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): Användning av samtidiga läkemedel i fas 3-migränförebyggande studier

Vissa samtidiga läkemedel tilläts i kliniska prövningar, inklusive några med specifika begränsningar.

Concomitant Medications in Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies for Migraine Prevention

Medications Allowed for the Acute Treatment of Migraine Headaches or Other Pain or Injury

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),1,2 and

  • chronic migraine (REGAIN).3

The study phases that are referenced are illustrated in Figure 1 and Figure 2.

Figure 1.  EVOLVE-1 and EVOLVE-2 Study Design4,5

Abbreviation: SP = study period.

Patients randomized to the 120-mg dose received a loading dose of 240 mg at the first injection only (Visit 3).

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .6 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Figure 2. REGAIN Study Design7

Abbreviations: OLE = open-label extension; SP = study period.

* Eligibility period determined between a minimum of 30 days and a maximum of 40 days.

a Patients randomized to the 120-mg dose received a loading dose of 240 mg at the first injection only (Visit 3).
b
At Visit 7, all patients who entered the open-label extension received galcanezumab at a dose of 240 mg.
c
At Visit 8, all patients received galcanezumab at a dose of 120 mg.
d
Starting at Visit 9, dosing was flexible (galcanezumab 120 mg or 240 mg) at the discretion of the investigator.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.6 Any other dose described here is not approved and therefore is not recommended.

Medications for the acute treatment of migraine headaches or other pain or injury were allowed during phase 3 migraine prevention studies.8 These included

  • acetaminophen (paracetamol)

  • NSAIDs

  • triptans

  • ergotamine and derivatives

  • isometheptene mucate

  • dichloralphenazone and acetaminophen combination (Midrin), or

  • combinations thereof.8,9

Medications allowed with restrictions included

  • opioid and barbiturates no more than 3 days/month, and

  • single dose of injectable steroids only once during the study, in an emergency setting.8

Medications Allowed for Migraine Prevention

In general, migraine preventive treatments were not allowed at any time in the episodic migraine studies from the start of the prospective lead-in phase through the end of the double-blind treatment period.8 However, in the chronic migraine prevention study, up to 1/3 of enrolled patients were allowed to continue migraine prophylactic treatment with either topiramate or propranolol if 

  • the patient had been on a stable dose for at least 2 months prior to baseline, and

  • dosing remained stable throughout the double-blind treatment period.8,9

In each study, patients discontinued botulinum toxin A or B in the head or neck area at least 4 months prior to baseline.8

Concomitant Medications and Therapies Allowed and Not Allowed

As shown inTable 1 , medications or classes of medications, herbal remedies, and physical treatments (such as electrical stimulation or physical therapy on the head or neck area) with potential for impact on migraine headache outcome were disallowed.8 Otherwise, concomitant medications without potential impact on migraine were permitted although some required stabilization prior to study entry in order to decrease potential confounding factors. Patients with prior exposure to therapeutic antibodies were excluded.8

Table 1. Treatments Allowed and Treatments Not Allowed as Concomitant Therapy During the Treatment Phase in Galcanezumab Phase 3, Double-Blind, Placebo-Controlled Clinical Studies 8

Allowed (restrictions noted)

Not Allowed for Any Reason or Indication

Acetaminophen (paracetamol)

NSAIDs

Triptans

Ergotamine and derivatives

Isometheptene mucate, dichloralphenazone and acetaminophen combination (Midrin), or 

combinations thereof. a

Acetazolamide

Acupuncture

Anticonvulsants/Antiepileptics b

Antipsychotics

Beta-blockers c

Botulinum toxin applied to head/neck area

Cannabis / Cannabinoids

Chiropractic procedures, physiotherapy, TENS or other electric devices on head and neck

Corticosteroids for oral use

Flunarizine

Herbals with anti-inflammatory effect (feverfew, willow bark, petasites/butterbur), herbals with sympathomimetic effect (ma huang, ephedra, bitter orange, synephrine) and herbals with catecholamine transmitter reuptake inhibition (St John’s Wort)

MAOIs

Memantine

Serotonin 5HT2a/2c antagonists, eg: trazodone, nefazodone

Stimulants (prescription strength), eg: methylphenidate, dextroamphetamine, mixed amphetamine salts

