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): Läkemedelsinteraktion med preventivmedel

Läkemedelsinteraktionsstudier har inte genomförts. En genomgång av de placebokontrollerade säkerhetsuppgifterna vid migrän visade liknande säkerhet hos galcanezumab-behandlade patienter som fick ett oralt preventivmedel och de som inte var det.

Drug Interactions

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.1

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.1

There are no known interactions for galcanezumab, drug-drug or otherwise.2

Contraceptive Use in Clinical Trials

Galcanezumab has been studied in migraine prevention.3-5 The safety of concomitant oral contraceptive use was evaluated in the migraine population and is summarized below.

Women and men with reproductive potential were required to use a reliable method of birth control

  • during the clinical studies for migraine prevention and

  • for 5 months following the final dose of investigational product.2

Migraine Prevention Population

A review of the safety of concomitant oral contraceptive use with galcanezumab was conducted. The review was based on a pooled analysis set of the double-blind treatment phases for the phase 2 and phase 3 placebo-controlled migraine prevention studies.3-6

This pooled analysis included a total of 2853 adult female patients, of which 1411 patients received doses of galcanezumab (120 mg or 240 mg) administered subcutaneously.2

The definition of oral contraceptive use is available in the Appendix.

This safety analysis reviewed, by oral contraceptive use, the

  • frequency of SAE and discontinuation due to AEs 

  • EAIRs of TEAEs 

  • EAIRs of CV TEAEs, and

  • EAIRs of categorial changes in blood pressure.2

These outcomes are summarized separately below.

Serious Adverse Events and Discontinuations due to Adverse Events

There were no clinically meaningful differences in the incidence of SAEs between galcanezumab-treated patients

  • and placebo-treated patients who were using oral contraceptives, and

  • who were using oral contraceptives compared with those who were not.2 

Galcanezumab-treated patients receiving oral contraceptives had a higher incidence of discontinuations due to AEs (3.5%) compared to the non-oral contraceptive users (1.9%).2

Upon further review of the data, the reasons for discontinuation due to AEs in the galcanezumab-treated patients taking oral contraceptives were generally similar to the events in the non-oral contraceptive user group: nasopharyngitis (2), injection site reaction (2), depression (1), rash pruritic (1), weight increased (1), and migraine (1).2

There was no obvious pattern to the reasons for discontinuation due to AEs, and the events resulting in discontinuations in the galcanezumab-treated patients receiving oral contraceptives were all non-serious.2 There was no significant treatment-by-oral contraceptive subgroup interaction.

These findings are summarized in Table 1.

Table 1. Summarya of SAEs and DCAEs by Oral Contraceptive Use2

 

OC Use

Placebo
n/N (%)

GMB Pooled
n/N (%)

Treatment-by-Subgroup
P-Value

SAE

Yes

2/205 (1.0)

1/226 (0.4)

.361

No

12/1237 (1.0)

17/1185 (1.4)

DCAE

Yes

2/205 (1.0)

8/226 (3.5)

.165

No

21/1237 (1.7)

22/1185 (1.9)

Abbreviations: DCAE = discontinuation due to adverse event; GMB Pooled = galcanezumab 120 mg and 240 mg pooled; N= number of patients in the analysis population; n = number of patients in specific category; OC = oral contraceptive; SAE = serious adverse event.

a Analysis of the double-blind treatment phase of the phase 2 and phase 3 migraine prevention studies.

Exposure-Adjusted Incidence Rates by Oral Contraceptive Use

EAIRs are a measure of whether TEAEs occur at an increased frequency with increased treatment duration.2

No significant treatment-by-oral contraceptive subgroup interaction in EAIRs between galcanezumab-treated patients who used oral contraceptives compared with those who did not for TEAEs, CV TEAEs, nor categorical changes in blood pressure.

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.

3. 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

4. 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

5. 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

6. Skljarevski V, Oakes TM, Zhang Q, et al. Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol. 2018;75(2):187-193. http://dx.doi.org/10.1001/jamaneurol.2017.3859

Glossary

AE = adverse event

CV = cardiovascular

EAIR = exposure-adjusted incidence rate

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

PK = pharmacokinetics

TEAE = treatment-emergent adverse event

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.

Appendix

Oral contraceptive use was defined using the baseline or double-blind treatment phases and was identified using the medication name and Anatomical Therapeutic Chemical code, with the route of administration being oral.2 The oral hormone contraceptive preparations identified were 

  • progestogens and oestrogens fixed combinations

  • progestogens

  • antiandrogens and oestrogens, and

  • oestrogens.2

Datum fӧr senaste ӧversyn 2020 M01 09


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