Filgrastim-ayow side effects

Generic name: (filgrastim-ayow)

Dosage Form: injection, soln

Brand name: Releuko

Medically reviewed by A Rash, MD. Last updated on Mar 23, 2022.

What is Filgrastim-ayow

Filgrastim-ayow side effects are unwanted reactions that may be experienced when using this medication.

Releuko is a granulocyte colony-stimulating factor that has been synthesized by humans (G-CSF). G-CSF is a chemical that the body produces. It promotes the proliferation of neutrophils, a kind of white blood cell vital to the body’s anti-infection defenses.

Mechanism of Action of Filgrastim-ayow

Colony-stimulating factors are glycoproteins that stimulate hematopoietic cell proliferation, differentiation commitment, and certain end-cell functional activation by binding to particular cell surface receptors.

Monocytes, fibroblasts, and endothelial cells produce endogenous G-CSF, a lineage-specific colony-stimulating factor. G-CSF affects neutrophil progenitor proliferation, differentiation, and selected end-cell functions (including enhanced phagocytic ability, priming of the cellular metabolism associated with respiratory burst antibody-dependent killing, and increased expression of some cell surface antigens) in the bone marrow. G-CSF is not species-specific, and it has been demonstrated to have minimal direct in vivo or in vitro effects on hematopoietic cell types other than neutrophils’ generation or activity.¶

Who should not take Filgrastim-ayow

Do not take this medication if you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.

Before you take Filgrastim-ayow

Talk to your healthcare provider about all of your medical conditions, including if you:

have a sickle cell disorder.
have kidney problems.
are receiving radiation therapy.
are pregnant or plan to become pregnant. It is not known if Filgrastim-ayow will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Filgrastim-ayow passes into your breast milk.

Inform your doctor about all of your medications, including prescription and over-the-counter medications, vitamins, and herbal supplements.

Filgrastim-ayow side effects?

This may cause serious side effects, including:

Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach (abdomen) area or your left shoulder.
A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
Serious allergic reactions. Filgrastim-ayow can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Filgrastim-ayow and call your healthcare provider or get emergency medical help right away.
Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death if you have a sickle cell disorder and receive Filgrastim-ayow. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
Kidney injury (glomerulonephritis). Filgrastim-ayow can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
- swelling of your face or ankles
- blood in your urine or dark-colored urine
- you urinate less than usual

Capillary leak syndrome. Filgrastim-ayow can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
- swelling or puffiness and are urinating less than usual o
- trouble breathing
- swelling of your stomach area (abdomen) and feeling of fullness
- dizziness or feeling faint
- a general feeling of tiredness

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
- Filgrastim-ayow may increase the risk of developing a precancerous condition called MDS or a type of blood cancer called AML in people who were born with low white blood cell counts (congenital neutropenia).
- If you have breast cancer or lung cancer, when Filgrastim-ayow is used with chemotherapy and radiation therapy, or with radiation therapy only, you may have an increased risk of developing MDS or AML.
- Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding.
- Call your healthcare provider if you develop any of these symptoms during treatment with Filgrastim-ayow.

Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Filgrastim-ayow. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Filgrastim-ayow. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Filgrastim-ayow.
Inflammation of your blood vessels (cutaneous vasculitis). Tell your healthcare provider right away if you develop purple spots or redness of your skin.
Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received filgrastim products. Symptoms may include fever, abdominal pain, feeling tired, and back pain or chest pain Call your healthcare provider if you experience these symptoms.

The most common side effects experienced in patients receiving Filgrastim-ayow include:

- Patients with cancer receiving chemotherapy: fever, pain, rash, cough, shortness of breath, nausea
- Patients with acute myeloid leukemia receiving chemotherapy: pain, nose bleed, and rash
- Patients with cancer receiving chemotherapy followed by bone marrow transplant: rash
- Patients with severe chronic neutropenia: pain, decreased red blood cells, nose bleed, diarrhea, reduced sensation, and hair loss

Clinical Trials Experience

Since studies conducted in clinical trials take place in diverse conditions, the rates of adverse reactions found in clinical trials for a drug are not directly comparable to rates seen in the clinical trials of a different drug. They may not correspond to the actual rates in the clinical setting.

Acute Reactions of Patients who have cancer receiving Myelosuppressive Chemotherapy

The adverse reaction information in Table results from three placebo-controlled, randomized studies on patients suffering from:

small-cell lung cancers receiving standard-dose chemotherapy using chemotherapy with cyclophosphamide, doxorubicin as well as the drug etoposide (Study 1)
small-cell lung cancer that receives ifosfamide, doxorubicin, and the drug etoposide (Study 2) as well as
Non-Hodgkin’s Lymphoma (NHL) who are receiving chemotherapy with doxorubicin vindesine, cyclophosphamide methotrexate, methylprednisolone, (“ACVBP”) as well as mitoxantrone, ifosfamide methotrexate, teniposide the folinic acid, methylprednisolone as well as methotrexate (“VIM3”) (Study 3).

