Releuko

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML.
• Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.
• See Full Prescribing Information for recommended dosage adjustments and timing of administration ( 2.1 ) Patients with cancer undergoing bone marrow transplantation 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours.
• See Full Prescribing Information for recommended dosage adjustments and timing of administration.
• ( 2.2 ) Patients undergoing autologous peripheral blood progenitor cell collection and therapy 10 mcg/kg/day subcutaneous injection ( 2.3 ) Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis ( 2.3 ) Patients with congenital neutropenia Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily ( 2.4 ) Patients with cyclic or idiopathic neutropenia Recommended starting dose is 5 mcg/kg subcutaneous injection daily ( 2.4 ) Patients acutely exposed to myelosuppressive doses of radiation 10 mcg/kg/day subcutaneous injection ( 2.5 ) Direct administration of less than 0.3 mL (180 mcg) using RELEUKO prefilled syringe is not recommended due to potential for dosing errors.
• ( 2.6 )
• 2.1 Dosage in Patients with Cancer Receiving Myelosuppressive Chemotherapy or Induction and/or Consolidation Chemotherapy for AML The recommended starting dosage of RELEUKO is 5 mcg/kg/day‚ administered as a single daily injection by subcutaneous injection‚ by short intravenous infusion (15 to 30 minutes)‚ or by continuous intravenous infusion.
• Obtain a complete blood count (CBC) and platelet count before instituting RELEUKO therapy and monitor twice weekly during therapy.
• Consider dose escalation in increments of 5 mcg/kg for each chemotherapy cycle‚ according to the duration and severity of the absolute neutrophil count (ANC) nadir.
• Recommend stopping RELEUKO if the ANC increases beyond 10‚000/mm 3 [see Warnings and Precautions ( 5.10 )].
• Administer RELEUKO at least 24 hours after cytotoxic chemotherapy.
• Do not administer RELEUKO within the 24- hour period prior to chemotherapy [see Warnings and Precautions ( 5.13 )].
• A transient increase in neutrophil count is typically seen 1 to 2 days after initiation of RELEUKO therapy.
• Therefore, to ensure a sustained therapeutic response administer RELEUKO daily for up to 2 weeks or until the ANC has reached 10‚000/mm 3 following the expected chemotherapy-induced neutrophil nadir.
• The duration of RELEUKO therapy needed to attenuate chemotherapy-induced neutropenia may be dependent on the myelosuppressive potential of the chemotherapy regimen employed.
• 2.2 Dosage in Patients with Cancer Undergoing Bone Marrow Transplantation The recommended dosage of RELEUKO following bone marrow transplantation (BMT) is 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours.
• Administer the first dose of RELEUKO at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
• Monitor CBCs and platelet counts frequently following marrow transplantation.
• During the period of neutrophil recovery‚ titrate the daily dosage of RELEUKO against the neutrophil response (see Table 1).
• Table 1.
• Recommended Dosage Adjustments During Neutrophil Recovery in Patients with Cancer Following BMT Absolute Neutrophil Count RELEUKO Dosage Adjustment When ANC greater than 1,000/mm 3 for 3 consecutive days Reduce to 5 mcg/kg/day a Then, if ANC remains greater than 1,000/mm 3 for 3 more consecutive days Discontinue RELEUKO Then, if ANC decreases to less than 1,000/mm 3 Resume at 5 mcg/kg/day a If ANC decreases to less than 1,000/mm 3 at any time during the 5 mcg/kg/day administration‚ increase RELEUKO to 10 mcg/kg/day‚ and then follow the above steps.
• 2.3 Dosage in Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy The recommended dosage of RELEUKO for the mobilization of autologous peripheral blood progenitor cells (PBPC) is 10 mcg/kg/day given by subcutaneous injection.
• Administer RELEUKO for at least 4 days before the first leukapheresis procedure and continue until the last leukapheresis.
• Although the optimal duration of RELEUKO administration and leukapheresis schedule have not been established‚ administration of filgrastim for 6 to 7 days with leukaphereses on days 5‚ 6‚ and 7 was found to be safe and effective [see Clinical Studies (14.4) ] .
