ively. The estimated rate of major birth defects (2.2% - 2.9%)
and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy .
Data
Animal Data
When galcanezumab-gnlm was administered to female rats by subcutaneous injection in two studies (0, 30, or 100 mg/kg;
0 or 250 mg/kg) prior to and during mating and continuing throughout organogenesis, no adverse effects on embryofetal
development were observed. The highest dose tested (250 mg/kg) was associated with a plasma exposure (Cave, ss) 38
times that in humans at the recommended human dose (RHD) of 120 mg. Administration of galcanezumab-gnlm (0, 30, or
100 mg/kg) by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse
effects on embryofetal development. The higher dose tested was associated with a plasma Cave, ss 64 times that in
humans at the RHD.
Administration of galcanezumab-gnlm (0, 30, or 250 mg/kg) by subcutaneous injection to rats throughout pregnancy and
lactation produced no adverse effects on pre- and postnatal development. The higher dose tested was associated with a
plasma Cave, ss 34 times that in humans at the RHD.
8.2 Lactation
Risk Summary
There are no data on the presence of galcanezumab-gnlm in human milk, the effects on the breastfed infant, or the effects
on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for EMGALITY and any potential adverse effects on the breastfed infant from EMGALITY or from the
underlying maternal condition.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of EMGALITY did not include sufficient numbers of patients aged 65 and over to determine whether theyrespond differently from younger patients.
11 DESCRIPTION
Galcanezumab-gnlm is a humanized IgG4 monoclonal antibody specific for calcitonin-gene related peptide (CGRP)ligand. Galcanezumab-gnlm is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Galcanezumab-gnlm is composed of two identical immunoglobulin kappa light chains and two identical immunoglobulingamma heavy chains and has an overall molecular weight of approximately 147 kDa.
EMGALITY (galcanezumab-gnlm) injection is a sterile, preservative-free, clear to opalescent and colorless to slightlyyellow to slightly brown solution, for subcutaneous use available in a single-dose prefilled pen or a single-dose prefilledsyringe to deliver 120 mg galcanezumab-gnlm. Each mL is composed of 120 mg galcanezumab-gnlm; L-histidine, USP(0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80, USP (0.5 mg); Sodium Chloride, USP (8.8 mg);
Water for Injection, USP. The pH range is 5.3 - 6.3.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand
and blocks its binding to the receptor.
12.2 Pharmacodynamics
There are no relevant data on the pharmacodynamic effects of galcanezumab-gnlm.
12.3 Pharmacokinetics
Galcanezumab-gn |
