Serious hypersensitivity reactions including cases of anaphylaxis, angioedema and urticaria have been reported. 1

Serious hypersensitivity reactions may occur within 1 day after galcanezumab administration, however cases with a delayed onset (ranging from more than 1 day to 4 weeks after administration) have also been reported. In some cases, hypersensitivity reactions had a prolonged duration.1

If a serious hypersensitivity reaction occurs, administration of galcanezumab should be discontinued immediately and appropriate therapy initiated.  Patients should be informed on the possibility of a delayed onset hypersensitivity reaction and instructed to contact their physician.1

The system organ class "Immune system disorders" lists anaphylaxis and angioedema that have been reported in clinical studies and post-marketing reports (Frequency estimand rare, ≥ 1/10,000 to < 1/1,000).1

Furthermore both, pruritus and rash, are a common adverse reaction of galcanezumab (frequency estimand common, ≥ 1/100 to < 1/10) . Pruritus was reported by 0.7 % and 1.2 % of patients with 120 mg and 240 mg galcanezumab in migraine clinical trials, respectively.1

Urticaria has been reported by 0.3 % and 0.1 % of patients with 120 mg and 240 mg galcanezumab in migraine clinical trials. While urticaria is uncommon, serious cases have been reported in galcanezumab clinical studies.1

Read the full Summary of Product Characteristics for Emgality for full prescribing information and further details about adverse drug reactions reported in galcanezumab clinical trials and post-marketing reports.

Most events

• were nonserious
• were mild or moderate in severity, and
• did not lead to discontinuation of galcanezumab.7,8

The time course of hypersensitivity events did not appear different in the galcanezumab-treated patients compared to placebo and there was no trend for an increase in hypersensitivity events with increasing treatment duration up to 12 months.7

There were no anaphylaxis events reported in the phase 3 migraine prevention studies.7,8

Hypersensitivity events occurred more frequently in patients treated with galcanezumab than with placebo in

• EVOLVE-1
• EVOLVE-2, and
• REGAIN (Overview of Likely Hypersensitivity Events After Medical Review: Phase 3 Double-Blind, Placebo-Controlled Migraine Prevention Studies (EVOLVE-1, EVOLVE-2, REGAIN)).8

When considering all galcanezumab-treated patients during all treatment phases, the frequency of hypersensitivity events was comparable to the frequencies observed during the double-blind treatment phase.7

The frequency of treatment-emergent likely hypersensitivity events was not significantly different between the galcanezumab and placebo treatment groups during double-blind treatment in the CONQUER study and  during open-label treatment in the 12-month open-label safety study: Overview of Likely Hypersensitivity Events After Medical Review: Double-Blind Treatment Phase of the CONQUER Study and Overview of Likely Hypersensitivity Events After Medical Review: Open-Label Safety Study.5 

The incidence of treatment-emergent adverse events related to hypersensitivity events was similar between galcanezumab dose groups during open-label treatment in the 12-month open-label safety study: Overview of Likely Hypersensitivity Events After Medical Review: Open-Label Safety Study.7

Please note that the results of a maintenance dose of 240 mg galcanezumab once monthly are also included in this response. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

No patient in any treatment group had an immediate or a nonimmediate hypersensitivity-related serious adverse event (SAE) during the double-blind treatment period in the EVOLVE-1, EVOLVE-2, REGAIN, and CONQUER studies.5,7

Two serious cases of urticaria occurred during the open-label and posttreatment phase of REGAIN. Neither patient

• reported other associated symptoms, or
• was positive for treatment-emergent antidrug antibodies.8

In the EVOLVE-1, EVOLVE-2, and REGAIN studies, no event leading to discontinuation was reported by >1 patient, and all events resolved with supportive care. Patients discontinued because of:

• generalized rash and pruritic rash in the galcanezumab 120-mg group, and
• dyspnea and hypersensitivity in the galcanezumab 240-mg group.8

Discontinuations due to a hypersensitivity event during CONQUER were reported by

• 1 galcanezumab-treated patient during double-blind treatment (rash generalized),5 and
• 1 galcanezumab-treated patient during open-label treatment (upper body rash).7

One patient discontinued due to a hypersensitivity event of rash in the open-label safety study.6

Therapeutic proteins, including monoclonal antibodies, have been associated with hypersensitivity events.10 Therefore, these events were closely monitored in the phase 3 studies, in order to understand the potential for hypersensitivity with the use of galcanezumab.7

Galcanezumab is a self-administered medication. The package labeling contains no requirements to monitor the patient after administration for hypersensitivity reactions.7

It is not known if previous hypersensitivity to another biological product constitutes a risk factor for treatment with galcanezumab since galcanezumab studies excluded patients with a history of hypersensitivity to

• monoclonal antibodies, or 
• therapeutic proteins.7

Hypersensitivity is neither predictable nor preventable. No correlation with antibody formation has been observed.7

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)2,3
• chronic migraine (REGAIN),4 and
• episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).5

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine.6

The galcanezumab doses used and duration of the migraine prevention studies are summarized in Summary of Study Design in the Migraine Prevention Studies.

▼ 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.