• Monitor neutrophil counts after 4 days of RELEUKO‚ and discontinue RELEUKO if the white blood cell (WBC) count rises to greater than 100‚000/mm 3 .
• 2.4 Dosage in Patients with Severe Chronic Neutropenia Prior to starting RELEUKO in patients with suspected chronic neutropenia, confirm the diagnosis of severe chronic neutropenia (SCN) by evaluating serial CBCs with differential and platelet counts‚ and evaluating bone marrow morphology and karyotype.
• The use of RELEUKO prior to confirmation of a correct diagnosis of SCN may impair diagnostic efforts and may thus impair or delay evaluation and treatment of an underlying condition‚ other than SCN‚ causing the neutropenia.
• The recommended starting dosage in patients with Congenital Neutropenia is 6 mcg/kg as a twice daily subcutaneous injection and the recommended starting dosage in patients with Idiopathic or Cyclic Neutropenia is 5 mcg/kg as a single daily subcutaneous injection.
• Dosage Adjustments in Patients with Severe Chronic Neutropenia Chronic daily administration is required to maintain clinical benefit.
• Individualize the dosage based on the patient’s clinical course as well as ANC.
• In the SCN postmarketing surveillance study, the reported median daily doses of filgrastim were:
• 6 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia), and 1.2 mcg/kg (idiopathic neutropenia).
• In rare instances, patients with congenital neutropenia have required doses of filgrastim greater than or equal to 100 mcg/kg/day.
• Monitor CBCs for Dosage Adjustments During the initial 4 weeks of RELEUKO therapy and during the 2 weeks following any dosage adjustment‚ monitor CBCs with differential and platelet counts.
• Once a patient is clinically stable‚ monitor CBCs with differential and platelet counts monthly during the first year of treatment.
• Thereafter, if the patient is clinically stable, less frequent routine monitoring is recommended.
• 2.5 Dosage in Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) The recommended dose of RELEUKO is 10 mcg/kg as a single daily subcutaneous injection for patients exposed to myelosuppressive doses of radiation.
• Administer RELEUKO as soon as possible after suspected or confirmed exposure to radiation doses greater than 2 gray (Gy).
• Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.
• Obtain a baseline CBC and then serial CBCs approximately every third day until the ANC remains greater than 1,000/mm 3 for 3 consecutive CBCs.
• Do not delay administration of RELEUKO if a CBC is not readily available.
• Continue administration of RELEUKO until the ANC remains greater than 1,000/mm 3 for 3 consecutive CBCs or exceeds 10,000/mm 3 after a radiation-induced nadir.
• 2.6 Important Administration Instructions RELEUKO is supplied in single-dose vials (for subcutaneous use or intravenous infusion) and single-dose prefilled syringes (for subcutaneous use) [see Dosage Forms and Strengths (3) ].
• Prior to use‚ remove the vial or prefilled syringe from the refrigerator and allow RELEUKO to reach room temperature for a minimum of 30 minutes and a maximum of 24 hours.
• Discard any vial or prefilled syringe left at room temperature for greater than 24 hours.
• 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).
• Do not administer RELEUKO if particulates or discoloration are observed.
• Discard unused portion of RELEUKO in vials or prefilled syringes; do not re-enter the vial.
• Do not save unused drug for later administration.
• Subcutaneous Injection Inject RELEUKO subcutaneously in the outer area of upper arms, abdomen, thighs, or upper outer areas of the buttock.
• If patients or caregivers are to administer RELEUKO, instruct them in appropriate injection technique and ask them to follow the subcutaneous injection procedures in the Instructions for Use for the vial or prefilled syringe [see Patient Counseling Information (17) ] .
• Patient self-administration and administration by a caregiver may benefit from training by a healthcare professional.
• Training by the healthcare provider should aim to demonstrate to those patients and caregivers how to measure the dose of RELEUKO, and the focus should be on ensuring that a patient or caregiver can successfully perform all the steps in the Instructions for Use for the vial or prefilled syringe.
