Recurrent thrombocytopenia and bleeding after withdrawal of treatment.
After the abolition of Romiplostima, a relapse of thrombocytopenia is possible. In the event that the abolition of romiplostime occurs against the background of anticoagulants or antiplatelet agents, the risk of bleeding increases. Patients should be closely monitored for the timely detection of a decrease in the number of platelets and to prevent bleeding after the abolition of Romiplostima.When discontinuing therapy with Romiplotome, it is recommended that the therapy be re-started in accordance with the current treatment guidelines idiopathic thrombocytopenic purpura. Additional medical purposes may include the abolition of anticoagulants and / or antiaggregants or transfusion of thrombomass.
Increased reticulin in the bone marrow.
Increasing concentrations reticulin in bone marrow considered to be due to thrombopoietin receptor stimulation, leading to increase in the number of megakaryocytes in the bone marrow, which may subsequently facilitate release of cytokines. An increase in the concentration of reticulin can be suspected by the morphological changes in peripheral blood cells, and determined by bone marrow biopsy. Thus, before and during treatment with Romiplotome, it is recommended that a study of the smear of peripheral blood and counting the number of blood cells is recommended. In case of loss of efficacy, or detection of pathology in the smear of peripheral blood in a patient, it is necessary to cancel Romiplastim, conduct a physical examination,and consider the question of conducting bone marrow biopsy with staining on reticulin.
If possible, biopsy results should be compared with previous results. If the efficacy persists and pathology in the peripheral blood smear is observed, the physician should conduct an adequate clinical evaluation, including the decision to conduct bone marrow biopsy. It is also necessary to determine the risk / benefit ratio for romiplostima, and to review the possibilities of prescribing alternative therapy idiopathic thrombocytopenic purpura.
Thrombotic / thromboembolic complications.
The number of platelets exceeding the norm is a theoretical risk factor for the development of thrombotic / thromboembolic complications. The number of thrombotic / thromboembolic complications observed in clinical trials was the same for romiplostim and placebo, and the relationship between these complications and the increase in the number of platelets was not established. Follow the guidelines for dose adjustment.
Progression of existing malignant diseases of the hemopoietic system or myelodysplastic syndrome (MDS).
Stimulators of thrombopoietin receptors are growth factors that lead to growth of hematopoietic progenitor cells, differentiation, and platelet production. Thrombopoietin receptors are predominantly located on the surface of myeloid cells. There is a theoretical risk that stimulators of thrombopoietin receptors can stimulate the progression of existing malignant diseases of the hematopoiesis system or myelodysplastic syndrome.
Do not use Romiplastim for the treatment of thrombocytopenia associated with myelodysplastic syndrome or any other reason other than anddiopathic thrombocytopenic purpura outside clinical trials. In groups of patients with thrombocytopenia associated with myelodysplastic syndrome or any other reason other than anddiopathic thrombocytopenic purpura, the risk / benefit ratio for romiplostime is not defined. In an incomparable open clinical study of the treatment of patients with myelodysplastic syndrome Romiplostim observed cases of progression of the disease to acute myeloid leukemia,although this pathology is the expected outcome myelodysplastic syndrome, and the relationship with romiplostimom not established. In addition, in this study there have been cases of transient growth of blast cells. Transient increase in blast cells was reversible, and disappeared after the abolition of Romiplostima. This fact does not confirm the progression acute myeloid leukemia, since it is impossible to distinguish leukemic blast cells from normal blast cells.
Lack of response to romiplostim therapy
If you lose a response to treatment or can not maintain a stable amount of platelets in the treatment with Romiplostim at recommended doses, you need to establish the causative factors, including immunogenicity and an increase in the concentration of reticulin in the bone marrow.
The effect of Romiplostim on red and white blood cells
Changes in the number of red (decrease) and white (increase) in blood cells were observed during preclinical studies of drug toxicity (in rats and monkeys), but not in patients with anddiopathic thrombocytopenic purpura. It is necessary to determine the need to monitor these parameters in patients,receiving treatment with rhyplostim.
Impact on the ability to drive vehicles and manage mechanisms.
There has been no research on the impact on the ability to drive a car and control the mechanisms of research. During clinical trials, some patients experienced transient dizziness attacks, which could affect the ability to drive and control machinery.