Tremfya 100 mg solution for injection in pre-filled pen

  • Name:

    Tremfya 100 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Guselkumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/06/20

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Summary of Product Characteristics last updated on medicines.ie: 24/6/2020
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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Janssen Sciences Ireland

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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 24 June 2020 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

Free text change information supplied by the pharmaceutical company

2.       What you need to know before you use Tremfya

 

Serious allergic reactions, which can include the following symptoms, swollen face, lips, mouth, tongue or throat, difficulty swallowing or breathing and of hives and shortness of breath, have occurred with Tremfya (see “Serious side effects” in section 4).

 

4.         Possible side effects

 

 

            Possible serious allergic reaction (may affect up to 1 in 100 people) - the signs may include:

  •    difficulty breathing or swallowing
  •    swelling of the face, lips, tongue or throat
  •    severe itching of the skin, with a red rash or raised bumps
     
    Other side effects
    The following side effects are all mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
     
    Some side effects are very common (may affect more than 1 in 10 people):
  • upper respiratory infections
     
    Some side effects are common (may affect up to 1 in 10 people):
  • headache
  • joint pain (arthralgia)
  • diarrhoea
  • stomach flu (gastroenteritis)
  • redness, irritation or pain at the injection site
  • hives
  • fungal infection of the skin, for instance between the toes (e.g., athlete’s foot)
  • herpes simplex infections
     
    Some side effects are uncommon (may affect up to 1 in 100 people):
  • pain at the injection site
  • allergic reaction
  • skin rash

Updated on 24 June 2020 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

4.8     Undesirable effects

 

 

 

 

Table 1:                                                           List of adverse reactions

System Organ Class                         

Frequency

ADR

Infections and infestations

Very common

Upper respiratory infections

Common

Gastroenteritis

Common

Herpes simplex infections

Common

Tinea infections

Immune system disorders

Uncommon

Hypersensitivity

Uncommon

Anaphylaxis

Nervous system disorders

Common

Headache

Gastrointestinal disorders

Common

Diarrhoea

Skin and subcutaneous tissue disorders

Common

Urticaria

Uncommon

Rash

Musculoskeletal and connective tissue disorders

Common

Arthralgia

General disorders and administration site conditions

Common

Injection site erythemareactions

 

Uncommon

Injection site pain

 

 

 

Injection site reactions

In two phase III clinical studies through Week 48, 0.7% of Tremfya injections and 0.3% of placebo injections were associated with injection site reactions. Through Week 156, 0.5% of Tremfya injections were associated with injection site reactions. Adverse reactions of injection site erythema and injection site pain were the most commonly reported events of injection site reaction and were generally mild to moderate in severity; none were serious, and none led to discontinuation of Tremfya.

 

Updated on 10 December 2019 SmPC

Reasons for updating

  • 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)

Updated on 16 October 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 1 April 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 April 2019 SmPC

Reasons for updating

  • New SmPC for new product

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