• 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 RELEUKO or whether the patient would benefit from a different RELEUKO presentation.
• If a patient or caregiver experiences difficulty measuring the required dose, especially if it is other than the entire contents of the RELEUKO prefilled syringe, use of the RELEUKO vial may be considered.
• If the patient or caregiver misses a dose of RELEUKO, instruct them to contact their healthcare provider.
• Administration Instructions for the Prefilled Syringe The RELUEKO prefilled syringe with BD UltraSafe Plus™ 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 RELEUKO less than 0.3 mL (180 mcg) for direct administration.
• 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.
• For direct administration of doses less than 0.3 mL (180 mcg) use RELUEKO single-dose vial.
• Administration Instructions for Dilution (Vial Only) If required for intravenous administration‚ RELEUKO (vial only) may be diluted in 5% Dextrose Injection, USP from a concentration of 300 mcg/mL to 5 mcg/mL (do not dilute to a final concentration less than 5 mcg/mL).
• RELEUKO 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)‚ RELEUKO is compatible with glass bottles‚ polyvinyl chloride (PVC) and polyolefin intravenous bags‚ and polypropylene syringes.
• Do not dilute with saline at any time because the product may precipitate.
• Diluted RELEUKO solution can be stored at room temperature for up to 4 hours.
• This 4-hour time period includes the time during room temperature storage of the infusion solution and the duration of the infusion.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• RELEUKO prefilled syringe with BD UltraSafe Plus™ Passive Needle Guard may not accurately measure volumes less than 0.3 mL due to the needle spring mechanism design.
• Therefore, the direct administration of a volume less than 0.3 mL using RELEUKO prefilled syringe is not recommended due to the potential for dosing errors.
• For direct administration of doses less than 0.3 mL (180 mcg) use RELEUKO single-dose vial.
• In patients with cancer receiving myelosuppressive chemotherapy‚ 15 pediatric patients median age 2.6 (range 1.2 to 9.4) years with neuroblastoma were treated with myelosuppressive chemotherapy (cyclophosphamide‚ cisplatin‚ doxorubicin‚ and etoposide) followed by subcutaneous filgrastim at doses of 5, 10, or 15 mcg/kg/day for 10 days (n = 5/dose) (Study 8).
• The pharmacokinetics of filgrastim in pediatric patients after chemotherapy are similar to those in
• adults receiving the same weight-normalized doses, suggesting no age-related differences in the pharmacokinetics of filgrastim.
• In this population‚ filgrastim was well tolerated.
• There was one report of palpable splenomegaly and one report of hepatosplenomegaly associated with filgrastim therapy; however‚ the only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
• The safety and effectiveness of RELEUKO have been established in pediatric patients with SCN [see Clinical Studies ( 14.5 )].
• In a phase 3 study (Study 7) to assess the safety and efficacy of filgrastim in the treatment of SCN, 123 patients with a median age of 12 years (range 7 months to 76 years) were studied.
• Of the 123 patients, 12 were infants (7 months to 2 years of age), 49 were children (2 to 12 years of age), and 9 were adolescents (12 to 16 years of age).
• Additional information is available from a SCN postmarketing surveillance study, which includes long-term follow-up of patients in the clinical studies and information from additional patients who entered directly into the postmarketing surveillance study.
• Of the 731 patients in the surveillance study, 429 were pediatric patients < 18 years of age (range 0.9 to 17) [see Indications and Usage ( 1.5 ), Dosage and Administration ( 2.6 ) and Clinical Studies ( 14.5 )].
• Long-term follow-up data from the postmarketing surveillance study suggest that height and weight are not adversely affected in patients who received up to 5 years of filgrastim treatment.
• Limited data from patients who were followed in the phase 3 study for 1.5 years did not suggest alterations in sexual maturation or endocrine function.
• Pediatric patients with congenital types of neutropenia (Kostmann’s syndrome, congenital agranulocytosis, or Schwachman-Diamond syndrome) have developed cytogenetic abnormalities and have undergone transformation to MDS and AML while receiving chronic filgrastim treatment.
