Otezla 10mg, 20mg, 30mg
*Company:
Amgen Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 30 October 2024
File name
en_otezla_approved_smpc_v29.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to restricted prescription (C)
Updated on 30 October 2024
File name
ie_xi_Otezla_approved_pil_n40.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 29 October 2024
File name
XI_IE_otezla_approved_smpc_peadsindication.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 6.5 - 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 restricted prescription (C)
Updated on 29 October 2024
File name
XI_IE_otezla_approved_pil_peadsindication.pdf
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 2 - pregnancy, breast feeding and fertility
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to how the medicine works
Updated on 03 February 2023
File name
en_otezla_approved_smpc_v29.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to restricted prescription (C)
Updated on 21 July 2022
File name
ie_xi_Otezla_approved_pil_n40.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 14 July 2021
File name
xiie_otezla_approved_pil_v37.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The side effects migraine and tension headache have been moved from very common to common to align with the Summary of Product Characteristics.
The date of revision is July 2021
Updated on 11 May 2021
File name
iexi_otezla_approved_pil_v34.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Removal of Celgene Distribution B.V as a manufacturer for Otezla
Updated on 01 July 2020
File name
en_otezla_approved_pil_v33.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 09 April 2020
File name
en_otezla_approved_pil_v29.pdf
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
Free text change information supplied by the pharmaceutical company
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PIL (new text in bold/text that has been moved) |
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Section 1. What Otezla is and what it is used for |
…Behçet’s disease (BD) -to treat the mouth ulcers which is a common problem for people with this illness.
…What Behçet’s disease is Behçet’s disease is a rare type of inflammatory disease which affects many parts of the body. The most common problem is mouth ulcers.
…In Behçet’s disease, treatment with Otezlareduces the number of mouth ulcers and can stop them completely. It can also reduce theassociated pain. |
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Section 2 Warnings and Precautions |
Depression and suicidal thoughts Tell your doctor before starting Otezla if you have depression which is getting worse with thoughts of suicide.
You or your caregiver should also tell your doctor straight away of any changes in behaviour or mood, feelings of depression and of any suicidal thoughts you may have after taking Otezla.
Severe kidney problems If you have severe kidney problems, your dose will be different –see section 3.
If you are underweight Talk to your doctor while taking Otezla if you lose weight without meaning to.
Gut problems If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor. |
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Section 4 Side Effects |
…Serious side effects –depression and suicidal thoughts
…Tell your doctor straight away about any changes in behaviour or mood, feelings of depression, thoughts of suicide or suicidal behaviour (this is uncommon).
…Very common side effects (may affect more than 1 in 10 people)
…If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting. If your gut problems become severe, you should talk to your doctor. |
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Date of revision of the text |
April 2020 |
Updated on 09 April 2020
File name
en_otezla_approved_smpc_v29.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
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New text in bold/text moved
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SPC |
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Section 4.1 Therapeutic indications
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Behçet’s disease
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy. |
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Section 4.2 Posolgy and method of administration
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During pivotal trials the greatest improvement was observed within the first 24weeks of treatment for PsA and PSOR and within the first 12 weeks of treatment for BD. If a patient shows no evidence of therapeutic benefit after this time period, treatment should be reconsidered. The patient's response to treatment should be evaluated on a regular basis. |
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Section 4.8 Undesirable Effects |
….The most commonly reported adverse drug reactions with apremilast in BD are diarrhoea (41.3%), nausea (19.2%), headache (14.4%), upper respiratory tract infection (11.5%), upper abdominal pain (8.7%), vomiting (8.7%) and back pain (7.7%) and are mostly mild to moderate in severity.
The gastrointestinal adverse reactions generally occurred within the first 2 weeks of treatment and usually resolved within 4 weeks.
Table 2 Summary of adverse reactions in psoriatic arthritis (PsA), psoriasis (PSOR) and Behçet’s disease (BD)
Bodyweight loss …… The mean observed weight loss in BD patients treated with apremilast for 52 weeks was 0.52kg. A total of 11.8% of patients receiving apremilast had observed weight loss between 5-10% while 3.8% of the patients receiving apremilast had observed weight loss greater than 10%. None of these patients had overt clinical consequences from weight loss. None of the patients discontinued the study due to adverse reaction of weight decreased. |
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Section 5.1 Pharmcodynamic properties
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Pharmacodynamic effects … In clinical studies in patients with Behçet Disease treated with apremilast, there was a significant positive association between the change in plasma TNF-alpha and clinical efficacy as measured by the number of oral ulcers.
Behçet’s disease – addition of data from the RELIEF study. |
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Section 10 Date of revision of the text |
April 2020 |
Updated on 06 February 2020
File name
en_otezla_approved_spc_MAHtrans.pdf
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 7 of the SPC "Marketing Authorisation Holder" has been updated from Celgene to Amgen. The address has consequentally also been updated in this section.
Section 10 of the SPC "Date of revision of the text" has been updated to January 2020
Updated on 06 February 2020
File name
en_otezla_approved_pil_MAHtrans_ie.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The Marketing Authorisation Holder for Otezla has changed from Celgene to Amgen.
Updated on 25 October 2019
File name
ie-spc-18Nov19.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
In section 6.3, the shelf life has changed from 2 to 3 years
Updated on 06 September 2019
File name
OTEZLA PIL IRE V12 23Aug2019.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
- Improved presentation of PIL
Updated on 06 September 2019
File name
OTEZLA SPC IRE V12 23Aug2019.pdf
Reasons for updating
- Addition of joint SPC covering all presentations
- Change to section 6.3 - Shelf life
- 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
- Change to improve clarity and readability
Legal category:Product subject to restricted prescription (C)
Updated on 09 August 2019
File name
Otezla IRE PIL v11 31July2019.pdf
Reasons for updating
- Change to other sources of information section
Updated on 05 April 2019
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 20 March 2019
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 January 2019
File name
IE Clean SPC 10 20 30.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 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update section 4.8 of the SmPC to add the adverse drug reactions angioedema with a frequency unknown and urticaria with an uncommon frequency.
Update of sections 4.2 & 5.1 of the SmPC to include 5 year CSRs data from the PALACE and ESTEEM program
Updated on 03 January 2019
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 03 January 2019
File name
IE Clean SPC 10 20 30.pdf
Reasons for updating
- 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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Update section 4.8 of the SmPC and section 4 of the PIL to add the adverse drug reactions angioedema with a frequency unknown and urticaria with an uncommon frequency.
Updated on 14 August 2018
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 August 2018
File name
IE 10 20 30 Clean SPC.pdf
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Change the MAH name and address from Celgene Europe Limited, 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom to Celgene Europe BV, Winthontlaan 6 N, 3526 KV Utrecht, Netherlands.
Updated on 09 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 09 January 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 05 January 2018
File name
PIL_16207_882.pdf
Reasons for updating
- New PIL for new product
Updated on 05 January 2018
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 05 January 2017
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 21 December 2016
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 19 December 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 22 July 2016
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 20 July 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 February 2016
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
This change impacts section 6.3 of the SPC, changing the shelf-life from 21 to 24 months and there are also a few typographical changes throughout the SPC.
Updated on 12 February 2016
Reasons for updating
- Change to, or new use for medicine
Updated on 11 February 2016
Reasons for updating
- Change to, or new use for medicine
- PIL retired pending re-submission
Updated on 23 January 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 20 January 2015
Reasons for updating
- New PIL for new product