Filgrastim

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Filgrastim

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Neupomax can be administered by daily subcutaneous (sc) injection or daily short (30 minute) intravenous (iv) infusion. Also, the drug can be administered in the form of 24-hour intravenous or subcutaneous infusion.

The choice of route of administration should depend on the specific clinical situation, but in most cases, the subcutaneous route of administration is preferred.

In order to avoid pain, with the introduction it is best to change the injection site daily.

Standard Cytotoxic Chemotherapy Schemes 
At 5 mcg / kg of body weight 1 time per day, daily subcutaneously or intravenously, for 30 minutes. until, after the occurrence of the expected maximum reduction in the level of neutrophils, their number does not return to the normal level, at which the drug can be canceled.

The first dose of Neipomax should be administered no earlier than 24 hours after the end of the course of cytotoxic chemotherapy. The duration of therapy is up to 14 days. After induction and consolidation therapy of acute myeloid leukemia, the duration of use of Neipomax may increase up to 38 days depending on the type, doses and chemotherapy regimen used.

Usually a transient increase in the number of neutrophils is observed 1-2 days after the start of treatment with filgrastim. To achieve a stable therapeutic effect, it is not recommended to interrupt treatment until normal neutrophil values ​​are reached after the expected maximum reduction in their level. With an absolute number of neutrophils in excess of 10,000 / μl, treatment with Neipomax is stopped.

Myeloablative therapy followed by autologous or allogeneic bone marrow transplantation 
The initial dose is 10 mcg / kg per day intravenous drip for 30 minutes or 24 hours, or as a 24-hour s / c infusion.

The first dose of Neipomax should be administered no earlier than 24 hours after cytotoxic chemotherapy, and for bone marrow transplantation, no later than 24 hours.

The duration of therapy is not more than 28 days. The daily dose of the drug is corrected depending on the dynamics of the content of neutrophils. With an absolute neutrophil count of more than 1000 / μl for three consecutive days, the dose of Neipomax is reduced to 5 μg / kg / day. If during the use of this dose for another 3 consecutive days, the absolute number of neutrophils exceeds 1000 / mcl, the administration of Neupmax is stopped. If during treatment the absolute number of neutrophils is reduced to a level of less than 1000 / μl, the dose of Neipomax is increased again, in accordance with the above scheme.

Mobilization of peripheral blood stem cells in patients with neoplastic diseases. 
At 10 mcg / kg 1 time per day, s / c or by continuous 24-hour s / c infusion for 6 consecutive days. In this case, they usually spend 2 leukapheresis in a row, on the 5th and 6th days. In the case of additional leukapheresis, administration of Neipomax should be continued until the last leukapheresis.

Mobilization of PSKK after myelosuppressive chemotherapy 
At 5 mcg / kg per day by daily subcutaneous injections, starting from the first day after completion of chemotherapy and until the number of neutrophils reaches normal values. Leukapheresis should be carried out only when the absolute number of neutrophils exceeds normal values ​​(> 2000 / μl).

Mobilization of PSCC in healthy donors for allogeneic transplantation 
At 10 mcg / kg / day s / c for 4-5 days and carrying out 1 or 2 leukapheresis usually allows you to get more than 4 x 106 CD34 + cells / kg body weight of the recipient. There are no data on the safety and efficacy of filgrastim in healthy donors younger than 16 and older than 60 years.

Severe chronic neutropenia (TCN) 
Neupomax administered at an initial dose of 12 mcg / kg / day for congenital neutropenia and 5 mcg / kg / day for idiopathic or periodic neutropenia subcutaneously once or by several injections daily until the number of neutrophils consistently exceeds 1500 / mcl.After reaching a therapeutic effect, determine the minimum effective dose to maintain this level. After 1-2 weeks of treatment, the initial dose can be doubled or reduced by half, depending on the patient's response to therapy. Subsequently, every 1–2 weeks, individual dose adjustment can be made to maintain the average number of neutrophils in the range of 1500–10,000 / μl. In patients with severe infections, a regimen with a faster dose increase can be applied. The safety of filgrastim in the long-term treatment of patients with TCN doses of more than 24 mg per day has not been established.

Neutropenia in HIV infection 
The initial dose of 1-4 mcg (0.1 -0.4 million units) / kg subcutaneously 1 time per day until normalization of the number of neutrophils. The maximum daily dose should not exceed 10 mcg / kg. After achieving a therapeutic effect, it is recommended to apply Grasalva in a maintenance dose: 300 μg of s / c every other day. Subsequently, doses are adjusted individually for each individual case in order to maintain an average neutrophil count of more than 2000 / μl.

Application in children's practice 
Dosing recommendations for pediatric patients are the same as for adults.

Elderly patients, patients with impaired renal or hepatic function. 
Neapomax dose adjustment is not required.

Breeding instructions 
Subcutaneous the drug should not be further diluted.

When preparing a solution for infusion Neupomax diluted with only 5% dextrose solution. Dilution with 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibility).

Neupomax in diluted form in a concentration of from 2 to 15 μg / ml can be adsorbed by glass and plastics. In this case, to prevent absorption, it is necessary to add human serum albumin in the required amount to achieve its concentration in the final solution of 2 mg / ml. For a diluted solution of Neipomax at a concentration of more than 15 μg / ml, the addition of albumin is not required.

It is impossible to dilute Neipomaks to a concentration of less than 2 μg / ml.

Adverse reactions

From the musculoskeletal system:pains in bones, muscles and joints, osteoporosis.

From the digestive system: anorexia, diarrhea, hepatomegaly, nausea and vomiting.

Allergic reactions: skin rash, urticaria, swelling of the face, wheezing, shortness of breath, lowering blood pressure, tachycardia.

From the side of blood-forming organs: neutrophilia and leukocytosis (as a result of the pharmacological action of filgrastim), anemia, thrombocytopenia, enlargement and rupture of the spleen.

On the part of the respiratory system: adult respiratory distress syndrome, pulmonary infiltrates.

Since the cardiovascular system: decrease or increase in blood pressure, cutaneous vasculitis.

From the laboratory indicators: reversible increase in lactate dehydrogenase, alkaline phosphatase, gamma-glutamyltransferase, uric acid, transient hypoglycemia after a meal; very rarely: proteinuria, hematuria.

Other: headache, fatigue, weakness, nosebleeds, petechiae, erythema nodosum.

Contraindications

Hypersensitivity, severe congenital neutropenia with abnormal cytogenetics (Kostmann syndrome), increased doses of cytotoxic chemotherapeutic agents higher than recommended, hepatic and / or renal failure, up to 1 year old.

Special instructions