Treatment with the drug should be carried out only under the supervision of a doctor who has experience with colony-stimulating factors, provided that the necessary diagnostic capabilities are available.
The safety and efficacy of the drug in patients receiving high-dose chemotherapy have not been studied.The drug should not be used to increase the dose of cytotoxic chemotherapy above the dose set by the regimen.
Patients sensitive to granulocyte colony-stimulating factor or its derivatives are also at risk of developing hypersensitivity reactions to lipagglilgrastim in connection with possible cross-over-hypersensitivity. These patients should not use lipagfilgrastim in connection with the risk of developing a cross-reaction.
Most drugs of biological origin can trigger a response in the form of the appearance of a certain level of anti-drug antibodies. Such a humoral immune response may in some cases lead to the development of undesirable effects or loss of efficacy. If the patient does not respond to treatment, he should undergo further examination.
With the development of a severe allergic reaction, appropriate therapy should be conducted, followed by careful monitoring of the patient for several days.
Treatment with the drug does not prevent the development of thrombocytopenia and anemia caused by myelosuppressive chemotherapy.The drug can also cause thrombocytopenia, so it is recommended to regularly determine the number of platelets and the hematocrit. One-component or combined chemotherapeutic regimens known to be capable of causing severe thrombocytopenia should be used with caution.
Possible development of leukocytosis. No adverse events directly related to leukocytosis have been reported. The increase in the number of leukocytes in the blood corresponds to the pharmacodynamic effects of lipagglilgrastim. Given the clinical effects of lipagglilgrastim and the possible risk of leukocytosis, lipagfilgrastim should be monitored regularly during the treatment with the number of leukocytes. If the number of white blood cells after the estimated minimum level exceeds 50×109 / l, treatment with lipagfilgrastim should be immediately terminated.
The increased hematopoietic activity of bone marrow in response to therapy with growth factors leads to transient positive changes in the visualization of bones, which should be taken into account when interpreting the results of radionuclide scintigraphy.
With myelodysplastic syndrome and chronic myelogenous leukemia, the efficacy and safety of the drug have not been established. Patients with the aforementioned diseases, as well as with premalignant lesions of the myeloid germ of hematopoiesis, are not indicated. Particular attention should be paid to a differential diagnosis between the blast crisis of chronic myelogenous leukemia and acute myelogenous leukemia.
When applying granulocyte colony-stimulating factor cases of splenomegaly proceeding asymptomatically, and rupture of the spleen, including fatal cases, have been reported. When using the drug should monitor the size of the spleen (clinical examination, ultrasound). Spleen rupture should be suspected when there is pain in the upper left quadrant of the abdomen and pain in the upper part of the left shoulder. After application of the drug, adverse events were reported from the lungs, in particular, interstitial pneumonia. Patients with recent pulmonary infiltrates or pneumonia may have a higher risk of developing such adverse events.Symptoms of lung injury, such as cough, fever and shortness of breath, combined with pulmonary infiltrates confirmed by an X-ray study, accompanied by impairment of lung function and an increase in the number of neutrophils, can serve as first signs adult respiratory distress syndrome. In this case, discontinue use of the drug and conduct appropriate therapy.
The development of sickle-cell crisis was associated with the use of granulocyte colony-stimulating factor or its derivatives in patients with sickle-cell anemia. therefore lipagfilgrastim should be used with caution in patients with sickle-cell anemia, carefully monitor the relevant clinical and laboratory indicators, taking into account the possible increase in the spleen and the development of blood vessel thrombosis during drug therapy.
In patients with an increased risk of hypokalemia due to concomitant disease or simultaneous use of other drugs that cause hypokalemia, it is recommended to monitor the potassium content in the blood plasma.
The sodium content in 0.6 ml of a solution of lipagglilgrastim (one syringe) of less than 1 mmol (23 mg) is not clinically significant.
Due to the fact that the composition of the drug is sorbitol, this drug is not recommended in patients with hereditary fructose intolerance, sugarase / isomaltase insufficiency, glucose-galactose malabsorption syndrome.
Impact on the ability to drive vehicles and manage mechanisms
Lipagfilgrastim does not significantly affect the ability to drive vehicles and work with machinery. Patients should be warned about the possibility of developing dizziness. When dizziness occurs, you should refrain from performing these activities.