KEYTRUDA 25 mg/mL concentrate for solution for infusion
*Company:
MSD Ireland (Human Health) LimitedStatus:
UpdatedLegal 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 02 April 2024
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-134-CRT-25032024.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 28 March 2024
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-134-CRT-25032024.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 28 March 2024
File name
KEYTRUDA-H-C-3820-II-134-SPC-IE-en-CRT.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication for neoadjuvant / adjuvant non-small cell lung carcinoma
Updated on 18 December 2023
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-138-11122023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 18 December 2023
File name
KEYTRUDA-H-C-3820-II-138-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication for Biliary tract carcinoma
Updated on 07 December 2023
File name
KEYTRUDA-H-C-3820-II-139-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to section 5.1 (KN716).
Updated on 30 November 2023
File name
KEYTRUDA-H-C-3820-II-135-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication for HER2-negative Gastric cancer.
Updated on 30 November 2023
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-135-23112023.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 24 October 2023
File name
KEYTRUDA-H-C-3820-II-121-II136-II141-SPC-IE-en-CRT.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication for adjuvant NSCLC (extension of indication).
Updated on 24 October 2023
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-121-12102023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
File name
KEYTRUDA-H-C-3820-II-133-PTAC-en-IE-CRT.pdf
Reasons for updating
- Retire File
Free text change information supplied by the pharmaceutical company
Retired Patient guide document. The Patient Alert Card has been renamed to “Patient Card” and has been updated to include diabetic ketoacidosis (and associated symptoms), to change terminology from ‘immune-related adverse reactions’ to ‘immune-mediated adverse reactions’ and to include relevant components from the retired Patient Information Brochure.
File name
KEYTRUDA-H-C-3820-II-133-PTAC-en-IE-CRT.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
The Patient Alert Card has been renamed to “Patient Card” and has been updated to include diabetic ketoacidosis (and associated symptoms), to change terminology from ‘immune-related adverse reactions’ to ‘immune-mediated adverse reactions’ and to include relevant components from the retired Patient Information Brochure.
Updated on 01 September 2023
File name
KEYTRUDA-H-C-3820-II-133-SPC-IE-en-CRT.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication for Gastric or gastro-oesophageal junction (GEJ) adenocarcinoma.
Updated on 01 September 2023
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-133-23082023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 03 May 2023
File name
KEYTRUDA-H-C-3820-II-128-II-132-SPC-IE-en March 2023.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated adverse reactions (optic neuritis – frequency: rare).
Updated on 03 May 2023
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II-128-II-132-16032023.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 03 November 2022
File name
KEYTRUDA-H-C-3820-II-126-SPC-IE-en Oct 2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated section on “Hepatic impairment” in section 4.2 (also referenced in section 5.2).
Updated on 04 August 2022
File name
KEYTRUDA-H-C-3820-II-122-SPC-IE-en July 2022.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated adverse reactions (hypoparathyroidism – frequency: rare).
Updated on 04 August 2022
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II0122-18072022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 14 July 2022
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-PSUSA-II111-22062022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 14 July 2022
File name
KEYTRUDA-H-C-3820-II-111-SPC-IE-en June 2022.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated indications for Melanoma and for Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers; updated Adverse reactions (section 4.8) and Pharmacodynamic properties (section 5.1).
Updated on 31 May 2022
File name
KEYTRUDA-H-C-3820-II-110-SPC-IE-en May 2022.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication for Triple negative breast cancer in section 4.1 and corresponding updates in 4.2 and 5.1.
