Fylnetrra: Uses, Dosage, Side Effects & More - Medsayfa (2023)

Table of Contents
warn Precautions


included in"Precautions"Hi


ruptured spleen

Splenic rupture, including fatal cases, may occur following administration of products containing polyethylene glycol. Evaluate splenomegaly or splenic rupture in patients who report shoulder or left upper quadrant pain after receiving FYLNETRA.

acute respiratory distress syndrome

Acute respiratory distress syndrome (ARDS) may occur in patients receiving polyethylene glycol. Evaluate ARDS in patients who develop fever and pulmonary infiltrates or respiratory failure after receiving FYLNETRA. Withhold FYLNETRA in patients with ARDS.

severe allergic reaction

Severe allergic reactions, including anaphylaxis, may occur in patients receiving polyethylene glycol. Most reported incidents occurred during initial exposure. Hypersensitivity reactions, including anaphylaxis, may return within a few days of discontinuation of the initial anti-allergic treatment. Permanently discontinue FYLNETRA in patients with severe hypersensitivity reactions. FYLNETRA should not be administered to patients with a history of severe hypersensitivity reactions to pegfilgrastim products or filgrastim products.

For patients with sickle cell anemia

Severe and sometimes fatal sickle cell crisis may occur in patients with sickle cell disease receiving polyethylene glycol. Stop taking FYLNETRA if you experience a sickle cell crisis.


Glomerulonephritis has been reported in patients receiving polyethylene glycol. Diagnosis is based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Cases of glomerulonephritis have generally been reversible upon dose reduction or discontinuation of pegfilgrastim. If glomerulonephritis is suspected, etiology should be evaluated. If a causal relationship is suspected, dose reduction or discontinuation of FYLNETRA should be considered.


White blood cell count (WBC) 100 x 109/L or more have been observed in patients receiving products containing polyethylene glycol. Monitoring of a complete blood count (CBC) is recommended during treatment with FYLNETRA.


Cases of thrombocytopenia have been reported in patients receiving polyethylene glycol. Check your platelet count.

capillary leakage syndrome

Capillary leak syndrome, characterized by hypotension, hypoalbuminaemia, edema and haemoconcentration, has been reported following the administration of G-CSF, including products containing polyethylene glycol. Attacks vary in frequency, severity, and can be life-threatening if treatment is delayed. Patients with symptoms of capillary leak syndrome should be closely monitored and treated with standard symptomatic treatment, which may require intensive care.

Potential tumor growth stimulating effect on cancer cells

The granulocyte colony stimulating factor (G-CSF) receptor has been identified in tumor cell lines through which pegfilgrastim and filgrastim act. The possibility that pegfilgrastim-containing products act as growth factors in any type of cancer, including myeloid malignancies and myelodysplasias, for which pegfilgrastim-containing products are not approved, cannot be excluded.

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in breast and lung cancer patients

MDS and AML have been associated with the use of pegfilgrastim-containing products in combination with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Under these conditions, patients should be monitored for signs and symptoms of MDS/AML.


Aortitis has been reported in patients receiving polyethylene glycol. It can occur as early as the first week after starting treatment. Presentations may include systemic signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g. c-reactive protein and white blood cell count). Aortitis should be considered in patients with these signs and symptoms in the context of an unknown etiology. If aortitis is suspected, discontinue FYLNETRA.

nuclear images

Increased hematopoietic activity in the bone marrow in response to growth factor treatment is associated with transient positive changes in bone imaging. This should be taken into account when interpreting bone imaging results.

Patient advisory information

Advise patients to refer to the FDA-approved patient label (Patient informationyInstructions for use).

  • Patients should be made aware of the following risks and potential risks associated with the use of FYLNETRA:
  • ruptured spleen and splenomegaly
  • acute respiratory distress syndrome
  • severe allergic reaction
  • sickle cell anemia crisis
  • glomerulonephritis
  • Increased risk of myelodysplastic syndrome and/or acute myeloid leukemia in breast and lung cancer patients receiving FYLNETRA in combination with chemotherapy and/or radiotherapy
  • capillary leakage syndrome
  • Aortitis

Patients should be instructed to self-administer FYLNETRA using the following single-dose pre-filled syringes:

  • The importance of following the instructions for use.
  • Dangers of reusing syringes.
  • The importance of properly disposing of used syringes in accordance with local regulations.

non-clinical toxicology

Cancer, mutation, impaired fertility

Carcinogenicity and mutagenicity studies have not been conducted with pegfilgrastim containing products. Pegfilgrastim had no effect on the reproductive performance or fertility of male and female rats at cumulative weekly doses approximately 6 to 9 times the recommended human dose (based on body surface area).

use in some populations


Risk summary

Although the available data on the use of FYLNETRA or pegfilgrastim in pregnant women are insufficient to determine whether there is a drug-related risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, published studies include data on pregnant women. to a product containing filgrastim. These studies have not shown an association of filgrastim use during pregnancy with major birth defects, miscarriage or adverse maternal or fetal outcomes.

Animal studies have shown no evidence of reproductive or developmental toxicity in pregnant rats exposed to cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, signs of maternal toxicity were associated with increased embryolethality and spontaneous abortion at four times the maximum recommended human dose (see section 4.4).dane).

The estimated baseline risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies carry the risk of birth defects, miscarriage or other adverse outcomes. In the general US population, the estimated baseline risk of major birth defects and miscarriage in clinically diagnosed pregnancies is 2-4% and 15-20%, respectively.


animal information

Pregnant rabbits were given subcutaneous injections of pefilgrastim every other day during organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), treated rabbits showed reduced maternal food consumption, reduced maternal and fetal body weights, and delayed ossification of the fetal skull ; however, no structural abnormalities were observed in the offspring in any of the studies. An increased incidence of post-implantation and spontaneous abortions (more than half of the pregnancies) was observed at cumulative doses approximately 4 times the recommended human dose, which was not seen when pregnant rabbits were given the recommended human dose. Three studies were conducted in pregnant rats with cumulative doses of pegfilgrastim up to approximately 10 times the recommended human dose during the following stages of pregnancy: during organogenesis, copulation to mid-gestation, and early gestation to mid-partum. . No evidence of spontaneous abortion or structural deformities was observed in any of the studies. Cumulative doses corresponding to approximately 3 and 10 times the recommended human dose caused transient signs of rippling of the ribs in the fetuses of treated dams (detected late in gestation but absent in late lactation pups).


Risk summary

There are no data on the presence of pegfilgrastim products in human milk, the effects on breastfed infants, or the effects on lactation. Other filgrastim products are rarely excreted in breast milk, and filgrastim products are not orally absorbed by neonates. The health and developmental benefits of breastfeeding should be weighed against the mother's clinical need for FYLNETRA and any potential adverse reactions in the breastfed infant due to FYLNETRA or maternal medical conditions.

pediatric use

The safety and efficacy of pegfilgrastim in children and adolescents have been established. Based on post-marketing surveillance and a review of the scientific literature, there were no overall differences in safety between adult and pediatric patients.

The use of pegfilgrastim in the treatment of pediatric chemotherapy-induced neutropenia is based on adequate and well-controlled adult studies as well as additional pharmacokinetic and safety data in pediatric sarcoma patients.clinical pharmacologyyclinical tests].

Use in the elderly

Of the 932 cancer patients treated with pegfilgrastim in clinical trials, 139 (15%) were 65 years of age or older and 18 (2%) were 75 years of age or older. No overall differences in safety or efficacy were observed between patients over 65 years of age and younger patients.

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