OPDIVO 10 mg/mL concentrate for solution for infusion
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
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 14 June 2024
File name
Opdivo-smpc-pancreatic-coeliac- IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 June 2024
File name
Opdivo-pil-pancreatic-coeliac- IE clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 30 April 2024
File name
OPDIVO II-137 - EN SmPC.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 April 2024
File name
OPDIVO II-137 - EN leaflet.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Free text change information supplied by the pharmaceutical company
1L UC
Updated on 20 February 2024
File name
2024 02 IE Opdivo SPC safety signal of myelitis - clean.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)
Updated on 20 February 2024
File name
2024 02 IE Opdivo PIL safety signal of myelitis - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 30 October 2023
File name
2023 10 26 IE Opdivo-CRS-clean.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)
Updated on 23 August 2023
File name
2023 08 21 IE Opdivo-SmPC-Stage IIB or IIC melanoma-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 4.8 - 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
New indication for stage IIB or IIC melanoma
Updated on 23 August 2023
File name
2023 05 IE Opdivo-PIL- Stage IIB or IIC melanoma-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of stage IIB or IIC melanoma indication
Updated on 07 July 2023
File name
2023 06 IE Opdivo-PIL- neo adjuvant NSCLC-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 07 July 2023
File name
2023 06 26 Opdivo-SmPC-neo adjuvant NSCLC-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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 02 June 2023
File name
2023 05 31 Opdivo-SmPC-adolescent melanoma-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to Sections 4.1, 4.2, 4.8, 5.1, 5.2, 6.6 and 10.
Updated on 07 November 2022
File name
IE SPC WS-2187 OPDIVO EN PI clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 October 2022
File name
OPDIVO-SPC-H-3985-WS-2289-PI-en IE.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
1506-GB-2200414_BMS Opdivo Alert Card.pdf
Reasons for updating
- Replace File
Updated on 09 September 2022
File name
IE-SPC-2289-en-clean OPDIVO.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)
Updated on 08 September 2022
File name
IE-SPC-2289-en-clean OPDIVO.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
To update of the efficacy analyses based upon 7.5 years of minimum follow-up for all subjects from study CA209067.
Updated on 05 May 2022
File name
IE-SPC-PSUR11-en-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2022
File name
2022 04 Opdivo IE-SmPC-1LOSCC648-AdjUC274-ipiinfusion-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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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extension of indication, change in ipi infusion time
Updated on 14 January 2022
File name
2022 01 Opdivo NI- SmPC-60mRCC-clean.pdf
Reasons for updating
- 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
Worksharing TYII RCC 1L CA209214 60-month data, SmPC update
Updated on 09 December 2021
File name
2021 12 Opdivo IE- SmPC-shelflifeext-en-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
The in-use shelf life has been extended from 24hours to 7days.
Updated on 10 November 2021
File name
2021 10 OPDIVO-IE-SmPC-120mg-CA209908-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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 06 October 2021
File name
2021 09 02 Opdivo-IE-SmPC-cHL205_clean.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
Update of sections 4.4, 4.8, and 5.1 of the SmPC based on final results from study CA209205 in classical Hodgkin's Lymphoma.
Updated on 09 September 2021
File name
2021 08 26 Opdivo-IE-SmPC-cystitis_clean.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 03 August 2021
File name
2021 07 28 Opdivo-IE-SmPC-577_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 4.8 - 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)
Updated on 05 July 2021
File name
2021 06 24 Opdivo-IE-SmPC-CRC_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 4.8 - 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 indication to include the treatment of mismatch repair deficient or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine based combination chemotherapy
Updated on 15 June 2021
File name
2021 06 01 Opdivo-IE-SmPC-MPM_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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
The SmPC is updated following the approval of the extension of indication variation for OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Date of revision to the text is 01 June 2021.
Updated on 27 April 2021
File name
2021 04 21 Opdivo-IE-SmPC-9ER-PSUR 10-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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 sections:
4.1, 4.2, 4.4, 4.8, 5.1, 6.6, 10
Updated on 27 April 2021
File name
2021 04 21 Opdivo-IE-PIL-9ER-PSUR 10-clean.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
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Changes to section 3, 4, 6 and section for Healthcare professionals.
