Emgality Injection
Galcanezumab
100mg/ml
ELI LILLY AND COMPANY
| Pack size | 3 Pre-filled Syringes (1ml) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | PHARMATRADE |
| Retail Price | 3666.00 AED |
Available as:
Indications
Emgality Injection is used for:
Migraine Prophylaxis, Cluster Headache
Adult Dose
Migraine Prophylaxis
Indicated for preventive treatment of migraine
Loading dose: 240 mg SC once (ie, 2 consecutive 120-mg SC injections)
Maintenance dose: 120 mg SC monthly
Cluster Headache
Indicated for treatment of episodic cluster headache
Loading dose: 300 mg SC once (ie, 3 consecutive 100-mg SC injections)
Maintenance dose: 300 mg SC monthly until cluster period ends
Hepatic impairment
Not expected to affect pharmacokinetics of galcanezumab; dedicated hepatic impairment studies not performed
Based on a population pharmacokinetic analysis, bilirubin concentration did not significantly influence the apparent systemic clearance (CL/F)
Child Dose
Renal Dose
Renal impairment
Not expected to affect pharmacokinetics of galcanezumab; dedicated renal impairment studies not performed
Mild or moderate (CrCl >30 mL/min): Clinical studies revealed that creatinine clearance did not affect the pharmacokinetics
Severe (CrCl <30 mL/min): Not studied
Administration
SC Preparation
Intended for patient self-administration
Provide proper training to patients and/or caregivers on how to prepare and administer, including aseptic technique
Protect syringe from direct sunlight
Remove from refrigerator and allow to sit at room temperature for 30 minutes; do not warm by using a heat source (eg, hot water, microwave)
Do not shake
Visually inspect for particulate matter and discoloration
Do not use if solution appears cloudy or there are visible particles
SC Administration
For SC injection only
Administer in the abdomen, thigh, back of the upper arm, or buttocks
Do not inject into areas where the skin is tender, bruised, red, or hard
Both prefilled pen and syringe are single-dose and deliver the entire contents
Contra Indications
History of serious hypersensitivity reactions to drug or excipients
Precautions
Hypersensitivity reactions (eg, rash, urticaria, dyspnea) reported; may occur days after administration and may be prolonged; discontinue administration and initiate appropriate therapy if serious reaction occurs
Pregnancy-Lactation
Pregnancy
There are no available data regarding use in pregnant women
Animal studies
Administration 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
Clinical considerations
Published data suggests that women with migraine may be at increased risk of preeclampsia during pregnancy
Lactation
Unknown if distributed in human milk
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition
Interactions
Adverse Effects
Side effects of Galcanezumab :
>10%
Injection site reactions (18%)
Frequency Not Defined
Hypersensitivity
Mechanism of Action
Human monoclonal antibody; inhibits calcitonin gene-related peptide (CGRP) receptor, which is thought to be causally involved in migraine pathophysiology
Note
Emgality 100mg/ml Injection manufactured by ELI LILLY AND COMPANY. Its generic name is Galcanezumab. Emgality is availble in United Arab Emirates.
Farmaco UAE drug index information on Emgality Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.