prolonging effects, more frequent ECG monitoring is 
recommended. ECG should be repeated if abnormal. Abnormalities should be managed promptly, and 
dose modifications should be considered (see sections 4.2 and 4.5). 
 
Muscle-related adverse events 
 
In Study 1, muscle spasms were observed in 22.6% of patients treated with Daurismo with low-dose 
cytarabine compared to 4.8% of the patients treated with low-dose cytarabine alone. 
 
All patients starting therapy with Daurismo must be informed of the risk of muscle-related adverse 
events. They must be instructed to report promptly any unexplained muscle pain, tenderness or 
weakness occurring during treatment with Daurismo or if symptoms persist after discontinuing 
treatment. 
 
Serum CK levels should be obtained prior to initiating Daurismo and as clinically indicated thereafter 
(e.g., if muscle signs and symptoms are reported). Management of high-grade CK elevation based on 
current standards of medical practice and following appropriate treatment guidelines is recommended. 
Dose modification or management recommendations should be followed (see section 4.2).  
 
Renal impairment 
 
Patients with pre-existing renal impairment or risk factors for renal dysfunction should be monitored 
closely. Renal function should be assessed prior to initiation of therapy and at least once weekly for 
the first month of therapy with Daurismo. Electrolytes and renal function should be monitored once 
monthly for the duration of therapy (see section 4.2).  
 
Excipients 
 
Lactose intolerance 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or 
glucose-galactose malabsorption should not take this medicinal product. 
 
Sodium content 
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 
'sodium-free'. 



  
 

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4.5 Interaction with other medicinal products and other forms of interaction 
 
Effects of other medicinal products on the pharmacokinetics of glasdegib 
 
In vitro, CYP3A4 is responsible for the majority of glasdegib depletion and contributed to the 
formation of other minor oxidative metabolites, with CYP2C8 and UGT1A9 playing a minor role in 
the metabolism of glasdegib.  
 
Substances that may increase glasdegib plasma concentration 
CYP3A4 inhibitors 
Ketoconazole, a strong inhibitor of CYP3A4, dosed at 400 mg once daily for 7 days, increased the 
mean area under the curve (AUCinf) by ~2.4-fold and maximum plasma concentration (Cmax) by 40% 
of a single 200 mg oral dose of glasdegib in healthy subjects. Caution should be used when 
administering concomitantly with strong CYP3A4 inhibitors (e.g., boceprevir, cobicistat, conivaptan, 
itraconazole, ketoconazole, posaconazole, telaprevir, troleandomycin, voriconazole, ritonavir, 
grapefruit or grapefruit juice ) as an increase in glasdegib plasma concentration may occur. If possible, 
alternate concomitant medicinal product with no or minimal CYP3A4 inhibition potential is 
recommended (see section 4.4). 
 
Gastric pH altering medicinal products 
Coadministration of a single 100 mg glasdegib dose under fasted condition with multiple doses of the 
proton-pump inhibitor (PPI), rabeprazole, resulted in no change in glasdegib plasma exposure (AUCinf 
ratio: 100.6%). Concomitant administration of glasdegib with acid-reducing agents (including PPIs, 
H2-receptor antagonists, and locally acting antacids) is permitted. 
 
Substances that may decrease glasdegib plasma concentration 
CYP3A4 inducers 
Rifampicin, a strong inducer of CYP3A4, administered at a dose of 600 mg once daily for 11 days, 
reduced the mean AUCinf by 70% and Cmax by 35% of a single 100 mg dose of glasdegib in healthy 
subjects. Concomitant use with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, 
enzalutamide, mitotane, phenytoin and St. John’s Wort) should be avoided, as this is likely to decrease 
glasdegib plasma concentrations.  
 
Simulations using physiologic-based pharmacokinetic modelling suggested that coadministration of 
efavirenz (a moderate inducer of CYP3A4) with glasdegib decreased glasdegib AUCinf by 55% and 
Cmax by 25%. Concomitant use of moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, 
modafinil, nafcillin) should be avoided as they may also reduce glasdegib plasma concentrations (see 
section 4.4). If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of 
Daurismo should be increased (see section 4.2). 
 
Effect of glasdegib on the pharmacokinetics of other medicinal products 
 
Pharmacodynamic interactions 
Medicinal products known to prolong QT interval 
Glasdegib may prolong QT interval. Therefore, the concomitant use of glasdegib with other medicinal 
products known to prolong QT interval or induce Torsades de Pointes should be carefully considered 
(see sections 4.2 and 4.4).  
 
Pharmacokinetic interactions 
 
Drug transporters 
In vitro studies indicated that glasdegib may have the potential to inhibit P-glycoprotein (P-gp, 
gastrointestinal [GI] tract) and breast cancer resistance protein (BCRP, systemically and at the GI 
tract) mediated transport at clinically relevant concentrations. Therefore, narrow therapeutic index 
substrates of P-gp (e.g., digoxin) or BCRP should be used with caution in combination with glasdegib.  
 



  
 

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In vitro studies of transporter inhibition 
In vitro studies indicated that glasdegib may have the potential to inhibit (MATE)1 and MATE2K at 
clinically relevant concentrations. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential/Contraception in males and females 
 
If Daurismo is used in women of childbearing potential, they should be advised to avoid becoming 
pregnant. The pregnancy status of female patients of childbearing potential should be verified prior 
to initiating treatment. If the patient becomes pregnant while taking Daurismo, the patient should be 
apprised of the potential hazard to the foetus. 
 
Based on its mechanism of action and findings from animal embryo-foetal developmental studies, 
Daurismo can cause foetal harm when administered to a pregnant woman. Women of childbearing 
potential who are receiving this medicinal product should always use effective contraception during 
treatment with Daurismo and for at least 30 days after the last dose. If a female patient becomes 
pregnant, or suspects a pregnancy, during treatment with Daurismo or during the 30 days after the last 
dose, she must notify her healthcare provider immediately (see section 4.4). 
 