Updated on 16 March 2021
File name
2021 03 11 OPDIVO-IE-SmPC-OS-data-238-CSR-clean.pdf
Reasons for updating
- 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
Update of section 4.8.
The safety profile of nivolumab used as monotherapy now encompasses all tumor settings (advanced-metastatic and adjuvant settings). The Package Leaflet has been revised accordingly.
Update of section 5.1.
Final formal RFS, RFS rates on all patients with minimum follow-up of 36 months and descriptive RFS and rates on all patients with minimum follow-up of 48 months.
Final formal OS analysis and rates on all patients with minimum follow-up of 48 months.
Updated on 16 March 2021
File name
2021 03 11 OPDIVO-IE-PIL-OS-data-238-CSR-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 November 2020
File name
2020 11 20 OPDIVO-UK-IE-SmPC-2L-OC-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 4.8 - 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. - New indication for OPDIVO in the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
- Section 4.2 - Addition of the recommended dose for the above indication i.e. 240 mg every 2 weeks over 30 minutes
- Section 4.4. - Addition of the following information: ' The majority of clinical data available in oesophageal squamous cell carcinoma are in patients of Asian origin (see section 5.1).Patients with a baseline performance score ≥ 2, brain metastases that were symptomatic or required treatment, apparent tumour invasion in organs located adjacent to the oesophagus (e.g. the aorta or respiratory tract), active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the clinical study in OSCC (see sections 4.5 and 5.1). In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.Physicians should consider the delayed onset of nivolumab effect before initiating treatment in patients with OSCC. A higher number of deaths within 2.5 months after randomisation was observed with nivolumab compared to chemotherapy. No specific factor(s) associated with early deaths could be identified (see section 5.1).
- Section 4.8 - ADR frequency of vasculitis updated from uncommon to rare. ADR frequency of hyperglycaemia updated from common to very common
- Section 5.1. Addition of the registrational clinical trial results
- Section 10 - Date of revision updated
Updated on 24 November 2020
File name
2020 11 20 OPDIVO-UK-IE-PIL-2L-OC-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 11 November 2020
File name
2020 11 05 OPDIVO-UK-IE-SmPC-9LA-NSCLC-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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Product information updated to include Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
4.2 Posology and method of administration
OPDIVO in combination with ipilimumab and chemotherapy
Non‑small cell lung cancer
The recommended dose is 360 mg nivolumab administered intravenously over 30 minutes every 3 weeks in combination with 1 mg/kg ipilimumab administered intravenously over 30 minutes every 6 weeks, and platinum-based chemotherapy administered every 3 weeks. After completion of 2 cycles of chemotherapy, treatment is continued with 360 mg nivolumab administered intravenously every 3 weeks in combination with 1 mg/kg ipilimumab every 6 weeks. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
4.4 Special warnings and precautions for use
First-line treatment of NSCLC
Patients with active autoimmune disease, symptomatic interstitial lung disease, medical conditions requiring systemic immunosuppression, active (untreated) brain metastasis, who received prior systemic treatment for advanced disease, or who had sensitising EGFR mutations or ALK translocations were excluded from the pivotal trial in first-line treatment of NSCLC (see sections 4.5 and 5.1). Limited data are available in elderly patients (≥ 75 years) (see section 5.1). In these patients, nivolumab in combination with ipilimumab and chemotherapy should be used with caution after careful consideration of the potential benefit/risk on an individual basis.
4.8 Undesirable effects
Safety information regarding nivolumab in combination with ipilimumab and chemotherapy, with its adverse drug reaction table
Immune‑related pneumonitis
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of pneumonitis including interstitial lung disease was 5.3% (19/358). Grade 2, Grade 3, and Grade 4 cases were reported in 2.2% (8/358), 1.1% (4/358), and 0.6% (2/358) of patients, respectively. Median time to onset was 18.1 weeks (range: 0.6-52.4). Resolution occurred in 14 patients (74%) with a median time to resolution of 4.3 weeks (range: 0.7-27.9+).
Immune‑related colitis
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of diarrhoea or colitis was 22.3% (80/358). Grade 2, Grade 3, Grade 4, and Grade 5 cases were reported in 7% (25/358), 5% (18/358), 0.3% (1/358), and 0.3% (1/358) of patients, respectively. Median time to onset was 5.1 weeks (range: 0.1-53.6). Resolution occurred in 70 patients (87.5%) with a median time to resolution of 1.4 weeks (range: 0.1-76.9+).