451 patients were randomly assigned for subcutaneous filgrastim at 230 mcg/m2(Study 1) or 240 mg/m2 (Study 2) or 4 or 5 mg/kg/day (Study 3) (n = 294) or placebo (n = 157). The subjects included in these studies had aged 61 years old, median age (range 29-78) years and 64% of them were male. The ethnicity ranged from 95 percent Caucasian and 4percent African American, and 1 percent Asian.

Table. adverse reactions in patients with cancer receiving chemotherapy that is myelosuppressive (With more than 5% More Incidence Filgrastim In comparison to Placebo)
* Percentage of difference (Filgrastim and Placebo) was 4.4%.
System Organ Class Preferred Time	Filgrastim (N = 294)	Placebo (N = 157)
Lymphatic and blood system disorders
Thrombocytopenia	38%	29%
Gastrointestinal disorders
Nausea	43%	32%
General problems and site-specific conditions
Pyrexia	48%	29%
Chest pain	13%	6%
Pain	12%	6%
Fatigue	20%	10%
Disorders of the connective and musculoskeletal system
Back back pain	15%	8%
Arthralgia	9%	2%
Bone pain	11%	6%
Pain in extremity*	7%	3%
Disorders of the nervous system
Dizziness	14%	3%
Thoracic, mediastinal and respiratory conditions
Cough	14%	8%
Dyspnea	13%	8%
Subcutaneous and skin tissue disorders
Rash	14%	5%
Investigations
Blood lactate dehydrogenase Accrosed	6%	1%
Blood alkaline phosphatase The number of people who have been increased	6%	1%

Acute adverse events with > 5 percent higher frequency in filgrastim patients as compared to placebo, and associated with complications of the malignancy or cytotoxic chemotherapy such as constipation, anemia, oral pain, diarrhea nausea, asthenia, malaise, peripheral edema, hemoglobin depletion, reduced appetite oropharyngeal pain, and alopecia.

Acute Reactions in Patients With Acute Myeloid Leukemia

The following adverse reaction data are taken from a double-blind, randomized placebo-controlled trial in patients suffering from AML (Study 4.) receiving an initial chemotherapy program consisting of intravenous daunorubicin for days 1, 2, and 3, cytosine arabinoside days 1-7; and etoposide for days 1 – 5, and three additional courses of treatment (induction 2 and consolidation 1 2,) consisting of daunorubicin intravenous both cytosine Arabinoside and etoposide. The safety group comprised 518 patients who were randomly assigned to either receive 5 mg/kg/day filgrastim (n = 257) or placebo (n 261). Its median age was 55 (range 16-89) years. 54% of them were male.
Negative reactions with > 22% greater frequency in patients with filgrastim compared to placebo patients included epistaxis back pain, pain in the extremity, erythema, as well as a maculopapular rash.
Adverse events with > 22% greater frequency in patients receiving filgrastim compared to placebo, and linked with the sequelae of a cancerous tumor or cytotoxic chemotherapy, included constipation, diarrhea, and transfusion reactions.

Adverse Reactions of Patients With Cancer who are undergoing bone Marrow Transplantation

The adverse reaction information below comes from a randomized, uncontrolled, study of patients suffering from chronic lymphoblastic leukemia, or lymphoblastic cancer receiving high dose chemotherapy (cyclophosphamide or cytarabine Melphalan) along with total body radiation (Study 5.) as well as one randomized, uncontrolled study of patients suffering from Hodgkin’s Disease (HD) or NHL that are receiving high-dose chemotherapy and autologous bone marrow transplantation (Study 6). Patients who received autologous bone marrow transplantation alone were included in the study. The study included 100 participants who received 30 mg/kg/day in a four-hour infusion (Study 5) or 10 mcg/kg/day 30 mcg/kg/day for a 24 hour infusion (Study 6) filgrastim (n = 72) with no placebo or treatment control (n 28). In the median, patients were 30 (range 15-57) years. 57% of them were male.
Reactions that cause adverse reactions with > 5 percent more incidence for filgrastim sufferers compared to those receiving no filgrastim were hypersensitivity and rashes.
In patients who received chemotherapy intensively and autologous BMT with more than 5 percent, higher frequency of filgrastim-treated patients as compared to patients who did not receive filgrastim include hypertension, anemia, thrombocytopenia sepsis, bronchitis, and insomnia.