Males 
Glasdegib may be present in semen. Male patients should not donate semen during treatment with 
Daurismo and for at least 30 days after the last dose. Male patients with female partners should be 
advised of the potential risk of exposure through semen and to always use effective contraception, 
including a condom (with spermicide, if available), even after a vasectomy, to avoid exposure of a 
pregnant partner or a female partner of childbearing potential during treatment with Daurismo and for 
at least 30 days after the last dose. Male patients must inform their healthcare provider immediately if 
their female partner becomes pregnant during treatment with Daurismo or during the 30 days after the 
last dose (see section 4.4). 
 
Pregnancy 
 
There are no data on the use of Daurismo in pregnant women. Based on its mechanism of action and 
findings in animal embryo-foetal developmental toxicity studies, glasdegib can cause foetal harm 
when administered to a pregnant woman (see section 5.3). Daurismo should not be used during 
pregnancy and in women of childbearing potential not using contraception (see section 4.4).  
 
Breast-feeding 
 
No studies have been conducted in humans to assess the effect of glasdegib on milk production, its 
presence in breast milk, or its effects on the breast-fed child. It is unknown whether glasdegib and its 
metabolites are excreted in human milk. Given the potential for serious adverse reactions in 
breast-feeding children from glasdegib, breast-feeding is not recommended during treatment with 
Daurismo and for at least one week after the last dose (see section 5.3).  
 
Fertility 
 
Based on non-clinical safety findings, glasdegib has the potential to impair reproductive function in 
males. Men should seek advice on effective fertility preservation prior to initiating treatment with 
Daurismo. Based on its mechanism of action, Daurismo may impair female fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Daurismo has minor influence on the ability to drive and use machines. However, patients 
experiencing fatigue or other symptoms (e.g., muscle cramps, pain, nausea) affecting the ability to 
react normally while taking Daurismo should exercise caution when driving or operating machines.  
 



  
 

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4.8 Undesirable effects 
 
Summary of the safety profile 
 
The overall safety profile of Daurismo is based on data from clinical studies, including Study 1 in 
84 patients with AML (N=75) and high-risk MDS (N=9). The median exposure to Daurismo across 
the dataset was 75.5 days. 
 
The most frequently (≥ 20%) reported adverse reactions in patients receiving Daurismo were anaemia 
(45.2%), haemorrhages (45.2%), febrile neutropenia (35.7%), nausea (35.7%), decreased appetite 
(33.3%), fatigue (30.9%), muscle spasms (30.9%), thrombocytopenia (30.9%), pyrexia (29.7%), 
diarrhoea (28.5%), pneumonia (28.5%), dysgeusia (26.1%), oedema peripheral (26.1%), constipation 
(25.0%), abdominal pain (25.0%), rash (25.0%), dyspnoea (25.0%) vomiting (21.4%), and weight 
decreased (20.2%).  
 
The most frequently reported adverse reactions leading to dose reductions in patients receiving 
Daurismo were muscle spasms (4.7%), fatigue (3.5%), febrile neutropenia (3.5%), anaemia (2.3%), 
thrombocytopenia (2.3%), and electrocardiogram QT prolonged (2.3%). The most frequently reported 
adverse reactions leading to permanent discontinuation in patients receiving Daurismo were 
pneumonia (5.9%), febrile neutropenia (3.5%), and nausea (2.3%). 
 
Tabulated list of adverse reactions 
 
Table 6 presents adverse reactions reported with Daurismo. The adverse reactions are listed by system 
organ class and frequency category. Frequency categories are defined as: very common (≥ 1/10) and 
common (≥ 1/100 to < 1/10). Within each frequency grouping, adverse reactions are presented in 
decreasing order of all grade frequencies. 
 



  
 

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Table 6: Adverse reactions reported in clinical studies (N=84) 

System organ class Preferred term 
All grades 

Frequency All grades 
(%) 

Grade ≥ 3 
(%) 

Infections and 
infestations 

Pneumonia 
Sepsis 
Urinary tract 
infection

Very common 
Common 
Common 

28.5 
5.9 
5.9 

23.8 
5.9 
1.1 

Blood and lymphatic 
system disorders 

Anaemia 
Febrile neutropenia 
Thrombocytopenia 
Neutropenia 

Very common 
Very common 
Very common 
Very common 

45.2 
35.7 
30.9 
15.4 

41.6 
35.7 
30.9 
11.9

Metabolism and 
nutrition disorders 

Decreased appetite Very common 33.3 3.5 

Nervous system 
disorders 

Dysgeusiaa Very common 26.1 0.0 

Cardiac disorders Electrocardiogram 
QT prolongedb 
Atrial fibrillation  

Common 
 

Common 

8.3 
 

7.1 

3.5 
 

2.3 
Vascular disorders Haemorrhagesc Very common 45.2 11.9 
Respiratory, thoracic 
and mediastinal 
disorders 

Dyspnoea Very common 25.0 7.1 

Gastrointestinal 
disorders 

Nausea 
Diarrhoea 
Constipation 
Abdominal paind 
Vomiting 
Stomatitis 

Very common 
Very common 
Very common 
Very common 
Very common 

Common 

35.7 
28.5 
25.0 
25.0 
21.4 
4.7 

2.3 
4.7 
1.1 
0.0 
2.3 
0.0 

Skin and 
subcutaneous tissue 
disorders 

Rashe 
Alopecia 

Very common 
Very common 

25.0 
10.7 

2.3 
0.0 

Musculoskeletal and 
connective tissue 
disorders 

Muscle spasmsf 
Arthralgia 

Very common 
Very common 

30.9 
11.9 

5.9 
0.0 

General disorders and 
administration site 
conditions 

Fatigue 
Weight decreased 
Pyrexia 
Oedema peripheral 

Very common 
Very common 
Very common 
Very common 

30.9 
20.2 
29.7 
26.1 

14.2 
2.3 
2.3 
0.0 

Investigations Platelet count 
decreased 
White blood cell 
count decreased 
Neutrophil count 
decreased 

Very common 
 

Very common 
 

Very common 

16.6 
 

15.4 
 

13.0 

16.6 
 

13.0 
 

13.0 

a. Dysgeusia includes the following preferred terms: dysgeusia, ageusia.  
b. Electrocardiogram QT prolonged includes the following preferred terms: electrocardiogram QT prolonged, ventricular 

tachycardia. 
c. Haemorrhages includes the following preferred terms: petechiae, epistaxis, contusion, haematoma, haemorrhage 

intracranial, purpura, rectal haemorrhage, anal haemorrhage, ecchymosis, gastrointestinal haemorrhage, gingival bleeding, 
haematuria, haemorrhage, mouth haemorrhage, cerebral haemorrhage, conjunctival haemorrhage, eye contusion, eye 
haemorrhage, gastric haemorrhage, haematemesis, haemoptysis, haemorrhoidal haemorrhage, implant site haematoma, 
injection site bruising, retroperitoneal haematoma, subarachnoid haemorrhage, thrombotic thrombocytopenic purpura, 
tracheal haemorrhage, urethral haemorrhage. 



