When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
4. Clinical particulars
4.4 Special warnings and precautions for use
Deleted:
Therapeutic experience with prasugrel is limited in Asian patients. Therefore, prasugrel should be used with caution in these patients.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Added:
Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
10. DATE OF REVISION OF THE TEXT
24 October 2011
Hypersensitivity including angioedema
Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel. Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8).
Thrombotic Thrombocytopaenic Purpura (TTP)
Added (bold) Deleted (strikethrough): TTP has been reported with the use of other thienopyridinesprasugrel. TTP is a serious condition and requires prompt treatment. Efient was not associated with TTP in clinical trials supporting registration. Sub heading updated: 4.6 Fertility, pregnancy and lactation 4.8 Undesirable effects Added: a. Summary of the safety profile b. Tabulated summary of adverse reactions Added (bold): Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class. Frequencies are defined as follows: Added (bold): Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ Class Common Uncommon Rare Not Known
Added (bold) Deleted (strikethrough):
TTP has been reported with the use of other thienopyridinesprasugrel. TTP is a serious condition and requires prompt treatment. Efient was not associated with TTP in clinical trials supporting registration.
Sub heading updated: 4.6 Fertility, pregnancy and lactation 4.8 Undesirable effects Added: a. Summary of the safety profile b. Tabulated summary of adverse reactions Added (bold): Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class. Frequencies are defined as follows: Added (bold): Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ Class Common Uncommon Rare Not Known
4.6 Fertility, pregnancy and lactation
4.8 Undesirable effects
Added: a. Summary of the safety profile b. Tabulated summary of adverse reactions Added (bold): Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class. Frequencies are defined as follows: Added (bold): Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ Class Common Uncommon Rare Not Known
a. Summary of the safety profile
b. Tabulated summary of adverse reactions
Added (bold):
Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class. Frequencies are defined as follows:
Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions
System Organ Class
Common
Uncommon
Rare
Not Known
CABG-related bleeding
For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.34% (3 of 90 89 patients) in the clopidogrel group. Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
Pharmacodynamics
Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (129%) and within-subject (912%) variability with both 5 µM and 20 µM ADP.
6. PHARMACEUTICAL PARTICULARS
6.5 Nature and contents of container
Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Not all pack sizes may be marketed.
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/08/503/015 Efient 5mg - 30 film-coated tablet
EU/1/08/503/016 Efient 10mg - 30 film-coated tablet
21 September 2009
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
18 May 2009
First SPC for new product.
25 February 2009