Injection site reaction is a very common adverse reaction of galcanezumab. It was reported by 9.9 % and 14.5 % of patients with 120 mg and 240 mg galcanezumab, respectively.

The most frequently reported injection site reactions were:

• injection site reaction
• injection site erythema
• injection site pruritus
• injection site bruising, and
• injection site swelling.1

Most of them were mild to moderate and less than 0.5 % of patients exposed to galcanezumab during the phase 3 studies discontinued the treatment due to an injection site reaction.1

Most injection site reactions were reported within 1 day and on average resolved within 5 days.1

Pruritus is a common adverse reaction of galcanezumab. It was reported by 0.7 % and 1.2 % of patients with 120 mg and 240 mg galcanezumab, respectively.1

Urticaria is an uncommon adverse reaction of galcanezumab reported in galcanezumab clinical trials. Urticaria was reported by 0.3 % and 0.1 % of patients with 120 mg and 240 mg galcanezumab, respectively. Some cases were reported as serious.1

Most events

• were nonserious
• were mild or moderate in severity, and
• did not lead to discontinuation of galcanezumab.2,3

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.2

There were no anaphylaxis events reported in the phase 3 migraine prevention studies.2,3

In EVOLVE-1, EVOLVE-2, and REGAIN, hypersensitivity events occurred more frequently in patients treated with galcanezumab than with placebo (Overview of Likely Hypersensitivity Events After Medical Review: Phase 3 Double-Blind, Placebo-Controlled Migraine Prevention Studies (EVOLVE-1, EVOLVE-2, REGAIN)).3 The frequency of hypersensitivity events of galcanezumab-treated patients was comparable to the frequencies observed during the double-blind treatment phase.2

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 and during open-label treatment in the 12-month open-label safety studies and during open-label treatment in the 12-month open-label safety studies: 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.2,4 

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.

In the double-blind treatment period in the EVOLVE-1, EVOLVE-2, REGAIN, and CONQUER studies, there were no hypersensitivity-related serious adverse events (SAE) reported.2,4

In the open-label and posttreatment phase of REGAIN, two serious cases of urticaria were reported. Neither patient

• reported other associated symptoms, or
• was positive for treatment-emergent anti-drug-antibodies.3 

There were 5 patients who discontinued due to a likely hypersensitivity event:

• 2 patients receiving 120 mg galcanezumab
• 2 patients receiving 240 mg galcanezumab, and
• 1 patient in placebo.2

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.3
  

Discontinuations due to a hypersensitivity event during CONQUER were reported by

• 1 galcanezumab-treated patient during double-blind treatment (rash generalized),4 and
• 1 galcanezumab-treated patient during open-label treatment (upper body rash).2

One patient discontinued due to a hypersensitivity event of rash in the open-label safety study.5

Therapeutic proteins, including monoclonal antibodies, have been associated with hypersensitivity events.7 Therefore, these events were closely monitored in the phase 3 studies, in order to understand the potential for hypersensitivity with the use of galcanezumab.2

Galcanezumab is a self-administered medication. The package labeling contains no requirements to monitor the patient after administration for hypersensitivity reactions.2

Galcanezumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients (L-histidine, L-histidine hydrochloride monohydrate, Polysorbate 80, Sodium chloride, Water for injections).1

Patients with a history of hypersensitivity to monoclonal antibodies or therapeutic proteins were excluded from the clinical development program, therefore it is not known if previous hypersensitivity to another biological product constitutes a risk factor for treatment with galcanezumab.2 Hypersensitivity is neither predictable nor preventable. No correlation with antibody formation has been observed.

Serious hypersensitivity reactions, including cases of anaphylaxis, angioedema, and urticaria, have been reported with galcanezumab. If a serious hypersensitivity reaction occurs, discontinue galcanezumab immediately and initiate appropriate therapy.1

Serious hypersensitivity reactions may occur within 1 day after galcanezumab administration, however cases with a delayed onset have also been reported.1

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)8,9
• chronic migraine (REGAIN),10 and
• episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).4

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study for the prevention of episodic or chronic migraine.5

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.