Description
Release form
Solution for intravenous and subcutaneous administration
Packing
5 vials of 1 ml.
Indications
Neutropenia (including in patients receiving cytostatic drugs for non-myeloid malignancies)
reduction in the duration of the neutropenia period and its clinical consequences in patients preparing for bone marrow transplantation
persistent neutropenia in patients with advanced HIV infection (absolute neutrophil count 1000 cells / μl or less)
mobilization peripheral stem cells (including after myelosuppressive therapy)
neutropenia (hereditary, periodic or idiopathic – the number of neutrophils is lower than or equal to but 500 cells / μl) and severe or recurring infections (history) in the last 12 months.
Contraindications
Hypersensitivity, severe congenital neutropenia with abnormal cytogenetics (Costmann syndrome), increased doses of cytotoxic chemotherapeutic agents are higher than recommended, hepatic and / or renal failure, age up to 1 year.
Special instructions for
blood tests should be performed during treatment with Neupomax
Composition
Active ingredient: filgrastim 300 mcg (30 MU)
Excipients: glacial acetic acid, sodium hydroxide (sodium hydroxide), sorbitol (sorbitol), polysorbate 80, water for injection
Dosage and Administration
Neupomax can be administered by daily subcutaneous (s / c) injection or daily short (30-minute) intravenous (iv) infusions. Also, the drug can be administered in the form of 24 hour intravenous or subcutaneous infusions.
The choice of route of administration should depend on the particular clinical situation, but in most cases, subcutaneous route of administration is preferred.
In order to avoid pain, it is best to change the injection site daily when administered.
Standard cytotoxic chemotherapy regimens
5 ?g / kg body weight 1 time per day daily subcutaneously or iv in a drip for 30 minutes. until, after the expected maximum decrease in the level of neutrophils, their number does not return to normal, at which the drug can be canceled.
The first dose of Neupomax 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 myelogenous leukemia, the duration of Neupomax may increase to 38 days, depending on the type, dose 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, interrupting treatment until normal neutrophils are reached after the expected maximum decrease in their level is not recommended. When the absolute number of neutrophils exceeds 10,000 / ?l, treatment with Neupomax is stopped.
Myelo-ablative therapy followed by autologous or allogeneic bone marrow transplantation
Initial dose is 10 mcg / kg per day by intravenous drip for 30 min or 24 hours, or as a 24-hour subcutaneous infusion.
The first dose of Neupomax should be administered no earlier than 24 hours after cytotoxic chemotherapy, and for bone marrow transplantation – no later than 24 hours.
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 / ?l for three consecutive days, the dose of Neupomax is reduced to 5 ?g / kg / day. If when applying this dose for an additional 3 consecutive days, the absolute number of neutrophils exceeds 1000 / ?l, the introduction of Neupomax is stopped. If during treatment the absolute number of neutrophils decreases to less than 1000 / ?l, the dose of Neupomax is increased again, in accordance with the above scheme.
Mobilization of peripheral blood stem cells in patients with tumor diseases.
At 10 mcg / kg 1 time per day sc or by continuous 24-hour sc infusion for 6 consecutive days. In this case, 2 leukapheresis is usually carried out in a row, on the 5th and 6th days. In case of additional leukapheresis, the administration of Neupomax should be continued until the last leukapheresis.
Mobilization of PSCA after myelosuppressive chemotherapy
5 mcg / kg daily by subcutaneous injection, starting from the first day after chemotherapy is completed and until the number of neutrophils reaches normal values. Leukapheresis should be performed only when the absolute number of neutrophils exceeds normal values ??(> 2000 / ?l).
Mobilization of PSCC in healthy donors for allogeneic
transplantation 10 ?g / kg / day sc for 4-5 days and 1 or 2 leukapheresis usually allows more than 4 x 106 CD34 + cells / kg of recipient body weight. 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 is given 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 several times daily until the neutrophil count stably exceed 1500 / µl. After the therapeutic effect is achieved, the minimum effective dose is determined to maintain this level. 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, you can make an individual dose adjustment to maintain the average number of neutrophils in the range of 1500-10000 / ?l. In patients with severe infections, a regimen with a more rapid increase in dose can be used. The safety of filgrastim during long-term treatment of patients with TCH with doses of more than 24 mcg per day has not been established.
Neutropenia for HIV infection
Initial dose of 1 -4 mcg (0.1 -0.4 million units) / kg subcutaneously 1 time per day until the number of neutrophils normalizes. The maximum daily dose should not exceed 10 mcg / kg. After achieving a therapeutic effect, it is recommended to use Grasalva in a maintenance dose: 300 mcg s / c every other day. Subsequently, the doses are corrected in each individual case separately to maintain the average number of neutrophils greater than 2000 / ?l.
Application in pediatric practice
Dosing recommendations for pediatric patients are the same as for adults.
Elderly patients, patients with impaired renal or hepatic function.
Neupomax dose adjustment not required.
Directions for dilution
If subcutaneously administered, the drug should not be diluted further.
When preparing a solution for infusion, Neupomax is diluted with only 5% dextrose solution. Dilution with 0.9% sodium chloride solution is not allowed (pharmaceutical incompatibility).
Neupomax diluted in a concentration of 2 to 15 ?g / ml can be adsorbed by glass and plastics. In this case, to prevent absorption in the solution, 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 diluted Neupomax solution in a concentration of more than 15 ?g / ml, albumin is not required.
Neupomax cannot be diluted to a concentration of less than 2 ?g / ml.
Side effects
From the musculoskeletal system: pain in the 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 hemopoietic 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, lung infiltrates.
From the cardiovascular system: lowering or increasing blood pressure, skin vasculitis.
From the laboratory side: a reversible increase in the content of lactate dehydrogenase, alkaline phosphatase, gamma-glutamyl transferase, uric acid, transient hypoglycemia after eating is very rare: proteinuria, hematuria.
Other: headache, fatigue, general weakness, nosebleeds, petechiae, erythema nodosum.
Storage conditions
In a dark place at a temperature of 2 8 ° C (do not freeze).
Expiration
2 years
Active ingredient
Filgrastim
Pharmstandard-Ufavita, Russia
