Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Potentiella läkemedelsinteraktioner med terapeutiska antikroppar

Baserat på PK-egenskaperna hos galcanezumab förväntas inte läkemedelsinteraktioner. Därför genomfördes inga läkemedelsinteraktionsstudier. Samtidig användning av terapeutiska antikroppar tilläts inte i fas 3-studierna.

Additional Information Regarding Potential Drug Interactions With Therapeutic Antibodies

Galcanezumab has been studied in migraine prevention.1-3

Patients who are taking, or are expected to take, therapeutic antibodies during the course of the galcanezumab phase 3 studies were excluded from participating.1-3.Examples of therapeutic antibodies included adalimumab, infliximab, trastuzumab, and bevacizumab.4

Prior use of therapeutic antibodies, other than antibodies to CGRP or its receptor, was allowed if

  • that use was more than 12 months prior to the pre-randomization visit in the migraine prevention studies,1-3 

Pharmacokinetic Characteristics

As a humanised IgG4 monoclonal antibody, galcanezumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.5

As such, it is not expected to

  • inhibit metabolic or induce enzymatic pathways

  • be metabolized by the cytochrome P450 families of drug-metabolizing enzymes, and

  • produce any active metabolites.4,6

Drug Interactions Studies Were Not Conducted

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.5

There are no known interactions for galcanezumab, drug-drug or otherwise.4

References

1. 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

2. 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

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.

6. Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-2668. https://doi.org/10.1002/jps.20178

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.

Datum fӧr senaste ӧversyn 2020 M01 15


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss