Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

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Emgality® ▼ (galcanezumab): Effekt av kroppsvikt

Effekten av galcanezumab analyserades inte med avseende på kroppsvikt.

Detailed Information

No Dose Adjustment is Needed on the Basis of Weight

No dose adjustment is needed on the basis of age (18 to 65 years), sex, weight, race or ethnicity as there was no clinically meaningful effect of these factors on the apparent clearance or apparent volume of distribution of galcanezumab.1

Based on population PK analyses where the body weight of patients ranged from 37.1 to 141.3 kg, body weight was identified as the only statistically significant covariate on CL/F affecting the PK of galcanezumab, with a less than proportional increase in CL/F with increasing body weight. However, in the context of PK variability, it was concluded that

  • no dose adjustment is needed on the basis of weight and

  • patients at the 5th (52 kg) and 95th (105 kg) percentiles of body weight would not be expected to have different efficacy profiles.2

Baseline Weight and BMI in Clinical Pharmacology Studies

The galcanezumab clinical pharmacology studies included 446 healthy subjects, of whom 419 received at least one dose of galcanezumab (1 to 600 mg). Baseline body weight and BMI for subjects in those studies are provided inBaseline Weight and BMI in Clinical Pharmacology Studies .2

Table 1. Baseline Weight and Body Mass Index in Galcanezumab Clinical Pharmacology Studies2


Weight
kg

Body Mass Index
kg/m
2

Mean

78.31

26.86

SD

14.42

4.11

Median

78.45

26.54

Minimum - Maximum

40.7 - 119.0

18.3 - 35.0

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

References

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

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

Glossary

BMI = body mass index

CL/F = apparent clearance

PK = pharmacokinetics

V/F = apparent volume of distribution

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 2018 M04 02


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