ZARXIO (for subcutaneous use or intravenous use) is supplied in single-dose vials and in single-dose prefilled syringes [see Dosage Forms and Strengths (3)].

Administration Instructions for Subcutaneous Injection

Inject ZARXIO subcutaneously in the outer area of upper arms, abdomen, thighs, or upper outer areas of the buttock. If patients or caregivers are to administer ZARXIO, instruct them in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for prefilled syringe with BD UltraSafe Passive ® Needle Guard or for the vial. 

If the patient or caregiver misses a dose of ZARXIO, instruct them to contact their healthcare provider.

Patients who will self-administer and caregivers who will administer to the patient may benefit from training by a healthcare professional. Training should aim to demonstrate to those patients and caregivers how to measure the dose of ZARXIO, and the focus should be on ensuring that a patient or caregiver can successfully perform all of the steps in the Instructions for Use for the vial or prefilled syringe with BD UltraSafe Passive® Needle Guard. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of ZARXIO prefilled syringe or whether the patient would benefit from the ZARXIO vial presentation. If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire content of the ZARXIO prefilled syringe, use of the ZARXIO vial may be considered [see Instructions for Use].

Instructions for the Prefilled Syringe

ZARXIO prefilled syringe with BD UltraSafe Passive® Needle Guard is not designed to allow for direct administration of doses of less than 0.3 mL (180 mcg). The spring-mechanism of the needle guard apparatus affixed to the prefilled syringe interferes with the visibility of the graduation markings on the syringe barrel corresponding to 0.1 mL and 0.2 mL. The visibility of these markings is necessary to accurately measure doses of ZARXIO less than 0.3 mL (180 mcg) for direct administration to patients. Thus, the direct administration to patients requiring doses of less than 0.3 mL (180 mcg) is not recommended due to the potential for dosing errors. If less than 0.3 mL is needed the ZARXIO single-dose vial should be used. 

Persons with latex allergies should not administer the ZARXIO prefilled syringe, because the needle cap contains natural rubber latex (derived from latex). For latex sensitive individuals the ZARXIO vial should be considered as the vial stopper is not made with natural rubber latex. 

Prior to use‚ remove the prefilled syringe from the refrigerator and allow ZARXIO to reach room temperature [between 20°C to 25°C (68°F to 77°F)] for a minimum of 30 minutes. If not used immediately, the prefilled syringe may be stored at room temperature for up to 8 days. Discard any prefilled syringe left at room temperature for greater than 8 days. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (the solution is clear and colorless to slightly yellowish). Do not administer ZARXIO if particulates or discoloration are observed.

Discard unused portion of ZARXIO in prefilled syringes. Do not save unused drug for later administration.

Instructions for the Single-dose vial

Prior to use‚ remove the vial from the refrigerator and allow ZARXIO to reach room temperature for a minimum of 30 minutes. If not used immediately, the vial may be stored at room temperature for up to 8 days. Discard any vial left at room temperature for greater than 8 days. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (the solution is clear and colorless to slightly yellowish). Do not administer ZARXIO if particulates or discoloration are observed.

Discard the unused portion of ZARXIO in single-dose vial and do not re-enter the vial. Do not save unused drug for later administration.

Administration Instructions for Dilution

If required for intravenous administration, ZARXIO may be diluted in 5% Dextrose Injection, USP to concentrations between 5 mcg/mL and 15 mcg/mL. ZARXIO diluted to concentrations from 5 mcg/mL to 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL. When diluted in 5% Dextrose Injection, USP or 5% Dextrose plus Albumin (Human)‚ ZARXIO is compatible with glass, polyvinylchloride, polyolefin, and polypropylene.

Do not dilute with Sodium Chloride Injection at any time because the product may precipitate.

Diluted ZARXIO solution from ZARXIO prefilled syringe can be stored at room temperature [between 20℃ to 25℃ (68℉ to 77℉)] for up to 24 hours. This 24‑hour time period includes the time during room temperature storage of the infusion solution and the duration of the infusion.

Diluted ZARXIO solution from ZARXIO vial can be stored refrigerated [2°C to 8°C (36°F to 46°F)] for up to 24 hours or at room temperature [between 20℃ to 25℃ (68℉ to 77℉)] for up to 4 hours, including the time during room temperature storage of the infusion solution and the duration of the infusion.