EmboCept® S

EmboCept40pxEmboCept® S

 
 
 
 
 

material Amilomer (DSM 35/50)
DSM Degradable Starch Microsphere
half-life 35 minutes
size of microsphere   50 µm
complete degradation 2 hours
indication temporary occlusion in the intra-arterial treatment of liver tumors in combination with cytostatic agents for maximizing the intra-tumoral drug accumulation. (TransArterial ChemoEmbolisation, DSM-TACE)
package size 450 mg amilomer in 7.5 ml saline solution
reference code PZN 07421383 (item reference code when placing an order)

medical device – only available on prescription

PZN 07421383
 

Active pharmaceutical ingredient

Amilomer – potato starch

Galenics

DSM: Degradable Starch Microspheres
Active substance: Amilomer
Particles’ size: 50 μm
Half- life time: approx. 35 min
Molecular sizes of the break-up products: 100-106 Dalton

Pharmacology / Pharmacokinetics

The starch microspheres consist of a three-dimensional, cross linked hydrophilic starch matrix, which swells heavily in a water suspension environment (the specific diameter refers to its swollen state) and are completely degradable by amylase. When applying EmboCept® S intra-arterially, this process leads to a temporary occlusion of the smaller arterial vessels. The amount of administered embolizate reflects on the reduction of blood flow in the respective target organ.

In combination with a chemotherapeutic agent it has the following advantages:

Specific accumulation of the same active substance administered in the tumour-affected area
Lower systemic levels of the active substance (significant reduction of side effects’ rate)
Tumour damage after a brief ischaemic effect
Short-term repeatability of chemoembolization
 

Working mechanism

Preferred accumulation of the applied active substances in the tissues affected by tumours
Lessened pressure on the liver’s parenchyma as result of elutriation through the portal veins
Lessened system’s active substances concentration
Improved blood circulation in the ischaemic areas affected by the tumour (arterial)

Application

EmboCept® S suspension for injection is an adjuvant for the inter-arterial therapy of tumours in combination with cytostatic drugs and other active substances / therapy methods, like:

Chemotherapeutics
Cytokines
Gene therapy medicinal products
Conducting thermo-ablations (LITT, RF)

Indication

EmboCept® S (Amilomer, DSM 50) – a purposeful and flexibly combinable component of the individualised loco-regional therapies of liver and lung tumours

DSM in the HCC therapy
DSM in the liver metastases of CRC therapy
DSM in the liver metastases of pancreatic cancer therapy
DSM in the liver metastases of other primary tumours therapy
DSM in the lung tumours therapy
DSM in combination with thermal ablations’ application
 

Therapy objectives

Improvement of the therapeutic index of the active substances applied
Improved quality of life
Prolongation of the patient survival

Tolerability and side-effects

EmboCept® S is a very well tolerated chemoembolization. However, within a relatively short time half-life time and as a result of a short ischaemic period, this therapy can cause some rare side effects.
These can be:

Pains in the area of the treated organs due to vessels closure (usually occur approximately after 30 – 60 minutes and disappear after approximately after 1 hour),
Discomfort in the epigastric region (ischaemic pains)
Temporary function disorders of the treated organ (e.g. increased liver activity)
Breathing disorders (uncommon and reversible after approximately 15 minutes)

In order to reduce the pain of the application, Premedication is recommended.*

Active substance Dosage / Application Point in time
Decortin / Prednison 100 mg / i.v. (short infusion) 20 min. before TACE
Zofran / Ondansetron 8 mg / i.v. Immediately before TACE
Dolantin / Penthidin 50 mg in 10 ml NaCl/
i.a. Over 3 min.
Immediately before TACE
 

*) ART recommendation

Due to the combination with cytostatic substances, further side effects may be observed: nausea, vomiting, diarrhoea, mucositis, fever, shivers, coughs, ulcers in the upper digestive tube (a direct link to the embolizate not possible).

Methods of application

EmboCept® S should be diluted with a ready-to use active substance-solution of approximately twice the volume (10-30 ml), so that the concentration of the starch microspheres is approx. 30 mg/ml. Due to the solubility of some active substances, occasionally a lower or a higher concentration must be chosen.

Dosage recommendation:

Percentage of liver affected by tumour < 25%: 3.0 ml of EmboCept® S
Percentage of liver affected by tumour 25 – 50%: up to 7.5 ml of EmboCept® S admixed
 

Since the starch microspheres are prone to rapid sedimentation, they must be shaken well before each application of the suspension. Up to 300 mg (5 ml) of EmboCept® S can be applied per single injection.

An amilomer / cytostatic suspension is applied to the target organ by placing an arterial catheter. Each injection is carried out within a small time frame (20 – 30 seconds). After each injection, the catheter is immediately rinsed out with a few millimetres of saline. After that, an angio-graphic control over the degree of vessel occlusion is gained. A few minutes should pass between each individual injection. A return flow of the contrast agent should only lead to the further angiographic control after 1-2 minutes, before a new application of amilomer / active substance suspension is affected. After the detection of a fully occluded vessel the therapy should not be continued under no circumstances, because there is a risk of reflux into A. gastroduodenalis and A. gastrica dextra, which can result in severe pain and damage of the relevant organs.

Drugdesign: Cytostatic drugs and starch microspheres improve tumor targeting in loco-regional therapies (Berger G, Berlin Charité)
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Advantages and disadvantages of the contrast medium Lipiodol in combination with DSM (Gruber-Rouh T, Frankfurt Universitätsklinik)
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TACE of liver metastases from uveal melanoma (Portugaller R H, Graz Universitätsklinik) – Only German version available
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Interventional port system for hepatic chemoperfusion and chemoembolization (Ricke J, Magedeburg Universitätsklinik) – Only German version available
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DSM-TACE / EmboCept® S – Blood flow investigation under using of EmboCept® S (Wilhelm K, Bonn Universitätsklinik) – Only German version available
Download, PDF

Video animation of EmboCept® S Mode of action

Live OP – DSM-TACE in a patinent with HCC


W. Jaschke (Innsbruck/AT), S. Müller-Hülsbeck (Flensburg/DE), C. Stroszczynski (Regensburg/DE) R. Müller-Wille (Regensburg/DE), W. Wohlgemuth (Regensburg/DE)