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.
In section 4.8 (Undesirable effects) addition of Sarcoidosis and Pulmonary Fibrosis to Table 2.
Section 4.4, Special warnings and precautions for use has been updated to add the text listed below under the following headings
Other opportunistic infections
Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Malignancies and lymphoproliferative disorders
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting. Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded. Deletion of the following information Psoriasis: New-onset and Worsening Cases of new onset psoriasis, including pustular psoriasis and palmoplantar psoriasis, and cases of worsening of pre-existing psoriasis have been reported with the use of TNF-blockers, including Humira. Many of these patients were taking concomitant immunosuppressants (e.g., MTX, corticosteroids). Some of these patients required hospitalization. Most patients had improvement of their psoriasis following discontinuation of their TNF-blocker. Some patients have had recurrences of the psoriasis when they were re-challenged with a different TNF-blocker. Discontinuation of Humira should be considered for severe cases and those that do not improve or that worsen despite topical treatments. Section 4.8 Undesirable effects Leukemia has been added to Table 2 Section 10 Date of revision of text Has been updated to March 2010
Deletion of the following information
Psoriasis: New-onset and Worsening
Cases of new onset psoriasis, including pustular psoriasis and palmoplantar psoriasis, and cases of worsening of pre-existing psoriasis have been reported with the use of TNF-blockers, including Humira. Many of these patients were taking concomitant immunosuppressants (e.g., MTX, corticosteroids). Some of these patients required hospitalization. Most patients had improvement of their psoriasis following discontinuation of their TNF-blocker. Some patients have had recurrences of the psoriasis when they were re-challenged with a different TNF-blocker. Discontinuation of Humira should be considered for severe cases and those that do not improve or that worsen despite topical treatments.
Section 4.8 Undesirable effects
Leukemia has been added to Table 2
Section 10 Date of revision of text
Has been updated to March 2010
The MAH address has been changed
Section 4.4: Update to section under Infections (more information about patients with TB), Serious Infections (new infections added), other Opportunistic infections (more information on infections and signs and symptoms of infections).
Section 4.8: Update to Table 1 and Table 2, section on Neoplasms benign and section under Infections to add extrapulmonary, blastomycosis, coccidioidomycosis, pneumocystis and candidiasis and delete pneumocystis carinii pneumonia.
Section 5.1: Typographical changes
Section 6.3: Update to shelf life
Section 10: Date of revision changed to February 2009
Polyarticular juvenile idiopathic arthritis
Change to section 4.4 pf SmPC
Crohn’s disease
Humira is indicated for treatment of severe, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
For induction treatment, Humira should be given in combination with corticosteroids. Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate (see section 4.2).