EMGALITY is indicated for the preventive treatment of migraine in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
The recommended dosage of EMGALITY is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as aloading 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 fromthe date of the last dose.
2.2 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 onhow to prepare and administer EMGALITY using the single-dose prefilled pen or single-dose prefilled syringe, includingaseptic technique [see How Supplied/Storage and Handling (16.2) and Instructions for Use]:
•Protect EMGALITY from direct sunlight.
•Prior to subcutaneous administration, allow EMGALITY to sit at room temperature for 30 minutes. Do notwarm 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 solutionand container permit [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16.1)].
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 notinject 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.
3 DOSAGE FORMS AND STRENGTHS
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
4 CONTRAINDICATIONS
EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients[see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash, urticaria, and dyspnea) have been reported with EMGALITY in clinical studies. If aserious or severe hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriatetherapy [see Contraindications (4), Adverse Reactions (6.1), and Patient Counseling Information (17)]. Hypersensitivityreactions can occur days after administration, and may be prolonged.
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
•Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trialsof a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed inclinical practice.
The safety of EMGALITY has been eva luated in 2586 patients with migraine who received at least one dose ofEMGALITY, representing 1487 patient-years of exposure. Of these, 1920 patients were exposed to EMGALITY oncemonthly for at least 6 months, and 526 patients were exp |