  
 

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d. Abdominal pain includes the following preferred terms: abdominal pain, abdominal pain upper, abdominal pain lower. 
e. Rash includes the following preferred terms: erythema, pruritus, rash, rash macular, rash maculo-papular, rash pruritic.  
f. Muscle spasms includes the following preferred terms: muscle contractions involuntary, muscle spasms, muscle tightness, 

musculoskeletal pain, myalgia.  
  
Description of selected adverse reactions 
 
Muscle spasms  
In Study 1, muscle spasms (all grades) were reported in 22.6% of patients in the Daurismo with low-dose 
cytarabine arm compared to 4.8% in the low-dose cytarabine alone arm. Grades 3 and 4 muscle spasms 
were reported in 4.7% of patients in the Daurismo with low-dose cytarabine arm compared to none in 
the low-dose cytarabine alone arm. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is no specific antidote for Daurismo. Management of Daurismo overdose should consist of 
symptomatic treatment and ECG monitoring.   
 
Glasdegib has been administered in clinical studies up to a dose of 640 mg/day. The dose-limiting 
toxicities reported were nausea, vomiting, dehydration, hypotension, fatigue, dizziness, hypoxia, 
pleural effusion and peripheral oedema. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX63 
 
Mechanism of action 
 
Glasdegib is an inhibitor of the Hedgehog (Hh) signal transduction pathway that binds to Smoothened 
(SMO), a transmembrane protein, leading to decreased Glioma-Associated Oncogene (GLI) 
transcription factor activity and downstream pathway signalling. Hh pathway signalling is required for 
maintaining a leukaemic stem cell (LSC) population thus, glasdegib binding to and inhibiting SMO 
reduces GLI1 levels in AML cells and the leukaemic initiating potential of AML cells. Hh pathway 
signalling is also implicated in resistance to chemotherapy and targeted therapy. In a preclinical model 
of AML, glasdegib in combination with low-dose cytarabine inhibited increases in tumour size to a 
greater extent than glasdegib or low-dose cytarabine alone. However, mechanism of action of the 
combination is not fully understood. 
 
Cardiac electrophysiology 
 
Heart rate corrected QT (QTc) interval prolongation has been observed in patients treated with 
Daurismo at a supratherapeutic dose of > 270 mg. The effect of glasdegib administration on corrected 
QT interval was evaluated in a randomised, single-dose, double-blind, 4-way crossover, placebo- and 
open-label moxifloxacin controlled study in 36 healthy subjects. At therapeutic plasma concentrations 
(achieved with a 150 mg single dose), the largest, placebo and baseline-adjusted corrected QT interval 
change was 8.03 msec (90% CI: 5.85, 10.22 msec). At approximately twice the therapeutic 
concentration (supratherapeutic, achieved with a 300 mg single dose), the QTc change was 13.43 msec 



  
 

14 

(95% CI: 11.25, 15.61 msec). Moxifloxacin (400 mg), used as a positive control, showed a mean QTc 
change from baseline of 13.87 msec. None of the subjects met categorical criterion of absolute 
corrected QT interval of ≥ 480 msec or increase from baseline in corrected QT interval ≥ 30 msec after 
receiving any treatment. None of the ECG abnormalities were considered clinically significant or 
reported as adverse events by the investigator (see section 4.4). 
 
Additionally, serial, triplicate ECGs were collected following a single and multiple dosing to evaluate 
the effect of single agent glasdegib on the corrected QT interval in 70 patients with advanced cancer 
(5 mg to 640 mg once daily). Based on the exposure-response analysis, the estimated mean change 
from baseline in QTc was 5.30 msec (95% CI: 4.40, 6.24 msec) at the mean observed Cmax at steady 
state following administration at the recommended 100 mg once daily dose of glasdegib. 
 
Clinical efficacy and safety 
 
Daurismo in combination with low-dose cytarabine was investigated in a multicentre, randomised, 
open-label Phase 2 study (Study 1) in a total of 132 patients, which included 116 patients with 
previously untreated de novo or secondary AML who were not eligible to receive intensive 
chemotherapy as defined by meeting at least one of the following criteria: a) age > 75 years, b) severe 
cardiac disease, c) baseline Eastern Cooperative Oncology Group (ECOG) performance status of 2, or 
d) baseline serum creatinine > 1.3 mg/dL. Patients were randomised 2:1 to receive Daurismo (100 mg 
orally once daily) with low-dose cytarabine (20 mg SC twice daily on days 1 to 10 of the 28-day 
cycle) (n=78) or low-dose cytarabine alone (n=38) in 28-day cycles until disease progression or 
unacceptable toxicity. Patients were stratified at randomisation by prognostic risk factor 
(good/intermediate or poor) based on cytogenetics. 
 
The baseline demographic and disease characteristics are shown in Table 7. The two treatment arms 
were generally balanced with respect to the baseline demographics and disease characteristics. Across 
both arms, 40% of the AML patients had poor cytogenetic risk and 60% had good/intermediate 
cytogenetic risk. 
 
Efficacy was established by an improvement in overall survival (OS defined from the date of 
randomisation to death of any cause) in the Daurismo with low-dose cytarabine arm, compared to 
low-dose cytarabine alone. After a median follow-up of approximately 20 months with 81% deaths 
observed, the Daurismo with low-dose cytarabine arm was superior to low-dose cytarabine alone in 
AML patients (Figure 1). The efficacy results are shown in Table 8. 
 



