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 immunoglobulin gamma 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 slightly yellow to slightly brown solution, for subcutaneous use. EMGALITY is supplied in a 1 mL single-dose prefilled pen to deliver 120 mg of galcanezumab-gnlm or a 1 mL single-dose prefilled syringe to deliver 100 mg or 120 mg of galcanezumab-gnlm. Each mL of solution contains 100 mg or 120 mg of galcanezumab-gnlm; L-histidine (0.5 mg); L-histidine hydrochloride monohydrate (1.5 mg); Polysorbate 80 (0.5 mg); Sodium Chloride (8.8 mg); Water for Injection, USP. The pH range is 5.3 - 6.3.

EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. treatment of episodic cluster headache

Migraine EMGALITY is indicated for the preventive treatment of migraine in adults

Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.

EMGALITY is a sterile clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows: Injection: 120 mg/mL in a single-dose prefilled pen Injection: 120 mg/mL in a single-dose prefilled syringe Injection: 100 mg/mL in a single-dose prefilled syringe Injection: 120 mg/mL solution in a single-dose prefilled pen Injection: 120 mg/mL solution in a single-dose prefilled syringe Injection: 100 mg/mL solution in a single-dose prefilled syringe

For subcutaneous use only. ( 2.1 , 2.2 , 2.3 ) Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. Episodic cluster headache recommended dosage: 300 mg (administered as three consecutive injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously

Recommended Dosing for Migraine The recommended dosage of EMGALITY is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously. If a dose of EMGALITY is missed, administer as soon as possible. Thereafter, EMGALITY can be scheduled monthly from the date of the last dose

Recommended Dosing for Episodic Cluster Headache The recommended dosage of EMGALITY is 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. If a dose of EMGALITY is missed during a cluster period, administer as soon as possible. Thereafter, EMGALITY can be scheduled monthly from the date of the last dose until the end of the cluster period

Important Administration Instructions EMGALITY is for subcutaneous use only. EMGALITY is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer EMGALITY using the single-dose prefilled pen or single-dose prefilled syringe, including aseptic technique : Protect EMGALITY from direct sunlight. Prior to subcutaneous administration, allow EMGALITY to sit at room temperature for 30 minutes. Do not warm by using a heat source such as hot water or a microwave. Do not shake the product. Inspect EMGALITY visually for particulate matter and discoloration prior to administration, whenever solution and container permit . Do not use EMGALITY if it is cloudy or there are visible particles. Administer EMGALITY in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. Do not inject into areas where the skin is tender, bruised, red, or hard. Both the prefilled pen and prefilled syringe are single-dose and deliver the entire contents.

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration, and may be prolonged. Hypertension: New-onset or worsening of pre-existing hypertension may occur. Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with EMGALITY in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy . Hypersensitivity reactions can occur days after administration and may be prolonged

Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including EMGALITY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. EMGALITY was discontinued in many of the reported cases. Monitor patients treated with EMGALITY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of EMGALITY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled

Raynaud's Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including EMGALITY. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. EMGALITY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.