Dosing & Uses
Dosage Forms & Strengths
single-dose prefilled pen
- 120mg/mL
single-dose prefilled syringe
- 100mg/mL
- 120mg/mL
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
Dosage Modifications
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)
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
Safety and efficacy not established
Adverse Effects
>10%
Injection site reactions (18%)
Frequency Not Defined
Hypersensitivity
Postmarketing Reports
Immune system disorders: Anaphylaxis, angioedema
Skin and subcutaneous tissue disorders: Rash
Warnings
Contraindications
History of serious hypersensitivity reactions to drug or excipients
Cautions
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
Cases of anaphylaxis and angioedema reported in postmarketing setting; hypersensitivity reactions can occur days after administration and may be prolonged
Pregnancy & Lactation
Pregnancy
There is pregnancy exposure registry that monitors pregnancy outcomes in women receiving therapy 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 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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Humanized monoclonal antibody; binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor
Absorption
Peak plasma time: 5 days
Steady-state achieved
- 240-mg loading dose: First dose
- 300-mg loading dose: Fourth dose
Distribution
Vd: 7.3 L; 34% interindividual variability
Metabolism
Expected to degrade into small peptides and amino acids via catabolic pathways similar to endogenous IgG
Elimination
Half-life: 27 days
Clearance: 0.008 L/hr
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
Missed dose
- If dose missed, administer as soon as possible
- Thereafter, can be scheduled monthly from the date of the last dose
Storage
Refrigerate at 2-8°C (36-46°F) in original carton to protect from light
If necessary, keep in original carton at room temperature (up to 30°C [86°F]) for up to 7 days; once stored out of refrigeration, do not place back in refrigerator
Do not freeze
Do not shake
Discard pen or syringe after use in a puncture-resistant container
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Emgality Syringe subcutaneous - | 120 mg/mL solution |  | |
| Emgality Pen subcutaneous - | 120 mg/mL injection |  | |
| Emgality Pen subcutaneous - | 120 mg/mL injection |  |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
