Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Användning hos patienter med nedsatt immunförsvar

Patienter med nedsatt immunförsvar utesluts inte från kliniska studier med galcanezumab för migränförebyggande. Undergruppsanalyser har inte genomförts.

Galcanezumab Use in Immunocompromised Patients

Exclusion Criteria in Phase 3 Double-Blind, Placebo-Controlled Migraine Prevention Clinical Trials

Immunocompromised patients were not explicitly excluded from galcanezumab migraine prevention clinical trials. Exclusion criteria included patients with a history or presence of any medical illness including, but not limited to a

  • hematologic disorder

  •  autoimmune disorder, or

  • any clinically significant laboratory abnormality, that in the judgement of the investigator indicates a medical problem that would preclude study participation.1

Patients were also excluded if, in the opinion of the investigator, the patient had other issues which would interfere with compliance with the study requirements and completion of evaluations required for the study.1

Analyses of patients who may have been immunocompromised in the phase 3 migraine prevention studies have not been conducted.

The decision to administer galcanezumab to a patient who is immunocompromised, or has a history of being immunocompromised, must be based on the clinical judgment of the prescribing healthcare practitioner after careful consideration of the patient's risk factors as well as the risks and benefits of treatment. The decision remains at the discretion of the prescribing physician.

CGRP mAbs Have no Direct Specific Immunomodulatory Effect

Antibodies, also referred to as immunoglobulins, are composed of 2 identical heavy and 2 identical light chains.2 These chains contain variable and constant sections, involved in antigen binding and biological activity, respectively. Five isotypes exist in humans including IgA, IgD, IgE, IgG, and IgM. Therapeutic mAbs are composed of IgG isotypes which are divided into 4 subclasses in order of decreasing serum concentrations including IgG1-4. IgG comprises approximately 85% of all antibodies and each IgG subclass has a different ability to activate host immune function.

Therapeutic mAbs are introduced into the host for a specific purpose.2 

Calcitonin gene-related peptide mAbs have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.2,3

Galcanezumab is a humanised IgG4 monoclonal antibody that binds CGRP thus preventing its biological activity.4

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.4

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.4

References

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

2. Silberstein S, Lenz R, Xu C. Therapeutic monoclonal antibodies: what headache specialists need to know. Headache. 2015;55(8):1171-1182. http://dx.doi.org/10.1111/head.12642

3. Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus on calcitonin gene-related peptide for prophylactic migraine therapy. Neurotherapeutics. 2018;15(2):324-335. http://dx.doi.org/10.1007/s13311-018-0622-7

4. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

Glossary

CGRP = calcitonin gene-related peptide

Ig = immunoglobulin

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

mAb = monoclonal antibody

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 2018 M04 24


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