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™
DC Bead Mode of Loading
Loading DC Bead
with doxorubicin:
Storage and
stability update
™
Grafting point
+
Dox
PVA macromer
backbone
-
SO3
-
-
SO3
Sulphonated polymer
chain backbone
SO3
+
Dox
3
SO
+
-
Dox
SO3
SO3
-
SO3
-
SO3
+
Dox
+
-
SO3
-
SO3
-
SO3
-
SO3
Hydration shell
associated with PVA
and ionic groups
SO3
-
Dox
3
SO3
Dox
SO
-
SO3
+
Dox
Dox
SO3
-
SO3
+
Dox
SO
3
-
+
Dox
SO3
Doxorubicin
Interaction of doxorubicin
with SO3- groups displaces
water from the
hydration shells
-
Bulk
(non-bound) water
-
+
3
SO
SO3
-
SO3
-
+
Dox
+
SO3
+
Dox
-
S
-
SO3
SO3
+
Dox
Loaded Beads
Hydrated Beads
Ordering Information:
Product Name
DC BeadM1
Label Colour and Size
70-150µm
100-300µm
300-500µm
500-700µm
2ml
2ml
2ml
2ml
DC2V001
DC2V103
DC2V305
DC2V507
Volume of Beads
Product Code
DC Bead
CE Mark approved for
loading with doxorubicin
Biocompatibles UK Limited
Tel: +44 (0)1252 732 732
Fax: +44 (0)1252 732 777
email:[email protected]
www.biocompatibles.com
Important Safety Information
DC Bead Indications:
• DC Bead is CE marked and is indicated for the treatment of malignant hypervascular
tumours and loading with doxorubicin drug
• DC Bead is also indicated for loading with irinotecan for the treatment of metastatic
colorectal cancer (mCRC)
For full instrutions for use, please refer to: www.biocompatibles.com/dcbead-ifu
DC BeadM1 Indications:
• DC BeadM1 is primarily intended as an embolic agent for the treatment of malignant
hypervascularised tumour(s)
• DC BeadM1 is compatible with irinotecan, which can be loaded prior to embolisation
and then, as a secondary action, elute a local, controlled and sustained dose to the
mCRC after embolisation
• DC BeadM1 is compatible with doxorubicin, which can be loaded prior to embolisation
and then, as a secondary action, elute a local, controlled and sustained dose to the
tumour after embolisation
For full instructions for use, please refer to: www.biocompatibles.com/dcbead-m1-ifu
Both products and/or all indications may not be available in your territory.
DC Bead and DC BeadM1 are not cleared by the FDA for sale or distribution in the USA.
DC Bead and DC BeadM1 Important Information:
Cautions: DC Bead and DC BeadM1
• Embolisation with DC Bead/DC BeadM1 should only be performed by a physician with
appropriate interventional occlusion training in the region intended to be embolised
• Do not use if the vial or packaging appear damaged
• Ensure that DC Bead/DC BeadM1 is an appropriate size for the intended vasculature
• Consider upsizing to a larger size of DC Bead in the presence of AV shunts or if
angiographic evidence of embolisation does not appear quickly during delivery
• Consideration should be given to Tc99m-MAA scanning if there is suspicion of AV shunting
Cautions: Irinotecan-loaded DC Bead and DC BeadM1
• On addition of non-ionic contrast/water mixture to irinotecan-loaded beads, some
irinotecan will be eluted over time. If the beads are not used immediately, up to
10mg irinotecan may be present in the contrast/water mixture. If this occurs,
a small dose of irinotecan may be available systemically at time of delivery
• Do not use irinotecan-loaded beads with contrast agents containing salts
(e.g. Calcium chloride)
• The maximum amount of irinotecan that can be loaded is 100mg irinotecan
per 2ml vial of DC Bead/DC BeadM1. Exceeding this amount may lead to some
irinotecan remaining free in solution. This free solution should be removed prior
to use to prevent the patient receiving the excess dose as a bolus
Peer-review published
storage and stability data
Potential Complications: DC Bead and DC BeadM1
• Undesirable reflux or passage of DC Bead/DC BeadM1 into normal
arteries adjacent to the targeted lesion or through the lesion into
other arteries or arterial beds
• Non-target embolisation
• Pulmonary embolisation
• Ischaemia at an undesirable location
• Capillary bed saturation and tissue damage
• Ischaemic stroke or ischaemic infarction
• Vessel or lesion rupture and haemorrhage
• Neurological deficits including cranial nerve palsies
• Vasospasm
• Death
• Recanalisation
• Foreign body reactions necessitating medical intervention
• Infection necessitating medical intervention
• Clot formation at the tip of the catheter and subsequent dislodgement causing
arterial thromboembolic sequelae
1
Reproducible and homogeneous
drug loading and elution
WARNING: Studies have shown that DC Bead and DC BeadM1 do not form
aggregates and, as a result, penetrate deeper into the vasculature as
compared to similarly sized PVA particles.