Updated on 31 May 2022
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II110-19052022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 13 May 2022
File name
KEYTRUDA-H-C-3820-II-109-115-117-SPC-IE-en April 2022.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- New indications for MSI-H or dMMR cancer and Cervical cancer in section 4.1 and corresponding updates in 4.2, 4.4 and 5.1 - Section 4.8: Updated frequencies of adverse reactions - Section 5.1: Updated efficacy data (KEYNOTE 426)
Updated on 13 May 2022
File name
QRD-IE-MT-UKNI-KEYTRUDA-LFT-II109-II117-25042022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 12 April 2022
File name
KEYTRUDA-H-C-3820-II-114-SPC-IE-en Feb 2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update section 5.1 of the SmPC with efficacy information from study KEYNOTE-087
Updated on 01 March 2022
File name
KEYTRUDA-H-C-3820-IA-120-SPC-IE-en Feb 2022.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated Pharmacotherapeutic group / ATC code.
Updated on 10 February 2022
File name
KEYTRUDA-H-C-3820-II-108-II-116-SPC-IE-en Jan 2022.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- New indication in section 4.1: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions”
- Section 4.2: Updated table 1
- Section 4.8: Changes include updated frequencies of adverse reactions
- Section 5.1: Changes include new section on KEYNOTE 564Updated on 10 February 2022
File name
QRD-IE-MT-KEYTRUDA-LFT-II-108-II-116-24012022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 03 December 2021
File name
QRD-IE-MT-KEYTRUDA-LFT-II-104-105-15112021.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 03 December 2021
File name
KEYTRUDA-H-C-3820-II-104-II-105-SPC-IE-en Nov 2021.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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.1: Addition of new indications: “KEYTRUDA, in combination with lenvatinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults (see section 5.1).” “KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation.”
4.2: Updated data related to combination therapy with lenvatinib
4.8: Updates for combination therapy with axitinib or lenvatinib
5.1: Updates include KEYNOTE 581 (combination therapy with lenvatinib in RCC patients naïve to treatment) and KEYNOTE 775 (Endometrial carcinoma)
Updated on 10 November 2021
File name
KEYTRUDA-H-C-3820-II-099-SPC-IE-en Oct 2021.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.1: Addition of new indication for Triple negative breast cancer (TNBC)
4.2: Updated data for Elderly
4.4: Added heading for “Use of pembrolizumab in combination with chemotherapy”
4.8: Updated classifications of adverse reactions
5.1: Added data for Triple negative breast cancer
Updated on 10 November 2021
File name
QRD-IE-MT-KEYTRUDA-LFT-II-099-19102021.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
File name
5000_KEYTRUDA_RMM_Patient_Alert_Card_renewal_Mar20.pdf
Reasons for updating
- Add New Doc
Updated on 09 September 2021
File name
KEYTRUDA-H-C-3820-IAIN-0112-SPC-IE-en August 2021.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)
Free text change information supplied by the pharmaceutical company
Addition of “cystitis noninfective” as rare adverse reaction in monotherapy (“Other immune‑related adverse reactions” heading in section 4.4 and table 2 in section 4.8).
Updated on 09 September 2021
File name
QRD-IE-MT-KEYTRUDA-LFT-IAIN-0112-18082021.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 July 2021
File name
QRD-IE-MT-KEYTRUDA-LFT-PSUSA-202009-II-097-24062021.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 07 July 2021
File name
KEYTRUDA-H-C-3820-PSUSA-202009-II-097-SPC-IE-en June 2021.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1: Addition of new indication for Oesophageal carcinoma
- Section 4.2: Updated text for PD-L1 testing
- Section 4.4: “cholangitis sclerosing and gastritis” added under “Other immune related adverse reactions”; added heading “Use of pembrolizumab for first line treatment of patients with oesophageal carcinoma”
- Section 4.8: Updates include reclassification of frequency of adverse reactions and addition of gastritis (common/uncommon) and cholangitis sclerosing (rare)
- Section 5.1: Added text for “Oesophageal Carcinoma”
Updated on 15 June 2021
File name
KEYTRUDA-H-C-3820-II-100-II-102-SPC-IE-en-CRT May 2021.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2: 400 mg Q6W dosing approved for combination indications which now reads “The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes." Section 5.1: Updates in line with above and updates from KEYNOTE 054
Updated on 13 May 2021
File name
KEYTRUDA-25mg-H-C-3820-II-094-SPC-en-CRT March 2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.4: Updated text under “Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin containing chemotherapy and whose tumours express PD L1 with CPS ≥ 10”
- Section 5.1: Updated KEYNOTE 361 data with added table 25 and figures 15 and 16
Updated on 01 April 2021
File name
KEYTRUDA-25mg-H-C-3820-II-090-SPC-IE-en March 2021 (002).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extension of Classical Hodgkin lymphoma indication added to section 4.1 (and related updates made to sections 4.2, 4.4, 4.8, 5.1).
