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
|
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?
- 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.
