NEULASTIM

Active material: Pegfilgrastim
When ATH: L03AA13
CCF: Stimulator leykopoeza
ICD-10 codes (testimony): D70
When CSF: 19.01.01.01
Manufacturer: F.Hoffmann-La Roche Ltd. (Switzerland)

DOSAGE FORM, COMPOSITION AND PACKAGING

The solution for the p / to the introduction clear, colorless.

Excipients: sodium acetate, sorbitol, polysorbate 20, water d / and.

0.6 ml – ampin (1) complete with needles d/and (1 PC.) polyethylene tube – packs cardboard.

Pharmacological action

Stimulator leykopoeza. Pegfilgrastim – Covalent conjugate of Filgrastim, recombinant human granulocyte colony stimulating factor (G-CSF), with one molecule of polyethylene glycol (PEG) 20 kDa, Sustained action by reducing renal clearance. Similarly filgrastim, pègfilgrastim regulates the formation and release of neutrophils from the bone marrow, markedly increases the number of neutrophils to normal or increased functional activity (chemotaxis and phagocytosis) in the peripheral blood for 24 h and causes a slight increase in the number of monocytes and / or lymphocytes.

G-CSF stimulates endothelial cells and may accelerate the growth of myeloid cells, including malignant cells, and some nemieloidnye cells in vitro. One pègfilgrastima after each cycle mielosupressivnoj zitostaticescoy therapy reduces the duration of neutropenia and the incidence of febrile neutropenia is similar to the daily introduction of Filgrastim (average, 11 ezhednevnыh introduced).

Pharmacokinetics

Absorption

After a single p/to the introduction of time (C)_max pègfilgrastima 16-120 no. Pegfilgrastima concentration in serum is maintained during the period of neutropenia after myelosuppressive chemotherapy.

Deduction

Derivation of nonlinear pègfilgrastima, dose-dependent, saturable. Clearance, primarily, carried out by neutrophils and decreases with increasing dose pègfilgrastima. In accordance with the self-tracking clearance, pègfilgrastima concentration in the serum declines rapidly with the onset of recovery in the number of Klebsiella.

Pharmacokinetics in special clinical situations

Given clearance involving neutrophils, probably, that the pharmacokinetics pègfilgrastima is not changed when renal or hepatic insufficiency.

Pharmacokinetics pègfilgrastima in patients over 65 years is similar to that of pharmacokinetics in adults.

Testimony

-neutropenia, febrile neutropenia in order to reduce the duration of neutropenia and febrile neutropenia in intensive myelosuppressive cytotoxic chemotherapy for malignant diseases.

Dosage regimen

The preparation appoint p/dose 6 mg (1 ampin) through 24 hours after each cycle of cytotoxic chemotherapy.

Recommendations for use at Neulastima children and adolescents under the age of 18 years no (insufficient data).

Instructions for use, treatment and destruction

Spric-tubik from drug Neulastim is intended for one-time use only.

Neulastim product is a sterile solution without preservatives.

Before the introduction of mortar Neulastima should inspect for the presence of extraneous visible particles. Can be entered only transparent and colorless solution.

Excessive shaking can destroy pègfilgrastim, making it biologically inactive.

Before injection solution in the syringe should be warm to room temperature.

Any unused product or its residues should be disposed of in accordance with the sanitary requirements.

Product Neulastim can be stored at room temperature (not higher than 30 ° C) within a maximum period of not more than a single 72 no.

Product Neulastim, After he was exposed at room temperature for more than 72 no, should not be used.

Accidental exposure to freezing temperatures during a single period of less 24 h has no negative impact on the stability of Neulastima.

Side effect

Side effects are marked with the following frequency: Often (>10%), often (>1%, but <10%):

On the part of the musculoskeletal system: Often (26%) – mild or moderate pain in the bones, that, In most cases, tested alone or cropped conventional analgesics; often – arthralgia, myalgia, back pain, limbs and neck.