  
 

15 

Table 7. Baseline demographic and disease characteristics in patients with AML 
Demographic and disease characteristics Daurismo with  

low-dose cytarabine 
(N=78) 

Low-dose cytarabine 
alone 

(N=38) 
Demographics 
Age  
Median (Min, Max) (Years) 
≥ 75 years N (%)  

 
77 (64, 92) 

48 (62)

 
76 (58, 83) 

23 (61) 
Sex, N (%) 
Male 
Female 

59 (76) 
19 (24)

23 (61) 
15 (39) 

Race, N (%) 
White 
Black or African American 
Asian 

75 (96) 
1 (1) 
2 (3) 

38 (100) 
0 (0) 
0 (0) 

Disease characteristics 
Disease history, N (%) 
De Novo AML 
Secondary AML 

 
38 (49) 
40 (51) 

 
18 (47) 
20 (53) 

Prior hypomethylating agent (decitabine 
or azacitidine) use, N (%) 

11 (14) 6 (16) 

ECOG PSa, N (%) 
0 to 1 
2 

36 (46) 
41 (53) 

20 (53) 
18 (47) 

Cytogenetic risk status, N (%) 
Good/Intermediate 
Poor 

49 (63) 
29 (37) 

21 (55) 
17 (45) 

Baseline severe cardiac disease, N (%) 52 (67) 20 (53) 
Baseline serum creatinine > 1.3 mg/dL,  
N (%)  

15 (19) 5 (13) 

Abbreviations: AML=acute myeloid leukaemia; ECOG PS=Eastern Cooperative Oncology Group Performance Status; 
N=number of patients. 
a. Baseline ECOG PS was not reported for one patient in the Daurismo with low-dose cytarabine arm. 

 



  
 

16 

Table 8. AML efficacy results from Study 1  
Endpoint/study population Daurismo with  

low-dose cytarabine 
Low-dose cytarabine 

alone 
OS in AML study population N=78 N=38 
     Median survival, months (95% CI) 8.3 (4.7, 12.2) 4.3 (1.9, 5.7) 
     Hazard ratio (95% CI)a 0.463 (0.299, 0.717) 
     p-valueb 0.0002 
OS in de novo AML study population N=38 N=18 
     Median survival, months (95% CI) 6.6 (3.7, 12.4) 4.3 (1.3, 10.7) 
     Hazard ratio (95% CI)a 0.670 (0.362, 1.239) 
     p-valueb 0.0991 
OS in secondary AML study population N=40 N=20 
     Median survival, months (95% CI) 9.1 (4.4, 16.5) 4.1 (1.5, 6.4) 
     Hazard ratio (95% CI)a 0.287 (0.151, 0.548) 
     p-valueb < 0.0001 
Good/intermediate cytogenetic risk group N=49 N=21 
     Median survival, months (95% CI) 11.1 (7.1, 14.9) 4.4 (1.8, 8.7) 
     Hazard ratio (95% CI)a 0.417 (0.233, 0.744) 
     p-valueb 0.0011 
Poor cytogenetic risk group N=29 N=17 
     Median survival, months (95% CI) 4.4 (3.4, 9.1) 3.1 (1.1, 6.4) 
     Hazard ratio (95% CI)a 0.528 (0.273, 1.022) 
     p-valueb 0.0269 

Abbreviations: AML=acute myeloid leukaemia; CI=confidence interval; N=number of patients; OS=overall survival.  
a. Hazard ratio (Daurismo with low-dose cytarabine/low-dose cytarabine alone) based on the Cox Proportional hazards model 

stratified by prognosis stratum. 
b. 1-sided p-value from stratified log-rank test based on cytogenetic risk. 
 
Figure 1. Kaplan-Meier plot of overall survival for AML patients 

 
Abbreviations: CI=confidence interval; LDAC=low-dose cytarabine; OS=overall survival. 
 
Improvement in OS was consistent across pre-specified subgroups by cytogenetic risk.  
  
Based on investigator reported response, a numerically higher complete response (CR) rate (defined as 
absolute neutrophil count ≥ 1000/μl, platelet count ≥ 100,000/μl, < 5% bone marrow blasts, 



  
 

17 

transfusion independent, and no extramedullary disease) was achieved for AML patients in the 
Daurismo with low-dose cytarabine arm (17.9% [95% CI: 9.4%, 26.5%]) vs the low-dose cytarabine 
alone arm (2.6% [95% CI: 0.0%, 7.7%]). 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Daurismo in all subsets of the paediatric population in treatment of AML (see section 4.2 for 
information on paediatric use).  
 
5.2 Pharmacokinetic properties 
 
Absorption  
 
Following a single 100 mg dose of glasdegib, peak concentration in plasma is rapidly reached with the 
median Tmax of 2 hours. Following repeat 100 mg once daily dosing to steady state, glasdegib median 
Tmax ranged from approximately 1.3 hours to 1.8 hours. 
 
Food effect 
 
After oral administration of glasdegib tablets, the mean absolute bioavailability is 77.1% compared to 
intravenous administration. Administration of glasdegib with a high-fat, high-calorie meal resulted in 
16% lower exposure (AUCinf) compared to overnight fasting. The impact of food on the 
pharmacokinetics of glasdegib is not considered clinically relevant. Glasdegib may be administered 
with or without food. 
 
Following 100 mg once daily glasdegib dosing, the mean (coefficient of variation, %CV) of glasdegib 
Cmax was 1,252 ng/mL (44%) and AUCtau was 17,210 ng•hr/mL (54%) in patients with cancer. 
 
Distribution 
 
Glasdegib is 91% bound to human plasma proteins in vitro. The mean (%CV) apparent volume of 
distribution (Vz/F) was 188 (20) L following a single dose of 100 mg glasdegib in patients with 
haematologic malignancies. 
 
Biotransformation 
 
The primary metabolic pathways for glasdegib were comprised of N-demethylation, glucuronidation, 
oxidation, and dehydrogenation. In plasma, the N-desmethyl and N-glucuronide metabolites of 
glasdegib accounted for 7.9% and 7.2% of the circulating radioactivity, respectively. Other 
metabolites in plasma individually accounted for < 5% of circulating radioactivity. 
 
