EMGALITY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EMGALITY (EMGALITY).
Monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and prevents its binding to the CGRP receptor, thereby inhibiting CGRP-mediated vasodilation and nociceptive signaling.
| Metabolism | Degraded into small peptides and amino acids via general protein catabolism. |
| Excretion | Primarily degraded into small peptides and amino acids via general protein catabolism; renal excretion of intact drug is negligible (<1%). |
| Half-life | Terminal elimination half-life is 27 days (range 23-31 days), supporting monthly subcutaneous dosing. |
| Protein binding | <1% bound to plasma proteins. |
| Volume of Distribution | 5.3 L (approximate), consistent with limited extravascular distribution; does not cross blood-brain barrier in significant amounts. |
| Bioavailability | Subcutaneous: 82% (compared to intravenous reference). |
| Onset of Action | Subcutaneous: Reduction in migraine days observed as early as 1 week after first dose, with maximal effect by 3-6 months. |
| Duration of Action | Duration of action supports monthly dosing; therapeutic effect wanes after 4 weeks post-injection. |
120 mg subcutaneously once monthly, with a loading dose of 240 mg subcutaneously (two 120 mg injections) at initiation.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for any degree of renal impairment, including end-stage renal disease. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B); not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment recommended; clinical studies included limited number of patients aged 65 and older. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EMGALITY (EMGALITY).
| Breastfeeding | No data on presence in human milk, effects on breastfed infant, or milk production. Galcanezumab is a large protein molecule (IgG1); likely present in human milk at low levels. M/P ratio not available. Consider developmental and health benefits of breastfeeding along with maternal need for drug and potential adverse effects on infant. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. In animal reproduction studies, subcutaneous administration of galcanezumab to pregnant monkeys during organogenesis at doses up to 10 times the maximum recommended human dose (MRHD) of 240 mg/month resulted in no adverse developmental effects. However, due to the IgG1 nature, galcanezumab is expected to cross the placenta, particularly during the second and third trimesters. Potential fetal risk cannot be excluded. Avoid use during pregnancy unless benefit outweighs risk. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["History of hypersensitivity to galcanezumab or to any excipients"]
| Precautions | ["Hypersensitivity reactions including angioedema and urticaria","Development of anti-drug antibodies potentially reducing efficacy","Use during pregnancy only if clearly needed (limited data)","Use with caution in patients with history of hypersensitivity to galcanezumab or any excipients"] |
Loading safety data…
| Fetal Monitoring | No specific monitoring required beyond routine prenatal care. Monitor for maternal adverse effects including injection site reactions, constipation, and hypersensitivity. |
| Fertility Effects | No human data on fertility. In animal studies, no adverse effects on male or female fertility were observed in monkeys at doses up to 10 times the MRHD. |