Olumiant 2 mg and 4 mg Film-Coated Tablets

  • Name:

    Olumiant 2 mg and 4 mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Baricitinib

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/19

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Summary of Product Characteristics last updated on medicines.ie: 26/11/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 26 November 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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 26 November 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 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     Special warnings and precautions for use

 

Venous Thromboembolism

 

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib. Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation. If clinical features of DVT/PE occur, Olumiant treatment should be discontinued temporarily interrupted and patients should be evaluated promptly, followed by appropriate treatment.

 

Hypersensitivity

 

In post-marketing experience, cases of drug hypersensitivity associated with baricitinib administration have been reported. If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.

 

 

4.8     Undesirable effects

 

System Organ Class

Very common

Common

Uncommon

Infections and infestations

Upper respiratory tract infectionsa

Herpes zoster,

Herpes simplexb

Gastroenteritis

Urinary tract infections

Pneumonia

 

Blood and lymphatic system disorders

 

Thrombocytosis >600 x 109 cells/Lc

Neutropaenia <1 x 109 cells/Lc

 

Metabolism and nutrition disorders

Hypercholesterolaemiac

 

Hypertriglyceridaemiac

Gastrointestinal disorders

 

Nausea

 

Hepatobiliary disorders

 

ALT increased ≥3 x ULNc

AST increased ≥3 x ULNc

Skin and subcutaneous tissue disorders

 

Rash

Acne

Immune

disorders

 

 

Swelling of the face,

Urticaria

Respiratory,

thoracic,

mediastinal

disorders

 

 

Pulmonary embolism

Vascular

disorders

 

 

Deep Vein Thrombosis

Investigations

 

 

Weight increased

Creatine phosphokinase increased >5 x ULNc

 

 

Reporting of suspected adverse reactions

[…] Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie, or

 

10.     DATE OF REVISION OF THE TEXT

 

22 November 2019 27 September 2018

 

 

LEGAL CATEGORY

 

OL76M

Updated on 2 October 2018 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

3 2 years

 10.       DATE OF REVISION OF THE TEXT

  04 September 2018 27 September 2018

Updated on 10 September 2018 PIL

Reasons for updating

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

Updated on 10 September 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SmPC

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

Free text change information supplied by the pharmaceutical company

4.8          Undesirable effects 

Tabulated list of adverse reactions

 

System Organ Class

Very common

Common

Uncommon

Infections and infestations

Upper respiratory tract infectionsa

Herpes zoster,

Herpes simplexb

Gastroenteritis

Urinary tract infections

Pneumonia

 

 

 

 

10.       DATE OF REVISION OF THE TEXT

25 January 201804 September 2018

 

Updated on 21 February 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Added (underline) deleted (strikethrough)

 

4.4          Special warnings and precautions for use

 

Vaccination

No data are available on the response to vaccination with live or inactivated vaccines in patients receiving baricitinib. Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended. International treatment guidelines on vaccination in rheumatoid arthritis patients should be followed when varicella zoster vaccination is considered prior to treatment with Olumiant. Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.

5.1          Pharmacodynamic properties

 

Vaccine study

The influence of baricitinib on the humoral response to non-live vaccines was evaluated in 106  RA patients under stable treatment with baricitinib 2 or 4   mg, receiving inactivated pneumococcal or tetanus vaccination. The majority of these patients (n  =  94) were co-treated with methotrexate. For the total population, pneumococcal vaccination resulted in a satisfactory IgG immune response in 68.0  % (95  %  CI: 58.4  %, 76.2  %) of the patients.  In 43.1  % (95  %  CI: 34.0  %, 52.8  %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.

 

 

10.       DATE OF REVISION OF THE TEXT

 

             9 November 201725 January 2018

                                                                                                                                    OL3MOL4M

Updated on 21 February 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 15 December 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Changes

 

Added (underline) deleted (strikethrough)

 

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Transporters

In vitro, baricitinib did inhibitis not an inhibitor of OAT1, OAT2, OAT3, organic cationic transporter (OCT) 1, (OCT)2, OATP1B1, OATP1B3, BCRP, and MATE1 and MATE2 K at clinically relevant concentrations. Clinically meaningful changes in the PK of medicinal products that are substrates for these transporters are unlikely, with the exception of OCT1 substrates. It cannot be ruled out that bBaricitinib is may be a clinically relevant inhibitor of OCT1 inhibitor, however there are currently no known selective OCT1 substrates for which clinically significant interactions might be predicted. In clinical pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters).

 

 

5.2       Pharmacokinetic properties

 

Biotransformation

 

Baricitinib metabolism is mediated by CYP3A4, with less than 10 % of the dose identified as undergoing biotransformation. No metabolites were quantifiable in plasma. In a clinical pharmacology study, baricitinib was excreted predominately as the unchanged active substance in urine (69 %) and faeces (15 %) and only 4 minor oxidative metabolites were identified (3 in urine; 1 in faeces) constituting approximately 5 % and 1 % of the dose, respectively. In vitro, baricitinib is a substrate for CYP3A4, OAT3, Pgp, BCRP and MATE2‑K, and an may be a clinically relevant inhibitor of the transporters OAT1, OAT3, OCT1, OCT2, OATP1B3, BCRP, MATE1 and MATE2‑K, but clinically meaningful interactions with medicines that are substrates for these transporters are unlikely, with the exception of OCT1 substrates. (see section 4.5). Baricitinib is not an inhibitor of the transporters OAT1, OAT2, OAT3, OCT2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations.

 

10.       DATE OF REVISION OF THE TEXT

 

             20 July 20179 November 2017

                                                                                                                                    OL2MOL3M

Updated on 8 December 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 8 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 August 2017 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

OLUMIANT® (baricitinib)

 

 

1.         NAME OF THE MEDICINAL PRODUCT

 

Olumiant] 2 mg film-coated tablets

 

 

4.4       Special warnings and precautions for use

 

                         Venous Thromboembolism

Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving baricitinib. Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation.If clinical features of DVT/PE occur, Olumiant treatment should be temporarily interrupted and patients should be evaluated promptly, followed by appropriate treatment.

 

 

4.8       Undesirable effects

 

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 Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517; website: www.hpra.ie; e-mail: medsafety@hpra.ie, or United Kingdom: Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

 

10.       DATE OF REVISION OF THE TEXT

 

20 July 2017

 

 

 

]OLUMIANT (Baricitinib) is a trademark of Eli Lilly and Company.                                                                              OL12M

Updated on 16 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 6 June 2017 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

Updated on 1 June 2017 PIL

Reasons for updating

  • New PIL for new product