Omalizumab

Trade name

Xolair

Presentation and preparation

Prefilled syringe:

75 mg/0.5 mL

150 mg/1 mL

Vial:

Vial size (powder volume)	Fluid to add	Volume to add	Resulting concentration
75 mg (negligible)	Provided water for injections	0.9 mL	125 mg/mL  (maximum withdrawable volume = 0.6mL)
150 mg (negligible)	Provided water for injections	1.4 mL	125 mg/mL (maximum withdrawable volume = 0.6mL)

Vials contain a significant amount of overage to allow the full dose to be withdrawn.

Add diluent directly to the powder then swirl vigorously for 1 minute. Do not shake. Continue swirling for 5 – 10 seconds every 5 minutes until all gel-like particles have dissolved, which may take 15 – 30 minutes or longer.

Refer to Product Information for detailed preparation instructions.

IV administration

Never administer intravenously.

Other routes of administration

IM: Contraindicated.

SC: Suitable. Inject into deltoid region of arm or thigh, or any other suitable SC injection site over 5 – 10 seconds. 

Maximum volume per site is 1.2 mL.

Additional information

Observe closely for anaphylactic reactions during and for at least 2 hours after administration.

Vial: Reconstituted solution should be clear or slightly opaque and viscous, colourless to pale brownish-yellow; all gel-like particles must be dissolved before use. Small bubbles or foam around the edge of the vial are acceptable. Reconstituted solution is stable for 8 hours when refrigerated.

Syringe: Needle cover may contain latex. Solution should be clear or slightly opalescent, and slightly yellow or brown.

Refrigerate, do not freeze.

Protect from light during storage.