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

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:

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:

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

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:

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

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

Acute Reactions in Patients with severe chronic Neutropenia

The first dose of filgrastim

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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