PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Calcitonin Gene-Related Peptide (CGRP) Antagonists

    DEA CLASS

    Rx

    DESCRIPTION

    Injectable, calcitonin gene-related peptide (CGRP) receptor antagonist
    Used for migraine prophylaxis in adults
    Significantly reduces monthly migraine days

    COMMON BRAND NAMES

    Emgality

    HOW SUPPLIED

    Emgality Subcutaneous Inj Sol: 1mL, 120mg

    DOSAGE & INDICATIONS

    For migraine prophylaxis.
    Subcutaneous dosage
    Adults

    240 mg subcutaneously once as a loading dose, followed by 120 mg subcutaneously once monthly.

    MAXIMUM DOSAGE

    Adults

    240 mg loading dose, then 120 mg/month subcutaneously.

    Geriatric

    240 mg loading dose, then 120 mg/month subcutaneously.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the galcanezumab solution is cloudy or discolored or has small particles. Galcanezumab is a clear to opalescent, colorless to slightly yellow to slightly brown solution.

    Subcutaneous Administration

    Galcanezumab is intended for patient self-administration. Provide proper training to patients and/or caregivers on how to prepare and administer galcanezumab, including aseptic technique.
    Prior to administration, allow galcanezumab to sit at room temperature for at least 30 minutes protected from direct sunlight. Do not warm using a heat source such as hot water or microwave.
    Do not shake.
    Clean injection site on the abdomen, thigh, back of the upper arm, or buttocks with an alcohol wipe, and allow skin to dry.
    Do not inject into areas where the skin is tender, bruised, red, or hard.
    If using the same body area for the 2 separate injections needed for the 240 mg dose, ensure the second injection is not at same location used for the first injection.
    If a dose is missed, give the next dose as soon as possible. Subsequently, schedule from the date of the last dose.
    Discard the prefilled pen or syringe in a FDA-cleared sharps disposal container. Do not discard in household trash.
    Storage: After removing galcanezumab from the refrigerator, it can be stored in the original carton at room temperature up to 86 degrees F (30 degrees C) for up to 7 days. Do not return galcanezumab to the refrigerator after it has reached room temperature.
     
    Single-dose, Prefilled Pen
    Twist off the base cap and throw it away in trash.
    Place and hold the clear base flat and firmly against skin.
    Turn the lock ring to the unlock position.
    Press and hold the teal injection button; a loud click will be heard. The injection could take about 10 seconds. When the injection is complete, a click will be heard.
    Remove the pen from the skin.
     
    Single-dose, Prefilled Syringe
    Pull needle cap off and throw it away in trash.
    Gently pinch and hold injection site skin.
    Insert the needle into skin at a 45-degree angle.
    Using slow and constant pressure, push the plunger rod all the way down with thumb until the prefilled syringe stops moving.
    Remove needle from skin, and gently let go of skin.

    STORAGE

    Emgality:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - May be stored at room temperature for up to 1 week
    - Product stored at controlled room temperature should not be returned to a refrigerator
    - Protect from light
    - Store between 36 to 46 degrees F
    - Store in original package until time of use

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Galcanezumab is contraindicated in patients with serious hypersensitivity to galcanezumab or any of the excipients.

    Pregnancy

    There are no adequate data on the developmental risk associated with galcanezumab use during human pregnancy. No adverse developmental effects were observed when rats and rabbits were given galcanezumab throughout organogenesis at exposures approximately 38 to 64-times the recommended human dose (RHD) of 120 mg. Administration of galcanezumab to rats throughout pregnancy and lactation produced no adverse effects on pre- and postnatal development at exposures up to 34-times the RHD. Women with migraine may be at increased risk of preeclampsia during pregnancy.[63583]

    Breast-feeding

    There are no data on the presence of galcanezumab in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for galcanezumab and any potential adverse effects on the breast-fed infant from galcanezumab or the underlying maternal condition.

    ADVERSE REACTIONS

    Moderate

    antibody formation / Delayed / 4.8-12.5
    erythema / Early / Incidence not known
    dyspnea / Early / Incidence not known

    Mild

    injection site reaction / Rapid / 18.0-18.0
    pruritus / Rapid / Incidence not known
    rash / Early / Incidence not known
    urticaria / Rapid / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Galcanezumab products.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate data on the developmental risk associated with galcanezumab use during human pregnancy. No adverse developmental effects were observed when rats and rabbits were given galcanezumab throughout organogenesis at exposures approximately 38 to 64-times the recommended human dose (RHD) of 120 mg. Administration of galcanezumab to rats throughout pregnancy and lactation produced no adverse effects on pre- and postnatal development at exposures up to 34-times the RHD. Women with migraine may be at increased risk of preeclampsia during pregnancy.[63583]

    There are no data on the presence of galcanezumab in human milk, the effects on the breast-fed infant, or the effects on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for galcanezumab and any potential adverse effects on the breast-fed infant from galcanezumab or the underlying maternal condition.

    MECHANISM OF ACTION

    Galcanezumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function. CGRP is distributed throughout the nervous system, and it is concentrated at anatomical sites, such as the trigeminovascular system, which are involved in migraine pathophysiology. Centrally, CGRP is involved in nociceptive transmission through second and third order neurons and pain modulation in the brainstem. Peripherally, CGRP mediates vasodilation through smooth muscle receptors. CGRP concentrations are elevated during acute migraine attacks and may be chronically elevated in chronic migraineurs.[63169] [63583]

    PHARMACOKINETICS

    Galcanezumab is administered subcutaneously. Galcanezumab exhibits linear kinetics. Serum galcanezumab steady-state concentration is achieved after a 240 mg loading dose. The apparent volume of distribution is 7.3 L (34% interindividual variability). Galcanezumab is degraded into small peptides and amino acids by catabolic pathways in the same manner as endogenous immune globulin. Galcanezumab apparent clearance is 0.008 L/hour. The half-life of galcanezumab is approximately 27 days.[63583]
     
    Affected cytochrome P450 isoenzymes and drug transporters: none

    Subcutaneous Route

    After a subcutaneous galcanezumab dose, the time to maximum concentration is approximately 5 days. Injection site location did not significantly affect the absorption of galcanezumab.[63583]