galcanezumab

Therapeutic Classification: vascular headache suppressants

Pharmacologic Classification: monoclonal antibodies, calcitonin gene-related peptide receptor antagonists

Indications ⬆ ⬇

REMS

Migraine prevention.
Treatment of episodic cluster headaches.

Action ⬆ ⬇

Monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which reduces the neuroinflammatory and vasodilatory effects of CGRP.

Therapeutic effects:

Reduction in frequency of migraines and cluster headaches.

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Some tissue distribution.

Metabolism/Excretion: Degraded into small peptides and amino acids via catabolic pathways.

Half-Life: 27 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	5 days	1 mo

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Local: injection site reactions

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

Migraine Prevention

SC (Adults ): 240 mg once initially as loading dose, then 120 mg once monthly.

Episodic Cluster Headache

SC (Adults ): 300 mg once at the onset of the cluster period, then 300 mg once monthly until the end of the cluster period.

Availability ⬆ ⬇

Solution for injection (prefilled pens and prefilled syringes): 100 mg/mL; 120 mg/mL

Assessment ⬆ ⬇

Assess frequency and intensity of migraines and cluster headaches.
Monitor for signs and symptoms of hypersensitivity reactions (rash, urticaria, dyspnea) during therapy. If reaction is severe, discontinue galcanezumab and treat as needed.

Implementation ⬆ ⬇

SC: Prior to use allow vial to sit at room temperature for at least 30 min, protect from direct sunlight. Do not use other methods to warm solution (hot water or microwave). Do not shake. Solution is clear to opalescent, colorless to light yellow; do not administer solutions that are discolored, cloudy, or contain particulate matter. Store in refrigerator in original carton to protect from light; do not freeze. May be stored in original carton to protect from light up to 7 days at room temperature; discard if at room temperature >7 days. Do not put back in refrigerator.
- Inject entire contents into abdomen, thigh, or upper arm. Do not inject into areas where the skin is tender, bruised, red, or hard.

Migraines

SC: Loading dose: 240 mg (2 consecutive SUBQ injections of 120 mg each) once. Monthly: follow loading dose with monthly doses of 120 mg.

Cluster Headaches

SC: 300 mg (3 consecutive SUBQ injections of 100 mg each) at onset of cluster period; then monthly until end of cluster period.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take as directed. Administer missed doses as soon as possible and schedule next dose from date last dose administered. Educate patient and/or caregiver on correct technique for injection and disposal of equipment. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Instruct patient to notify health care professional immediately if signs and symptoms of hypersensitivity reaction (itching, rash, hives, swelling of face, mouth, tongue or throat, trouble breathing) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to galcanezumab during pregnancy. Health care professionals 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.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in frequency of migraines and cluster headaches.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0002- Eli Lilly and Company
- 0002-1436- EMGALITY
  - 0002-1436-11- 1 SYRINGE in 1 CARTON (0002-1436-11) > 1 mL in 1 SYRINGE (0002-1436-01)

0002- Eli Lilly and Company
- 0002-1436- EMGALITY
  - 0002-1436-61- 2 SYRINGE in 1 CARTON (0002-1436-61) > 1 mL in 1 SYRINGE

0002- Eli Lilly and Company
- 0002-2377- EMGALITY
  - 0002-2377-11- 1 SYRINGE in 1 CARTON (0002-2377-11) > 1 mL in 1 SYRINGE (0002-2377-01)

0002- Eli Lilly and Company
- 0002-3115- EMGALITY
  - 0002-3115-09- 3 SYRINGE in 1 CARTON (0002-3115-09) > 1 mL in 1 SYRINGE (0002-3115-01)

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Pronunciation ⬇

Classifications ⬆ ⬇