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NEW
FASTER
LOADING
TIMES
DC Bead AND DC BeadM1
loading INSTRUCTIONS
TM
TM
Made to a higher standard. Yours.
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The unique, patent-protected chemistry and distinct performance characteristics
of DC Bead™ are backed by extensive research, more than 100 peer-reviewed
publications and over 10 years’ clinical use.
nly DC Bead™ has loading with doxorubicin and irinotecan within
O
CE-Mark approved indication statement
Only DC Bead™ has peer-reviewed published studies which demonstrate:
14-day storage and stability with doxorubicin and irinotecan1,2
Homogeneous loading and elution3
Sustained in-vivo elution of doxorubicin within therapeutic range for over 30 days4
DC Bead™ is made to a higher standard. Yours.
Made to a higher standard. Yours.
BTG have worked with pharmacists to simplify the loading
instructions for DC Bead™ and DC BeadM1™, which now include
more specific detail on frequency of agitation. This has enabled
us to reduce published loading times, allowing a vial of 100-300µm
or DC BeadM1™ to be loaded in <60 minutes.
For any questions regarding loading and preparation
of DC Bead™ or DC BeadM1™, please contact:
[email protected]
Made to a higher standard. Yours.
NEW
FASTER
LOADING
TIMES
DC Bead loading with
IRINOTECAN SOLUTION
TM
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100mg irinotecan in solution into one vial of DC Bead™
DC Bead™ and DC BeadM1™ have loading with irinotecan within their CE-Marked indication statement
•Prior to loading, please read the irinotecan dosage table below
•Use needles with a diameter between 18 and 21 gauge
•In order to minimise the risk of microbial contamination, loading and
preparation of DC Bead™/DC BeadM1™ must be carried out using strict
aseptic technique under controlled conditions
•Throughout the loading process, avoid the introduction
of air bubbles and eliminate any that occur
Dosage
Loading Times
Storage
Minimum number
of vials required
With irinotecan solution (20mg/ml)
Physical and chemical stability of DC Bead™
loaded with irinotecan solution 1
DC Bead™ loading times for up to 100mg
irinotecan per vial of DC Bead (>98%)
Number of
DC Bead™
vial(s)
Planned dose
of irinotecan
(mg)
Number of vial(s)
of irinotecan
solution (100mg)
DC BeadM1™
70-150µm
DC Bead™
100-300µm
1
100
1
60min
60min
2
200
2
Irinotecan-loaded DC Bead™ (100mg/2ml)
14 days (at 2-8°C)
Irinotecan-loaded DC Bead™ mixed with
non-ionic contrast media
USE IMMEDIATELY
These loading times are achieved for DC Bead™ and irinotecan when the
syringe is gently agitated* every 30 minutes until loading time is complete.
Kaiser et al demonstrated chromatographic purity of irinotecan eluted from
DC Bead™ after extended storage period.1
*Invert the syringe ten times to ensure the beads are mobilised and exposed to the solution.
1
Kaiser et al, J Oncol Pharm Pract16 (2010): 53-61
Made to a higher standard. Yours.
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. 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. 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. BTG does not promote off-label use of its products. Cautions: DC Bead™ and DC BeadM1™ : Embolisation with DC Bead™ and 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 Tc99mMAA scanning if there is suspicion of AV shunting. Potential Complications: DC Bead™/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. Cautions: Irinotecan-loaded DC Bead™/DC BeadM1™: After Irintoecan loading it is not recommended that saline solution is added to the irinotecan-loaded DC Bead™/DC BeadM1™ as this can result in a small dose of irinotecan being made available systemically at the time of delivery. Use only non-ionic contrast media. Do not use contrast agents
containing salts (eg calcium chloride). The use of iso-osmolar contrast media such as Visipaque™ is at doctor’s discretion due to salt content. In case iso-osmolar contrast is used, a maximum volume of 5ml per vial of DC Bead™/DC BeadM1™ is suggested. The addition of non-ionic-contrast media to irinotecan-loaded DC Bead™/DC BeadM1™ causes the elution of up to 20mg irinotecan
if not used immediately. This might result in a bolus of irinotecan to be delivered. The mean size diameters of the Irinotecan-loaded DC Bead™/DC BeadM1™ can reduce by up to 30% compared to the original size of DC Bead™/DC BeadM1™. The overall size distribution of Irinotecan-loaded DC Bead™/DC BeadM1™ will remain within the manufacturer specifications for DC Bead™/DC
™
B
e
a
d
M
1
as supplied, with a shift towards the lower limits of the product size range. The volume of Irinotecan-loaded DC Bead™/DC BeadM1™ will reduce by up to 30% compared to the original volume of DC Bead™/DC BeadM1™ contained in the product vial. Patients with metastatic colorectal cancer treated with irinotecan-loaded DC Bead™/DC BeadM1™ experience more immediate side
™
effects for example, fever, abdominal pain and vomiting, compared with patients who had received an irinotecan-based systemic regimen. Patients treated with systemic chemotherapy however, have a much higher incidence of systemic drug effects such as diarrhoea, asthenia, leukopenia and anaemia (Fiorentini et al. Anticancer Research 2012; 32: 1387-96). 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 the USA, the European Union and certain other territories. Copyright © 2015, Biocompatibles UK Ltd. GXUS-DCB-2015-0046a.
