Tasonermin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 28, 2026🚩 Report this page

Tasonermin

Other Immunostimulants

Sold as Beromun

EU EMA

Drug class: Other Immunostimulants
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Tasonermin is an active pharmaceutical ingredient in the Other Immunostimulants group (L03AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	May 28, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 28, 2026[1]

Beromun is indicated in adults. as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated limb perfusion (ILP).

How to take

Sources & citations

[1]European Medicines Agency · EMEA/H/C/000206 · revised May 28, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

This treatment should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities for continuous monitoring for medicinal product leakage into the systemic circulation.
Posology Beromun:
Upper limb: 3 mg total dose by ILP Lower limb: 4 mg total dose by ILP Melphalan: Melphalan dose should be calculated according to the litre-volume method of Wieberdink (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
Dosimetry in isolation perfusion of the limbs by assessments of perfused tissue volume and grading of toxic tissue reactions. ), to a maximum dose of 150 mg. 13 mg/l perfused upper limb volume 10 mg/l perfused lower limb volume Paediatric population The safety and efficacy of Beromun in children under 18 years have not been established.
No data are available. 3 Method of administration Precautions to be taken before handling or administering the medicinal product When preparing and handling Beromun solutions, the use of gloves is recommended. If Beromun dry powder or reconstituted solution should come into contact with the skin or mucous membranes, they should be washed thoroughly with water.
6. Beromun should be administered by mild hyperthermic ILP. 30. Perfusion level should be chosen to adequately encompass affected tissue (external iliac, common femoral, femoro-popliteal, popliteal, axillary and brachial being accepted routes) and catheters introduced.
External heat loss from the limb should be prevented by application of thermal blankets and limb temperature continuously monitored by thermistor probes inserted into subcutaneous tissue and muscle. Hand and foot, if not affected, should be protected by Esmarch (expulsion) bandages.
A tourniquet should be applied to the proximal limb. 4). Adjustment of flow rate and tourniquet may be required to ensure leakage from perfusion circuit to systemic circulation is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10 %.
Beromun should only be administered if leakage is less than 10 %. 35, Beromun should be injected as a bolus into the arterial line of the circuit. After 30 minutes perfusion of Beromun alone, melphalan should be added as a bolus into the reservoir of the circuit, or slowly into the arterial line of the circuit.
The temperature should then be increased to >39°C (but not exceeding 40°C) in two different sites of measurement in the tumour area. The duration of the perfusion including melphalan should be 60 minutes. Thus, the duration of the total perfusion should be 90 minutes.
At the end of the perfusion, the perfusate should be collected into the reservoir while washout fluid is added simultaneously to the circuit and circulated at the same flow rate of 35 to 40 ml/litre limb volume/minute. 4). Surgical resection of the tumour remnant should be undertaken whenever possible.
4).

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 28, 2026[1]

Summary of the safety profile Undesirable effects may be related to Beromun, to melphalan, or to the ILP procedure and associated measures, or to a combination of these factors. The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction.
Adverse reactions are either local, affecting the limb treated with ILP, or systemic. Systemic adverse reactions include mild constitutional reactions and toxic effects on different organ systems. Tabulated summary of adverse reactions Adverse reactions have been ranked under headings of frequency using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).
Infections and infestations Common:
Infection, wound infection Uncommon: Sepsis Blood and lymphatic system disorders Common: Leukopenia, thrombocytopenia Immune system disorders Common: Hypersensitivity reaction Nervous system disorders Common: Nerve injury, peripheral neurotoxicity, altered state of consciouness, headache Cardiac disorders Very common: Arrhythmia Common: Cardiac failure Vascular disorders Common: Venous thrombosis, arterial thrombosis, shock, hypotension 8 Uncommon: Peripheral arterial occlusive disease Respiratory, thoracic and mediastinal disorders Common: Adult respiratory distress syndrome Uncommon: Pulmonary oedema Gastrointestinal disorders Very common: Nausea, vomiting Common: Diarrhoea, constipation Uncommon: Abdominal pain upper, gastritis erosive Hepatobiliary disorders Very common: Hepatotoxicity Skin and subcutaneous tissue disorders Very common: Skin reaction Common: Skin necrosis, oedema peripheral Uncommon: Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common: Compartment syndrome, myalgia Renal and urinary disorders Common: Proteinuria Uncommon: Renal failure acute General disorders and administration site conditions Very common: Fever, chills, pain, fatigue Common: Night sweats Investigations Uncommon: Blood creatinine increased Surgical and medical procedures Common: Extremity necrosis, severe enough to warrant amputation Description of selected adverse reactions Extremity necrosis and compartment syndrome might be severe enough to warrant amputation.
Late onset of peripheral arterial occlusive disease (PAOD) of the lower limbs has been reported in patients several years after ILP, predominantly in patients presenting with established cardiovascular risk factors, or who had undergone additional irradiation therapy of the concerned limb.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised May 28, 2026[1]

ILP should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities for continuous monitoring for medicinal product leakage into the systemic circulation.
Beromun must not be administered systemically. Please refer to the Summary of Product Characteristics of melphalan prior to commencing an ILP procedure. 5 Induction of general anaesthesia and subsequent mechanical ventilation should be applied according to standard methods.
It is important to maintain a constant level of anaesthesia in order to prevent large fluctuations in systemic blood pressure, which can affect leakage between systemic circulation and perfusion circuit. During the ILP, central venous pressure and arterial pressure monitoring is strongly recommended.
Furthermore, blood pressure, urine output and electrocardiographic monitoring should be routinely undertaken in the first 24 to 48 hours post-ILP, or longer if indicated. A Swan-Ganz catheter may be considered for monitoring pulmonary artery pressure and wedge pressure during the ILP and in the post-operative period.
Prophylaxis and treatment of fever, chills and other influenza-like symptoms associated with Beromun administration can be achieved by pre-ILP administration of paracetamol (oral or by suppository) or an alternative analgesic/antipyretic.
For the prophylaxis of shock, patients should always be maximally hydrated prior to, during and after the perfusion procedure. This is to ensure optimal haemodynamic conditions and ensure a high urinary output, especially after the perfusion, to allow for rapid clearance of any residual tasonermin.
Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure. Colloids and hydroxyethyl starch fluids are preferred, as they are less likely to leak out of the vascular system.
g. dopamine, can be considered for administration during the ILP procedure, as well as in the post-operative period. In the event of severe shock before the end of the ILP, the limb perfusion should be discontinued and appropriate therapy administered.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drugs in the same class

Sources & citations