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.

References:
7. Releuko® Full Prescribing Information https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7
8. Neupogen® Full Prescribing Information https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97cc73cc-b5b7-458a-a933-77b00523e193

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
480 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	480 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.

References:
7. Releuko® Full Prescribing Information https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7

Coding Information

HCPCS Code	Descriptor
Q5125	Injection, filgrastim-ayow, biosimilar, (releuko), 1 microgram

HCPCS Code	Q5125
Descriptor	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.

References:
7. Releuko® Full Prescribing Information https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7

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
Autologous peripheral blood progenitor cell collection Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.	10 mcg/kg/day	Subcutaneous injection
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
Acute myelosuppressive radiation exposure Increase survival in patients acutely exposed to myelosuppressive doses of radiation.	10 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.

References:
7. Releuko® Full Prescribing Information https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=74e1ec6e-1630-4654-895c-2bd355f939e7

Important Safety Information

Indications and Usage

RELEUKO® is a leukocyte growth factor indicated to:

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
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
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)
Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
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
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)

Contraindications
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products.

Before you take RELEUKO®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

Warnings and Precautions

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO® in patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO®. Discontinue RELEUKO® if sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO® in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO®. Consider dose-reduction or interruption of RELEUKO® in patients with kidney injury.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
Aortitis has been reported in patients receiving filgrastim products. Discontinue treatment if aortitis is suspected.

Adverse Reactions

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
With AML are pain, epistaxis and rash.
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
Undergoing peripheral blood progenitor cell mobilization and collection are bone pain, pyrexia and headache.
With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

IMPORTANT SAFETY INFORMATIONN

Important Safety Information

Indications and Usage

RELEUKO® is a leukocyte growth factor indicated to:

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
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
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)
Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
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
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)

Contraindications
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products.

Before you take RELEUKO®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

Warnings and Precautions

Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO® in patients with ARDS.
Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO®. Discontinue RELEUKO® if sickle cell crisis occurs.
Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO® in patients with serious allergic reactions.
Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO®. Consider dose-reduction or interruption of RELEUKO® in patients with kidney injury.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
Aortitis has been reported in patients receiving filgrastim products. Discontinue treatment if aortitis is suspected.

Adverse Reactions

Most common adverse reactions in patients:

With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
With AML are pain, epistaxis and rash.
With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
Undergoing peripheral blood progenitor cell mobilization and collection are bone pain, pyrexia and headache.
With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.