In vitro interaction studies  
In vitro CYP inhibition and induction 
In vitro studies indicated that glasdegib is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, 
CYP2C19, CYP2D6, and CYP3A4/5 at clinically relevant concentrations. In vitro studies indicated 
that glasdegib is not an inducer of CYP1A2, CYP2B6, or CYP3A4 at clinically relevant 
concentrations. 
 
In vitro studies of UGT inhibition  
In vitro studies indicated that glasdegib is not an inhibitor of uridine-diphosphate 
glucuronosyltransferase (UGT)1A4, UGT1A6, UGT2B7, and UGT2B15 at clinically relevant 
concentrations. Glasdegib may have the potential to inhibit UGT1A1, and possibly UGT1A9, 
however, clinically relevant drug-drug interactions are not expected. 
 



  
 

18 

In vitro studies of organic anion and cation transporter inhibition  
In vitro studies indicated that glasdegib is not an inhibitor of organic anion transporting polypeptide 
(OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter 
(OCT)2, at clinically relevant concentrations. 
 
Elimination 
 
The mean ( SD) plasma half-life of glasdegib was 17.4  3.7 hours after a single dose of 100 mg 
glasdegib in patients. The geometric mean oral clearance after multiple dosing was 6.45 L/hr. 
Following oral administration of a 100 mg radiolabeled dose of glasdegib to healthy subjects, mean 
48.9% and 41.7% of the radioactivity dosed was recovered in urine and faeces, respectively. The 
overall mean mass balance of the dosed radioactivity in the excreta was 90.6%. Unchanged glasdegib 
was the major component of human plasma, accounting for 69.4% of the total drug-related material. 
Unchanged glasdegib recovered in the urine and faeces accounted for 17.2% and 19.5% of the dose, 
respectively.  
 
Linearity/non-linearity 
 
The steady state systemic glasdegib exposure (Cmax and AUCtau) increased in a dose-proportional 
manner over the dosing range of 5 mg to 600 mg once daily. 
 
Special populations 
 
Hepatic impairment 
Data from a dedicated pharmacokinetic trial have shown that plasma exposures for total glasdegib 
(AUCinf and Cmax) were similar between subjects with normal hepatic function and subjects with 
moderate hepatic impairment (Child-Pugh Class B), whilst geometric mean AUCinf and Cmax values 
were 24% and 42% lower, respectively, for subjects with severe hepatic impairment (Child-Pugh 
Class C), compared to the normal hepatic function group. The glasdegib unbound exposure (unbound 
AUCinf) is increased by 18% and 16% in subjects with moderate and severe impairment, respectively, 
relative to subjects with normal hepatic function. Peak glasdegib unbound exposure (unbound Cmax) 
increased by 1%, for moderate hepatic impairment and decreased by 11% for severe hepatic 
impairment, relative to subjects with normal hepatic function. These changes are not considered to be 
clinically relevant.  
 
Renal impairment 
Data from a dedicated pharmacokinetic trial in subjects with varying degrees of renal function 
impairment indicate that total glasdegib exposure (AUCinf) increased by 105%, and 102 % with 
moderate (30 mL/min ≤ eGFR < 60 mL/min), and severe (eGFR < 30 mL/min) renal impairment, 
respectively, relative to subjects with normal (eGFR ≥ 90 mL/min) renal function. Peak glasdegib 
exposure (Cmax) increased by 37%, and 20% for subjects with moderate, and severe renal impairment, 
respectively, relative to subjects with normal renal function. These changes are not considered to be 
clinically relevant. 
 
Elderly  
In patients assigned to treatment with Daurismo with low-dose cytarabine (n=88; Study 1), 97.7% of 
the patients were aged 65 or older and 60.2% of the patients were aged 75 or older. Study 1 did not 
include a sufficient number of patients younger than age 65 to determine differences in adverse 
reactions reported from patients older than 65. 
 
Age, race, gender, and body weight  
There are limited data in patients younger than 65 years of age. Population pharmacokinetic analyses 
in adult patients (n=269) indicate that there are no clinically relevant effects of age, gender, race, body 
weight on the pharmacokinetics of glasdegib. 
 



  
 

19 

5.3 Pre-clinical safety data 
 
The primary target organ findings following repeat oral administration of glasdegib in rats and dogs 
for up to 26 and 39 weeks in duration, respectively, included the kidney (degeneration/necrosis) in rat 
and dog, the liver (necrosis/inflammation) in dog only, and the testis (degeneration), growing incisor 
teeth (necrosis/broken), growing bone (partial to full closure of epiphysis), and peripheral nerve 
(axonal degeneration) in rat only. Additional clinical observations of alopecia, weight loss, and muscle 
tremors/twitching, known class effects of SMO inhibitors, were observed in both species. These 
systemic toxicities were generally dose-dependent and observed at exposures ranging from 
approximately < 0.03 to 8-times the clinically relevant exposure based on nonclinical to clinical 
comparison of the observed unbound AUC at the recommended clinical dose of 100 mg once daily. 
 
Complete reversibility of toxicities to the kidney (degeneration/necrosis), peripheral nerve (axonal 
degeneration), seminiferous tubule (testicular degeneration), and the clinical observations of muscle 
tremors/twitching was demonstrated following up to 16-week recovery, whereas partial recovery was 
demonstrated in the liver (necrosis/inflammation). The observation of alopecia, bone and teeth effects, 
and testicular hypospermatogenesis did not recover. In addition, QTc prolongation was identified in 
telemetered dogs at unbound Cmax exposures approximately 4-times the observed unbound Cmax 
exposure at the recommended clinical dose of 100 mg once daily. 
 
Glasdegib was not mutagenic in vitro in the bacterial reverse mutation (Ames) assay and was not 
clastogenic in the in vitro chromosome aberration assay in human lymphocytes. Glasdegib was not 
clastogenic or aneugenic in the rat micronucleus assay. 
 
Carcinogenicity studies have not been conducted with glasdegib. 
 
In repeat-dose toxicity studies in rats, findings observed in the male reproductive tract included 
adverse testicular changes with glasdegib at doses  50 mg/kg/day, and consisted of minimal to severe 
hypospermatogenesis characterised by partial to complete loss of spermatogonia, spermatocytes and 
spermatids and testicular degeneration. 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). Safety margin for NOAEL (10 mg/kg/day) is 0.6, hence lower than 
clinically relevant. 
 