2
M1
DC Bead and DC BeadM1 are manufactured by Biocompatibles UK Ltd.
Cautions: Doxorubicin-loaded DC Bead and DC Bead
• Exceeding a loading dose of 37.5mg doxorubicin per 1ml DC Bead/DC BeadM1
may lead to some systemic distribution of doxorubicin and related side effects
DC Bead and DC BeadM1 are manufactured by Biocompatibles UK Ltd, Chapman House, Farnham Business Park, Weydon Lane, Farnham, Surrey, GU9 8QL, UK. DC Bead and DC BeadM1 are trademarks and/or registered trademarks of
Biocompatibles UK Ltd. Biocompatibles UK Ltd is a BTG International group company. BTG and the BTG roundel logo are trademarks of BTG International Ltd and are registered trademarks in US, EU and certain other territories.
DC Bead and DC BeadM1 are not currently cleared by the FDA for sale or distribution in the USA. © Copyright 2013 Biocompatibles UK Ltd. GxUS-DCB-2013-0019.
References:
1. Hecq J-D, Lewis AL, Vanbeckbergen D et al. Doxorubicin-loaded drug-eluting beads (DC Bead) for use in transarterial
chemoembolization: A stability assessment. J Oncol Pharm Pract 19 (2013): 65-74
2. Jordan O, Denys A, De Baere et al. J Vasc Interv Radiol 21 (2010): 1084-90
3. Biocompatibles UK Ltd data on file: 847BB/158; 856BB/074; 863BB/069 and 864BB/013
4. Biocompatibles UK Ltd data on file. SP2146
Biocompatibles
Excellence in Interventional Oncology
Biocompatibles UK Ltd is a
BTG International group company
Biocompatibles
Excellence in Interventional Oncology
Biocompatibles UK Ltd is a
BTG International group company
This folder contains:
• DC Bead and DC BeadM1 with doxorubicin: Instructions for use
• DC Bead and DC BeadM1 with doxorubicin: Loading instructions
• Doxorubicin-loaded drug-eluting beads (DC Bead ) for use in
transarterial chemoembolization: A stability assessment.
™
Hecq J-D, Lewis AL, Vanbeckbergen D et al. J Oncol Pharm Pract 19 (2013): 65-74
For electronic copies, please scan here or visit www.biocompatibles.com/ifustability
™
The DC Bead instructions for use (IFU) have recently been updated to
include a storage period of 14 days for the doxorubicin-loaded product,
as supported by internal and external studies. DC Bead loaded with
doxorubicin may be stored for up to 7 days once mixed with non-ionic
contrast medium.
1,3
™
“
™
Doxorubicin-loaded DC Bead are shown to have adequate physicochemical
stability over a period of 14 days when stored in syringes or vials under refrigerated
conditions for up to 14 days. The admixtures of doxorubicin loaded beads with
contrast medium are stable for up to 7 days under refrigerated conditions.
”
Hecq J-D, Lewis AL, Vanbeckbergen D et al. J Oncol Pharm Pract 19 (2013): 65-74
Statistically equivalent elution profile of DC Bead™ on day of loading with
doxorubicin vs DC Bead™ loaded with doxorubicin and stored for 14 days at 2-8˚C
Physical and chemical stability of DC Bead and DC BeadM1
1
1
14 days (at 2-8°C)
Doxorubicin-loaded DC Bead and DC BeadM1 (75mg/2ml)
In-vitro Elution of Doxorubicin (nominal 75mg dose) from DC Bead™ (500-700µm)
100
7 days (at 2-8°C)
Doxorubicin-loaded DC Bead and DC BeadM1 with non-ionic contrast
90
Loading and preparation of DC Bead and DC BeadM1 must be carried out using strict aseptic
technique under controlled conditions.
