A recombinant humanised monoclonal antibody called Emgality (Galcanezumab) is indicated for the prevention of migraine attacks and episodic cluster headaches.

Emgality (Galcanezumab) Uses:

• Migraine prophylaxis:

  • It is used for the prevention of migraine attacks (prophylaxis)

Emgality (Galcanezumab) Dose in Adults

Emgality (Galcanezumab) Dose in the prophylaxis of Migraine:

• 120 mg once a month as a maintenance dose after the initial loading dose of 240 mg subQ.

• Missed dose:

  • It is important to take the missed dose as soon as you remember.
  • After the last injection, the monthly prescribed dose should be given.

Use in Children:

The safety and efficacy of the drug in children have not been established. 

Pregnancy Risk Category: N (Not assigned)

• Animal reproduction studies have shown adverse outcomes for fetuses.
• Galcanezumab, a monoclonal anti-bodiogen that crosses the placental boundary, is especially effective in the third trimester.
• The drug has a long half-life, so females who are trying to conceive must be aware of this fact.

Galcanezumab can be used during lactation

• It is unknown if the drug will be excreted into breastmilk.
• Manufacturer suggests weighing the advantages of treatment for the mother against the potential risks to the infant from drug exposure.

Emgality Dose in Kidney Disease:

The manufacturer has not recommended any adjustments in the dose. However, renal failure is not expected to change the pharmacokinetics of the drug.

Emgality Dose in Liver disease:

The manufacturer has not recommended any adjustments in the dose. However, liver impairment is not expected to change the pharmacokinetics of the drug. 

Common Side Effects of Emgality (Galcanezumab):

• Immunologic:

  • Antibody development

• Local:

  • Injection site reaction

• Hypersensitivity:

  • Hypersensitivity reaction

Contraindications to Emgality (Galcanezumab):

Serious allergic reactions to galcanezumab or any component of the formulation.

Warnings/Precautions

• Hypersensitivity

  • It is possible to experience allergic reactions, such as a rash or urticaria.
  • After the drug is administered, allergic reactions can occur for days or even weeks.
  • If an allergic reaction occurs, the treatment should be stopped immediately.

• Cardiovascular disease

  • Patients with a history including a stroke, Myocardial Infarction, unstable Angina, PCI (percutaneous interventions), Deep vein thrombosis and pulmonary embolism should not use it.
  • These patients were not included in clinical trials.

Galcanezumab: Drug Interaction

Monitoring parameters:

Monitor the response to the treatment by calculating the number of monthly migraine days. 

How to administer (Emgality) Galcanezumab?

• The medication is given by subcutaneous injection. Before delivering the injection, it is advisable to let it sit at room temperature for at least 30 minutes.
• The injection shouldn't be heated using a microwave or any other appliance.
• Avoid direct sunlight exposure. The injection should be given into the abdomen, 3 - 5 cms from the navel, thighs, buttocks or upper arms. 
• You should not administer the injections to infected, tender, red or bruised areas of skin.
• Before using the syringe, it should not be shaken. It is important to immediately administer the entire contents of the pre-filled pen/syringe.
• Two injections of 120mg each should be given to a loading dose of 220 mg. 

Mechanism of action of Emgality (Galcanezumab):

• A monoclonal humanised antibody called galcanezumab binds to the CGRP (calcitonin-related peptide) ligand and prevents it from attaching to its receptors.

Metabolism:

• Through the catabolic process, it is transformed into tiny peptides or amino acids by the body's natural immunoglobulins.

Half-life elimination:

• 27 days

Time to peak:

• 5 days

International Brands of Galcanezumab:

• Emgality

Galcanezumab Brand Names in Pakistan:

No Brands Available in Pakistan.