When a pharmaceutical company changes an SPC or PIL, 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.
Section 4.8 has been updated to add systemic vasculitis as a rare side-effect.
Section 4.8 of the SPC: Autoimmune hepatitis has been added as a rare undesirable effect under Hepatobiliary disorders
Section 4.8 of SPC: Sarcoidosis has been added as a rare undesirable effect under Nervous system disorders.
Section 3: Pharmaceutical form expanded
Section 4.2: Updated with “Enbrel is administered by subcutaneous injection”
Section 4.4: Updated with “The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.” In the infections information
Section 4.4: Updated with “Enbrel should be used with caution in patients with a history of hepatitis C.” in the Hepatitis C information
Section 4.4: Updated with “The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.” in the Combination Therapy information
Section 4.5: Updated with “Physicians should use caution when considering combination therapy with sulfasalazine.” in the Concurrent treatment with sulfasalazine information
Section 4.8: addition of “† Please see sub-section ‘Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis’ above.” In General disorders and administration site conditions information Section 4.8: Update to information in Concurrent treatment with anakinra information. Section 5.1: Update to description of Pharmacotherapeutic group Section 5.2: Expansion of abbreviation - Enzyme-Linked Immunosorbent Assay (ELISA) Section 6.1: Addition of E number for Mannitol Section 6.3: Addition of information on in use shelf life Section 6.6: Addition of “Any unused product or waste material should be disposed of in accordance with local requirements.” Section 9: Update to date of last renewal
Section 4.8: Update to information in Concurrent treatment with anakinra information.
Section 5.1: Update to description of Pharmacotherapeutic group
Section 5.2: Expansion of abbreviation - Enzyme-Linked Immunosorbent Assay (ELISA)
Section 6.1: Addition of E number for Mannitol
Section 6.3: Addition of information on in use shelf life
Section 6.6: Addition of “Any unused product or waste material should be disposed of in accordance with local requirements.”
Section 9: Update to date of last renewal
Section 4.2 – addition of Continuous therapy beyond 24 weeks may be appropriate for some patients. To Plaque Psoriasis section Section 4.8 – addition of details from 5th double blind clinical trial and update to other clinical trial information Section 5.1 – addition of “An analysis of clinical trial data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option (intermittent or continuous). Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs.” Section 5.1 – addition of “In long-term (up to 34 months) open-label studies where Enbrel was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.” To Adults with plaque psoriasis section
Section 4.8 – addition of details from 5th double blind clinical trial and update to other clinical trial information
Section 5.1 – addition of “An analysis of clinical trial data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option (intermittent or continuous). Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs.”
Section 5.1 – addition of “In long-term (up to 34 months) open-label studies where Enbrel was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.” To Adults with plaque psoriasis section
Section 4.1 - Addition of paediatric psoriasis indication, i.e. the following wording
“Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies”
Several changes relating to this and the studies conducted are contained throughout the SPC
Section 4.4 – update with information on opportunistic infections
Section 4.8
Addition of ‘not known (could not be accurately estimated through clinical studies).’ to headings of frequency.
Addition of ‘Not known: Macrophage activation syndrome*, anti-neutrophilic cytoplasmic antibody positive vasculitis’ to Immune system disorders.
Common: Pruritus
Uncommon: Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset and pustular, primarily palms & soles)
Rare: Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme
Very rare: Toxic epidermal necrolysis
Addition of text - There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Section 6.3
Section 4.4 and Section 4.5
Addition in both sections for statement regarding interaction with abatacept
Addition of Interstitial lung disease as an undesirable effect
Section 5.1
Update to the ‘Antibodies to Enbrel’ section
Section 4.2
Addition of wording for a Patient Alert Card
Section 4.4
Addition of warnings to the SPC regarding the evaluation of patients for infections before, during and after Enbrel use, screening for TB, what action to take should TB infection be found, the risk of reactivation of hepatitis B virus, and the worsening of hepatitis C
Section 4.5
Update to the interations section of the EU Enbrel SPC to include a statement relating to an absence of interaction between etanercept and either digoxin or warfarin
Section 10
Updated website address for EMEA