Immune‑related hepatitis
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of liver function test abnormalities was 13.4% (48/358). Grade 2, Grade 3, and Grade 4 cases were reported in 3.1% (11/358), 3.4% (12/358), and 1.1% (4/358) of patients, respectively. Median time to onset was 10.6 weeks (range: 1.1-68.3). Resolution occurred in 37 patients (80.4%) with a median time to resolution of 5 weeks (range: 0.3+-45.0+).
Immune‑related nephritis and renal dysfunction
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of nephritis or renal dysfunction was 7% (25/358). Grade 2, Grade 3, and Grade 4 cases were reported in 2.2% (8/358), 1.7% (6/358), and 0.6 (2/358) of patients, respectively. Median time to onset was 10.6 weeks (range: 0.1-51.3). Resolution occurred in 14 patients (56%) with a median time to resolution of 6.3 weeks (range: 0.1+-82.9+).
Immune‑related endocrinopathies
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of thyroid disorders was 24% (86/358). Grade 2 and Grade 3 thyroid disorders were reported in 12.3% (44/358) and 0.3% (1/358) of patients, respectively. Hypophysitis occurred in 1.4% (5/358) of patients. Grade 2 and Grade 3 cases were reported in 0.6% (2/358) and 0.8% (3/358) of patients, respectively. Grade 2 hypopituitarism occurred in 0.3% (1/358) of patients. Grade 2 and Grade 3 adrenal insufficiency occurred in 1.7% (6/358) and 1.4% (5/358) of patients, respectively. Diabetes mellitus including Type 1 diabetes mellitus was not reported. Median time to onset of these endocrinopathies was 12.1 weeks (range: 1.9-58.3). Resolution occurred in 30 patients (35.3%). Time to resolution ranged from 1.4 to 72.4+ weeks.
Immune‑related skin adverse reactions
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of rash was 37.7% (135/358). Grade 2, Grade 3, and Grade 4 cases were reported in 11.5% (41/358), 4.2% (14/358), and 0.3% (1/358) of patients, respectively. Median time to onset was 3.3 weeks (range: 0.1-83.1). Resolution occurred in 96 patients (71.6%) with a median time to resolution of 9.4 weeks (range: 0.1+-84.1+).
Infusion reactions
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the incidence of hypersensitivity/infusion reactions was 4.7% (17/358). Grade 2, Grade 3, and Grade 4 cases were reported in 2.2% (8/358), 0.3% (1/358), and 0.3% (1/358) of patients, respectively.
Laboratory abnormalities
In patients treated with nivolumab 360 mg every 3 weeks in combination with ipilimumab 1 mg/kg every 6 weeks and chemotherapy in NSCLC, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 9.2% for anaemia, 4.3% for thrombocytopaenia, 9.8% for leucopoenia, 5.8% for lymphopaenia, 14.7% for neutropaenia, 1.2% for increased alkaline phosphatase, 3.5% for increased AST, 4.3% for increased ALT, 0% for increased total bilirubin, 1.2% for increased creatinine, 7.1% for hyperglycaemia, 0% for hypoglycaemia, 6.7% for increased amylase, 11.9% for increased lipase, 1.4% for hypocalcaemia, 1.2% for hypercalcaemia, 1.7% for hyperkalaemia, 0.3% for hypermagnesaemia, 1.2% for hypomagnesaemia 3.5% for hypokalaemia, and 10.7% for hyponatraemia.
Immunogenicity
Of the patients who were treated with nivolumab in combination with ipilimumab and chemotherapy and evaluable for the presence of anti-nivolumab antibodies or neutralising antibodies against nivolumab, the incidence of anti-nivolumab antibodies was 33.8% and the incidence of neutralising antibodies was 2.6%. Of the patients who were treated with nivolumab in combination with ipilimumab and chemotherapy and evaluable for the presence of anti-ipilimumab antibodies or neutralising antibodies against ipilimumab, the incidence of anti-ipilimumab antibodies was 7.5%, and the neutralising antibodies was 1.6%.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Non‑small cell lung cancer
First-line treatment of NSCLC
5.2 Pharmacokinetic properties
Nivolumab in combination with ipilimumab and chemotherapy
When nivolumab 360 mg every 3 weeks was administered in combination with ipilimumab 1 mg/kg every 6 weeks and with 2 cycles of chemotherapy, the CL of nivolumab decreased approximately 10% and the CL of ipilimumab increased approximately 22%, which were not considered clinically relevant.
