Emgality (Galcanezumab) is a recombinant humanized monoclonal antibody that is indicated for the prevention of migraine attacks and episodic cluster headache.
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:
- 240 mg subQ initially as a single loading dose, followed by a maintenance dose of 120 mg once a month.
-
Missed dose:
- The missed dose should be administered as soon as possible.
- The monthly scheduled dose should be administered from the date of the last injection.
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
|
Risk Factor X (Avoid combination) |
|
|
Belimumab |
Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. |
Monitoring parameters:
Monitor the response to the treatment by calculating the number of monthly migraine days.
How to administer (Emgality) Galcanezumab?
- Subcutaneous injection is used to administer the drug. It is best to keep the injection at room temperature for at least 30 minutes before administering it.
- You should not heat the injection using a microwave or any other method.
- 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):
- Galcanezumab, a monoclonal humanized antibody, binds to CGRP (calcitonin-related peptide) ligand and blocks its binding to its receptors.
Metabolism:
- It is converted by the body's endogenous immunoglobulins into small peptides or amino acids through the catabolic pathway.
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.