Emgality
(Galcanezumab-Gnlm)Dosage & Administration
Get Your Patient on Emgality
See your patient's specific prior authorization requirements including coverage restrictions and step therapies
By using PrescriberAI, you agree to the AI Terms of Use.
Emgality Prescribing Information
Warnings and Precautions (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. 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. | 03/2025 |
EMGALITY® is a calcitonin-gene related peptide antagonist indicated in adults for the:
- preventive treatment of migraine. ()
1.1 MigraineEMGALITY is indicated for the preventive treatment of migraine in adults.
- treatment of episodic cluster headache. ()
1.2 Episodic Cluster HeadacheEMGALITY is indicated for the treatment of episodic cluster headache in adults.
- For subcutaneous use only. (,
2.1 Recommended Dosing for MigraineThe 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.
,2.2 Recommended Dosing for Episodic Cluster HeadacheThe 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.
)2.3 Important Administration InstructionsEMGALITY 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
[see How Supplied/Storage and Handling and Instructions for Use]:- 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[see Dosage Forms and Strengths and How Supplied/Storage and Handling ]. 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.
- Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. ()
2.1 Recommended Dosing for MigraineThe 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.
- 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. ()
2.2 Recommended Dosing for Episodic Cluster HeadacheThe 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.
- Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. ()
2.3 Important Administration InstructionsEMGALITY 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
[see How Supplied/Storage and Handling and Instructions for Use]:- 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[see Dosage Forms and Strengths and How Supplied/Storage and Handling ]. 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 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
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com.
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
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.
EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients
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