6.6 Special precautions for disposal and other handling
Nivolumab in combination with ipilimumab and chemotherapy
The prescribed dose for the patient is 360 mg given regardless of body weight.
10. DATE OF REVISION OF THE TEXT
05 November 2020
Updated on 11 November 2020
File name
2020 11 05 OPDIVO-UK-IE-PIL-9LA-NSCLC-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Product information updated to include Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
Updated on 10 August 2020
File name
2020 07 23 OPDIVO-UK-IE-PIL-5Y-OS-067-clean.pdf
Reasons for updating
- Change to information for healthcare professionals
File name
UK IRE Opdivo Patient Alert Card_1506UK2000477-01_Final.pdf
Reasons for updating
- Replace File
Updated on 27 July 2020
File name
2020 07 23 OPDIVO-UK-IE-SmPC-5Y-OS-067-clean.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
This SmPC revision includes updated efficacy data i.e. overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). Updated safety data and analysis in terms of the type, frequency and severity of reported events are also provided. Sections 4.8 and 5.1 have been updated as a result.
Updated on 30 April 2020
File name
2020 04 23 OPDIVO-Renewal-HLH-UK-IE-PIL_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Black Triangle removed
Warnings and precautions
- Haemophagocytic lymphohistiocytosis. A rare disease in which our immune system makes too many of otherwise normal infection fighting cells called histiocytes and lymphocytes. Symptoms may include enlarged liver and/or spleen, skin rash, lymph node enlargement, breathing problems, easy bruising, kidney abnormalities, and heart problems.
Driving and using machines
OPDIVO Nivolumab or OPDIVO in combination with ipilimumab may have a minor influence on the ability to drive and use machinesis unlikely to affect your ability to drive or use machines; however, use caution when performing these activities until you are sure that OPDIVO nivolumab does not adversely affect you.
OPDIVO contains sodium
Tell your doctor if you are on a low‑sodium (low‑salt) diet before you are given OPDIVO. This medicine contains 2.5 mg sodium (main component of cooking/table salt) per in each mL of concentrate. OPDIVO contains 10 mg sodium per 4 ml vial, 25 mg sodium per 10 ml vial or 60 mg sodium per 24 ml vial, which is equivalent to 0.5%, 1.25% or 3% respectively, of the recommended maximum daily dietary intake of sodium for an adult.
Other side effects that have been reported (frequency not known) with OPDIVOnivolumab alone and/or OPDIVOnivolumab in combination with ipilimumab include:
- A condition where the immune system makes too many infection-fighting cells called histiocytes and lymphocytes that may cause various symptoms (called haemophagocytic lymphohistiocytosis)
Manufacturer
Swords Laboratories t/a Bristol‑Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15, D15 H6EF
Ireland
This leaflet was last revised in April 2020
Updated on 30 April 2020
File name
2020 04 23 OPDIVO-Renewal-HLH-UK-IE-SmPC_clean.pdf
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- 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
Opdivo 5 year renewal update.
Overview of changes below (not exhaustive):
The black triangle has been removed.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 10 mg of nivolumab.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
4.7 Effects on ability to drive and use machines
Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines. Nivolumab or nivolumab in combination with ipilimumab may have a minor influence on the ability to drive and use machines. Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that nivolumab does not adversely affect them.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19 June 2015
Date of latest renewal: 23 April 2020
10. DATE OF REVISION OF THE TEXT
23 April 2020
Haemophagocytic lymphohistiocytosis (HLH) PRAC recommendation.
As per PRAC recommendation, sections 4.4 (Warnings and Precautions) and 4.8 (Undesirable Effects) of the SmPC have been revised to add “haemophagocytic lymphohistiocytosis”. The patient leaflet has been updated accordingly.
