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Taltz ® (ixekizumab) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
According to the study protocols for psoriasis and psoriatic arthritis, if a patient experienced an acute allergic/hypersensitivity reaction after injection of investigational product, consideration for any premedication for future injections was agreed upon between the investigator and sponsor and/or its designee.
Medications considered appropriate for premedication included but were not restricted to acetaminophen/paracetamol up to 1000 mg and antihistamines (for example, oral diphenhydramine 50 mg), given 30 to 60 minutes prior to investigational product injection.
Patients were permitted to self-premedicate at home prior to administration of investigational product as directed by the investigator.1
Examples of potential allergic/hypersensitivity reactions that might merit premedication included
mild-to-moderate skin rashes
mild-to-moderate generalized pruritus or urticaria, and
Please note that ixekizumab is contraindicated with serious hypersensitivity to the active substance or to any of the excipients.3
Premedication in Clinical Trials
Of patients experiencing an ISR during the induction period of UNCOVER-1, -2, and -3, one patient who received ixekizumab used premedication for ISR when taking future injections.2
No patients who received ixekizumab during the 24-week double-blind treatment periods of SPIRIT-P1 and SPIRIT-P2 used premedication for ISR with future injections.2
Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.3
Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.3
1. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
ISR = injection site reaction
▼ 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.
Datum fӧr senaste ӧversyn 2019 M05 06