In embryo-foetal developmental toxicity studies conducted in rats and rabbits, glasdegib was severely 
toxic to the conceptus as evidenced by complete resorption and/or abortion of foetuses, and 
teratogenic effects at lower dose levels. Teratogenic effects included craniofacial malformations, 
malformed limbs, paws/digits, trunk and tail, dilation of brain, malpositioned/malformed eyes, 
misshapen head, small tongue, absent palate, teeth and viscera, diaphragmatic hernia, oedema, 
persistent truncus arteriosus, heart defects, absent lung, absent trachea, rib and vertebral abnormalities, 
and malformed or absent structures in the appendicular skeleton (notably the long bones). Severe 
developmental malformations were observed at maternal systemic exposures lower than the relevant 
human exposure at the recommended dose of 100 mg once daily. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core 
 
Sodium starch glycolate 
Microcrystalline cellulose (E460(i)) 
Calcium hydrogen phosphate (anhydrous) (E341ii) 
Magnesium stearate (E470b) 



  
 

20 

 
Film-coating 
 
Lactose monohydrate 
Hypromellose (E464) 
Titanium dioxide (E171) 
Macrogol (E1521) 
Triacetin (E1518) 
Iron oxide yellow (E172) 
Iron oxide red (E172) (100 mg tablets only) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container   
 
PVC (polyvinyl chloride) blister sealed with aluminium foil containing 10 film-coated tablets, or 
high-density polyethylene (HDPE) bottle with polypropylene closure containing 30 or 60 film-coated 
tablets.  
 
Daurismo 25 mg film-coated tablets  
 
One carton contains 60 film-coated tablets in 6 blisters. 
One carton contains 60 film-coated tablets in an HDPE bottle. 
 
Daurismo 100 mg film-coated tablets  
 
One carton contains 30 film-coated tablets in 3 blisters. 
One carton contains 30 film-coated tablets in an HDPE bottle. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal  
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 



  
 

21 

8. MARKETING AUTHORISATION NUMBER(S)  
 
Daurismo 25 mg film-coated tablets 
EU/1/20/1451/001 
EU/1/20/1451/002 
 
Daurismo 100 mg film-coated tablets 
EU/1/20/1451/003 
EU/1/20/1451/004 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  



  
 

22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



  
 

23 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Pfizer Manufacturing Deutschland GmbH 
Betriebsstätte Freiburg 
Mooswaldallee 1 
79090 Freiburg 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
 Risk management plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
 Additional risk minimisation measures  

 
The MAH shall ensure that in each Member State where DAURISMO is marketed, all male patients 
are provided via their prescribing physicians with the Patient Alert Card. The Patient Alert Card 
should contain the following key elements:  

 Glasdegib may be present in semen carrying a potential risk of reproductive and 
developmental toxicity  

 Effective contraception (condom with spermicide, if available) should be used, even after 
vasectomy and for at least 30 days after the last dose due to the potential risk of exposure of 
male patients’ female partners to glasdegib through semen 



  
 

24 

 The importance of informing a healthcare provider as soon as a pregnancy is suspected, either 
for a female patient or female partner of a male patient 

 A reminder not to donate semen while taking Daurismo and for 30 days after last dose  
 The recommendation to seek advice on effective fertility preservation for men prior to 

initiating treatment with glasdegib. 
 
 
  



  
 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



  
 

26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING  



  
 

27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON – 25 MG TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 25 mg film-coated tablets  
glasdegib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains glasdegib maleate equivalent to 25 mg of glasdegib. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose (see leaflet for further information). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
60 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



  
 

28 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1451/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Daurismo 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 
  



  
 

29 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABELS – 25 MG TABLETS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 25 mg film-coated tablets  
glasdegib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains glasdegib maleate equivalent to 25 mg of glasdegib. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose (see leaflet for further information). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
60 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



  
 

30 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1451/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Daurismo 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



  
 

31 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS  
 
BLISTERS – 25 MG TABLETS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 25 mg tablets 
glasdegib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG (as MA holder logo) 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



  
 

32 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
CARTON – 100 MG TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 100 mg film-coated tablets 
glasdegib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains glasdegib maleate equivalent to 100 mg of glasdegib. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose (see leaflet for further information). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



  
 

33 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1451/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Daurismo 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC  
SN  
NN  
 
  



  
 

34 

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BOTTLE LABEL – 100 MG TABLETS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 100 mg film-coated tablets 
glasdegib 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains glasdegib maleate equivalent to 100 mg of glasdegib. 
 
 
3. LIST OF EXCIPIENTS 
 
Contains lactose (see leaflet for further information). 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP: 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



  
 

35 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1451/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Daurismo 100 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



  
 

36 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS   
 
BLISTERS – 100 MG TABLETS  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Daurismo 100 mg tablets 
glasdegib 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG (as MA holder logo) 
 
 
3. EXPIRY DATE 
 
EXP: 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 
  



  
 

37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



  
 

38 

Package leaflet: Information for the patient 
 

Daurismo 25 mg film-coated tablets 
Daurismo 100 mg film-coated tablets 

glasdegib 
 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Daurismo is and what it is used for  
2. What you need to know before you take Daurismo  
3. How to take Daurismo  
4. Possible side effects  
5. How to store Daurismo 
6. Contents of the pack and other information 
 
 
1. What Daurismo is and what it is used for 
 
Daurismo is a cancer medicine containing the active substance glasdegib. 
 
Daurismo is used with another cancer medicine, cytarabine, to treat adults newly diagnosed with a 
blood cancer called acute myeloid leukaemia (AML).  
 
How Daurismo works 
 
In AML, cancer cells called stem cells constantly make new leukaemic cancer cells. Daurismo works 
by blocking a key process in these stem cells, called the Hedgehog (Hh) pathway. This reduces their 
ability to make new cancer cells. By blocking the Hh pathway, Daurismo can also make cancer cells 
more sensitive to a cancer medicine, cytarabine, used to treat AML. Combining Daurismo with the 
medicine cytarabine may increase how long patients are likely to live by decreasing growth of the 
cancer and possibly by increasing cancer cell death.  
 