Tizanidine

Therapeutic antibodies de

TCAs

Triptans for prevention of menstrual related migraine

Venlafaxine

Verapamil

Opioid and barbiturates f

Single dose of injectable steroids g

ACE inhibitors
ARBs
Benzodiazepines
Bupropion
Calcium-channel blockers (except verapamil and flunarizine)
Clonidine
Guanfacine
Mirtazapine
SSRIs/NRIs/SNRIs (other than venlafaxine)
Use of electric devices (ie, TENS), physiotherapy, chiropractic procedures on low back and extremities h


Beta-blockers, ophthalmic
Cyclandelate
Cyproheptadine
Melatonin i

Abbreviations: ACE = angiotensin converting enzyme; ARB = angiotensin receptor blocker; CGRP = calcitonin gene-related peptide; MAOI = monamine oxidase inhibitor; NRI = norepinephrine reuptake inhibitor;  NSAIDS = nonsteroidal anti-inflammatory drug; SP = study period; SNRI = serotonin norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; TENS = transcutaneous electrical nerve stimulation.

a Medications allowed for the acute treatment of migraine headaches or other pain or injury.

b In the chronic migraine prevention study (REGAIN), up to 1/3 of enrolled patients were allowed to continue migraine prophylactic treatment with topiramate if  the patient had been on a stable dose for at least 2 months prior to baseline, and dosing remained stable throughout the double-blind treatment period.

c In the chronic migraine prevention study (REGAIN), up to 1/3 of enrolled patients were allowed to continue migraine prophylactic treatment with propranolol if  the patient had been on a stable dose for at least 2 months prior to baseline, and dosing remained stable throughout the double-blind treatment period.

d Examples of therapeutic antibodies include adalimumab, infliximab, trastuzumab, bevacizumab. Patients who are taking, or are expected to take, therapeutic antibodies during the course of the study were excluded. Patients who have previously completed or withdrawn from studies investigating galcanezumab or other CGRP antibodies were also excluded.

e Prior use of therapeutic antibodies, other than antibodies to CGRP or its receptor, is allowed if that use was more than 12 months prior to Visit 2.

f Allowed for the acute treatment of migraine headaches or other pain or injury, no more than 3 days/month during SP II, III, and IV (SP IV = REGAIN open-label extension)

g Allowed only once during the study for the acute treatment of migraine headaches or other pain or injury, in an emergency setting during SP III and IV (SP IV = REGAIN open-label extension)

h Restricted medication during SP II-III: Use of the following medications for indications other than migraine prevention is allowed providing the dose is stable 2 months prior to Visit 2 and is expected to remain stable during Visit 2 through 12 (EVOLVE-1, EVOLVE-2),  Visit 2 through 7 (REGAIN).

i Restricted medication during SP II-III: Use of these medications for indications other than migraine prevention is allowed.

Therapeutic Indication

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.6

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.6

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. Skljarevski V, Zhang Q, Detke H, et al. Phase 3 Study (EVOLVE-2) of Galcanezumab in Episodic Migraine: Results of 6-Month Treatment Phase. Poster presented at: Diamond Headache Clinic Research & Educational Foundation (DHCREF) Headache Update 2017; July 13-16, 2017; Lake Buena Vista, Florida.

5. Stauffer V, Zhang Q, Skljarevski V, et al. Phase 3 Study (EVOLVE-1) of Galcanezumab in Episodic Migraine: Results of 6-Month Treatment Phase. Poster presented at: Diamond Headache Clinic Research & Educational Foundation (DHCREF) Headache Update 2017; July 13-16, 2017; Lake Buena Vista, Florida.

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

7. Detke H, Shufang W, Skljarevski V, et al. A Phase 3 Placebo-Controlled Study of Galcanezumab in Patients with Chronic Migraine: Results from the 3-month Double-Blind Treatment Phase of the REGAIN Study. Poster presented at: Diamond Headache Clinic Research & Educational Foundation (DHCREF) Headache Update 2017; July 13-16, 2017; Lake Buena Vista, Florida.

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

9. Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

NSAID = nonsteroidal anti-inflammatory drug

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 M02 05


Kontakta Medicinsk Information på Lilly

Kontakta oss på telefon

Kontorstid vardagar 9.00-17.00

Eller så kan du

Skriv din fråga till oss