Neupogen syringe-tubes, units 0.5 ml

Name: Neupogen syringe-tubes, units 0.5 ml
SKU: 104419
Availability: OutOfStock

€1.00

Out of stock

(E-mail when Stock is available)

EAN: 8715131011055 SKU: 104419 Categories: Medicine, Oncology

Description

Oncological diseases

neutropenia, febrile neutropenia in patients receiving intensive myelosuppressive cytotoxic chemotherapy for malignant diseases (except for chronic myeloleukosis and myelodysplastic syndrome), as well as neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by allogenic or autologous bone marrow transplantation;

mobilization of peripheral blood stem cells, including after myelosuppressive therapy.

severe congenital, recurrent or idiopathic neutropenia (absolute neutrophil count less than or equal to 0.5-109/l) in children and adults with a history of severe or recurrent infections;

persistent neutropenia (absolute neutrophil count less than or equal to 1.0-109/l) in patients with advanced HIV infection to reduce the risk of bacterial infections when other treatments are not available.

Active ingredient

Filgrastim

How to take, the dosage

Daily by p/k or as short intravenous infusions (30-minute infusions) on 5% dextrose solution (see Dilution Instructions) until neutrophil counts pass the expected minimum (nadir) and return to the normal range. The choice of route of administration depends on the specific clinical situation. The p/k route of administration is preferred.

Interaction

The safety and efficacy of administration of Neupogen® on the same day as myelosuppressive cytotoxic chemotherapy have not been established. Because of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, administration of Neupogen® 24 hours before or after administration of these drugs is not recommended.

Special Instructions

Treatment with Neupogen should only be performed under the supervision of an oncologist or hematologist experienced in the use of G-CSF, with the necessary diagnostic capabilities. Cell mobilization and apheresis procedures should be performed at an oncology or hematology center experienced in this field and the ability to adequately monitor hematopoietic progenitor cells.

a) Malignant Cell Growth
The safety and effectiveness of Neupogen® in patients with myelodysplastic syndrome and chronic myeloleukemia are not established, so it is not indicated for these diseases. Particular attention should be paid to the differential diagnosis between acute myeloleukemia and the blast crisis of chronic myeloleukemia.
Human G-CSF can stimulate growth of myeloid cells in vitro. Similar effects may be observed in vitro for some non-myeloid cells.

b) Patients receiving cytotoxic chemotherapy

Leukocytosis: less than 5% of patients receiving Neupogen® in doses over 0.3 million units (3 µg/kg/day) had leukocyte counts increased to 100-109/l or more. No adverse events directly related to such leukocytosis have been described. However, given the possible risks associated with high leukocytosis, the leukocyte count should be determined regularly during treatment with Neupogen®. If it exceeds 50-109/l after passing the expected minimum, Neupogen® should be discontinued immediately. If Neupogen® is used to mobilize PSCC, it should be discontinued when the leukocyte count exceeds 70-109/l.

Synopsis

Clear colorless or slightly yellowish liquid, odorless or faintly odorless.

Contraindications

hypersensitivity to the drug or its components in history;

severe congenital neutropenia (Kostmann syndrome) with cytogenetic disorders;

Neupogen® should not be used to increase doses of cytotoxic chemotherapy drugs above those recommended;

concomitant administration with cytotoxic chemotherapy and radiation therapy;

terminal stage of chronic renal failure;

lactation;

period of newborn (immediately after birth to 28 days of life).

With caution:

pregnancy;

malignant and pre-tumor diseases of myeloid nature (including acute myeloiditis). acute myeloleukemia de novo and secondary);

in combination with high-dose chemotherapy.

Side effects

Organism in general: headache, fatigue, injection site reactions (less than 2% of patients with severe chronic neutropenia (CCN)).

Musculoskeletal system: often – mild to moderate (10%); sometimes – severe (3%) bone and muscle pain, which in most cases are treated with the usual analgesics; arthralgia, osteoporosis, acute gouty arthritis, exacerbation of rheumatoid arthritis.

Gastrointestinal tract: diarrhea, hepatomegaly.

Cardiovascular system: very rare – transient arterial hypotension that does not require drug correction, cutaneous vasculitis (during long-term therapy in 2% of patients with TCH), arrhythmias (relationship with drug administration is not established), vascular disorders (venoocclusive disease, relationship with Neupogen® administration is not established).

Respiratory system: pulmonary infiltrates, adult respiratory distress syndrome, respiratory failure, interstitial pneumonia, possibly with poor prognosis (after chemotherapy, especially after administration of regimens including bleomycin, relationship with Neupogen® administration has not been established).

Skin and its appendages: alopecia, skin rash; rarely, Sweet’s syndrome (febrile acute dermatosis, relationship with Neupogen® administration has not been established.)

Blood and lymphatic system: Splenomegaly, pain in the upper left quadrant of the abdomen; rare, vascular thrombosis; very rare, rupture of the spleen, thrombocytopenia, anemia and nasal bleeding (with long-term administration), leukocytosis, myelodysplastic syndrome and leukemia (in 3% of patients with severe congenital neutropenia (Kostmann syndrome), association with drug intake not identified).

Genitourinary system: rarely – mild or moderate dysuria.

Hypersensitivity reactions: rarely – rash. More than half of the hypersensitivity reactions are associated with the administration of the first dose, more often after IV administration of the drug. Sometimes resumption of treatment is accompanied by relapse of symptoms.

Laboratory parameters: reversible, dose-dependent and mild to moderate increase in lactate dehydrogenase, alkaline phosphatase, and γ-glutamyltransferase, hyperuricemia, transient hypoglycemia after meals; very rare – proteinuria, hematuria.

Neupogen® does not increase the incidence of adverse reactions to cytotoxic chemotherapy. Adverse events reported with equal frequency in patients treated with Neupogen®/chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhea, lethargy, anorexia, mucous membrane inflammation, headache, cough, skin rash, chest pain, general weakness, sore throat, constipation and non-specific pain (no specific diagnosis).

Overdose

No cases of overdose have been reported.

Pregnancy use

Category C drug.

Additional information

Weight	0.020 kg
Shelf life	2 years. Do not use after the expiration date stated on the package.
Conditions of storage	At a temperature of 2-8 °C. .
Manufacturer	Amgen Europe B.V., Netherlands
Medication form	solution for injection
Brand	Amgen Europe B.V.