If you have any questions about how Daurismo works or why this medicine has been prescribed for 
you, ask your doctor. 
 
 
2. What you need to know before you take Daurismo  
 
Do not take Daurismo  
- if you are allergic to glasdegib or any of the other ingredients of this medicine (listed in 

section 6).  
 



  
 

39 

Warnings and precautions  
Talk to your doctor, pharmacist or nurse before taking Daurismo 

- if you or your partner are able to become pregnant (see section Pregnancy, breast-feeding and 
fertility). 

- if you have ever had QT interval prolongation (a change in electrical activity of the heart that 
can cause serious irregular heart rhythms) or know you are at danger of the condition. 

- if you take other medicines that you have been told can prolong QT interval. 
- if blood tests show you have abnormal levels of electrolytes (e.g. calcium, magnesium, 

potassium). 
- if you have kidney problems. 
- if you have a history of muscle cramps or weakness. 

 
Tell your doctor immediately while taking this medicine 

- if your muscles hurt or you have unexplained muscle cramps or weakness during treatment 
with Daurismo. Your doctor may need to change your dose, or stop your treatment 
temporarily or permanently. 
 

Children and adolescents 
Daurismo is not to be used in patients less than 18 years of age. 
 
Other medicines and Daurismo 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines. This includes medicines obtained without a prescription and herbal medicines. This is 
because Daurismo can affect the way some other medicines work. Some other medicines can affect the 
way Daurismo works. 
 
In particular, the following may increase the risk of side effects with Daurismo: 

- boceprevir – a medicine used to treat hepatitis C. 
- cobicistat, ritonavir, telaprevir – medicines used to treat HIV infection. 
- itraconazole, ketoconazole, voriconazole, posaconazole – medicines used to treat fungal 

infections.  
- troleandomycin – a medicine used to treat bacterial infections. 
- conivaptan – a medicine used to regulate imbalance of water and salt.  
- amiodarone, disopyramide, dofetilide, ibutilide, sotalol, quinidine – medicines used to treat 

heart problems. 
- droperidol, haloperidol, pimozide – medicines used to treat psychotic diseases. 
- moxifloxacin – a medicine used to treat a certain type of bacterial infections. 
- methadone – a medicine used to treat pain and for the treatment of opioid addiction.  

 
The following medicines may reduce the effectiveness of Daurismo: 

- carbamazepine, phenytoin, anti-epileptics – medicines used to treat seizures or fits. 
- rifampicin – a medicine used to treat tuberculosis (TB). 
- St. John’s wort (Hypericum perforatum) – a herbal product used to treat mild depression and 

anxiety. 
- enzalutamide – a medicine used to treat prostate cancer. 
- mitotane – a medicine used to treat adrenal gland cancer. 
- bosentan – a medicine used to treat high blood pressure. 
- efavirenz, etravirine – medicines used to treat HIV infection. 
- modafinil – a medicine used to treat sleep disorders. 
- nafcillin  – a medicine used to treat certain types of bacterial infections. 

 
Daurismo with food and drink 
Do not drink grapefruit juice or eat grapefruit while on treatment with Daurismo as it may change the 
amount of Daurismo in your body. 
 



  
 

40 

Pregnancy, breast-feeding and fertility 
 
Pregnancy 
You must not become pregnant while taking Daurismo and you must not take it if you are pregnant. 
Daurismo can cause severe birth defects in babies or lead to the death of an unborn baby. 
 
Your doctor will give you more information about the effects of Daurismo on the unborn baby and 
will carry out a pregnancy test before you start taking the medicine. 
 
You must talk to your doctor immediately if you or your partner become pregnant or suspect you 
could be pregnant during treatment and for 30 days after your last dose of Daurismo. If you are 
pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for 
advice before taking this medicine. 
 
Contraception in women and men 
Women 
You should always use effective birth control (contraception) while taking Daurismo and for at least 
30 days after the last dose of Daurismo. Talk to your doctor about birth control methods that are right 
for you and your partner. 
 
Men 
Men should always use effective contraception, including condoms (with spermicide, if available), 
even if you have had a vasectomy, while taking Daurismo and for at least 30 days after the last dose of 
Daurismo. 
 
You should not donate semen at any time while you are taking Daurismo and for at least 30 days after 
your last dose. 
 
Breast-feeding 
Do not breast-feed while taking Daurismo or during the one week after the last dose of Daurismo. It is 
not known if Daurismo passes into your breast milk and harms your baby. 
 
Fertility 
Daurismo may affect male and female fertility. Talk to your doctor about fertility preservation before 
taking Daurismo. 
 
Driving and using machines 
If you feel tired, or get muscle cramps, pain or nausea (feeling sick) while on treatment with 
Daurismo, take special care when driving and using machines. 
 
Daurismo contains sodium 
This medicine contains less than 1 mmol sodium (less than 23 mg) per tablet, that is to say Daurismo 
is essentially ‘sodium -free’. 
 
Daurismo contains lactose  
This medicine contains lactose (found in milk or dairy products).  
 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicine. 
 
 
3. How to take Daurismo 
 
Take Daurismo once a day at about the same time every day. Always take this medicine exactly as 
your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.  
 



  
 

41 

The recommended dose is one tablet of 100 mg taken by mouth once a day with or without food.  
 
If you get certain side effects while you are taking Daurismo (see section 4 “Possible side effects”), 
your doctor may lower your dose or stop treatment, either temporarily or permanently.  
 
If you vomit after taking Daurismo 
If you vomit after taking a dose of Daurismo, do not take an extra dose, just take your next dose at the 
usual time. 
 
If you take more Daurismo than you should 
If you accidentally take too many tablets, tell your doctor, pharmacist or nurse right away. You may 
require urgent medical attention. 
 
If you forget to take Daurismo  
If you forget to take a tablet, then take it as soon as you remember unless more than 10 hours have 
passed since the scheduled dose time, in which case, you should skip the dose. Do not take a double 
dose to make up for a forgotten dose. 
 
If you stop taking Daurismo 
Do not stop taking Daurismo unless your doctor tells you to. 
 