• The relationship of these events to filgrastim product administration is unknown [see Warnings and Precautions ( 5.8 ) and Adverse Reactions ( 6 )].
• The use of RELEUKO to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on studies of filgrastim conducted in animals and clinical data supporting the use of filgrastim in other approved indications [see Dosage and Administration ( 2.1 to 2.4 ) and Clinical Studies ( 14.6 )] .

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Among 855 subjects enrolled in 3 randomized, placebo-controlled trials of filgrastim-treated patients receiving myelosuppressive chemotherapy, there were 232 subjects age 65 or older, and 22 subjects age 75 or older.
• No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
• Clinical studies of filgrastim in other approved indications (i.e., BMT recipients, PBPC mobilization, and SCN) did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
• Splenic Rupture [see Warnings and Precautions ( 5.1 )] Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.2 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] Glomerulonephritis [see Warnings and Precautions ( 5.5 )] Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautious ( 5.6 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.7 )] Myelodysplastic Syndrome [see Warnings and Precautions ( 5.8 )] Acute Myeloid Leukemia [see Warnings and Precautions ( 5.8 )] Thrombocytopenia [see Warnings and Precautions ( 5.9 )] Leukocytosis [see Warnings and Precautions ( 5.10 )] Cutaneous Vasculitis [see Warnings and Precautions ( 5.11 )] Aortitis [see Warnings and Precautions ( 5.15 )] Most common adverse reactions in patients:
• ( 6.1 ) With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea.
• With AML (≥ 2% difference in incidence) are pain, epistaxis and rash.
• With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash.
• Undergoing peripheral blood progenitor cell mobilization and collection (≥ 5% incidence) are bone pain, pyrexia and headache.
• With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.
• To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835 5472, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. * Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
• Biosimilarity of RELEUKO ® has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
• Adverse Reactions in Patients with Cancer Receiving Myelosuppressive Chemotherapy The following adverse reaction data in Table 2 are from three randomized, placebo-controlled studies in patients with:
• small cell lung cancer receiving standard dose chemotherapy with cyclophosphamide‚ doxorubicin‚ and etoposide (Study 1) small cell lung cancer receiving ifosfamide, doxorubicin‚ and etoposide (Study 2), and non-Hodgkin’s lymphoma (NHL) receiving doxorubicin, cyclophosphamide, vindesine, bleomycin, methylprednisolone, and methotrexate (“ACVBP”) or mitoxantrone, ifosfamide, mitoguazone, teniposide, methotrexate, folinic acid, methylprednisolone, and methotrexate (“VIM3”) (Study 3).
• A total of 451 patients were randomized to receive subcutaneous filgrastim 230 mcg/m 2 (Study 1), 240 mcg/m 2 (Study 2) or 4 or 5 mcg/kg/day (Study 3) (n = 294) or placebo (n = 157).
• The patients in these studies were median age 61 (range 29 to 78) years and 64% were male.
• The ethnicity was 95% Caucasian, 4% African American, and 1% Asian.
• Table 2.
• Adverse Reactions in Patients with Cancer Receiving Myelosuppressive Chemotherapy (With ≥ 5% Higher Incidence in Filgrastim Compared to Placebo) System Organ Class Preferred Term Filgrastim (N = 294) Placebo (N = 157) Blood and lymphatic system disorders Thrombocytopenia 38% 29% Gastrointestinal disorders Nausea 43% 32% General disorders and administration site conditions Pyrexia 48% 29% Chest pain 13% 6% Pain 12% 6% Fatigue 20% 10% Musculoskeletal and connective tissue disorders Back pain 15% 8% Arthralgia 9% 2% Bone pain 11% 6% Pain in extremity Percent difference (Filgrastim – Placebo) was 4%. 7% 3% Nervous system disorders Dizziness 14% 3% Respiratory, thoracic and mediastinal disorders Cough 14% 8% Dyspnea 13% 8% Skin and subcutaneous tissue disorders Rash 14% 5% Investigations Blood lactate dehydrogenase Increased 6% 1% Blood alkaline phosphatase increased 6% 1% Adverse events with ≥ 5% higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy delivered included anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, edema peripheral, hemoglobin decreased, decreased appetite, oropharyngeal pain, and alopecia.
