What is Tasonermin used for?

Indicated in adults as an adjunct to surgery for subsequent tumour removal, to prevent or delay amputation, or as palliative treatment of irresectable soft tissue sarcomas of the limbs, in combination with melphalan, via mild hyperthermic isolated limb perfusion (ILP). Indicated in adults as an adjunct to surgery for subsequent tumour removal, to prevent or delay amputation, or as palliative treatment of irresectable soft tissue sarcomas of the limbs, in combination with melphalan, via mild hyp

What pharmaceutical form is Tasonermin available in?

Tasonermin: Proszek do sporządzania roztworu do infuzji 1 mg (dotętnicza)

Is Tasonermin OTC or prescription only?

Tasonermin requires a doctor's prescription.

What are the side effects of Tasonermin?

The most frequently reported adverse reactions in clinical trials were pyrexia, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction. Adverse reactions may be local, affecting the limb treated by ILP, or systemic. Systemic adverse reactions include mild constitutional reactions and toxic effects on different organ systems. Infections and infestations Common: infection, wound infection Uncommon: Sepsis Blood and lymphatic system disorders Common: Leucopenia, thro

What ATC class does Tasonermin belong to?

Tasonermin: ATC L03AX11. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Tasonermin

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Tasonermin — Description, Dosage, Side Effects | PillsCard

The in vivo antitumour activity is probably based on both direct and indirect effects. Direct inhibition of tumour cell proliferation: Tasonermin exhibits cytotoxic or cytostatic activity in vitro against a variety of tumour cell lines of different histiogenesis. Direct effects on tumour vasculature: Tasonermin affects the morphology and reduces proliferation of endothelial cells and modifies the expression of specific cell surface and secretory proteins (including adhesion molecules and coagulation-modulating proteins, interleukins and haematopoietic growth factors). These changes in turn lead to a procoagulant state resulting in microvascular thrombosis. Fu‍‍‍‍‍‍‍‍‍‍‍‍‍rthermore, leucocyte adherence and extravasation increase, leading to tumour infiltration by lymphocytes, monocytes and granulocytes. The reason for the differential sensitivity of tumour vasculature (high) versus normal vasculature (low) is currently unknown. Direct and indirect immunomodulation: Tasonermin has a profound effect on the cellular components of the immune system. Proliferation of activated T- and B-lymphocytes occurs, as does the development of cytotoxic T cells and an increase in immunoglobulin-secreting cells; monocytes/macrophages are activated to destroy tumour cells; granulocytes become activated such that they have enhanced phagocytic activity, respiratory burst and degranulation occur, and adherence to endothelium increases. In addition to these direct effects, tasonermin modulates the immune response by inducing the production of cytokines as well as low-molecular-weight mediators (prostaglandins and platelet-activating factor). Certain lines of evidence suggest that these immunomodulatory activities are relevant to the antitumour effects; for example, the antitumour activities of tasonermin are much less pronounced in immunodeficient animals. Additionally, animals that reject experimental tumours following treatment with tasonermin can develop specific immunity to that type of tumour cell.