DC Bead loading with IRINOTECAN SOLUTION
TM
100mg irinotecan in solution into one vial of DC Bead™
1
Transfer the DC Bead™
2
Load DC Bead™
3
Completion of Loading
For this step, you will need:
For this step, you will need:
For this step, you will need:
• DC Bead™ vial(s). Please refer to dosage table overleaf
• Irinotecan solution (100mg per vial). Please refer to dosage table to
determine number of vials for planned dose
• Loaded DC Bead™
• Syringe(s) containing DC Bead™ from Step 1
• Syringe cap
• 20ml syringe* for each vial of DC Bead™
• 18-gauge needle or transfer device
* If contrast media is added in the pharmacy, a larger syringe
should be used to accommodate the total anticipated volume.
• Syringe cap
• 18-gauge needle or transfer device
1a. Remove the flip cap from
the DC Bead™ vial but do
not remove the metal ring
securing the stopper
2a. T
ransfer the required volume of
irinotecan solution into the syringe
containing the DC Bead™
3a. When loading time is complete, the solution
may retain some colouration which is to
be expected and is not an indication that
DC Bead™ has failed to load
1b. Transfer the contents of the vial
into a 20ml syringe* using a transfer
device or needle (minimum
18G/ >0.84mm inner diameter)
2b. Cap the syringe
3b. Retaining a total volume of 2ml of loaded beads and
solution, expel the liquid into a suitable waste container
1c. Expel excess saline (packing solution)
to leave only DC Bead™ in the syringe
2c. G
ently agitate the DC Bead™ by
inverting the syringe ten times to
ensure the beads are mobilised
and exposed to the solution
2d. Store and agitate the DC Bead™
according to the loading table overleaf
Notes:
•In order to transfer beads, it may be helpful to flush the vial with the saline
(packing solution)
•It may not be possible to transfer every single bead – it is normal for a few
beads to be left in the vial
•In order to expel the saline packing solution from the syringe, an 18-gauge
5μm filter needle or disk filter may be helpful
Notes:
•The recommended dose of 100mg per vial of DC Bead™ is achieved
with 5ml irinotecan solution(20mg/ml). A maximum of 50mg
irinotecan per 1ml of DC Bead™ should not be exceeded
Made to a higher standard. Yours.
3c. Cap the syringe and store until required
(refer to storage table overleaf)
Notes:
•The total volume of 2ml of loaded DC Bead™ and loading solution
maintains the hydration of DC Bead™ during storage
•During storage, the syringe should be protected from light
Made to a higher standard. Yours.
ORDERING INFORMATION
DC BeadM1™
Size
Label Colour
Volume of Beads
Product Code
DC Bead™
70-150μm
100-300μm
300-500μm
500-700μm
Black and yellow
Yellow
Blue
Red
2ml
2ml
2ml
2ml
DC2V001
DC2V103
DC2V305
DC2V507
DC Bead™ and DC BeadM1™
are manufactured by:
Biocompatibles UK Ltd,
a BTG International group company
Chapman House, Farnham Business Park
Weydon Lane, Farnham, Surrey
GU9 8QL, UK
OUR BTG CUSTOMER SERVICES TEAM: [email protected]
AUSTRIA
tel. +43-720880739
NETHERLANDS
tel. +31-202410932
BELGIUM
tel. +32-28087916
PORTUGAL
tel. +351-308802698
FRANCE
tel. +33-184884056
SPAIN
tel. +34-911981738
GERMANY
tel. +49-3030809275
SWITZERLAND
tel. +41-315280675
IRELAND
tel. +353-15134139
UK
tel. +44-2033187881
ITALY
tel. +39-0694805067
Other countries: Please visit www.btg-im.com for details of your local distributor
References:
1. Jordan O, Denys A, De Baere T et al. J Vasc Interv Radiol 21 (2010): 1084-90.
2. Hecq J-D, Lewis AL, Vanbeckbergen D et al. J Oncol Pharm Pract 19 (2012): 65-74.
3. Kaiser J, Thiesen J and Krämer I. J Oncol Pharm Pract 16 (2010): 53-61.
4. Namur J, Citron SJ, Sellers MT et al. J Hepatol 55 (2011): 1332-8.
DC Bead™ and DC BeadM1™ Important Safety Information: Cautions: DC Bead™ and DC BeadM1™: Embolisation with DC Bead™ and 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. Potential Complications: DC Bead™/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. Cautions: Doxorubicin-loaded DC Bead™/DC BeadM1™: 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. Cautions: Irinotecan-loaded DC Bead™/DC BeadM1™: On addition of contrast/water mixture to loaded beads some irinotecan will be eluted. On delivery a bolus of between 10-20mg irinotecan may be delivered. Do not use irinotecan-loaded beads with contrast agents containing
salts (eg 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.
Imagine where we can go.
DC Bead and DC BeadM1 are trademarks of Biocompatibles UK Ltd and DC Bead is a registered trademark in China, EU, Japan and Republic of Korea. Biocompatibles UK Ltd is a BTG International group company. ‘Imagine where we can go’,
BTG and the BTG roundel logo are trademarks of BTG International Ltd. BTG and the BTG roundel logo are registered trademarks in the US, EU and certain other territories. All rights reserved. © 2015 Biocompatibles UK Ltd. GxUS-DCB-2015-0089.
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