CNS: often – headache.

The respiratory system: cough, breathlessness, pulmonary infiltrates, respiratory dysfunction, respiratory distress syndrome.

From the side of hematopoiesis: splenomegaly, pain in the upper left quadrant of the abdomen; rarely – thrombosis vessels; rarely – splenic rupture, leukocytosis.

From the digestive system: nausea (<1%).

From the body as a whole: often – chest pain (noncardia), fever.

From the laboratory parameters: obratimoe, slight to moderate clinically insignificant increase in uric acid (7%), Alkaline phosphatase (10%) and LDH (20%).

Allergic reactions: anaphylaxis, rash, hives, angioedema, dyspnea, and hypotension, at the beginning or during the subsequent introduction. Sometimes resumption of treatment is accompanied by recurrent symptoms.

Local reactions: pain at the injection site.

Contraindications

-neutropenia with chronic mielolakose and mielodisplastičeskih syndromes;

-acute leukemia;

— to increase the doses of cytotoxic chemotherapy dosing regimes installed above;

— the simultaneous appointment with cytotoxic chemotherapy- and radiotherapy;

- Pregnancy;

- Lactation (breast-feeding);

- Up to 18 years;

-hypersensitivity to pègfilgrastimu, filgrastimu or to any other component of the drug.

FROM caution should designate product in malignant and myeloid diseases, pretumorous nature (in t. no. de novo acute myeloid leukemia and secondary); in combination with high-dose chemotherapy; when sickle-cell anemia.

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breast-feeding).

Cautions

Neulastimom treatment should be carried out only under the supervision of hematologist or oncologist, with experience in the use of G-CSF.

Neulastim should not be used in patients with acute leukemia, receiving myelosuppressive chemotherapy (safety and efficacy have not been studied pègfilgrastima).

The safety and efficacy of Neulastima in patients, treated with high-dose chemotherapy has not been studied.

Cough, fever and dyspnea in combination with radiological infiltrative changes, deterioration in lung function and increase the number of neutrophils can be signs of respiratory distress syndrome in adults (RDS). Then, at the discretion of the doctor Neulastim should be repealed and assign appropriate treatment.

Registered separate cases of splenic rupture after application of granulocyte colony stimulating factor, some – fatal.

Provision should be made for the possibility of a rupture of the spleen in patients with complaints of pain in the upper left part of the abdomen or in the top of the left shoulder.

Monotherapy Neulastimom does not exclude the development of thrombocytopenia and anemia if you continue mielosupressivnoj chemotherapy in the full dose. It is recommended that regular monitoring of platelet count and hematocrit.

In patients with sickle cell anemia, leukocytosis is a poor prognostic factor, so they need regular blood tests to perform, and to consider the possibility of splenomegaly and thrombosis.

Leucocytosis ≥ 100 x10⁹/l is less, than 1% patients, receiving Neulastim, It is temporary and usually observed after 24-48 hours after drug administration, in accordance with its pharmacodynamic effects. There are no side effects, directly linked with leukocytosis, not disclosed.

The safety and efficacy of pègfilgrastima in the mobilization of peripheral blood stem cells in patients and healthy donors were not appropriately.

Overdose

Cases of overdose not mentioned.

Drug Interactions

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic therapy, Neulastim must be entered through the 24 hours after administration of cytotoxic chemotherapeutic agents.

When concomitant administration of 5-fluorouracil or other antimetabolites possible potentiation of bone marrow suppression in vivo.

Interaction with other growth factors and cytokines haemopoetic unknown.

The ability to interact with lithium, that also contributes to the release of neutrophils, not specifically explored. No confirmation, This interaction can be dangerous.

Research, on specific interactions or metabolize, not performed.

Signs of Neulastima interaction with other drugs currently not fixed.

Pharmaceutical interaction

Neulastim is not compatible with the solution of sodium chloride.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at 2 ° to 8 ° C; Do not freeze. Shelf life – 2 year.