EMGALITY (galcanezumab-gnlm) injection

EMGALITY (galcanezumab-gnlm) injection

EMGALITY (galcanezumab-gnlm) injection

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); Lhistidine 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 INDICATIONS AND USAGE

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

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

EMGALITY (galcanezumab-gnlm) injection Mechanism of Action

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

EMGALITY (galcanezumab-gnlm) injection DOSAGE AND ADMINISTRATION

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.

EMGALITY (galcanezumab-gnlm) injection CONTRAINDICATIONS

EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

EMGALITY (galcanezumab-gnlm) injection WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with EMGALITY in clinical studies and the post marketing setting. Cases of anaphylaxis and angioedema have also been reported in the post marketing 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.

EMGALITY (galcanezumab-gnlm) injection USE IN SPECIFIC POPULATIONS

Pregnancy: There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women.

Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development.

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Lactation: There are no data on the presence of galcanezumab-gnlm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EMGALITY and any potential adverse effects on the breastfed infant from EMGALITY or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clinical studies of EMGALITY did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

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