Instruction for use: Leucomax

Dosage form: Powder lyophilized for the preparation of solution for injection

Active substance: Molgramostimum

ATX

L03AA03 Molgrastim

Pharmacological group

Stimulators of hematopoiesis

The nosological classification (ICD-10)

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

Composition and release form

1 bottle with lyophilized powder for the preparation of the injection solution contains molregostimma 50, 150, 300 or 400 mcg.

Characteristic

Recombinant human granulocyte-macrophage colony-stimulating factor.

Pharmachologic effect

Mode of action - Leukopoietic.

It regulates hemopoiesis and activates the maturation (proliferation and differentiation of progenitor cells) of myeloid and lymphoid cells (granulocytes, monocytes / macrophages, T-lymphocytes).

Pharmacodynamics

It is able to enhance the expression of Class II antigens of the main histocompatibility complex on human monocytes and to increase the production of antibodies; Has a pronounced effect on the functional activity of mature neutrophils, including increased phagocytosis of bacteria, increased cytotoxicity against malignant cells and activation of oxidative metabolism processes in neutrophils.

Clinical Pharmacology

With a single administration, the action developed after 1-4 h; The maximum was reached in the range from 6 to 18 hours.

Indication of the drug Leucomax

Leukopenia, incl. With antitumor therapy, infections (including HIV, cytomegalovirus retinitis in AIDS patients with ganciclovir), myelodysplastic syndromes, aplastic anemia, bone marrow transplantation (to accelerate the recovery of myelopoiesis).

Contraindications

Hypersensitivity, myeloid leukemia.

Application of pregnancy and breastfeeding

Not recommended.

Side effects

Anorexia, nausea, vomiting, diarrhea, abdominal pain, stomatitis, cramps, myalgia, asthenia, headaches, dizziness, paresis, confusion, increased intracranial pressure, cerebral circulatory disorders, arterial hypotension, fainting, heart rhythm disturbances, heart failure, Pulmonary edema, increased capillary permeability, exudative pericarditis, exudative pleurisy, dyspnea, bronchospasm, swelling, fever, bone pain, nonspecific pain in the chest, increased sweating, decreased h Isla platelets, hemoglobin and serum albumin level, rash, itching, angioedema, anaphylactic shock, tenderness at the injection site.

Dosing and Administration

IV or SC - from 1 to 10 mcg / kg per day. The maximum daily dose is 10 mkg / kg. The solution is prepared immediately before administration by dissolving the powder in pyrogen-free or sterile water.

Precautionary measures

It is necessary to constantly monitor blood (leukocytes, leukocyte formula, platelets, hematocrit, albumin concentration, etc.). If severe hypersensitivity reactions develop (anaphylactic shock, angioedema, bronchospasm), exudative pleurisy, exudative pericarditis, treatment is discontinued. With caution appoint a patient with lung disease or an autoimmune pathology in the anamnesis.

Storage conditions of the drug Leucomax

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Leucomax

2 years.

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