Acute Reactions in Patients with severe chronic Neutropenia

The following adverse reactions were discovered in a controlled, randomized study of patients suffering from SCN who received the drug filgrastim (Study 7.). A total of 123 patients were randomly assigned to an observation period of 4 months which was followed by subcutaneous filgrastim therapy as well as immediate subcutaneous therapy. A median of age 12 was observed (range from 7 months to 75 years) and 46% of them were male. The dose of filgrastim was determined using the neutropenia classification.

The first dose of filgrastim

The diagnosis of Idiopathic Neutropenia: 3.6 mcg/kg/day
Cyclic neutropenia: 6 mcg/kg/day
Congenital neutropenia: 6 mg/kg/day divided twice per day

The dosage was gradually increased to 12 mg/kg/day, divided 2 times per day in the event that the response was not evident.

Negative reactions that had > 5 percent higher frequency in filgrastim users in comparison to those who received no filgrastim had arthralgia and back pain, bone pain, muscle spasms muscle pain, pain in the extremity, splenomegaly, and anemia and upper respiratory tract infections, and urinary tract infection (upper respiratory tract infection, as well as urinary tract infections, were more prevalent in the filgrastim group and total infections related events were less common in filgrastim treated patients) epistaxis and diarrhea, chest pain, hypoesthesia, and alopecia.

Immunogenicity

Like any therapeutic protein, there is a possibility for the development of antibodies. The detection of the formation of antibodies is dependent on the specificity and sensitivity of the test. In addition, the reported rate of antibodies (including neutralizing antibodies) positive results in an assay could be affected by a variety of factors, such as the methodology used in the assay and sample handling, the time of collection of samples as well as concomitant medications and the underlying illness. Therefore, comparing the frequency of antibodies in studies that follow with the frequency that antibodies are found in studies elsewhere, or with other filgrastim products could be inaccurate.

The frequency of the development of antibodies among patients who receive filgrastim is not fully understood. Although evidence suggests that only a tiny proportion of patients developed binding antibodies against filgrastim, the nature and specificity of these antibodies have not been thoroughly studied. In studies conducted with filgrastim in clinical trials, the rate of antibodies that bind to filgrastim was 3.3% (11/333). In the 11 patients studied, there was no evidence of neutralizing response was found with a bioassay that was based on cells.

Cytopenias that result from an antigen-specific response to growth factor have been observed on occasion in patients receiving other growth factors recombinant.

These are not all the possible side effects of Filgrastim-ayow. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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10 Single-dose Prefilled Syringes with a Needle Guard
Filgrastim-ayow Injection
300 mcg/0.5 mL
A Recombinant Granulocyte Colony Stimulating
Factor (rG-CSF) derived from E. coli
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F) in the original
Sterile Solution – No Preservative
RX Only

NDC 70121-1568-1 Rx only
Filgrastim-ayow Injection
300 mcg/0.5 mL
Single-dose Prefilled Syringe
For subcutaneous use only

NDC 70121-1568-1
Filgrastim-ayow
RX Only
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli
1 x 300 mcg/0.5 mL single-dose prefilled syringe with the needle guard
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F)
in the original carton to protect from light.
DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative
Dosage: See Prescribing Information

10 x 1 mL Single-dose Vials
Discard unused portion.
NDC 70121-1569-7
Filgrastim-ayow
300 mcg/mL
A Recombinant Granulocyte Colony Stimulating
Factor (rG-CSF) derived from E. coli
For subcutaneous or intravenous use only.
Store Refrigerated at 2° to 8°C (36°F to 46°F) in the original
carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative
RX Only

NDC 70121-1569-1
Rx only
Filgrastim-ayow) Injection
300 mcg/mL
single-dose vial
For subcutaneous or intravenous use only

10 Single-dose Prefilled Syringes with a Needle Guard
NDC 70121-1570-7
Filgrastim-ayow Injection
480 mcg/0.8 mL
A Recombinant Granulocyte Colony Stimulating
Factor (rG-CSF) derived from E. coli
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F) in the original
carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative
RX Only

NDC 70121-1570-1
Rx only
Filgrastim-ayow Injection
480 mcg/0.8 mL
Single-dose Prefilled Syringe
For subcutaneous use only

NDC 70121-1570-1
Filgrastim-ayow Injection
RX Only
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. coli
1 x 480 mcg/0.8 mL single-dose prefilled syringe with needle guard
For Subcutaneous Use Only.
Store Refrigerated at 2° to 8°C (36°F to 46°F)
in the original carton to protect from light.
DO NOT FREEZE. DO NOT SHAKE.
Sterile Solution – No Preservative