Romiplostim

Trade name

NPlate

Presentation and preparation

Caution: Complex preparation.

For subcutaneous administration:

Vial size* (powder volume)	Fluid to add	Volume to add	Resulting concentration
250 microgram (0.03 mL)	Water for injections	0.72 mL	500 microgram/mL
500 microgram (0.05 mL)	Water for injections	1.2 mL	500 microgram/mL

For doses less than 23 micrograms, further dilution required:

Vial size	Fluid to add	Volume to add	Resulting concentration
Reconstituted 250 microgram	Sodium chloride 0.9%	2.25 mL	125 microgram/mL
Reconstituted 500 microgram	Sodium chloride 0.9%	3.75 mL	125 microgram/mL

Further dilute reconstituted solution to 125 microgram/mL using sodium chloride 0.9%. Diluted solutions must be used within 4 hours of preparation.

*Vials contain overfill to ensure the labelled vial contents can be withdrawn from the vial.

Vials labelled ‘250 microgram’ contain 375 micrograms including overfill.

Vials labelled ‘500 microgram’ contain 625 micrograms including overfill.

Gently swirl and invert the vial to reconstitute.

Do not shake.

The solution usually takes less than 2 minutes to dissolve.

IV administration

Never administer intravenously.

Other routes of administration

IM: Not recommended.

SC: Suitable.

For doses of 23 micrograms or greater: Administer 500 microgram/mL reconstituted solution undiluted.

For doses less than 23 micrograms: Dilute reconstituted solution to 125 microgram/mL using sodium chloride 0.9% as per table in Presentation and Preparation. Administer within 4 hours of preparation.

Additional information

Caution: Complex preparation.

Great care should be taken when preparing romiplostim: volumes and doses are small. Verify calculations, final concentration and final volume drawn up for administration.

Administer using a syringe with 0.01 mL graduations. Round volume to the nearest 0.01 mL.

Do not shake.

Protect from light during storage and after reconstitution.

Refrigerate, do not freeze.