80
These storage times:
™
• Optimise efficiencies for the pharmacy when loading DC Bead with doxorubicin
Eluted (%)
70
60
50
Initial test (day 0)
40
+ 14 days (2-8˚C)
30
• Minimise waste of unused syringes of loaded product – even after the addition of contrast
20
™1
• Do not affect the drug release and delivery properties of the loaded DC Bead
10
Graph adapted from: Hecq J-D, Lewis AL, Vanbeckbergen D et al. J Oncol Pharm Pract 19 (2013): 65-74
0
1
• Do not affect the chromatographic purity of the doxorubicin – no impact on drug properties
0
20
40
60
80
Time (minutes)
Microbiological stability of DC Bead and DC BeadM1
™
Rigorous microbiological studies demonstrate that DC Bead loaded with doxorubicin and stored for
14 days at 2-8°C does not sustain or promote growth of micro-organisms likely to be present in the
hospital environment at time of loading.
4
“
™
Doxorubicin-loaded DC Bead maintained
their spherical shape throughout the release.
Jordan O, Denys A, De Baere et al. J Vasc Interv Radiol 21 (2010): 1084-90
”
100
120
™
DC Bead Mode of Loading
Loading DC Bead
with doxorubicin:
Storage and
stability update
™
Grafting point
+
Dox
PVA macromer
backbone
-
SO3
-
-
SO3
Sulphonated polymer
chain backbone
SO3
+
Dox
3
SO
+
-
Dox
SO3
SO3
-
SO3
-
SO3
+
Dox
+
-
SO3
-
SO3
-
SO3
-
SO3
Hydration shell
associated with PVA
and ionic groups
SO3
-
Dox
3
SO3
Dox
SO
-
SO3
+
Dox
Dox
SO3
-
SO3
+
Dox
SO
3
-
+
Dox
SO3
Doxorubicin
Interaction of doxorubicin
with SO3- groups displaces
water from the
hydration shells
-
Bulk
(non-bound) water
-
+
3
SO
SO3
-
SO3
-
+
Dox
+
SO3
+
Dox
-
S
-
SO3
SO3
+
Dox
Loaded Beads
Hydrated Beads
Ordering Information:
Product Name
DC BeadM1
Label Colour and Size
70-150µm
100-300µm
300-500µm
500-700µm
2ml
2ml
2ml
2ml
DC2V001
DC2V103
DC2V305
DC2V507
Volume of Beads
Product Code
DC Bead
CE Mark approved for
loading with doxorubicin
Biocompatibles UK Limited
Tel: +44 (0)1252 732 732
Fax: +44 (0)1252 732 777
email:[email protected]
www.biocompatibles.com
Important Safety Information
DC Bead Indications:
• DC Bead is CE marked and is indicated for the treatment of malignant hypervascular
tumours and loading with doxorubicin drug
• DC Bead is also indicated for loading with irinotecan for the treatment of metastatic
colorectal cancer (mCRC)
For full instrutions for use, please refer to: www.biocompatibles.com/dcbead-ifu
DC BeadM1 Indications:
• DC BeadM1 is primarily intended as an embolic agent for the treatment of malignant
hypervascularised tumour(s)
• DC BeadM1 is compatible with irinotecan, which can be loaded prior to embolisation
and then, as a secondary action, elute a local, controlled and sustained dose to the
mCRC after embolisation
• DC BeadM1 is compatible with doxorubicin, which can be loaded prior to embolisation
and then, as a secondary action, elute a local, controlled and sustained dose to the
tumour after embolisation
For full instructions for use, please refer to: www.biocompatibles.com/dcbead-m1-ifu
Both products and/or all indications may not be available in your territory.
DC Bead and DC BeadM1 are not cleared by the FDA for sale or distribution in the USA.
