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.