galcanezumab (Rx)

Brand and Other Names:Emgality, galcanezumab-gnlm
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

>10%

Injection site reactions (18%)

Frequency Not Defined

Hypersensitivity

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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

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Pregnancy

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

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.

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Pharmacology

Mechanism of Action

Human monoclonal antibody; inhibits calcitonin gene-related peptide (CGRP) receptor, which is thought to be causally involved in migraine pathophysiology

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

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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

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Images

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Formulary

FormularyPatient Discounts

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.