Updated on 22 April 2020
File name
2020 04 20 OPDIVO-Anagni name change-UK-IE-PIL-en-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
This leaflet was last revised in March 2020
Updated on 22 April 2020
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2020 04 20 OPDIVO-Anagni name change-UK-IE-SmPC-en-clean.pdf
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- Change to section 10 - Date of revision of the text
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10. DATE OF REVISION OF THE TEXT
30 March 2020
Updated on 23 January 2020
File name
2020 01 21 OPDIVO-Myocarditis-SmPC-UK-IE-clean.pdf
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 10 - Date of revision of the text
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4.2 Posology and method of administration
|
Grade 4 rash |
Permanently discontinue treatment
|
|
|
Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) |
Permanently discontinue treatment (see section 4.4) |
|
|
Immune-related myocarditis |
Grade 2 myocarditis |
Withhold dose(s) until symptoms resolve and management with corticosteroids is completec
|
|
Grade 3 or 4 myocarditis |
Permanently discontinue treatment |
|
|
Other immune-related adverse reactions |
Grade 3 (first occurrence) |
Withhold dose(s)
|
|
|
|
|
|
Grade 4 or recurrent Grade 3 ; persistent Grade 2 or 3 despite treatment modification; inability to reduce corticosteroid dose to 10 mg prednisone or equivalent per day |
Permanently discontinue treatment |
Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
a During administration of the second phase of treatment (nivolumab monotherapy) following combination treatment, permanently discontinue treatment if Grade 3 diarrhoea or colitis occurs.
b Recommendation for the use of hormone replacement therapy is provided in section 4.4.
c The safety of re-initiating nivolumab or nivolumab in combination with ipilimumab therapy in patients previously experiencing immune-related myocarditis is not known.
4.4 Special warnings and precautions for use
Other immune-related adverse reactions
Rare Ccases of myotoxicity (myositis, myocarditis, and rhabdomyolysis), some with fatal outcome, have been reported with nivolumab or nivolumab in combination with ipilimumab. If a patient develops signs and symptoms of myotoxicity, close monitoring should be implemented, and the patient referred to a specialist for assessment and treatment without delay. Based on the severity of myotoxicity, nivolumab or nivolumab in combination with ipilimumab should be withheld or discontinued (see section 4.2), and appropriate treatment instituted.
The diagnosis of myocarditis requires a high index of suspicion. Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. If myocarditis is suspected, prompt initiation of a high dose of steroids (prednisone 1 to 2 mg/kg/day or methylprednisolone 1 to 2 mg/kg/day) and prompt cardiology consultation with diagnostic workup according to current clinical guidelines should be initiated. Once a diagnosis of myocarditis is established, nivolumab or nivolumab in combination with ipilimumab should be withheld or permanently discontinued (see section 4.2).
10. DATE OF REVISION OF THE TEXT
20 January 2020
Updated on 23 January 2020
File name
2020 01 21 OPDIVO-Myocarditis-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
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Date of revision updated
Updated on 09 January 2020
File name
2019 12 20 OPDIVO-Shelf-life-SmPC-UK-IE-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
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6.3 Shelf life
Unopened vial
40 mg/4 mL and 100 mg/10 mL vials: 3 years
240 mg/24 mL vial: 2 years
10. DATE OF REVISION OF THE TEXT
20 December 2019
Updated on 09 January 2020
File name
2019 12 20 OPDIVO-Shelf-life-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
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Updated date of revision
Updated on 04 November 2019
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2019 10 24 OPDIVO-SmPC-UKIE-5-year- data -057 017-clean .pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
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Addition of 5-year efficacy data for studies CA209057 & 017 to SmPC
Updated on 23 October 2019
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2019 10 21 OPDIVO-SmPC-UKIE-Adj-Mel-Flatdose-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
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Updated on 23 October 2019
File name
2019 10 21 OPDIVO-PIL-UKIE-Adj-Mel-Flatdose-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 23 October 2019
File name
2019 09 26 OPDIVO-H-3985-PSUR 8 - CMV-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 30 September 2019
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2019 09 26 OPDIVO-H-3985-PSUR 8 - CMV-SmPC-UK-IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
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4.4
Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-related colitis. Infectious and other aetiologies of diarrhoea should be ruled out, therefore appropriate laboratory tests and additional examinations must be performed. If diagnosis of corticosteroid-refractory immune-related colitis is confirmed addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered.