⚠️ Warnings

Pregnancy Pregnancy: Tasonermin is contraindicated during pregnancy. Breast-feeding Breast-feeding: Breast-feeding is contraindicated for 7 days following ILP. ILP must be performed in specialised centres and by surgical teams experienced in the management of limb sarcomas and the ILP procedure, with rapid access to an intensive care unit and continuous monitoring for potential leakage of the medicinal product into the systemic circulation. Tasonermin must not be administered systemically. Induction of general anaesthesia and subsequent mechanical ventilation must be performed according to standard methods. It is important to maintain a constant level of anaesthesia to prevent major fluctuations in systemic blood pressure, which may influence leakage between the systemic circulation and the perfusion circuit. During the ILP procedure, monitoring of central venous and arterial pressure is strongly recommended. Blood pressure, urinary output and electrocardiographic monitoring should also be performed routinely for the first 24 to 48 hours post-ILP, or longer if indicated. Haemodynamic monitoring with a Swan-Ganz pulmonary artery wedge pressure catheter should be considered for pulmonary artery pressure monitoring during and after the ILP procedure. Prophylaxis and treatment of pyrexia, chills and other influenza-like symptoms associated with the administration of Tasonermin may be achieved through pre-ILP administration of paracetamol (oral or rectal) or an alternative analgesic/antipyretic. For the prophylaxis of shock, patients must always be well hydrated before, during and after the perfusion procedure. This ensures optimal haemodynamic conditions and ensures a high urinary output, particularly after perfusion, in order to allow rapid clearance of any residual tasonermin. Additional resuscitation fluids (crystalloid or colloid solutions) should be available for volume expansion in the event of a significant fall in blood pressure. Colloids or hydroxyethyl starch fluids are preferred as they are less likely to leak from the vascular system. Additionally, according to the clinical situation, consideration should be given to the administration of a vasoconstrictive agent, e.g.‍‍‍‍‍‍‍‍‍‍‍‍‍ dopamine, during the ILP procedure as well as in the post-procedure period. In the event of severe shock before completion of the ILP, limb perfusion should be discontinued and appropriate therapy administered. In order to minimise the risk of perfusate leakage into the systemic circulation, the perfusion rate must not exceed 40 ml/litre limb volume/minute. Potential leakage must be determined using radioactively labelled albumin or erythrocytes injected into the perfusion circuit, with appropriate measures for continuous monitoring of radioactivity in the systemic circulation. It may be necessary to adjust the perfusion rate and tourniquet to ensure that leakage is stable (when the systemic level of radioactivity has reached a plateau) and does not exceed 10%. Perfusion must be terminated if cumulative leakage levels into the systemic circulation exceed 10%. In such cases, a standard washout procedure must be performed using at least two litres of dextran 70 for intravenous infusion or another similar fluid. Following the ILP procedure, a standard washout procedure using dextran 70 for intravenous infusion or another similar fluid must always be performed. Following lower limb perfusion, 3 to 6 litres should be used, and 1 to 2 litres following upper limb perfusion. Popliteal and brachial perfusions may not require more than 1 litre. Washout should continue until a clear (pink, transparent) venous flow is obtained. Measures should be taken to ensure that periods of interruption of oxygen supply to the limb are as brief as possible (20 minutes maximum). Surgical resection of any remaining tumour should be performed whenever possible. If necessary, a second ILP procedure may be considered 6–8 weeks after the first. Physicians should take into account the leakage rate of the previous ILP if a second ILP is indicated. The maximum tolerated dose (MTD) of tasonermin for ILP is 4 mg, which is 10 times the systemic MTD. Therefore, whenever significant systemic leakage of tasonermin occurs, serious adverse effects are to be expected. Doses of up to 6 mg of other TNFα preparations have been administered via ILP, but this dose was found to be unacceptable in terms of locoregional toxicity. Combination with cardiotoxic substances (e.g. anthracyclines) should be avoided, as tasonermin may increase cardiotoxicity, as observed in 13-week preclinical toxicology studies. Concomitant administration of substances that may cause significant hypotension is not recommended. Several therapeutic measures are generally used during ILP and in the immediate postoperative period. These include anaesthetic agents, analgesics, antipyretics, intravenous fluids, anticoagulant agents and vasopressors. There is no evidence that any of these agents counteracts the pharmacodynamic effects of tasonermin. No significant interactions have been reported to date, but caution is recommended. If signs of systemic toxicity appear, e.g. pyrexia, cardiac arrhythmias, shock/hypotension, adult respiratory distress syndrome (ARDS), general supportive measures should be applied and the patient transferred to an Intensive Care Unit for monitoring. Volume expanders and vasoconstrictors are recommended. Artificial respiratory support may be necessary if ARDS develops. Renal and hepatic function must be carefully monitored. Haematological dysfunctions, particularly leucopenia, thrombocytopenia and coagulation disorders, may be expected. In isolated patients treated with Tasonermin, cases of compartment syndrome characterised by pain, swelling and neurological symptoms as well as muscle injury affecting the perfused limb have been observed. Consequently, patients should be monitored during the first three days following ILP. If a diagnosis of compartment syndrome is established, the following therapy should be considered: - Fasciotomy of all muscle compartments of the affected limb, - Forced diuresis and alkalinisation of the urine if muscle injury with elevated myoglobin levels in plasma and urine occurs.

Tasonermin

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