DC Bead and DC BeadM1 Important Information:
Cautions: DC Bead and DC BeadM1
• Embolisation with DC Bead/DC BeadM1 should only be performed by a physician with
appropriate interventional occlusion training in the region intended to be embolised
• Do not use if the vial or packaging appear damaged
• Ensure that DC Bead/DC BeadM1 is an appropriate size for the intended vasculature
• Consider upsizing to a larger size of DC Bead in the presence of AV shunts or if
angiographic evidence of embolisation does not appear quickly during delivery
• Consideration should be given to Tc99m-MAA scanning if there is suspicion of AV shunting
Cautions: Irinotecan-loaded DC Bead and DC BeadM1
• On addition of non-ionic contrast/water mixture to irinotecan-loaded beads, some
irinotecan will be eluted over time. If the beads are not used immediately, up to
10mg irinotecan may be present in the contrast/water mixture. If this occurs,
a small dose of irinotecan may be available systemically at time of delivery
• Do not use irinotecan-loaded beads with contrast agents containing salts
(e.g. Calcium chloride)
• The maximum amount of irinotecan that can be loaded is 100mg irinotecan
per 2ml vial of DC Bead/DC BeadM1. Exceeding this amount may lead to some
irinotecan remaining free in solution. This free solution should be removed prior
to use to prevent the patient receiving the excess dose as a bolus
Peer-review published
storage and stability data
Potential Complications: DC Bead and DC BeadM1
• Undesirable reflux or passage of DC Bead/DC BeadM1 into normal
arteries adjacent to the targeted lesion or through the lesion into
other arteries or arterial beds
• Non-target embolisation
• Pulmonary embolisation
• Ischaemia at an undesirable location
• Capillary bed saturation and tissue damage
• Ischaemic stroke or ischaemic infarction
• Vessel or lesion rupture and haemorrhage
• Neurological deficits including cranial nerve palsies
• Vasospasm
• Death
• Recanalisation
• Foreign body reactions necessitating medical intervention
• Infection necessitating medical intervention
• Clot formation at the tip of the catheter and subsequent dislodgement causing
arterial thromboembolic sequelae
1
Reproducible and homogeneous
drug loading and elution
WARNING: Studies have shown that DC Bead and DC BeadM1 do not form
aggregates and, as a result, penetrate deeper into the vasculature as
compared to similarly sized PVA particles.
2
M1
DC Bead and DC BeadM1 are manufactured by Biocompatibles UK Ltd.
Cautions: Doxorubicin-loaded DC Bead and DC Bead
• Exceeding a loading dose of 37.5mg doxorubicin per 1ml DC Bead/DC BeadM1
may lead to some systemic distribution of doxorubicin and related side effects
DC Bead and DC BeadM1 are manufactured by Biocompatibles UK Ltd, Chapman House, Farnham Business Park, Weydon Lane, Farnham, Surrey, GU9 8QL, UK. DC Bead and DC BeadM1 are trademarks and/or registered trademarks of
Biocompatibles UK Ltd. Biocompatibles UK Ltd is a BTG International group company. BTG and the BTG roundel logo are trademarks of BTG International Ltd and are registered trademarks in US, EU and certain other territories.
DC Bead and DC BeadM1 are not currently cleared by the FDA for sale or distribution in the USA. © Copyright 2013 Biocompatibles UK Ltd. GxUS-DCB-2013-0019.
References:
1. Hecq J-D, Lewis AL, Vanbeckbergen D et al. Doxorubicin-loaded drug-eluting beads (DC Bead) for use in transarterial
chemoembolization: A stability assessment. J Oncol Pharm Pract 19 (2013): 65-74
2. Jordan O, Denys A, De Baere et al. J Vasc Interv Radiol 21 (2010): 1084-90
3. Biocompatibles UK Ltd data on file: 847BB/158; 856BB/074; 863BB/069 and 864BB/013
4. Biocompatibles UK Ltd data on file. SP2146
Biocompatibles
Excellence in Interventional Oncology
Biocompatibles UK Ltd is a
BTG International group company
Biocompatibles
Excellence in Interventional Oncology
Biocompatibles UK Ltd is a
BTG International group company