Tremfya 100 mg solution for injection in pre-filled pen
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 June 2024
File name
EN-Tremfya-20240621-IE-PIL-N-042-clean-approved.pdf
Reasons for updating
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004271/N/0042: Article 61.3: Update of Tremfya Prefilled Pen IFU
Updated on 26 July 2022
File name
Tremfya-PIL-renewal-IENI-clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 26 July 2022
File name
Tremfya-SmPC-renewal-July2022 clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 March 2022
File name
Tremfya-SmPC-PSA2yr-Feb2022 clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 October 2021
File name
Tremfya-SmPC-PSA5yr-Sep2021 clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 October 2021
File name
Tremfya-PIL-PSA5yr-Sep2021 clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 17 August 2021
File name
Tremfya-PIL-PSA1yr-March2021 Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 01 April 2021
File name
Tremfya-SmPC-PSA1yr-March2021 clean.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated with PSA 1yr data
Updated on 01 April 2021
File name
IE-Tremfya-PIL-Pen-C06-November2020-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH was abbreviated
Updated on 17 February 2021
File name
IE-Tremfya-PIL-Pen-C06-November2020-clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 26 November 2020
File name
Tremfya-SmPC-C08-20November 2020-clean.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 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 November 2020
File name
IE-Tremfya-PIL-Pen-C06-November2020-clean.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 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 June 2020
File name
Tremfya-PIL-Pen-C05-CHMP14May20-clean.pdf
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
File name
Tremfya-SmPC-C07-CHMP14May20-clean.pdf
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 |
|
|
|
|
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
File name
Tremfya-SmPC-C06-06Dec19-clean.pdf
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
File name
Tremfya-SmPC-C05-CHMP19Sep19-clean.pdf
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 01 April 2019
File name
Tremyfa-PIL-Pen-C04-14Feb19-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 01 April 2019
File name
Tremfya-SmPC-C04-14Feb19-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)