Zarsio (filgrastim) solution for injections and infusions 30 million units/0.5 ml. 1 syringe №5

Description

Zarsio (filgrastim) solution for injections and infusions 30 million units/0.5 ml. 1 syringe №5

Composition 

active substance: filgrastim (recombinant human granulocyte colony-stimulating factor);

1 ml of solution contains 60 million IU (600 mcg) or 96 million IU (960 mcg) filgrastim;

the pre-filled syringe (syringe dose) contains 30 million IU (300 mcg) or 48 million IU (480 mcg) of filgrastim in 0.5 ml;

Excipients: glutamic acid, sorbitol (E 420), polysorbate 80, water for injections.

Dosage form

Solution for injection or infusion.

Main physical and chemical properties: clear colorless or slightly yellowish solution.

Pharmacotherapeutic group

Immunostimulants. Colony-stimulating factors. Filgrastim.

ATX code L0ZA A02.

Pharmacological properties

This drug belongs to the group of colony-stimulating factors.
Filgrastim – the main active ingredient of the drug, is a recombinant human granulocyte colony-stimulating factor. This substance is obtained by the same technology as recombinant deoxyribunocleic acid, which is isolated from bacterial cells “Escherichia coli”.

The introduction of this drug accelerates the recovery of the hematopoietic system, which reduces the likelihood of complications of a hemorrhagic nature, and, as a consequence – the need for blood transfusions.
In general, accelerates the normalization of blood composition, eliminates the need to control the content of platelets in the blood, has other useful properties.

Indications

This drug is used to treat neutropenia. In particular, it is effective for:

•  reducing the duration of neutropenia and reducing the incidence of febrile neutropenia in patients receiving cytotoxic chemotherapy in the treatment of cancer (except for chronic myelogenous leukemia and MDS);
•  reduction of the duration of neutropenia in patients receiving myeloablative therapy followed by bone marrow transplantation;
•  mobilization of peripheral blood stem cells in patients;
•  long-term therapy to increase the number of neutrophils and reduce the frequency and duration of infectious complications in children and adults with severe chronic congenital, recurrent or idiopathic neutropenia;
•  reducing the risk of bacterial infections in persistent neutropenia in patients with HIV in the active phase;
•  mobilization of peripheral blood stem cells (PSCC) in healthy donors for allogeneic PSCC transplantation.

Contraindications

The drug in question is contraindicated in cases where the patient has a pronounced hypersensitivity (allergy) to the main or to one of the auxiliary components.
Also contraindicated in:

•  chronic myelogenous leukemia and myelodysplastic syndrome;
•  severe congenital neutropenia (Costman’s syndrome) with cytogenetic disorders.

Method of application and dose

The drug is administered in the form of injections or infusions – subcutaneous, intravenous (intravenously – only in diluted form). The drug is administered daily at the same time of day, until the normalization of the number of neutrophils in the blood. Dilution is made exclusively with glucose (dextrose) – 5%. The exact dosage, dilution proportions and duration of treatment are determined by the attending physician individually.

Recommended dosages:

•  in the treatment of patients with cancer – 5 mcg per 1 kg of body weight per day (more effectively administered subcutaneously), usually 14-38 days;
•  in the treatment of patients receiving myeloablative therapy, 24 hours after bone marrow transplantation  10 mcg per 1 kg of body per day (more effectively administered as an infusion). The dose can be adjusted;
•  at independent therapy for the purpose of mobilization of peripheral blood stem cells (PSKK) – on 10 mkg on 1 kg of weight (in the form of infusion), usually 5-7 days;
•  at treatment after chemotherapy for the purpose of mobilization (PSKK) – on 5 mkg on 1 kg a day, (it is entered hypodermically);
•  with severe chronic neutropenia – 12 mcg per 1 kg of patient weight (up to several times a day);
•  idiopathic / periodic neutropenia – 5 mcg per 1 kg of patient weight;
•  in the treatment of HIV-infected – the initial dose of 1 μg / 1 kg, which increases to 4 μg / 1 kg;
•  at mobilization of PSKK before PSKK transplantation – on 10 mkg / 1 kg, 4-5 days.

After normalization of the level of neutrophils in the blood, the recommended maintenance dose is 300 mcg per day, regardless of body weight.

Overdose

No overdose has been reported so far.

Side effects

Possible side effects (often transient), such as:

•  myalgia, bone pain, rheumatoid arthritis;
•  dysuria, nausea, vomiting, alopecia, diarrhea, constipation, weakness, anorexia, cough, rash, chest and throat pain,
•  changes in the composition of the blood;
•  lowering blood pressure;
•  skin vasculitis;
•  Svita syndrome;
•  infiltrates in the lungs, pulmonary insufficiency;
•  allergic, anaphylactic reactions (manifested at the first injection);
•  diseases of the spleen (enlargement), up to rupture;
•  thrombocytopenia.