• Adverse Reactions in Patients with Acute Myeloid Leukemia Adverse reaction data below are from a randomized, double-blind, placebo-controlled study in patients with AML (Study 4) who received an induction chemotherapy regimen of intravenous daunorubicin days 1, 2, and 3; cytosine arabinoside days 1 to 7; and etoposide days 1 to 5 and up to 3 additional courses of therapy (induction 2, and consolidation 1, 2) of intravenous daunorubicin, cytosine arabinoside, and etoposide.
• The safety population included 518 patients randomized to receive either 5 mcg/kg/day filgrastim (n = 257) or placebo (n = 261).
• The median age was 54 (range 16 to 89) years and 54% were male.
• Adverse reactions with ≥ 2% higher incidence in filgrastim patients compared to placebo included epistaxis, back pain, pain in extremity, erythema, and rash maculo-papular.
• Adverse events with ≥ 2% higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy included diarrhea, constipation, and transfusion reaction.
• Adverse Reactions in Patients with Cancer Undergoing Bone Marrow Transplantation The following adverse reaction data are from one randomized, no treatment-controlled study in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma receiving high-dose chemotherapy (cyclophosphamide or cytarabine, and melphalan) and total body irradiation (Study 5) and one randomized, no treatment-controlled study in patients with Hodgkin's disease (HD) and NHL undergoing high-dose chemotherapy and autologous bone marrow transplantation (Study 6).
• Patients receiving autologous bone marrow transplantation only were included in the analysis.
• A total of 100 patients received either 30 mcg/kg/day as a 4-hour infusion (Study 5) or 10 mcg/kg/day or 30 mcg/kg/day as a 24-hour infusion (Study 6) filgrastim (n = 72), no treatment control or placebo (n = 28).
• The median age was 30 (range 15 to 57) years, 57% were male.
• Adverse reactions with ≥ 5% higher incidence in filgrastim patients compared to patients receiving no filgrastim included rash and hypersensitivity.
• Adverse reactions in patients receiving intensive chemotherapy followed by autologous BMT with ≥ 5% higher incidence in filgrastim patients compared to patients receiving no filgrastim included thrombocytopenia, anemia, hypertension, sepsis, bronchitis, and insomnia.
• Adverse Reactions in Patients with Cancer Undergoing Autologous Peripheral Blood Progenitor Cell Collection The adverse reaction data in Table 3 are from a series of 7 trials in patients with cancer undergoing mobilization of autologous peripheral blood progenitor cells for collection by leukapheresis.
• Patients (n = 166) in all these trials underwent a similar mobilization/collection regimen:
• Filgrastim was administered for 6 to 8 days‚ in most cases the apheresis procedure occurred on days 5‚ 6, and 7.
• The dosage of filgrastim ranged between 5 to 30 mcg/kg/day and was administered subcutaneously by injection or continuous infusion.
• The median age was 39 (range 15 to 67) years, and 48% were male.
• Table 3.
• Adverse Reactions in Patients with Cancer Undergoing Autologous PBPC in the Mobilization Phase (≥ 5% Incidence in Filgrastim Patients) System Organ Class Preferred Term Mobilization Phase (N = 166) Musculoskeletal and connective tissue disorders Bone pain 30% General disorders and administration site conditions Pyrexia 16% Investigations Blood alkaline phosphatase increased 11% Nervous system disorders Headache 10% Adverse Reactions in Patients with Severe Chronic Neutropenia The following adverse reaction data were identified in a randomized, controlled study in patients with SCN receiving filgrastim (Study 7). 123 patients were randomized to a 4-month observation period followed by subcutaneous filgrastim treatment or immediate subcutaneous filgrastim treatment.
• The median age was 12 years (range 7 months to 76 years) and 46% were male.
