Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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

Dosjusteringar krävs inte hos patienter med nedsatt njurfunktion.

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.

Datum fӧr senaste ӧversyn 2019 M02 18


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