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): Information om missad eller försenad dos vid migränförebyggande

Administrera en missad dos så snart som möjligt.

Management of Missed or Delayed Doses

Patients should be instructed to inject a missed dose as soon as possible and then resume monthly dosing.1

Do not take a double dose to make up for forgotten injection.2

 If you have forgotten to inject a dose of Emgality, inject the missed dose as soon as possible and then inject the next dose after a month from that date.2

Recommended Dose for Migraine Prevention

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

There is no recommendation to repeat a loading dose of galcanezumab after missed doses. The PK profile of galcanezumab enables some flexibility with regard to when doses are administered. Prolonged dosing delays may require some time to re-establish steady-state galcanezumab plasma concentrations. Please consider the t1/2 and PK characteristics of galcanezumab to determine whether a repeat loading dose is warranted.

Dose Administration in Phase 3 Migraine Prevention Studies

Galcanezumab has been studied in phase 3 randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),3,4 and

  • chronic migraine (REGAIN).5

In the phase 3 clinical trials, injections were allowed to be administered within ±2 days of the scheduled visit.6

Management of Missed or Incomplete Loading Dose

A 240 mg loading dose for the galcanezumab 120 mg monthly maintenance dose allows for concentrations to reach steady-state by month 1.6

In the phase 2 dose-ranging study, a loading dose was not implemented.7 In that study, the galcanezumab 120 mg dose did not achieve statistically significant separation from placebo in mean change from baseline migraine headache days until month 3.

Pharmacokinetic modeling of phase 3 data confirmed that the 240 mg loading dose achieved steady-state galcanezumab concentrations by month 1 for the 120 mg/month dose regimen.6

In the event of a missed or incomplete loading dose, complete the loading dose as soon as possible. Then continue with the monthly maintenance dose from the date of last dose.

Pharmacokinetic Considerations

The galcanezumab steady-state Cmax (Cmax, ss) at monthly doses of 120 mg is achieved after the 240 mg loading dose.1

The time to Cmax was 5 days postdose.1

The half life of galcanezumab was 27 days.1

Steady-state concentrations are achieved by month 1 for the 120-mg monthly dose with a 240-mg loading dose.6 

Therapeutic Indication

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

References

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

2. Emgality [package leaflet]. Eli Lilly Nederland B.V., The Netherlands.

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

7. 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

PK = pharmacokinetics

t1/2 = elimination half-life

Tmax = time of maximum observed drug concentration

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 2017 M10 18

Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss