Emgality

Calcitonin Gene-Related Peptide (CGRP) Antagonists

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.

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 more than 1 injection per dose, ensure each subsequent injection is not at same location as previous 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.

angioedema / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

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

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

Emgality

Rx

Injectable, calcitonin gene-related peptide (CGRP) antagonist
Used for migraine prophylaxis and treatment of episodic cluster headaches in adults
Significantly reduces monthly migraine days and cluster headache attack frequency

240 mg subcutaneously once as a loading dose, followed by 120 mg subcutaneously once monthly. Guidelines classify galcanezumab as having established efficacy for migraine prophylaxis.

300 mg subcutaneously at the onset of the cluster period and once monthly until the end of the cluster period.

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

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

There are no drug interactions associated with Galcanezumab products.

Emgality Subcutaneous Inj Sol: 1mL, 100mg, 120mg

300 mg/month subcutaneously.

300 mg/month subcutaneously.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Galcanezumab is a humanized immunoglobulin G4 (IgG4) monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. 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]

Galcanezumab is administered subcutaneously. Galcanezumab exhibits linear kinetics. A loading dose of 240 mg achieved serum galcanezumab steady-state concentration after the first dose. A dose of 300 mg monthly would achieve steady-state concentration after the fourth 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

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]

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. There is a pregnancy exposure registry that monitors outcomes in women exposed to galcanezumab 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 visiting www.migrainepregnancyregistry.com.[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.