KEYTRUDA 25 mg/mL concentrate for solution for infusion

  • Name:

    KEYTRUDA 25 mg/mL concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Pembrolizumab

  • 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

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Summary of Product Characteristics last updated on medicines.ie: 15/6/2020

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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 15 June 2020 SmPC

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 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 SmPC

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 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 SmPC

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 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 SmPC

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 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 SmPC

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 7 June 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 7 June 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 3 - dose and frequency

Updated on 10 April 2019 SmPC

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 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 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 January 2019 SmPC

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 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 SmPC

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 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 SmPC

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 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 SmPC

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 SmPC

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 3 July 2018 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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