Updated on 30 September 2019
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2019 09 26 OPDIVO-H-3985-PSUR 8 - CMV-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
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Date of revision updated
Updated on 29 May 2019
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2019 05 27 OPDIVO-CSR CA209171 & CA209172-SmPC-UK-IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
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- SmPC section 4.2, 4.8 and 5.1: statement on limited data in NSCLC elderly has been removed, based on data from study CA209171
- SmPC section 4.4: inclusion/exclusion criteria for studies CA209172 and CA209171 have been reflected, to differentiate from the pivotal trials in advanced melanoma and NSCLC
- SmPC section 5.1: description of studies CA209171 & CA209172 has been added, including efficacy results based on investigator-assessed response rates at week 12 (CA209172) and based on investigator-assessed ORR (CA209171)
Updated on 13 May 2019
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2019 05 07 OPDIVO-Hypoparathyroidism-PIL-UK-IE-clean.pdf
Reasons for updating
- 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 13 May 2019
File name
2019 05 07 OPDIVO-Hypoparathyroidism-SmPC-UK-IE-clean.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
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In Section 4.4 and 4.8 hypoparathyroidism has been added.
Section 10 has been updated to reflect the new date of revision.
Updated on 01 April 2019
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2019 03 28 OPDIVO-H-3985-PSUR-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 April 2019
File name
2019 03 28 OPDIVO-H-3985-PSUR-SmPC-UK-IE-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
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Update to Section 4.8 and 10.
Updated on 20 February 2019
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2019 02 01 OPDIVO-H-3985-IG-1059-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 February 2019
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2019 02 01 OPDIVO-H-3985-IG-1059-SmPC-UK-IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
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7. MARKETING AUTHORISATION HOLDER
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Update to date of revision.
Updated on 15 January 2019
File name
2019 01 11 OPDIVO-pil-1l-rcc-uk-ie-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 January 2019
File name
2019 01 11 OPDIVO-smpc-1l-rcc-uk-ie-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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
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Updated on 14 December 2018
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2018 12 13 OPDIVO-SmPC-non-clear-cell-UK-IE-clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
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UK IRE Opdivo Patient Alert Card 1506UK1800878-02FINAL.pdf
Reasons for updating
- Add New Doc
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Changes include:
o An instruction to tell your doctor before you start receiving nivolumab if you have received a bone marrow or stem cell transplant from another person (allogeneic)
Updated on 24 September 2018
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2018 09 20 OPDIVO-PIL-PSUR6-UK-IE-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 21 September 2018
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2018 09 20 OPDIVO-PIL-PSUR6-UK-IE-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 21 September 2018
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2018 09 20 OPDIVO-SmPC-PSUR6-UK-IE-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
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PSUR 6 - Product information update to add pericardial disorders (considering pericarditis, pericardial effusion, cardiac tamponade, and Dressler's Syndrome)
Updated on 31 July 2018
File name
2018 07 30 OPDIVO-Adj-Melanoma-PIL-UK-IE-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 31 July 2018
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2018 07 30 OPDIVO-SmPC-Adj-Melanoma-UK-IE-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 4.8 - 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)
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2018 05 17 OPDIVO-PIL-240mg Vial-UK-IE-clean.pdf
Updated on 29 May 2018
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2018 05 17 OPDIVO-SmPC-240mg Vial-UK-IE-clean.doc
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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)
- Change to section 10 - Date of revision of the text
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 10 mg of nivolumab.
One vial of 4 mL contains 40 mg of nivolumab.
One vial of 10 mL contains 100 mg of nivolumab.
One vial of 24 mL contains 240 mg of nivolumab.
6.3 Shelf life
Unopened vial
40 mg/4 mL and 100 mg/10 mL vials: 3 years
240 mg/24 mL vial: 2 years.
6.5 Nature and contents of container
4 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a dark blue flip-off seal (aluminium). Pack size of 1 vial.
10 mL of concentrate in a 10 mL vial (Type I glass) with a stopper (coated butyl rubber) and a grey flip-off seal (aluminium). Pack size of 1 vial.
24 mL of concentrate in a 25 mL vial (Type I glass) with a stopper (coated butyl rubber) and a red matte flip-off seal (aluminium). Pack size of 1 vial.
