Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Taltz® ▼ (ixekizumab): Förmedicinering inför injektionen

Beslutet om en person ska förmedicineras bör fattas av ordinerande läkare.

Protocols for Premedication in the Clinical Trials

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

  • mild-to-moderate ISRs (eg, injection-site erythema, injection-site pruritus, etc).1,2

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

Therapeutic Indications

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

References

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

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

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


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