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TM
DC Bead loading with
IRINOTECAN SOLUTION
NEW
FASTER
LOADING
TIMES
btg-im.com
100mg irinotecan in solution into one vial of DC Bead
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DC Bead and DC BeadM1 have loading with irinotecan within their CE-Marked indication statement
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•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
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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
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DC Bead loading times for up to 100mg
irinotecan per vial of DC Bead (>98%)
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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
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Irinotecan-loaded DC Bead (100mg/2ml)
14 days (at 2-8°C)
Irinotecan-loaded DC Bead mixed with
non-ionic contrast media
USE IMMEDIATELY
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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.
*Invert the syringe ten times to ensure the beads are mobilised and exposed to the solution.
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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 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: 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 BeadM1
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.
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DC Bead loading with IRINOTECAN SOLUTION
TM
100mg irinotecan in solution into one vial of DC Bead
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1
2
Transfer the DC Bead
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3
Load DC Bead
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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
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• 20ml syringe* for each vial of DC Bead
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• 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(s) containing DC Bead from Step 1
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2a. Transfer the required volume of
irinotecan solution into the syringe
containing the DC Bead
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
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• 18-gauge needle or transfer device
• Syringe cap
• Syringe cap
1a. Remove the flip cap from
the DC Bead vial but do
not remove the metal ring
securing the stopper
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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
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3b. R
etaining a total volume of 2ml of loaded beads and
solution, expel the liquid into a suitable waste container
2c. Gently agitate the DC Bead by
inverting the syringe ten times to
ensure the beads are mobilised
and exposed to the solution
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1c. Expel excess saline (packing solution)
to leave only DC Bead in the syringe
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3c. Cap the syringe and store until required
(refer to storage table overleaf)
2d. Store and agitate the DC Bead
according to the loading table overleaf
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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
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Made to a higher standard. Yours.
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
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