Praluent 150 mg solution for injection in pre-filled pen
*Company:
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No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 05 December 2023
File name
1.3.1 SPC Ireland & NI - Type IAIN variation - Needle shield description - S23.549.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 November 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Ireland & UK(NI) - Paediatric indication.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 November 2023
File name
1.3.2 IE-NI Mock-up PIL 150mg (2).pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
Updated on 10 July 2023
File name
1.3.2 IENI Mock-up PIL 150mg (3).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 03 April 2023
File name
1.3.2 IE-NI Mock-up PIL 150mg - Project ALFA (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 February 2023
File name
1.3.2 IE-NI Mock-up PIL 150mg - Project ALFA.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 03 January 2023
File name
1.3.1 SPC Ireland & NI - Project ALFA.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 June 2022
File name
1.3.2 IE Mock-up PIL 150mg - Type II OBS14697 Study results (1).pdf
Reasons for updating
- Change to section 3 - how to take/use
Updated on 15 June 2022
File name
1.3.1 SPC Ireland & NI - Type II variation EMEAHC003882II068 (1).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2021
File name
1.3.2 IE Mock-up PIL 150mg - NI Addition to ROI S21.545 (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 December 2021
File name
1.3.1 SPC Ireland & NI - CCDS v11.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 December 2021
File name
1.3.2 IE Mock-up PIL 150mg - NI Addition to ROI S21.545.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 January 2021
File name
1.3.2 IE Mock-up PIL 150mg 795924 Pediatric hoFH & Malta Update.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 06 January 2021
File name
1.3.5 SPC Ireland (2).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 November 2020
File name
1.3.5 SPC Ireland.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 November 2020
File name
1.3.2 IE Mock-up PIL 150mg 791510 SYDNEY-ACCRA (2) (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 November 2020
File name
1.3.2 IE Mock-up PIL 150mg 791510 SYDNEY-ACCRA (2).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 02 November 2020
File name
1.3.2 IE Mock-up PIL 75mg 791516 SYDNEY-ACCRA.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 03 September 2020
File name
1.3.5 SPC Ireland ACCRA pre-filled pen- SYDNEY pre-filled pen (clean).pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 June 2020
File name
1.3.2 IE Mock-up PIL 150mg 782378 Renewal (2).pdf
Reasons for updating
- Change to date of revision
Updated on 16 June 2020
File name
1.3.5 SPC Ireland Renewal.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 June 2020
File name
1.3.2 IE Mock-up PIL 150mg 782378 Renewal.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 18 February 2020
File name
1.3.2 IE Mock-up PIL 150mg 771284 CCDSv7 angioedema SA1776-79.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 13 December 2019
File name
Praluent SmPC IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2019
File name
Praluent SmPC.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 September 2019
File name
PIL 150mg.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 12 September 2019
File name
Praluent PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 03 April 2019
File name
NEW PIL 150mg 746994 v3 - cropped.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 26 March 2019
File name
SPC IE Praluent SA604-7.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Clinical efficacy and safety in primary hypercholesterolaemia and mixed dyslipidaemia
Summary of the Phase 3 Clinical Trials Program - 75 mg and/or 150 mg every 2 weeks (Q2W) dosing regimen
Evaluation of Cardiovascular (CV) events
A cardiovascular outcomes trial whose primary endpoint is adjudicated major adverse cardiovascular events (MACE, i.e. CHD death, myocardial infarction, ischemic stroke, and unstable angina requiring hospitalisation) is ongoing.
Clinical efficacy and safety in prevention of cardiovascular events
ODYSSEY OUTCOMES study
A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years. Patients had experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with a lipid-modifying-therapy (LMT) regimen that was statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of those statins, with or without other LMT. Patients were randomized 1:1 to receive either alirocumab 75 mg once every two weeks (Q2W) or placebo Q2W. At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL or 1.29 mmol/dL), alirocumab was adjusted to 150 mg Q2W. For patients who had their dose adjusted to 150 mg Q2W and who had two consecutive LDL-C values below 25 mg/dL (0.65 mmol/L), down-titration from 150 mg Q2W to 75 mg Q2W was performed. Patients on 75 mg Q2W who had two consecutive LDL-C values below 15 mg/dL (0.39 mmol/L) were switched to placebo in a blinded fashion. Approximately 2615 (27.7%) of 9451 patients treated with alirocumab required dose adjustment to 150 mg Q2W. Of these 2615 patients, 805 (30.8%) were down-titrated to 75 mg Q2W. Overall, 730 (7.7%) of 9451 patients switched to placebo. A total of 99.5% of patients were followed for survival until the end of the trial. The median follow-up duration was 33 months.
The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients. Most patients (88.8%) were receiving high intensity statin therapy with or without other LMT at randomization. The mean LDL-C value at baseline was 92.4 mg/dL (2.39 mmol/L).
Alirocumab significantly reduced the risk for the primary composite endpoint of the time to first occurrence of Major Adverse Cardiovascular Events (MACE-plus) consisting of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.0003). Alirocumab also significantly reduced the following composite endpoints: risk of CHD event; major CHD event; cardiovascular event; and the composite of all-cause mortality, non-fatal MI, and non-fatal ischemic stroke. A reduction of all-cause mortality was also observed, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI: 0.73, 0.98). The results are presented in Table 3.
Updated on 19 March 2019
File name
NEW PIL 150mg 746994 v3 - cropped.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 15 March 2019
File name
1.3.1 SPC IE-approved-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
a Cardiovascular Risk reduction variation
Updated on 24 October 2018
File name
1.3.2 mock-up PIL 150mg - 724312.pdf
Reasons for updating
- XPIL Created
Updated on 27 September 2018
File name
1.3.2 mock-up PIL 150mg - 724312.pdf
Reasons for updating
- New PIL for new product
Updated on 27 September 2018
File name
1.3.1 SPC Ireland-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)