Updated on 01 April 2021
File name
QRD-EN-Keytruda-PIL-II-090-15032021 (002).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Updated on 12 February 2021
File name
KEYTRUDA-25mg-H-C-3820-II-091-IAIN-0101-SPC-IE-en Jan 2021 (002).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC change details:
- New 1L Colorectal cancer indication in section 4.1 (and related updates made to sections 4.2, 4.4, 4.8, 5.1)
- Vasculitis added as immune related adverse reaction in sections 4.4, 4.8 (Uncommon in Combination with chemotherapy; Rare in monotherapy)
- Reclassification of frequencies of some adverse reactions in section 4.8
Updated on 12 February 2021
File name
QRD-EN-Keytruda-PIL-II-091-IAIN-0101-11022021 (002).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 16 December 2020
File name
KEYTRUDA-25mg-H-C-3820-IAIN-098-SPC-IE-en Nov 2020 (002).pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.8: Addition of Sjogren’s syndrome in table 2 adverse reactions.
Updated on 16 December 2020
File name
QRD-EN-Keytruda-PIL-IAIN098-12122020 (002).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 September 2020
File name
KEYTRUDA-25mg-H-C-3820-II-087-G-088-SPC-IE-en July 2020.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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
Same SPC re-uploaded
Updated on 02 September 2020
File name
KEYTRUDA-25mg-H-C-3820-II-087-G-088-SPC-IE-en July 2020.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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
Section 5.1: Updates under “KEYNOTE 189” and “KEYNOTE 407”
Section 6.5: Addition of “bromobutyl” stopper
Updated on 02 September 2020
File name
KEYTRUDA-25mg-H-C-3820-II-087-G-088-SPC-IE-en July 2020.pdf.
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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
Section 5.1: Updates under “KEYNOTE 189” and “KEYNOTE 407”
Section 6.5: Addition of “bromobutyl” stopper
Updated on 15 June 2020
File name
KEYTRUDA-25mg-H-C-3820-II-057-PSUSA-201909-SPC-IE-en June 2020 (002).pdf.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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.4: Updated warnings (myelitis added under “Other immune related adverse reactions”; added “KEYNOTE-042” data)
- Section 4.8: Added adverse reactions: myelitis (rare: monotherapy); gastrointestinal ulceration (uncommon)
- Section 5.1: Added section: “KEYNOTE-042: Controlled study of NSCLC patients naïve to treatment”
Updated on 15 June 2020
File name
QRD_EN_KEYTRUDA_25mg_ml_PIL_II-057-PSUSA-201909_June_2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 07 April 2020
File name
KEYTRUDA-25mg-H-C-3820-R-081-SPC-IE-en March 2020.pdf.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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Removal of black triangle
- Section 4.1: Headings added to indications
- Section 4.2: Updated posology; updated table 1
- Section 4.4: Updated warnings
- Section 4.7: Update for “Effects on ability to drive and use machines”
- Section 9: Date of latest renewal added
Updated on 07 April 2020
File name
QRD_EN_KEYTRUDA_25mg_ml_PIL_R081_Mar_2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Removal of Black Inverted Triangle
Updated on 10 December 2019
File name
KEYTRUDA-25mg-H-C-3820-II-065-080-SPC-IE-en Nov 2019 (002).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1 – new indication: “KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment or metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1”
- added text regarding adrenal insufficiency (primary and secondary) reported in patients receiving pembrolizumab
- updated frequencies of adverse reactions in section 4.8.
