Emgality® (Galcanezumab)

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Galcanezumab: Use in Patients With Renal Impairment

Dosage adjustments are not required in patients with renal impairment.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country. 

Patients With Renal Impairment in Migraine and Cluster Headache Studies

Galcanezumab has been studied in migraine prevention and cluster headache.1-5

Patients with renal impairment were allowed to enroll in the phase 3 migraine prevention and cluster headache studies (Patients With Renal Impairment in Phase 2 and Phase 3 Galcanezumab Studies). A creatinine clearance analysis was done at baseline to understand the level of renal impairment in patients enrolling in phase 3 studies. However, further subgroup analyses by renal function were not conducted because the PK of galcanezumab was not impacted by renal function.6

Patients With Renal Impairment in Phase 2 and Phase 3 Galcanezumab Studiesa6

Renal Impairment

Number of Patients 

Patient Time (years) 

Mild (60 mL/min ≤ CGCL <90 mL/min)

643

382.1

Moderate (30 mL/min ≤ CGCL <60 mL/min)

35

21.7

Severe (<30 mL/min)

1

0.5

Total

679

404.3

Abbreviation: CGCL = Cockcroft-Gault creatinine clearance.

aRenal disease risk group is from all phase 2 and phase 3 galcanezumab clinical trials. 

Dosage Adjustments Are Not Required in Patients With Renal Impairment

Specific clinical pharmacology studies to evaluate the effects of renal impairment on the PK of galcanezumab were not conducted.6

Renal elimination of IgG monoclonal antibodies is low. Based on population PK analyses, creatinine clearance did not significantly influence the CL/F of galcanezumab at a range of

  • 24 to 308 mL/min in patients with migraine, or
  • 41 to 271 mL/min in patients with cluster headache.6

References

1Stauffer 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

2Skljarevski 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

3Detke 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

4Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440

5Dodick DW, Goadsby PJ, Lucas C, et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double-blind treatment. Cephalalgia. 2020;40(9):935-948. http://dx.doi.org/10.1177/0333102420905321

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

CL/F = apparent clearance

IgG = immunoglobulin G

PK = pharmacokinetics

Fecha de la última revisión: 2019 M02 18


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