• The dosage of filgrastim was determined by the category of neutropenia.
• Initial dosage of filgrastim:
• Idiopathic neutropenia:
• 3.6 mcg/kg/day Cyclic neutropenia:
• 6 mcg/kg/day Congenital neutropenia:
• 6 mcg/kg/day divided 2 times per day The dosage was increased incrementally to 12 mcg/kg/day divided 2 times per day if there was no response.
• Adverse reactions with ≥ 5% higher incidence in filgrastim patients compared to patients receiving no filgrastim included arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, and urinary tract infection (upper respiratory tract infection and urinary tract infection were higher in the filgrastim arm, total infection related events were lower in filgrastim-treated patients), epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of filgrastim products.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. splenic rupture and splenomegaly (enlarged spleen) [see Warnings and Precautions ( 5.1 )] acute respiratory distress syndrome [see Warnings and Precautions ( 5.2 )] anaphylaxis [see Warnings and Precautions ( 5.3 )] sickle cell disorders [see Warnings and Precautions ( 5.4 )] glomerulonephritis [see Warnings and Precautions ( 5.5 )] alveolar hemorrhage and hemoptysis [see Warnings and Precautious ( 5.6 )] capillary leak syndrome [see Warnings and Precautions ( 5.7 )] leukocytosis [see Warnings and Precautions ( 5.10 )] cutaneous vasculitis [see Warnings and Precautions ( 5.11 )] Sweet’s syndrome (acute febrile neutrophilic dermatosis) decreased bone density and osteoporosis in pediatric patients receiving chronic treatment with filgrastim products myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy [see Warnings and Precautions ( 5.8 )] aortitis [see Warnings and Precautions ( 5.15 )] extramedullary hematopoiesis

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Review the steps for direct patient administration with patients and caregivers.
• Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of RELEUKO vial and prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe.
• 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 RELEUKO or whether the patient would benefit from a different RELEUKO presentation.
• Advise patients of the following risks and potential risks with RELEUKO:
• Rupture or enlargement of the spleen may occur.
• Symptoms include left upper quadrant abdominal pain or left shoulder pain.
• Advise patients to report pain in these areas to their physician immediately [see Warnings and Precautions ( 5.1 )].
• Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur.
• Advise patients to report dyspnea to their physician immediately [see Warnings and Precautions ( 5.2 )].
• Serious allergic reactions may occur, which may be signaled by rash, facial edema, wheezing, dyspnea, hypotension, or tachycardia.
• Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur [see Warnings and Precautions ( 5.3 )].
• In patients with sickle cell disease, sickle cell crisis and death have occurred.
• Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of human granulocyte colony-stimulating factors [see Warnings and Precautions ( 5.4 )].
• Glomerulonephritis may occur.
• Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production.
• Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately [see Warnings and Precautions ( 5.5 )].
• There may be an increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with congenital neutropenia who receive filgrastim products and in patients with breast and lung cancer who receive filgrastim products in conjunction with chemotherapy and/or radiation therapy.
• Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding.
• Advise patients to report to their physician signs and symptoms of MDS/AML [see Warnings and Precautions ( 5.8 ) ].
• Cutaneous vasculitis may occur, which may be signaled by purpura or erythema.
• Advise patients to report signs or symptoms of vasculitis to their physician immediately [see Warnings and Precautions ( 5.11 )].
• Aortitis may occur.
• Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers.
• Advise patients to report signs and symptoms of aortitis to their physician immediately [see Warnings and Precautions ( 5.15 )].
• Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) that efficacy studies of filgrastim products for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies ( 14.6 )] .
• Instruct patients who self-administer RELEUKO using the prefilled syringe or single-dose vial of the:
• Importance of following the applicable Instructions for Use.
• Dangers of reusing needles, syringes, or unused portions of single-dose vials.
• Importance of following local requirements for proper disposal of used syringes, needles, and unused vials.
• Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the RELEUKO prefilled syringe.
• If difficulty occurs, use of the RELEUKO vial may be considered.