Updated on 10 December 2019
File name
QRD_EN_KEYTRUDA_25mg_ml_PIL_II065_080_Nov_2019 (002).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to warnings or special precautions for use
Updated on 04 September 2019
File name
KEYTRUDA-25mg-H-C-3820-II-068-069-074-IB-079-G-SPC-IE-en Aug 2019 (002).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 – new indication: “KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults (see section 5.1).”
Sections 4.2 and 4.4: Added details on KEYTRUDA in combination with axitinib in RCC
Section 4.8: Updated side effects including Combination with axitinib
Section 5.1: Added details for Renal cell carcinoma
Section 6.3: Extended In-use stability
Updated on 04 September 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_II_068_069_074_IB_079_G_Aug_2019 (002).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Free text change information supplied by the pharmaceutical company
Change to section 1 – what the product is used for; section 4 possible side effects; section 5 how to store or dispose
Updated on 04 September 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_II_068_069_074_IB_079_G_Aug_2019 (002).
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
Free text change information supplied by the pharmaceutical company
Change to section 1 – what the product is used for; section 4 possible side effects; section 5 how to store or dispose
Updated on 31 July 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_II071_075_076_June_2019 (002).pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 30 July 2019
File name
KEYTRUDA-25mg-H-C-3820-II-071-075-076-SPC-IE-en June 2019 (002).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.5: Added statement: “Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions”
Section 4.8: New “Paediatric population” heading
Section 5.1: updates to figure 7, table 17, figure 11, table 21, table 22; new “Paediatric population” heading
Section 5.2: Update to “Special populations”
Updated on 07 June 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_PSUR 7.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 07 June 2019
File name
KEYTRUDA-25mg-H-C-3820-PSUSA-00010403-201809-SPC-IE-en May 2019.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.8: Added “haemophagocytic lymphohistiocytosis” as rare side effect in table 2
Updated on 11 April 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_II062.pdf
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 10 April 2019
File name
KEYTRUDA-25mg-H-C-3820-II-062-SPC-IE-en Mar 2019.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Update posology in section 4.2: “The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. The recommended dose of KEYTRUDA as part of combination therapy is 200 mg every 3 weeks administered as an intravenous infusion over 30 minutes.”
- Section 5.1: Updates under “Clinical efficacy and safety”
Updated on 22 March 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_II060.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 22 March 2019
File name
KEYTRUDA-25mg-H-C-3820-II-060-SPC-IE-en Mar 2019.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1: Added new indication: “KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults”
- Section 4.2: Update to “Special Populations”
- Section 4.4: Added text “Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in previously untreated patients with non-small cell lung cancer whose tumours express PD-L1”
- Section 4.8: Update adverse reactions for “Combination with chemotherapy” and “Immune-related pneumonitis”
- Section 5.1: Added text on “KEYNOTE-407”
Updated on 23 January 2019
File name
QRD_KEYTRUDA_25mg_ml_PIL_PSUSA-00010403-201803.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 January 2019
File name
KEYTRUDA-25mg-H-C-3820-PSUSA-00010403-201803-SPC-IE-en Jan 2019.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
- Updates to section 4.8 table 2:
- addition of “pure red cell aplasia” and “Vogt-Koyanagi-Harada syndrome” as rare adverse reactions
- addition of text below table 2: “g. myasthenic syndrome (myasthenia gravis, including exacerbation)
Updated on 19 December 2018
File name
QRD_KEYTRUDA_25mg_ml_PIL_II047_II058.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 December 2018
File name
KEYTRUDA-25mg-H-C-3820-II-047-II-058-II-054-SPC-IE-en Dec 2018.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to sections: 4.1, 4.2, 4.4, 4.8, 5.1, 10
Updated on 21 September 2018
File name
QRD_KEYTRUDA_25mg_ml_PIL_II042_II043 (2).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 September 2018
File name
KEYTRUDA-25mg-H-C-3820-II042-II043-SPC-IE-en Sep 2018 (2).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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1: New indications:
- “KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations”
- “KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy”
- Section 4.2:
- Updated data for “PD-L1 testing for patients with NSCLC, urothelial carcinoma, or HNSCC”
- Added text: “Efficacy and safety data from patients ≥ 75 years are limited (see sections 4.4 and 5.1)”.
