KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Name:
KEYTRUDA 25 mg/mL concentrate for solution for infusion
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/06/20
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 2/9/2020
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MSD Ireland (Human Health) Limited
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When a pharmaceutical company changes any document, 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.
Updated on 2 September 2020
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Same SPC re-uploaded
Updated on 2 September 2020
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
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 2 September 2020
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
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
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
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 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 7 April 2020
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
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 7 April 2020 PIL
Reasons for updating
- Change to section 2 - driving and using machines
- Removal of Black Inverted Triangle
Updated on 10 December 2019
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
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 PIL
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 4 September 2019
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
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 4 September 2019 PIL
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 4 September 2019 PIL
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 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 30 July 2019
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
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 7 June 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 7 June 2019
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
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 PIL
Reasons for updating
- Change to section 3 - dose and frequency
Updated on 10 April 2019
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
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 PIL
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
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
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 January 2019
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
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 PIL
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
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
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 PIL
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
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
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 PIL
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 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 15 August 2018
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
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
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
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 3 July 2018
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 3 July 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 5 June 2018
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 5 June 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 13 May 2018
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 April 2018
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 PIL
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 SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 January 2018 PIL
Reasons for updating
- New PIL for new product