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Emgality ® (galkanezumab)
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of
chronic migraine (REGAIN),3 and
episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).4
Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine (CGAJ).5
Exclusion Criteria in Phase 3 Double-Blind, Placebo-Controlled Migraine Prevention Clinical Trials
Immunocompromised patients were not explicitly excluded from phase 3 galcanezumab clinical trials for migraine prevention.6
However, patients were excluded if they had a history or presence of any medical illness including, but not limited to a hematologic disorder, autoimmune disorder, or any clinically significant laboratory abnormality or medical condition, that in the judgment of the investigator indicated a medical problem that would preclude study participation.6
Patients could also be excluded if, in the opinion of the investigator, the patient had other issues which would interfere with their reliability to
be compliant with the study requirements
follow study procedures, or
complete evaluations and visits required for the study.6
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.7 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.7
The CGRP mAbs have been engineered to bind to either the CGRP peptide or receptor with high specificity and minimized interaction with the immune system.7-9 As CGRP is not an immune system target, CGRP mAbs have no direct immunomodulatory effect.
Galcanezumab is a humanised IgG4 monoclonal antibody that binds CGRP thus preventing its biological activity.10
Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.10
The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.10
1. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212
2. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543
3. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640
4. Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9
5. Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2
7. 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
8. 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
9. Levin M, Silberstein SD, Gilbert R, et al. Basic considerations for the use of monoclonal antibodies in migraine. Headache. 2018;58(10):1689-1696. http://dx.doi.org/10.1111/head.13439
CGRP = calcitonin gene-related peptide
Ig = immunoglobulin
IgA = immunoglobulin A
IgD = immunoglobulin D
IgE = immunoglobulin E
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 2021 M01 15