Instruction for use: Immugrast

Dosage form: Solution for intravenous and subcutaneous administration

Active substance: Filgrastimum

ATX

L03AA02 Filgrastim

Pharmacological group:

Stimulators of hemopoiesis

The nosological classification (ICD-10)

B23.2 HIV disease, with manifestations of hematologic and immunological disorders, not elsewhere classified: Anemia in HIV-infected patients; Neutropenia in patients with AIDS

D72 Other disorders of white blood cells: Lymphocytopenia; Hereditary neutropenia

D72.8.0 * Leukopenia: Autoimmune neutropenia; Congenital neutropenia; Granulocytopenia; Idiopathic and drug-induced leukopenia; Idiopathic neutropenia; Leukopenia aplastic; Leukopenia radiation; Leukopenia with radiation therapy; Radiation leukopenia; Hereditary neutropenia; Neutropenia in patients with AIDS; Periodic neutropenia; Radiation leukopenia; Persistent neutropenia; Febrile neutropenia; Two-stage cytopenia; Radiation cytopenia; Neutropenia is cyclic

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Z94.8 Presence of another transplanted organ or tissue: Pancreas transplantation; Transplantation of spongy tissue; Bone marrow transplantation; A bone marrow transplant; Bone marrow transplantation; Xenotransplantation; TCM; Cell islet allotransplantation; Parathyroid autotransplantation

Composition

Solution for intravenous and subcutaneous administration 1 ml

active substance: Filgrastim 30 million ME (300 μg)

Auxiliary substances: D-sorbitol - 50 mg; Polysorbate 80 - 0.04 mg; Sodium acetate trihydrate 0.204 mg; Glacial acetic acid 0.48 ml; Water for injection - up to 1 ml

Pharmachologic effect

Mode of action - Leukopoietic.

Dosing and Administration

IV, SC.

The drug is administered daily sc, IV, in the form of short 30-minute infusions or as 24-hour IV or infusion. The choice of route of administration depends on the specific clinical situation. Preferably after the route of administration.

Standard schemes of cytotoxic chemotherapy

In a dose of 5mkg (0.5 million IU) / kg once a day daily sc, or in the form of short intravenous infusions. The first dose of the drug is administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. A transient increase in the number of neutrophils is usually observed 1-2 days after the beginning of treatment with Immugrast®. To achieve a stable therapeutic effect, it is necessary to continue therapy with Immugrast® until the number of neutrophils passes the expected minimum and reaches normal values. If necessary, the duration of the course of therapy can be up to 14 days, depending on the severity of the disease and the severity of neutropenia. After induction and consolidation therapy of acute myelogenous leukemia, the duration of therapy with Immugrast® can increase up to 38 days, depending on the type, dosage and mode of administration of the cytotoxic drugs used.

It is not recommended to cancel Immugrast® prematurely, before the expected minimum of neutrophil count.

After myeloablative chemotherapy followed by bone marrow transplantation

The recommended initial dose is 10 μg (1 million IU) / kg diluted in 20 ml of a 5% dextrose solution as a 30-minute or 24-hour IV infusion or by continuous infusion for 24 hours. The first The dose of Immugrast® should be administered no earlier than 24 hours after cytotoxic chemotherapy, and with bone marrow transplantation - no later than 24 hours after the infusion of the bone marrow. The duration of therapy is not more than 28 days. After the maximum reduction in the number of neutrophils, the daily dose is adjusted depending on the dynamics of their number. If the neutrophil count in the peripheral blood exceeds 1 · 109 / L for three consecutive days, the dose of Immugrast® is reduced to 5 μg (0.5 million IU) / kg; If at this dose the absolute number of neutrophils exceeds 1 · 109 / l for another three consecutive days, Immugrast® is canceled. If during the treatment period the absolute number of neutrophils decreases less than 1 · 109 / l, the dose of Immugrast® is increased again, in accordance with the above scheme.

Mobilization of peripheral blood stem cells after myelosuppressive therapy followed by autologous transfusion of PSKK with or without bone marrow transplantation or in patients with myeloablative therapy followed by transfusion of PSKK

At a dose of 10 μg (1 million IU) / kg by injection once a day or a continuous 24-hour infusion for 6 consecutive days, usually two leukapheresis procedures are sufficient in a row on days 5-6. In some cases, additional leukapheresis is possible. The appointment of Immugast® should be continued until the last leukapheresis.

Mobilization of PSKC after myelosuppressive therapy

In a dose of 5 mkg (0.5 million IU) / kg by daily SC injection from the first day after completion of chemotherapy and until the amount of neutrophils passes through the expected minimum and reaches normal values. Leukapheresis should be performed during the period when the absolute amount of neutrophils rises from less than 0.5 · 109 / L to more than 5 · 109 / L. Patients who did not receive intensive chemotherapy, it is enough to have one leukapheresis. In some cases, additional leukapheresis is recommended.