It is important to take Daurismo every day, as long as your doctor prescribes it to you. If you cannot 
take the medicine as your doctor has prescribed, or you feel you do not need it anymore, speak with 
your doctor right away. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Daurismo may cause severe birth defects. It may also lead to the death of a baby before it is born or 
shortly after being born. You must not become pregnant while taking this medicine (see section 2, 
“What you need to know before you take Daurismo”). 
 
Other side effects with Daurismo, in combination with cytarabine, include: 
 
Very common: may affect more than 1 in 10 people 

- low haemoglobin 
- bleeding 
- fever  
- nausea 
- loss of appetite 
- muscle pain 
- feeling tired 
- decrease in the number of platelets in the blood  
- diarrhoea 
- pneumonia 
- changes in taste 
- swelling of arms and legs 
- constipation 
- abdominal (belly) pain 
- rash 
- shortness of breath 
- vomiting 
- weight loss 



  
 

42 

- decrease in the number of white blood cells 
- decrease in the number of a type of white blood cells (neutrophils) 
- joint pain 
- hair loss 

 
Common: may affect up to 1 in 10 people 

- changes in the electrical activity of the heart 
- heart palpitations 
- blood infection 
- burning sensation during urination and frequent and urgent need to urinate (may be symptoms 

of urinary tract infection) 
- mouth irritation 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Daurismo 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and the blister foil or bottle 
after “EXP”. The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not use this medicine if the pack is damaged or shows signs of tampering. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Daurismo contains  
- The active substance is glasdegib. 

Daurismo 25 mg film-coated tablets: each film-coated tablet contains glasdegib maleate 
equivalent to 25 mg of glasdegib. 
Daurismo 100 mg film-coated tablets: each film-coated tablet contains glasdegib maleate 
equivalent to 100 mg glasdegib. 
 

- The other ingredients are:  
Tablet core: sodium starch glycolate, microcrystalline cellulose, calcium hydrogen phosphate 
anhydrous, and magnesium stearate. See section 2 “Daurismo contains sodium.” 
Film-coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol, triacetin, iron 
oxide yellow, and iron oxide red (100 mg tablets only). See section 2 “Daurismo contains 
lactose.” 

 



  
 

43 

What Daurismo looks like and contents of the pack 
 
Daurismo 25 mg film-coated tablets 
- Round, yellow film-coated tablets, debossed with “Pfizer” on one side and “GLS 25” on the other 

side.  
- Provided in blisters of 10 tablets. Each pack contains 60 tablets in either 6 blisters or in one plastic 

bottle. 
 
Daurismo 100 mg film-coated tablets  
- Round, pale orange film-coated tablets, debossed with “Pfizer” on one side and “GLS 100” on the 

other side.  
- Provided in blisters of 10 tablets. Each pack contains 30 tablets in either 3 blisters or in one plastic 

bottle. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder  
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
Manufacturer 
Pfizer Manufacturing Deutschland GmbH 
Betriebsstätte Freiburg 
Mooswaldallee 1 
79090 Freiburg 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 

Belgique/België/Belgien 
Pfizer S.A. / N.V. 
Tél/Tel: +32 (0)2 554 62 11 

Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje 
Tel. + 370 52 51 4000 

България 
Пфайзер Люксембург САРЛ, Клон България 
Тел.: +359 2 970 4333 

Luxembourg/Luxemburg 
Pfizer S.A. 
Tél/Tel: +32 (0)2 554 62 11 

Česká republika 
Pfizer PFE, spol. s r.o. 
Tel.: +420 283 004 111 

Magyarország 
Pfizer Kft. 
Tel.: +36-1-488-37-00 

Danmark 
Pfizer ApS 
Tlf: +45 44 20 11 00 
 

Malta 
Vivian Corporation Ltd. 
Tel. +356 21344610 

Deutschland 
Pfizer Pharma GmbH 
Tel: +49 (0)30 550055 51000 
  

Nederland 
Pfizer bv 
Tel: +31 (0)10 406 43 01 

Eesti 
Pfizer Luxembourg SARL Eesti filiaal  
Tel.: +372 666 7500 

Norge 
Pfizer Norge AS 
Tlf: +47 67 52 61 00 
 



  
 

44 

Ελλάδα 
Pfizer Ελλάς A.E. 
Τηλ.: +30 210 6785 800 

Österreich 
Pfizer Corporation Austria Ges.m.b.H. 
Tel: +43 (0)1 521 15-0 

España 
Pfizer, S.L. 
Tel: +34 91 490 99 00 

Polska 
Pfizer Polska Sp.z.o.o 
Tel.:+48 22 335 61 00 
 

France 
Pfizer  
Tél: +33 (0)1 58 07 34 40 

Portugal 
Pfizer Biofarmacêutica, Sociedade Unipessoal Lda 
Tel: +351 21 423 5500 

Hrvatska 
Pfizer Croatia d.o.o. 
Tel: +385 1 3908 777 

România 
Pfizer Romania S.R.L. 
Tel: +40 (0) 21 207 28 00 

Ireland 
Pfizer Healthcare Ireland 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 

Slovenija 
Pfizer Luxembourg SARL 
Pfizer, podružnica za svetovanje s področja 
farmacevtske dejavnosti, Ljubljana 
Tel.: + 386 (0)1 52 11 400 
 

Ísland 
Icepharma hf. 
Sími: +354 540 8000 

Slovenská republika 
Pfizer Luxembourg SARL, organizačná zložka  
Tel.: + 421 2 3355 5500 

Italia 
Pfizer S.r.l. 
Tel: +39 06 33 18 21 

Suomi/Finland 
Pfizer Oy 
Puh./Tel: +358 (0)9 43 00 40 

Kύπρος 
Pfizer Ελλάς Α.Ε. (Cyprus Branch)  
Τηλ: +357 22 817690 

Sverige  
Pfizer Innovations AB 
Tel: +46 (0)8 550 520 00 

Latvija 
Pfizer Luxembourg SARL filiāle Latvijā 
Tel.: + 371 670 35 775 

United Kingdom 
Pfizer Limited 
Tel: +44 (0) 1304 616161 

 
 
This leaflet was last revised in MM/YYYY 
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET