Galcanezumab

Galcanezumab is a prescription medicine used for the preventive treatment of migraine and to treat episodic cluster headaches in adults.

• Galcanezumab is available under the following different brand names: Emgality, Galcanezumab-gnlm

Adult dosage

Single-dose prefilled pen

• 120mg/mL

Single-dose prefilled syringe

• 100mg/mL
• 120mg/mL

Migraine Prophylaxis

Adult dosage

• Loading dose: 240 mg SC once (i.e., 2 consecutive 120-mg SC injections)
• Maintenance dose: 120 mg SC monthly

Cluster Headache

Adult dosage

• Loading dose: 300 mg SC once (ie, 3 consecutive 100-mg SC injections)
• Maintenance dose: 300 mg SC monthly until cluster period ends

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Galcanezumab include:

• injection site reactions such as pain, redness, itching, or irritation.

Serious side effects of Galcanezumab include:

• hypersensitivity reactions, and
• signs of an allergic reaction: hives, difficult breathing, swelling of face, lips, tongue, or throat.

Rare side effects of Galcanezumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Galcanezumab has no noted severe interactions with any other drugs.
• Galcanezumab has no noted serious interactions with any other drugs.
• Galcanezumab has no noted moderate interactions with any other drugs.
• Galcanezumab has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• History of serious hypersensitivity reactions to drug or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Galcanezumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Galcanezumab?”

Cautions

• Hypersensitivity reactions (eg, rash, urticaria, dyspnea) reported; may occur days after administration and may be prolonged; discontinue administration and initiate appropriate therapy if a serious reaction occurs
• Cases of anaphylaxis and angioedema reported in postmarketing setting; hypersensitivity reactions can occur days after administration and may be prolonged

Pregnancy and Lactation

• There are no available data regarding use in pregnant women
• Clinical considerations
• Published data suggest 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.