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/15/1014/001
EU/1/15/1014/-002
EU/1/15/1014/003
10. DATE OF REVISION OF THE TEXT
17 May 2018
Updated on 29 May 2018
File name
2018 05 17 OPDIVO-PIL-240mg Vial-UK-IE-clean.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 - date of revision
Updated on 24 May 2018
File name
2018 04 26 OPDIVO-SmPC-GVHD-UK-IE-clean.doc
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 May 2018
File name
2018 04 26 OPDIVO-SmPC-GVHD-UK-IE-clean.doc
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 04 May 2018
File name
2018 04 26 OPDIVO-PIL -GVHD-UK-IE-Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 26 April 2018
File name
2018 04 23 OPDIVO-PIL-Posology-UK-IE-clean.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 29 March 2018
File name
PIL_16375_88.pdf
Reasons for updating
- New PIL for new product
Updated on 29 March 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 March 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
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Updated on 17 January 2018
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
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6.3 Shelf life
Unopened vial
3 years.
6.4 Special precautions for storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
The unopened vial can be stored at controlled room temperature up to 25°C with room light for up to 48 hours.
10. DATE OF REVISION OF THE TEXT
12 January 2018
Updated on 16 January 2018
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 14 November 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
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Section 4.1- is updated with a grammatical change
Section 4 8 -is updated with longer follow-up for subjects proceeding to allogeneic transplant following nivolumab treatment
Section 5.1- is updated with longer follow-up data from CA209205 Cohort B and with data from Cohort C
Section 10 - date of revision has been revised to -9th November 2017
Updated on 13 November 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 23 October 2017
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
- Change to section 10 - Date of revision of the text
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- The informative statement in Section 4.1 of the SmPC has been revised to include OS
- Section 5.1 of the SmPC has been updated to reflect the OS data at 3-year- The pooled safety data (mono and combo) included in the Section 4.8 of the SmPC has been updated to reflect longer follow-up (up to 28 m) from study CA209067, as well as additional follow-up from melanoma studies supporting currently approved indications.
Updated on 23 October 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 27 September 2017
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
- Change to section 10 - Date of revision of the text
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4.4.
Other immune-related adverse reactions
The following immune-related adverse reactions were reported in less than 1% of patients treated with nivolumab monotherapy in clinical trials across doses and tumour types: pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barré syndrome, myasthenic syndrome, and encephalitis. Cases of Vogt-Koyanagi-Harada syndrome have been reported post-marketing (see section 4.8).
4.8.
Table 2: Adverse reactions in clinical trials
|
Not known |
Vogt-Koyanagi-Harada syndromeh |
Vogt-Koyanagi-Harada syndrome |
h Post-marketing event (also see section 4.4)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store.
10.
18 September 2017
Updated on 26 September 2017
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 12 July 2017
Reasons for updating
- 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)
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"1734 patients" was replaced by "2022 patients".
Updated on 13 June 2017
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
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
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Updated on 07 June 2017
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Updated on 11 May 2017
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
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Updated on 10 May 2017
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 27 April 2017
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
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Updated on 25 April 2017
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
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Revised SmPC: “solid organ transplant rejection” is added to SmPC section 4.4 & 4.8 and SmPC section 4.8 is also updated with “pemphigoid”. The package leaflet has been updated accordingly.
Updated on 21 April 2017
Reasons for updating
- 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 03 April 2017
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
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Updated on 31 March 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 March 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
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Updated on 01 March 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 February 2017
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 - how to report a side effect
- Change to section 10 - Date of revision of the text
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Updated on 03 February 2017
Reasons for updating
- 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
- Company name change or merger
Updated on 06 January 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
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Updated on 06 January 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 02 December 2016
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
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
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Updated on 01 December 2016
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 12 May 2016
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
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Updated on 12 May 2016
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
Updated on 08 April 2016
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 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
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• treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults (EMEA/H/C/3985/II/002)
• treatment of advanced renal cell carcinoma after prior therapy in adults (EMEA/H/C/3985/II/008)
The full indications for Opdivo are as follows:
Melanoma
OPDIVO as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Non-Small Cell Lung Cancer (NSCLC)
OPDIVO is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
Renal Cell Carcinoma (RCC)
OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
Updated on 07 April 2016
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 21 December 2015
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
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Updated on 21 December 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Correction of spelling/typing errors
Updated on 03 November 2015
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)
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Updated on 03 November 2015
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 23 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 23 June 2015
Reasons for updating
- New PIL for new product