OPDIVO 10 mg/mL concentrate for solution for infusion

  • Name:

    OPDIVO 10 mg/mL concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Nivolumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/04/20

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Summary of Product Characteristics last updated on medicines.ie: 30/4/2020

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Bristol-Myers Squibb Pharma EEIG

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Medicine Name OPDIVO 10 mg/mL concentrate for solution for infusion Active Ingredients Nivolumab
Medicine Name ORENCIA 125 mg solution for injection in pre-filled pen Active Ingredients Abatacept
Medicine Name ORENCIA 250 mg powder for concentrate for solution for infusion Active Ingredients Abatacept
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1 - 0 of 16 items.Total: Infinity pages

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 30 April 2020 PIL

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 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 4.7 - 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 PIL

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 SmPC

Reasons for updating

  • 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

10.     DATE OF REVISION OF THE TEXT

 

30 March 2020

Updated on 23 January 2020 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 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

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 3 myocarditis

Permanently discontinue treatment

 

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 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Date of revision updated

Updated on 9 January 2020 SmPC

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

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 9 January 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Updated date of revision

Updated on 4 November 2019 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of 5-year efficacy data for studies CA209057 & 017 to SmPC

Updated on 23 October 2019 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 October 2019 PIL

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 PIL

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 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

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 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Date of revision updated

Updated on 29 May 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

  • 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 PIL

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 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 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


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 1 April 2019 PIL

Reasons for updating

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

Updated on 1 April 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

Update to Section 4.8 and 10.

Updated on 20 February 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 20 February 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

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 PIL

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 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 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 14 December 2018 SmPC

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)

Updated on 5 November 2018 Ed-Both

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

 

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 September 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

PSUR 6 - Product information update to add pericardial disorders (considering pericarditis, pericardial effusion, cardiac tamponade, and Dressler's Syndrome)

Updated on 31 July 2018 PIL

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 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)

Updated on 28 June 2018

Updated on 29 May 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 May 2018 SmPC

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 4 May 2018 PIL

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 PIL

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018 PIL

Reasons for updating

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

Updated on 28 March 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 28 March 2018 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

In section 4.8 (undesirable effects) tumour lysis syndrome has been added

Updated on 17 January 2018 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 14 November 2017 SmPC

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

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-  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 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 23 October 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - 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

-          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 PIL

Reasons for updating

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

Updated on 27 September 2017 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 4.8 – Undesirable effects - how to report a side effect
  • 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

 

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 PIL

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 SmPC

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)

Free text change information supplied by the pharmaceutical company

In section 4.8, a typo was corrected in the Immunogenicity subsection
"1734 patients" was replaced by "2022 patients".

Updated on 13 June 2017 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Revision of the SmPC with the new indication in Urothelial Carcinoma (UC).

Updated on 7 June 2017 PIL

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 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

OPDIVO in SCCHN indication approved in EU

Updated on 10 May 2017 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 27 April 2017 SmPC

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

Section 5.1 of the SmPC has been updated to reflect the final overall survival and duration of response with longer follow-up for study CA209037. Following a request from CHMP, efficacy by PD-L1 status (1%) and BRAF status is  also reflected. Additionally, long term survival (i.e. the 3-year, 4-year and 5-year OS-rates) from study CA209003 has also been included in SmPC section 5.1.

Updated on 25 April 2017 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 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

Type IB-035-G variation following the receipt of the PRAC Recommendation for the signal of pemphigoid (dated 09 February 2017) and the signal of transplant rejection (dated 09 March 2017).
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 PIL

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 3 April 2017 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 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

PSUR 3 - the PRAC Recommendation to update SmPC sections 4.4 and 4.8 to include encephalitis.

Updated on 31 March 2017 PIL

Reasons for updating

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

Updated on 2 March 2017 SmPC

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

Var II/023 - Update of sections 4.8 and 5.1 of the SmPC with the 24 months data from the completed studies 017 and 057.

Updated on 1 March 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 6 February 2017 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 - how to report a side effect
  • 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

TYII variation (II/0018) - update of safety information on TEN and SJS & add myositis, myocarditis and rhabdomyolysis as ADRs in the PI (section 4.2, 4.4 & 4.8 and Package Leaflet)

Updated on 3 February 2017 PIL

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 6 January 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 6 January 2017 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Type IB variation (IB/0028) approval - extension of the shelf-life of the product after dilution/ reconstitution from 4 hours to 8 hours.

Updated on 2 December 2016 SmPC

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Approval of Type II variation (EMEA/H/C/003985/II/0012) - Extension of indication to include treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. EC Decision issued on 21-Nov-2016

Updated on 1 December 2016 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 12 May 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 12 May 2016 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC for OPDIVO updated based on EC decision granted on 11-May-2016 for Type II variation (EMEA/H/C/003985/II/003) to include OPDIVO in combination with ipilimumab for treatment of advanced (unresectable or metastatic) melanoma in adults.

Updated on 8 April 2016 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 4.6 - 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC updated as per EC Decision for type II variations for OPDIVO (nivolumab) related to extension of indication to include:
• 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 7 April 2016 PIL

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 21 December 2015 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 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

Variation II/0004. The scope of this variation was to update the safety information on toxic epidermal necrolysis (TEN) and encephalitis in the Product Information (PI) - section 4.4, 4.8 and Package Leaflet

Updated on 3 November 2015 PIL

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 3 November 2015 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

This II/001 variation was to include the squamous non-small cell lung cancer (NSCLC) indication from the Nivolumab BMS Marketing Authorisation (MA) into the OPDIVO MA.

Updated on 23 June 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 June 2015 SmPC

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

None provided