What is InductOs?
InductOs is an implant kit consisting of a powder for solution containing the active ingredient dibotermin alfa, a solvent and a matrix (collagen sponge).
What is InductOs used for?
InductOs is used to help the bone grow. It can be used in the following cases:
- lumbar spinal fusion surgeries. This is a type of intervention that is performed to relieve back pain caused by a damaged vertebral disc: the disc that separates two vertebrae (the bones of the spine) is removed and the vertebrae are fused together (joined). InductOs is used together with a special metal cage that serves to correct the position of the spine. In this type of intervention, InductOs can be used to replace autogenous bone transplantation (transplant where the bone to be transplanted is taken from another part of the patient's body or from a donor) in adult patients who have been subjected to at least 6 months to treatment for a lesion of the disc without undergoing operations;
- treatment of tibia fractures. InductOs is used as a complementary therapy to standard treatment and fracture treatment. The medicine is used only when the nail to fix the bone does not require reaming (perforation to place the nail).
The medicine can only be obtained with a prescription.
How is InductOs used?
InductOs should be used by a specialist surgeon in the field. InductOs must be reconstituted in solution before use, then distributed on the matrix. It is then necessary to wait at least 15 minutes (but no more than two hours). It is therefore possible to cut the matrix according to the dimensions required before use. The contents of a kit are generally sufficient. In the lumbar spinal fusion operation, the damaged vertebral disc is removed and replaced with two metal cages containing InductOs. The metal cages fix the position of the vertebrae and InductOs stimulates the growth of the bone between the two vertebrae to join them permanently in the correct position. For the tibia fracture, InductOs is applied around the fractured bone to aid healing.
How does InductOs work?
The active ingredient in InductOs, dibotermin alfa, acts on the bone structure. This is a copy of a protein called morphogenic bone protein-2 (BMP-2), which is produced naturally by the body and which promotes the formation of new bone tissue. When applied, dibotermin alfa stimulates the bone tissue around the matrix to produce new tissue. The new bone develops starting from the matrix, which then gradually disappears. Dibotermin alfa is produced by a method known as "recombinant DNA technology": that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce this substance. Dibotermin alfa acts exactly like the BMP-2 proteins naturally produced by the body.
How has InductOs been studied?
InductOs has been studied in 279 patients who underwent lumbar spinal fusion surgery. Spinal fusion performed with InductOs was compared with a fusion performed with a bone graft with tissue taken from the hip during surgery. The main measure of effectiveness was the confirmation of the fusion of the vertebrae by radiological examination and the improvement of pain and disability reported by the patient, two years after the operation.
InductOs has been studied in 450 patients with tibial fractures. InductOs was compared with standard care and the main measure of effectiveness was the number of patients who did not need further treatment for tibial fracture (such as bone transplantation or replacement of intramedullary nails used to join bones) in the year following the intervention.
What benefit has InductOs shown during the studies?
In spinal fusion, InductOs demonstrated the same efficacy as bone transplantation. Two years after surgery, 57% of patients (69 of 122) treated with InductOs responded to treatment, compared with 59% (78 of 133) patients who underwent bone transplantation.
In patients with tibial fractures, the use of InductOs in addition to standard care was more effective than standard care alone in reducing the risk of therapy failure. 46% of patients who received standard care needed further surgery within a year to heal the fracture, compared with 26% of patients who also received InductOs.
What is the risk associated with InductOs?
In spinal fusion surgery, the most common side effects with InductOs (seen in more than 1 patient in 10) are accidental wounds, neuralgia (pain in the nerve endings), lower back pain and bone disorders (for example, delayed healing), which however, they are also frequently observed in patients receiving standard care. In the tibial fracture surgery, the most common side effects with InductOs (seen in more than 1 in 10 patients) are pain and infections. Infections are more common with InductOs than standard treatment when the patient's bones are fixed using reamed intramedullary nails. For the full list of all side effects reported with InductOs, see the Package Leaflet.
InductOs should not be used in people who may be hypersensitive (allergic) to dibotermin alfa or any of the other ingredients. InductOs should also not be administered to:
- patients still in the growth phase;
- patients who have been diagnosed with cancer or who are undergoing cancer therapy;
- patients with an outbreak of infection at the point of surgery;
- patients whose fractured area is not supplied with a sufficient amount of blood;
- patients with fractures related to other diseases, for example, fractures due to Paget's disease or tumors.
Why has InductOs been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of InductOs outweigh its risks for single-level anterior lumbar spinal fusion (L4 - S1) as a replacement for autogenous bone graft and for the treatment of traumatic fractures of the tibia in adult patients, in addition to the usual treatment. The Committee therefore recommended that the product be granted marketing authorization.
More information on InductOs:
On 9 September 2002, the European Commission granted a marketing authorization valid throughout the European Union for InductOs to Wyeth Europa Ltd. The marketing authorization was renewed on 9 September 2007.
The full EPAR for InductOs can be found here.
Last update of this summary: 06-2008.
