Otezla 10mg, 20mg, 30mg

  • Name:

    Otezla 10mg, 20mg, 30mg

  • Company:
    info
  • Active Ingredients:

    Apremilast

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/07/20

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Summary of Product Characteristics last updated on medicines.ie: 9/4/2020

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Amgen Ireland Ltd

Amgen Ltd

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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 1 July 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 9 April 2020 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

Free text change information supplied by the pharmaceutical company

PIL (new text in bold/text that has been moved)

 

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.

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.

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)

  • Diarrhoea
  • Nausea
  • headaches, migraines or tension headaches
  • upper respiratory tract infections such as cold, runny nose, sinus infection

 

…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.

Date of revision of the text

April 2020

Updated on 9 April 2020 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

New text in bold/text moved

 

SPC

 

Section 4.1 Therapeutic indications

 

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.

Section 4.2 Posolgy and method of administration

 

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.

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)

  • Upper respiratory tract infection and headache have been added as common adverse events in Behçet’s disease in Table 2

 

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.

Section 5.1 Pharmcodynamic properties

 

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.

Section 10 Date of revision of the text

April 2020

Updated on 6 February 2020 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 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 6 February 2020 PIL

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 SmPC

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 6 September 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle
  • Improved presentation of PIL

Updated on 6 September 2019 SmPC

Reasons for updating

  • Addition of joint SmPC 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 9 August 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 5 April 2019 PIL

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 PIL

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 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 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 3 January 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 3 January 2019 SmPC

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 PIL

Reasons for updating

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

Updated on 14 August 2018 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 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 9 January 2018 SmPC

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

Addition of new language on diarrhoea, nausea, and vomiting in section 4.4 & 4.8

Updated on 9 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 5 January 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 5 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 January 2017 SmPC

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

Revision of the text date updated

Updated on 4 January 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 21 December 2016 SmPC

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

Update to sections 4.4 and 4.8. Addition of Psychiatric disorders (suicidal ideation and behaviour, and depression).

Updated on 19 December 2016 PIL

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 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to sections 4.8 and 10.

Updated on 20 July 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 February 2016 SmPC

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 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 11 February 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • PIL retired pending re-submission

Updated on 23 January 2015 SmPC

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

None provided

Updated on 20 January 2015 PIL

Reasons for updating

  • New PIL for new product