Active Ingredient: Dibotermin alfa
Dibotermin alfa is indicated for single-level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
For this indication, competent medicine agencies globally authorize below treatments:
Interstitial
4 - 8 mg
From 4 To 8 mg once every day
The appropriate dose is determined by the volume of wetted matrix required for the intended indication.
If the surgical setting requires that only a portion of the product is needed, the wetted matrix should be cut to the desired size, and the unused portion must be discarded.
Dosing table for dibotermin alfa 4 mg pack:
| Dibotermin alfa wetted matrices (4 mg pack) | Dimensions of wetted matrix | Volume of wetted matrix | Concentration of wetted matrix | Dibotermin alfa dose |
|---|---|---|---|---|
| 1 matrix | 2.5 cm x 5 cm | 1.3 cm³ | 1.5 mg/cm³ | 2 mg |
| 2 matrices | 2 x (2.5 cm x 5 cm) | 2.7 cm³ | 1.5 mg/cm³ | 4 mg |
Dosing table for dibotermin alfa 12 mg pack:
| Portion of dibotermin alfa wetted matrix (12 mg pack) | Dimensions of wetted matrix | Volume of wetted matrix | Concentration of wetted matrix | Dibotermin alfa dose |
|---|---|---|---|---|
| 1/6 of the matrix | 2.5 cm x 5 cm | 1.3 cm³ | 1.5 mg/cm³ | 2 mg |
| 1/3 of the matrix | 2.5 cm x 10 cm | 2.7 cm³ | 1.5 mg/cm³ | 4 mg |
| 2/3 of the matrix | 5 cm x 10 cm | 5.3 cm³ | 1.5 mg/cm³ | 8 mg |
| Entire matrix | 7.5 cm x 10 cm | 8 cm³ | 1.5 mg/cm³ | 12 mg |
The required volume of dibotermin alfa is determined by the intervertebral disc space and the size, shape, and internal volume of the lumbar interbody fusion device(s) being used. Care must be taken not to compress the product or overfill the volume intended for new bone formation.
Typically, 4 mg (2.7 cm 3 of wetted matrix) of dibotermin alfa is used in the intervertebral disc space. The maximum dosage is limited to 8 mg (5.3 cm 3 of wetted matrix) of dibotermin alfa in the intervertebral disc space. Dibotermin alfa must be placed within the lumbar interbody fusion device(s) or in the anterior portion of the intervertebral disc space.
Dibotermin alfa must not be used alone for this indication, but should be used with an approved (CE-marked) lumbar interbody fusion device(s). Compatibility has been demonstrated with titanium, polyetheretherketone (PEEK), and allograft bone.
Care and caution must be used to prevent overfilling the lumbar interbody fusion device and/or the anterior portion of the intervertebral disc space.
4 mg pack: The matrix is pre-cut in 2 pieces each of 2.5 × 5 cm.
12 mg pack: The matrix is in 1 piece of 7.5 cm x 10 cm. The wetted matrix should be cut into 6 equal pieces (approximately 2.5 × 5 cm) as an aid for dose selection. The selected pieces can be further cut as required.
The hollow geometry of the lumbar interbody fusion device must be carefully and loosely filled with the volume of dibotermin alfa corresponding to the internal volume of the device.
As per standard practice, disc material and the cartilaginous portions of the vertebral endplates should be removed, preserving the cortical portions of the endplates, and haemostasis should be achieved.
For instructions to implant the lumbar interbody fusion device, please refer to the manufacturer’s instructions for use.
Dibotermin alfa must not be implanted posterior to the lumbar interbody fusion device where direct access to the spinal canal and/or nerve root(s) is possible. If leakage into the spinal canal and the nerve root is possible, a physical barrier between the matrix and any neurological tissue must be re-created by using, for example, local bone or allograft.
Once dibotermin alfa and the lumbar interbody fusion device(s) are implanted, the inside of the intervertebral disc space must not be irrigated. Outside the intervertebral disc space, the surgical field should be irrigated as needed, and any fluid loss from the wetted matrix should be washed away.
If a surgical drain is required, the drain should be placed remotely from the implantation site or, preferably, one layer superficial to the implantation site.
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