Emgality® ▼ (galcanezumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Emgality Summary of Product Characteristics (SmPC)

Emgality® ▼ (galcanezumab): Use in Patients With Comorbid Coagulopathies or Clotting Disorders

The use of galcanezumab is not contra-indicated in patients with coagulopathies or clotting disorders.

Summary

  • Patients with coagulopathies or clotting disorders were not explicitly excluded from phase 3 studies.1

  • There were a small number of patients with a history of these conditions in the studies, but subgroup analyses on these conditions were not conducted.1

Information from the label

The use of galcanezumab is not contra-indicated in patients with coagulopathies or clotting disorders.2

Coagulopathies or clotting disorders are not mentionned among the adverse events listed in the summary of product characteristics.2

Exclusion Criteria

Patients with coagulopathies or clotting disorders were not explicitly excluded from the phase 3 migraine prevention studies.1,3-5

However, patients were excluded from participation in the galcanezumab clinical trials if they had a history or presence of any medical illness including, but not limited to hematologic, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicated a medical problem that would preclude study participation.1

Historical Illnesses and Preexisting Conditions in Phase 3 Studies

Phase 3 Migraine Prevention Studies

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),4,5 and

  • chronic migraine (REGAIN).3

There was a small number of patients with historical illnesses or preexisting conditions related to coagulopathies or clotting disorders in the EVOLVE-1, EVOLVE-2, and REGAIN studies: Table 1. Subgroup analyses on the baseline historical illnesses and preexisting conditions were not conducted in these patients.1

Table 1. Summary of Historical Illness or Preexisting Conditions: Coagulopathies and Clotting Disorders in Phase 3 Double-Blind, Placebo-Controlled Migraine Prevention Studies1

Preferred Term

PBO
N=1451
n (%)

GMB 120 mg
N=705
n (%)

GMB 240 mg
N=730
n (%)

Anti-factor V antibody positive

0 (0.00)

0 (0.00)

1 (0.14)

Coagulation time shortened

1 (0.07)

0 (0.00)

0 (0.00)

Coagulopathy

1 (0.07)

0 (0.00)

0 (0.00)

Congenital coagulopathy

0 (0.00)

0 (0.00)

1 (0.14)

Factor II mutation

0 (0.00)

2 (0.28)

0 (0.00)

Factor V deficiency

1 (0.07)

0 (0.00)

0 (0.00)

Factor V Leiden mutation

3 (0.21)

0 (0.00)

1 (0.14)

Factor VII deficiency

0 (0.00)

0 (0.00)

1 (0.14)

MTHFR gene mutation

0 (0.00)

2 (0.28)

1 (0.14)

MTHFR deficiency

1 (0.07)

0 (0.00)

0 (0.00)

Platelet aggregation abnormal

1 (0.07)

0 (0.00)

0 (0.00)

Von Willebrand's disease

0 (0.00)

1 (0.14)

0 (0.00)

Abbreviations: GMB = galcanezumab; MTHFR = methylenetetrahydrofolate reductase; PBO = placebo.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .2 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Laboratory Measures

Galcanezumab treatment was not associated with clinically meaningful abnormalities of chemistry or hematology in the phase 3 migraine prevention, placebo-controlled studies.1,6

Two galcanezumab-treated patients reported treatment-emergent adverse events of "bleeding time prolonged" and "platelet count increased" during double-blind treatment: Table 2. The events were mild or moderate in severity and neither patient discontinued due to the event.1

Table 2. Treatment-Emergent Adverse Events Potentially Related to Bleeding From the Double-Blind Treatment Phase of Phase 3 Studies1

Preferred term

PBO
N=1628
n (%)

GMB Alla
N=1601
n (%)

Bleeding time prolonged

0 (0.00)

1 (0.06)

Hypercoagulation

1 (0.06)

0 (0.00)

Platelet count increased

0 (0.00)

1 (0.06)

Abbreviations: GMB = galcanezumab; PBO = placebo.

a All galcanezumab doses combined.

Published Literature

The role of CGRP in platelet aggregation in rats and humans has been evaluated in the literature.7,8

References

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

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

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. 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

5. 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

6. Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine studies. BMC Neurology. 2020;20(1):25. http://dx.doi.org/10.1186/s12883-020-1609-7. Published correction appears in BMC Neurology. 2020;20(1):90. http://dx.doi.org/10.1186/s12883-020-01675-7

7. Matsumoto Y, Ueda S, Matsushita S, et al. Calcitonin gene-related peptide inhibits human platelet aggregation. Jpn Circ J. 1996;60(10):797-804. http://dx.doi.org/10.1253/jcj.60.797

8. Booth BP, Fung HL. Regulation of in vivo whole blood aggregation in rats by calcitonin gene related peptide. Can J Physiol Pharmacol. 1998;76(7-8):811-813. http://dx.doi.org/10.1139/cjpp-76-7-8-811

Glossary

CGRP = calcitonin gene-related peptide

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

PK = pharmacokinetics

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.

Date of Last Review: April 09, 2020

Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 8am - 4pm, excluding Bank Holidays

Or you can

Ask us a question Chat with Us If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a question