Galcanezumab

Dosage Forms

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]

Pharmacology

Mechanism of Action

Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Pharmacokinetics/Pharmacodynamics

Distribution

V_d: 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.

Time to Peak

5 days

Half-Life Elimination

27 days

Use: Labeled Indications

Cluster headache (prevention): Preventative treatment of cluster headache during cluster episodes in adults.

Migraine prophylaxis: Preventive treatment of migraine in adults.

Contraindications

Serious hypersensitivity to galcanezumab or any component of the formulation.

Dosage and Administration

Dosing: Adult

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 prophylaxis: SubQ: Initial: 240 mg as a single loading dose, followed by 120 mg once monthly.

Missed dose: Administer missed doses as soon as possible and schedule monthly from the date of the last injection.

Dosing: Geriatric

Refer to adult dosing.

Administration

SubQ: For subcutaneous 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 or hot water). Do not shake. Administer in abdomen (avoiding 2 inches around the navel), thigh, upper arm, or buttocks avoiding areas of skin that are tender, bruised, red or hard. 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.

Storage

Store at 2°C to 8°C (36°F to 46°F) in the original carton. Protect from light until time of use. If necessary, may be stored at room temperature (up to 30°C [86°F]) in the original carton for up to 7 days; do not return back to the refrigerator. Discard if storage conditions are exceeded. Do not freeze or shake.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>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

Warnings/Precautions

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.

Monitoring Parameters

Number of monthly migraine days or weekly cluster headache attack frequency

Pregnancy

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Galcanezumab is a humanized monoclonal antibody (IgG₄). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Consider the long half-life prior to use in females who are or may become pregnant until information related to pregnancy is available (Tepper 2018).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber injection site irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.