Patients
With Renal Impairment in the Clinical Studies
Galcanezumab
has been studied in migraine prevention.1-3
Patients
with renal impairment were allowed to enroll in the phase 3 studies
(Table 1). 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.4
Table
1. Patients With Renal Impairment in Phase 2 and Phase 3 Galcanezumab
Studiesa4
|
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.
a
Renal 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 and hepatic impairment on the PK of galcanezumab have not
been conducted.5
Renal
elimination of IgG monoclonal antibody is low. Similarly, IgG
monoclonal antibodies are mainly eliminated via intracellular
catabolism and hepatic impairment is not expected to influence the
clearance of galcanezumab.5
Based
on a population PK analysis, bilirubin concentration or
Cockcroft-Gault creatinine clearance (range: 24 to 308 mL/min) did
not significantly influence the apparent clearance of galcanezumab.5
No
dose adjustment is required in patients with mild to moderate renal
impairment or hepatic impairment.5
Therapeutic
Indication
Galcanezumab
is indicated for the prophylaxis of migraine in adults who have at
least 4 migraine days per month.5
The
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.5
References
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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5.
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
Glossary
CL/F
= apparent clearance
IgG
= immunoglobulin G
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.