EMGALITY
Clinical safety rating
cautionComprehensive clinical and safety monograph for EMGALITY (EMGALITY).
Comprehensive clinical and safety monograph for EMGALITY (EMGALITY).
Preventive treatment of migraine in adultsPreventive treatment of episodic cluster headache in adults
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. |
| Molecular Weight | 146 |
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 | Insufficient human data; animal studies show no evidence of harm, but lack of human studies precludes recommendation. Use only if clearly needed. |
| 2nd trimester | Insufficient human data; animal studies show no evidence of harm. Caution advised. |
| 3rd trimester | Monoclonal antibodies are actively transported across placenta in third trimester, potentially exposing fetus. Use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for EMGALITY (EMGALITY).
| Placental transfer | Minimal in first trimester; increases in second and third trimesters due to active transport via FcRn receptors. Likely crosses placenta, with increasing transfer as pregnancy progresses. |
| Breastfeeding | Unknown if distributed into human breast milk; other monoclonal antibodies are excreted in milk only in small amounts. Consider developmental benefits of breastfeeding vs potential adverse effects. |
| Lactation Rating | L3 (Moderately Safe) |
| 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. |
| 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. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
Hypersensitivity to galcanezumab or any excipient
| 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 |
| Food/Dietary | No known food interactions. No dietary restrictions required. Grapefruit and other CYP450 substrates do not interact as galcanezumab is a monoclonal antibody cleared via proteolytic degradation. |
| Clinical Pearls | Administer subcutaneously in abdomen, thigh, or upper arm. Rotate injection sites. Can be used with or without food. Discontinue other migraine preventive medications if switching to galcanezumab. Monitor for hypersensitivity reactions including anaphylaxis. Constipation is common and may be severe in some patients. No dose adjustment needed for renal or hepatic impairment. |
| Patient Advice | Inject once monthly at the same time each month. · Store in refrigerator, but may be kept at room temperature for up to 7 days. · Do not shake the syringe. Allow to warm to room temperature for 30 minutes before injection. · Report any signs of allergic reaction such as rash, itching, or difficulty breathing. · Common side effects include injection site reactions and constipation; notify your doctor if constipation becomes severe. · It may take 2-3 months to see full benefit; continue medication as prescribed even if migraines persist initially. · Do not use if you are pregnant or breastfeeding without consulting your doctor. · Keep medication out of reach of children. |
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