Dosing and administration
Initial dosing
The initial dosage of PEMGARDA® in adults and adolescents (12 years of age and older weighing at least 40 kg) is 4500 mg administered as a single IV infusion.
Repeat dosing
The repeat dosage is 4500 mg of PEMGARDA administered as a single IV infusion every 3 months. Repeat dosing should be timed from the date of the most recent PEMGARDA dose.
PEMGARDA should only be administered in settings in which healthcare providers have immediate access to medications to treat a severe hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
Administration
The entire 50 mL infusion must be administered using infusion pump or gravity infusion set over a minimum of 1 hour.
- Due to potential overfill, the entire contents of prepared IV bag should be administered to avoid underdosing
- PEMGARDA should be prepared and administered by a qualified healthcare provider using aseptic technique
Monitoring
Clinically monitor patients during infusion and observe patients for at least 2 hours after infusion is complete.
In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.
Storage and handling
Refrigerate unopened vials at 2-8 °C (36-46 °F) in the original carton to protect from light.
Do not freeze or shake. Do not use if seal is broken or missing.
If immediate administration is not possible, the diluted solution may be stored at room temperature under ambient light for up to 4 hours. Do not shake the diluted solution.
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