Mobilization of PSKC in healthy donors for allogeneic transplantation

In a dose of 10 mcg (1 million units) / kg / day p / c, for 4-5 days. Leukapheresis is performed from day 5 and, if necessary, until day 6 in order to obtain CD34 + cells in an amount of ≥4 × 10 6 cells / kg of body weight of the recipient. The effectiveness and safety of Immugast® in healthy donors under the age of 16 and older than 60 years have not been investigated.

Severe chronic neutropenia

Daily c / o, once or divided into several introductions. The initial dose for congenital neutropenia is 12 mkg (1.2 million IU) / kg / day, with idiopathic or intermittent neutropenia - 5 mkg (0.5 million IU) / kg / day, to a stable excess of neutrophil counts 1.5 · 109 / l. After achieving the therapeutic effect, the minimum effective dose should be determined to maintain this content of neutrophils. After 1-2 weeks of treatment, the initial dose can be doubled or halved, depending on the patient's response to therapy. Subsequently, every 1-2 weeks, a dose adjustment can be performed to maintain the amount of neutrophils in the range of 1.5-10 × 109 / L.

In patients with severe infections, a scheme with a faster increase in dose can be used. In 97% of patients who responded positively to the treatment, the full therapeutic effect is observed with the appointment of filgrastim doses up to 24 mcg / kg / day. The daily dose of Immugrast® should not exceed 24 mcg / kg.

Neutropenia in HIV infection

The initial dose of 1-4 mcg (0.1-0.4 million IU) / kg / day once p / c, before the normalization of the number of neutrophils (≥2 · 109 / l). The normalization of the number of neutrophils usually comes in 2 days. After reaching a therapeutic effect, a maintenance dose of 300 mkg / day every other day. In the future, individual dose adjustment and prolonged therapy with Immugrast® may be required to maintain the neutrophil count more than 2 · 109 / L.

Special instructions for dosing

Elderly: there are no special recommendations for this group of patients.

Children: when applied in pediatric practice in patients with severe chronic neutropenia and oncological diseases, the safety profile of filgrastim did not differ from that in adults. Recommendations for dosing for children of the same age are the same as for adults receiving myelosuppressive or cytotoxic chemotherapy.

Correction of filgrastim dose is not required in patients with severe renal or hepatic insufficiency, Their pharmacokinetic and pharmacodynamic parameters are similar to those of healthy volunteers.

Recommendations for the preparation of a solution for intravenous administration

If necessary, / in the introduction of Immugrast®, the required amount of the drug is injected from the syringe into a vial or plastic container with 5% dextrose solution.

Immugrast® cannot be diluted with 0.9% sodium chloride solution.

If the drug is diluted to less than 15 mkg / ml (less than 1.5 million IU / ml), then serum albumin should be added to the solution so that the final concentration of albumin is 2 mg / ml. For example, with a final solution volume of 20 ml, the total dose of the Immugrast® preparation should be less than 300 μg (less than 30 million ME) with the addition of 0.2 ml of a 20% human albumin solution. It is not possible to dilute Immugrast® to a final concentration of less than 2 μg / ml (less than 0.2 million IU / ml).

Immouragast® when diluted with 5% dextrose solution or 5% dextrose solution and albumin is compatible with glass and a number of plastics, including. PVC, polyolefin (copolymer of polypropylene and PE) and polypropylene.

Syringes with Immugrast® are for single use only.

A ready-made solution of Immugrast® is stored at a temperature of 2 to 8 ° C for no more than 24 hours.

Release form

Solution for intravenous and subcutaneous administration, 30 million IU / ml. In bottles of colorless glass class I (USP), sealed with rubber stoppers and aluminum caps with safety plastic lids of 1 ml. 1 fl. In a pack of cardboard.

Manufacturer

«Dr. Reddy C Laboratories Ltd.» Hyderabad, Andhra Pradesh, India.

The address of the place of production: site number 47, Bachupalli Village, Kutbullapur Mandal, Ranga Reddy District, Andhra Pradesh, India.

Claims of consumers should be directed to the address of the representative office of the firm "Dr. Reddi'c Laboratories Ltd.": 115035, Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Immugrast

At a temperature of 2-8 ° C (do not freeze). Conditions of transportation: in thermocontainers, at a temperature of 2-8 ° C (do not freeze)

Keep out of the reach of children.

Shelf life of the drug Immugrast

2 years.

Do not use after the expiry date printed on the package.