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 at baseline and during therapy.
Monitor for signs and symptoms of hypersensitivity reaction including anaphylaxis (rash, urticaria, dyspnea, angioedema) during therapy. If severe reaction occurs, discontinue galcanezumab and treat as indicated.

Implementation ⬆ ⬇

SC: Bring prefilled pen or syringe to room temperature for ≥30 min; protect from direct sunlight. Do not shake. Solution is clear to opalescent, colorless to light yellow; do not administer if discolored, cloudy, or contains particulates. Do not freeze. May be stored in original carton to protect from light for ≤7 days at room temperature; do not re-refrigerate.
- Inject entire contents SUBQ into abdomen, thigh, or upper arm. Do not inject into areas where skin is tender, bruised, red, or hard.
- Loading doses require multiple SUBQ injections to attain appropriate dose.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient on correct technique for preparation, SUBQ injection and disposal of equipment.
Instruct patient to notify health care provider 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 provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Inform patient of pregnancy exposure registry. Health care providers or the pregnant patient may enroll by calling 1-833-464-4724 or visiting www.migrainepregnancyregistry.com.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in frequency of migraines and cluster headaches.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

73424- ImClone Systems LLC
- 73424-0556-
  - 73424-0556-7- 2 BAG in 1 BOX (73424-0556-7) / 1 BOTTLE in 1 BAG / 3308 g in 1 BOTTLE (73424-0556-1)

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Pronunciation ⬇

Classifications ⬆ ⬇