Sprycel 10 mg/mL powder for oral suspension

Due to change to SmPC, date of revision for PIL has been updated

Under the sub-heading Effects on growth and development in paediatric patients, the below text has been added

Growth retardation has been observed in paediatric patients treated with SPRYCEL in clinical trials (see section 4.8). After a maximum of 2 years of treatment, a downward trend in expected height has been observed, at the same degree as observed with the use of chemotherapy alone, without impacting expected weight and BMI and no association with hormones abnormalities or other laboratory parameters. Monitoring of bone growth and development in paediatric patients is recommended.

PSUR 18 (28 Jun 2020 to 27 Jun 2021) - to update SPRYCEL PI with addition of the adverse reaction “chylothorax” with a frequency “uncommon” to section 4.8 of the SmPC, update of section 4.4 of the SmPC to reflect the cases of chylothorax that have also been reported in patients presenting with pleural effusion

PSUR 18 (28 Jun 2020 to 27 Jun 2021) - to update SPRYCEL PI with addition of the adverse reaction “chylothorax” with a frequency “uncommon” to section 4 of the PIL

Minor editorial changes throughout SPC, and update to the date of revision due to changes impacting the PIL (LENC).

Manufacturer Legal entity name change FROM 'Swords Laboratories T/A Lawrence Laboratories' TO  'Swords Laboratories Unlimited Company T/A Lawrence Laboratories'

Section 5.1 update ATC code from L01XE06 to L01EA02

Section 6.3 update of shelf life from 2 years to 3 years for the Unopened bottle

After the manufacturer details the list of Local Representative was removed from section 6 and the date of revision has been updated

SmPC Section 4.4 (Special warnings and precautions for use)
Addition of paragraph ‘Effects on growth and development in paediatric patients’ 
[...] Growth retardation has been observed in paediatric patients treated with SPRYCEL in clinical trials (see section 4.8). Monitoring of bone growth and development in paediatric patients is recommended.
​
Date of Revision of Text: 25 February 2021
 

SmPC Section 4.4 (Special warnings and precautions for use)
Addition of paragraph ‘Effects on growth and development in paediatric patients’ 
[...] Growth retardation has been observed in paediatric patients treated with SPRYCEL in clinical trials (see section 4.8). Monitoring of bone growth and development in paediatric patients is recommended.
​
Date of Revision of Text: 25 February 2021
 

Existing/new pharmacokinetics (PK) analyses together with a review of literature data on the dasatinib PK profile in fasted conditions. The following sections of the SmPC are updated (changes marked in blue):

·         SmPC Section 4.2 - Method of administration […] SPRYCEL can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2). […]

·         SmPC Section 5.2 - Pharmacokinetic properties - Absorption
[…] Dasatinib exposure variability is higher under fasted conditions (47% CV) compared to light-fat meal (39% CV) and high-fat meal (32% CV) conditions.
Based on the patient population PK analysis, variability in dasatinib exposure was estimated to be mainly due to inter-occasion variability in bioavailability (44% CV) and, to a lesser extent, due to inter-individual variability in bioavailability and inter-individual variability in clearance (30% and 32% CV, respectively). The random inter-occasion variability in exposure is not expected to affect the cumulative exposure and efficacy or safety. […]