galcanezumab (Rx)

Brand and Other Names:Emgality, galcanezumab-gnlm

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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Interactions

Interaction Checker

and galcanezumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (3)

                • efgartigimod alfa

                  efgartigimod alfa will decrease the level or effect of galcanezumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • efgartigimod/hyaluronidase SC

                  efgartigimod/hyaluronidase SC will decrease the level or effect of galcanezumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

                • rozanolixizumab

                  rozanolixizumab will decrease the level or effect of galcanezumab by receptor binding competition. Use Caution/Monitor. Rozanolixizumab may lower systemic exposures and reduce effectiveness of medications that bind to the human neonatal Fc receptor (FcRn). Closely monitor for decreased efficacy of such medications. When long-term use of such medications is required, consider discontinuing rozanolixizumab and using alternative therapies.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Injection site reactions (18%)

                  Frequency Not Defined

                  Hypersensitivity

                  Postmarketing Reports

                  Immune system disorders: Anaphylaxis, angioedema

                  Skin and subcutaneous tissue disorders: Rash

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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

                  Cases of anaphylaxis and angioedema reported in postmarketing setting; hypersensitivity reactions can occur days after administration and may be prolonged

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                  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.

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                  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

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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

                  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.

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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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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.
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                  • 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.