- Added text: “When administering KEYTRUDA as part of a combination with pemetrexed and platinum chemotherapy, KEYTRUDA should be administered first. See also the prescribing information for pemetrexed and the selected platinum chemotherapy.”
- Section 4.4:
- Added data for “Use of pembrolizumab in combination with chemotherapy for first-line treatment of patients with NSCLC”
- Section 4.8:
- Updated safety data; table 2 (adverse reactions) now divided into “Monotherapy” and “Combination with chemotherapy”
- Section 5.1:
- Added data for “KEYNOTE-189: Controlled trial of combination therapy in non-squamous NSCLC patients naïve to treatment” and “Head and Neck Squamous Cell Carcinoma”
- Section 5.2:
- Updated Pharmacokinetic data
Updated on 17 August 2018
File name
QRD_KEYTRUDA_25mg_ml_PIL_II044_II048_IB055 (2).pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 August 2018
File name
QRD_KEYTRUDA_PIL_KTD_25mg_ml_PSUSA_MAT June 2018 (2).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 15 August 2018
File name
KEYTRUDA-25mg-H-C-3820-IB055-SPC-IE-en Aug 2018 (2).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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.2: transition to 200 mg fixed dosing
- Section 4.8: Aseptic meningitis added as rare Nervous system disorder
- Section 5.1: New information under “Dosing for patients with melanoma and NSCLC”
Updated on 18 July 2018
File name
KEYTRUDA-25mg-H-C-3820-II-052-SPC-IE-en July 2018 (2).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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.1: Amended indication: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD‑L1 with a combined positive score (CPS) ≥ 10 (see section 5.1)
- Section 4.2: Amended heading and details for: PD-L1 testing for patients with NSCLC or urothelial carcinoma
- Section 4.4: Amended heading and details for: Use of pembrolizumab in urothelial cancer for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD‑L1 with CPS ≥ 10
- Section 5.1: updates to tables 15 and 16
Updated on 03 July 2018
File name
KEYTRUDA_25mg_H_C_3820_PSUSA_00010403_201709_SPC_IE_en_June_2018 (2).docx
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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)
Free text change information supplied by the pharmaceutical company
- Section 4.2: For Endocrinopathies in table 1, Grade > 3 hyperglycaemia has changed to Grade ≥ 3 hyperglycaemia
- Section 4.8: “pericarditis, pericardial effusion” added as uncommon Cardiac disorders in table 2
Updated on 03 July 2018
File name
QRD_KEYTRUDA_PIL_KTD_25mg_ml_PSUSA June 2018 (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 05 June 2018
File name
KEYTRUDA_25mg_H_C_3820_T_045_SPC_IE_en_May_2018.docx
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 05 June 2018
File name
QRD_KEYTRUDA_PIL_KTD_25mg_ml_T045.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 13 May 2018
File name
KEYTRUDA_25mg_HC3820II037GSPCIEenMarch2018.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 April 2018
File name
KEYTRUDA_25mg_HC3820II037GSPCIEenMarch2018.docx
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - 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)
Free text change information supplied by the pharmaceutical company
- Section 4.2: updated Table 1 (added “Grade 3 or 4 encephalitis, Grade 3 or 4 Guillain-Barré syndrome” under “Other immune-related adverse reactions”
- Section 4.4: added “sarcoidosis and encephalitis” and new heading “Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT)” under “Other immune-related adverse reactions”
- Section 4.8: added “encephalitis” (rare) under “Nervous system disorders”
Updated on 16 April 2018
File name
QRD-KEYTRUDA-PIL.KTD.25mg.ml.18.UK.6256-II-037-G (2).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 10 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 January 2018
File name
PIL_17389_95.pdf
Reasons for updating
- New PIL for new product