Product Information & Dosing

Product Information

Releuko® (filgrastim-ayow) Injection is available in single-dose, prefilled syringes with 27 gauge, ½ inch needle with an UltraSafe Plus™ Needle Guard.

Single-dose, prefilled syringe is equipped with 27 gauge, ½ inch needle with an UltraSafe Plus™ Needle Guard.

Ordering Information

Releuko® is available through wholesalers and directly from Amneal. 7

Dosage Strength Package Quantity NDC
300 mcg/0.5 mL
prefilled syringe
Pack of 1
Pack of 10
70121-1568-01
70121-1568-07
400 mcg/0.8 mL
prefilled syringe
Pack of 1
Pack of 10
70121-1570-01
70121-1570-07
Dosage Strength 300 mcg/0.5 mL
prefilled syringe
Package Quantity Pack of 1
Pack of 10
NDC 70121-1568-01
70121-1568-07
Dosage Strength 400 mcg/0.8 mL
prefilled syringe
Package Quantity Pack of 1
Pack of 10
NDC 70121-1570-01
70121-1570-07

Download coding & billing guide here

Contact Sales@amneal.com or call (866) 525-7270 for more information.

Coding Information

Releuko® Coding Information
HCPCS Code Descriptor
Q5125 Injection, filgrastim-ayow, biosimilar, (releuko), 1 microgram
Releuko® Coding Information HCPCS Code
Descriptor
Releuko® Coding Information Q5125
Injection, filgrastim-ayow, biosimilar, (releuko), 1 microgram

Centers for Medicare & Medicaid Services. Month 2022 Update of the Hospital Outpatient Prospective Payment System (OPPS). Updated October 10, 2022.

References:
Coding per Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations; Third Quarter, 2022 HCPCS Coding Cycle

Supply & Storage

Store Releuko® refrigerated at 2°C to 8°C (36°F to 46°F) in the original pack to protect from light. Do not leave Releuko® in direct sunlight. DO NOT freeze Releuko®. Avoid shaking. Transport via a pneumatic tube has not been studied.7

Releuko® has a shelf life of up to 24 months.



The expiration date is printed on each dispensing pack and vial label.

Dosing7

Indication

Dosage
(per kilogram of body weight)

Route   

Chemotherapy-induced Febrile Neutropenia Decrease the incidence of infection‚ as manifested by febrile
neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

5 mcg/kg/day

Subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

Acute Myeloid Leukemia (AML) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).

5 mcg/kg/day

Subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous
intravenous infusion.

Cancer Patients Receiving Bone Marrow Transplant (BMT) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).

10 mcg/kg/day

Intravenous infusion no longer than 24 hours

Severe Chronic Neutropenia Reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Recommended start:

    Congenital:

6 mcg/kg twice daily

    Cyclic or idiopathic:

5 mcg/kg/day

Subcutaneous injection

This is an abbreviated summary of the approved indications and dosing schedule. See full prescribing information for important dosing considerations.