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Bristol-Myers Squibb Pharmaceutical Limited

Watery Lane, Swords, Co. Dublin,
Telephone: 1 800 749 749
Medical Information Direct Line: Freephone: 1 800 749 749
Medical Information e-mail: Medical.information@bms.com
Summary of Product Characteristics last updated on medicines.ie: 14/11/2017
SPC OPDIVO 10 mg/mL concentrate for solution for infusion

When a pharmaceutical company changes an SPC or PIL, 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 14/11/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   09-Nov-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 23/10/2017 and displayed until 14/11/2017
Reasons for adding or 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
Date of revision of text on the SPC:   19-Oct-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 27/09/2017 and displayed until 23/10/2017
Reasons for adding or 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
Date of revision of text on the SPC:   18-Sep-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 12/07/2017 and displayed until 27/09/2017
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   02-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 13/06/2017 and displayed until 12/07/2017
Reasons for adding or 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
Date of revision of text on the SPC:   02-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

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

Updated on 11/05/2017 and displayed until 13/06/2017
Reasons for adding or 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
Date of revision of text on the SPC:   28-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

OPDIVO in SCCHN indication approved in EU
Updated on 27/04/2017 and displayed until 11/05/2017
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   21-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 25/04/2017 and displayed until 27/04/2017
Reasons for adding or 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
Date of revision of text on the SPC:   12-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 03/04/2017 and displayed until 25/04/2017
Reasons for adding or 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
Date of revision of text on the SPC:   24-Mar-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 02/03/2017 and displayed until 03/04/2017
Reasons for adding or 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
Date of revision of text on the SPC:   23-Feb-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 06/02/2017 and displayed until 02/03/2017
Reasons for adding or 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
Date of revision of text on the SPC:   27-Jan-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 06/01/2017 and displayed until 06/02/2017
Reasons for adding or 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
Date of revision of text on the SPC:   21-Dec-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 02/12/2016 and displayed until 06/01/2017
Reasons for adding or 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
Date of revision of text on the SPC:   21-Nov-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 12/05/2016 and displayed until 02/12/2016
Reasons for adding or 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
Date of revision of text on the SPC:   11-May-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 08/04/2016 and displayed until 12/05/2016
Reasons for adding or 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
Date of revision of text on the SPC:   04-Apr-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 21/12/2015 and displayed until 08/04/2016
Reasons for adding or 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
Date of revision of text on the SPC:   17-Dec-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 03/11/2015 and displayed until 21/12/2015
Reasons for adding or 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
Date of revision of text on the SPC:   28-Oct-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

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 23/06/2015 and displayed until 03/11/2015
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Nivolumab