Version May 2024
Cluster headache (prevention): SUBQ: 300 mg at the onset of the cluster period and then once monthly until the end of the cluster period.
Migraine, prevention (alternative agent):
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events (Ref). Limit use to patients with significant disability from frequent migraines who are unable to tolerate or do not respond to adequate trials of at least 2 other preventive therapies (Ref). An adequate trial for assessment of effect is considered to be at least 3 months at a therapeutic dose (Ref).
SUBQ: Initial: 240 mg as a single loading dose, followed by 120 mg once monthly (Ref).
Missed dose: Administer missed doses as soon as possible and schedule monthly from the date of the last injection.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); renal impairment is not expected to change the pharmacokinetics of galcanezumab.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); hepatic impairment is not expected to change the pharmacokinetics of galcanezumab.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Immunologic: Antibody development (5% to 13%; neutralizing: ≥50%)
Local: Injection site reaction (18%)
Frequency not defined: Hypersensitivity: Hypersensitivity reaction
Postmarketing: Anaphylaxis, angioedema, skin rash
Serious hypersensitivity to galcanezumab or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, and urticaria have been reported; reactions may occur days after administration and may be prolonged. Discontinue use and initiate appropriate therapy if hypersensitivity reactions occur.
Disease-related concerns:
• Cardiovascular disease: Patients with ECG abnormalities compatible with an acute cardiovascular event and patients with a recent history (within 6 months) of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism were excluded from clinical trials; use with caution in these patients.
• Peripheral vascular disease: Patients with history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, vasospastic angina or Raynaud disease, or clinical evidence of peripheral vascular disease were excluded from cluster headache clinical trials; use with caution in these patients.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Appropriate use: Patients on any other migraine or cluster headache preventive treatment and patients with medication overuse headache were excluded from clinical trials; use with caution in these patients.
• Immunogenicity: Anti-galcanezumab antibodies and neutralizing antibodies may develop.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Emgality: Galcanezumab-gnlm 120 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Emgality: Galcanezumab-gnlm 120 mg/mL (1 mL) [latex free; contains polysorbate 80]
Emgality (300 MG Dose): Galcanezumab-gnlm 100 mg/mL (1 mL) [latex free; contains polysorbate 80]
No
Solution Auto-injector (Emgality Subcutaneous)
120 mg/mL (per mL): $847.64
Solution Prefilled Syringe (Emgality (300 MG Dose) Subcutaneous)
100 mg/mL (per mL): $706.37
Solution Prefilled Syringe (Emgality Subcutaneous)
120 mg/mL (per mL): $847.64
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous:
Emgality: Galcanezumab-gnlm 120 mg/mL (1 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous:
Emgality: Galcanezumab-gnlm 100 mg/mL (1 mL); Galcanezumab-gnlm 120 mg/mL (1 mL) [contains polysorbate 80]
SUBQ: For SUBQ use only; intended for self-administration. Keep out of direct sunlight. Prior to administration, allow to come to room temperature for 30 minutes. Do not warm using a heat source (eg, microwave, hot water). Do not shake. Administer in abdomen (avoiding 2 inches around the navel), thigh (at least 2 inches above the knee and 2 inches below the groin), upper arm (caregiver may administer), or buttocks (caregiver may administer) avoiding areas of skin that are tender, bruised, red, or hard; inject into gently pinched and folded skin. Deliver entire contents of single-use prefilled pen or syringe. Administer the 240 mg loading dose as 2 injections of 120 mg, one after another, and the 300 mg dose as 3 injections of 100 mg, one after another; rotate injection site with each new injection.
Cluster headache (prevention): Preventative treatment of cluster headache during cluster episodes in adults.
Migraine, prevention: Preventive treatment of migraine in adults.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
In general, preventive treatment for migraine in patients trying to become pregnant should be avoided. Options for patients planning a pregnancy should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data and needs of the patient should pregnancy occur. A gradual discontinuation of preventive medications is generally preferred when the decision is made to stop treatment prior to conception (ACOG 2022; AHS [Ailani 2021]). IV calcitonin gene-related peptide receptor antagonists are not currently recommended for the prevention of migraine in patients planning to become pregnant due to lack of data. Due to the long half-life, use is not recommended for 6 months prior to conception, and use should be avoided in patients at high risk of unintended pregnancy due to theoretical concerns for potential adverse fetal effects (ACOG 2022; Loder 2018).
Galcanezumab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data following maternal use of galcanezumab during pregnancy are limited (Noseda 2021; Tepper 2018).
Galcanezumab is a calcitonin gene-related peptide (CGRP) receptor antagonist. Based on animal data, CGRP may help regulate placental blood flow, uterine relaxation, and maintain BP; CGRP antagonists could potentially increase the risk of gestational hypertension and preeclampsia (Dodick 2019). The risk of hypertensive disorders, including preeclampsia and eclampsia, are also increased in pregnant patients with migraine (ACOG 2022; Dodick 2019).
In general, preventive treatment for migraine should be avoided during pregnancy. Options for pregnant patients should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (ACOG 2022; AHS [Ailani 2021]). IV CGRP receptor antagonists are not currently recommended for the prevention of migraine in pregnant patients due to lack of data (ACOG 2022).
Galcanezumab is also approved for the prevention of cluster headache. However, use of galcanezumab is not recommended in pregnant patients due to limited data (Bjørk 2021).
Data collection to monitor pregnancy and infant outcomes following exposure to galcanezumab is ongoing. Health care providers are encouraged to enroll patients exposed to galcanezumab during pregnancy in the pregnancy registry; patients may also enroll themselves (1-833-464-4724 or www.migrainepregnancyregistry.com).
It is not known if galcanezumab is present in breast milk.
Galcanezumab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. In general, preventive treatment for migraine in lactating patients should be avoided. When needed, therapy should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]). IV calcitonin gene-related peptide receptor antagonists are not currently recommended for the prevention of migraine in lactating patients due to lack of data (ACOG 2022). If galcanezumab is needed for cluster headache, treatment may be considered after the first week postpartum (Bjørk 2021).
Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Distribution: Vd: 7.3 L
Metabolism: Expected to be degraded into small peptides and amino acids via catabolic pathways similar to that which is seen with endogenous IgG
Half-life elimination: 27 days
Time to peak: 5 days
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