Filstim solution for injection 0.48 mg syringe 1.6 ml No. 1

Filstim is an immunostimulant

to reduce the duration and incidence of neutropenia, including that accompanied by a febrile reaction, in patients receiving cytotoxic chemotherapy for non-myeloid malignant diseases; to reduce the duration of neutropenia and its clinical consequences in patients receiving myeloablative therapy followed by bone marrow transplantation; to mobilize autologous peripheral blood progenitor cells (PBPCs) after myelosuppressive therapy, to accelerate the recovery of hematopoiesis by administering these cells after myelosuppression or myeloablation; in long-term therapy aimed at increasing the number of neutrophil granulocytes, to reduce the frequency and shorten the duration of infectious complications in children and adults with severe congenital, periodic or malignant neutropenia (absolute number of neutrophil granulocytes <500 in 1 mm3) and with a history of severe or recurrent infections.

Warehouse

1.6 ml of solution contains 0.48 mg (48 million IU) of filgrastim granulocyte colony-stimulating factor (G-CSF); excipients: sodium acetate, trihydrate; polysorbate 80; sorbitol (E 420); water for injections.

Contraindication

Hypersensitivity to filgrastim, colony-stimulating factors, Escherichia coli or to any component of the drug.

Should not be used to increase the tolerability of increased doses of cytotoxic chemotherapy drugs.

Method of application

When conducting cytotoxic chemotherapy according to standard regimens, the drug is administered at a dose of 0.5 million IU (5 mcg) per 1 kg of body weight once a day subcutaneously or intravenously.

In myeloablative therapy followed by bone marrow transplantation, the initial dose of filgrastim is 1 million IU (10 mcg) per kg of body weight per day administered intravenously as a drip over 30 minutes or by continuous intravenous infusion over 24 hours, or subcutaneously.

Application features

Immunogenicity.

Because filgrastim is a peptide, there is a potential for immunogenicity. The rate of antibody formation to filgrastim is generally low. As expected, antibody binding does occur, as with all biologics. However, it has not been established to date that immunogenicity may manifest as a lack of effect when using the drug. According to data from four clinical studies involving healthy volunteers and patients with cancer, none of them developed anti-rH-CSF antibodies as a result of filgrastim administration.

Pregnant women

Not recommended for use during pregnancy.

Children

Used for children from 2 years old.

Drivers

Not studied.

Overdose

No effects associated with filgrastim overdose have been identified.

Side effects

From the blood and lymphatic system: anemia, splenomegaly, thrombocytopenia, spleen dysfunction.

From the side of metabolism: hypoglycemia, increased alkaline phosphatase activity, increased lactate dehydrogenase activity, hyperuricemia.

Neurological disorders: headache.

Respiratory, thoracic and mediastinal disorders: epistaxis.

Gastrointestinal: diarrhea.

From the hepatobiliary system: hepatomegaly.

Storage conditions

Store in the original packaging to protect from light at a temperature of 2 to 8 ° C. Keep out of the reach of children.