• Difference in product concentration of the RELEUKO prefilled syringe in comparison to the RELEUKO vial.
• When switching patients from the RELEUKO prefilled syringe to the RELEUKO vial, or vice versa, ensure that patients understand the correct volume to be administered since the concentration of RELEUKO differs between the prefilled syringe and the vial.
• Manufactured by:
• Kashiv BioSciences, LLC Piscataway, NJ 08854 US License Number 2131 Distributed by:
• Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2025-05 logo-barcode

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS RELEUKO is a clear, colorless, preservative-free solution available as:
• Vial:
• Injection:
• 300 mcg/mL in a single-dose vial Injection:
• 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial Prefilled Syringe:
• Injection:
• 300 mcg/0.5 mL in a single-dose prefilled syringe Injection:
• 480 mcg/0.8 mL in a single-dose prefilled syringe Vial Injection:
• 300 mcg/mL in a single-dose vial ( 3 ) Injection:
• 480 mcg/1.6 mL (300 mcg/mL) in a single-dose vial ( 3 ) Prefilled Syringe Injection:
• 300 mcg/0.5 mL in a single-dose prefilled syringe ( 3 ) Injection:
• 480 mcg/0.8 mL in a single-dose prefilled syringe ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• RELEUKO (filgrastim-ayow) injection is a clear, colorless, preservative-free solution supplied as:
• Vials Single-dose vials containing 300 mcg/mL of filgrastim-ayow.
• Dispensing packs of 10 vials (NDC 70121-1569-7).
• Single-dose vials containing 480 mcg/1.6 mL (300 mcg/mL) of filgrastim-ayow.
• Dispensing packs of 10 vials (NDC 70121-1571-7).
• Prefilled Syringes Single-dose, prefilled syringe with 27 gauge, 1/2 inch needle with an UltraSafe Plus TM Needle Guard, containing 300 mcg/0.5 mL of filgrastim-ayow.
• Carton of one single-dose prefilled syringe (NDC 70121-1568-1) Pack of 10 prefilled syringes (NDC 70121-1568-7).
• Single-dose, prefilled syringe with 27 gauge, 1/2 inch needle with an UltraSafe Plus TM Needle Guard, containing 480 mcg/0.8 mL of filgrastim-ayow.
• Carton of one single-dose prefilled syringe (NDC 70121-1570-1) Pack of 10 prefilled syringes (NDC 70121-1570-7).
• 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.

Quoted from the official label, section “How Supplied”.

What is in it

• Filgrastim-ayow, a leukocyte growth factor, is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.
• Filgrastim-ayow is produced by Escherichia coli ( E coli ) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene.
• Filgrastim-ayow has a molecular weight of 18‚800 daltons.
• The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli .
• Because filgrastim-ayow is produced in E coli ‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.
• Kanamycin, 50 mcg/mL is final concentration, is used during the fermentation step of the manufacturing process.
• Kanamycin is not detectable in the final product.
• RELEUKO (filgrastim-ayow) injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-ayow at a specific activity of 1.0 ± 0.6 x 10 8 U/mg (as measured by a cell mitogenesis assay).
• The product is available in single-dose vials for subcutaneous or intravenous use and prefilled syringes for subcutaneous use.
• The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim-ayow.
• The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim-ayow.
• The RELEUKO drug product has a pH of 4.0.
• See table below for product composition of each single-dose vial or prefilled syringe. 300 mcg/mL Vial 480 mcg/1.6 mL Vial 300 mcg/0.5 mL Syringe 480 mcg / 0.8 mL Syringe Filgrastim-ayow 300 mcg 480 mcg 300 mcg 480 mcg Acetic acid 0.604 mg 0.966 mg 0.302 mg 0.483 mg Polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg Sodium hydroxide 0.056 mg 0.090 mg 0.028 mg 0.045 mg Sorbitol 50 mg 80 mg 25 mg 40 mg Water for Injection, USP q.s. ad quantity sufficient to make. 1 mL 1.6 mL 0.5 mL 0.8 mL

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Filgrastim