Dear Healthcare Professional Letter on the risk of osteonecrosis of the jaw associated with use of denosumab (XGEVA): new contraindication and introduction of a patient reminder card to minimise the risk
30.10.2015
Amgen d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), would like to inform healthcare professionals of a new contraindication in patients with unhealed lesions from a dental or oral surgery and the introduction of a patient reminder card, to minimise the risk of osteonecrosis of the jaw during treatment with XGEVA (denosumab).
Summary
- Xgeva is now contra-indicated in patients with unhealed lesions from dental or oral surgery.
- A patient reminder card is introduced to increase patients’ awareness for the risk of osteonecrosis of the jaw and the necessary and the necessary precautions to minimise the risk.
- Patients treated with Xgeva should be given this patient reminder card with information on osteonecrosis of the jaw, as well as the package leaflet.
Further information
Osteonecrosis of the jaw is a very common reported adverse reaction in patients treated with Xgeva and may be developed up to one individual out of ten. The product information is being updated to reflect the current knowledge on osteonecrosis of the jaw and to optimise risk minimisation. Changes to the product information include the addition of a contraindication in patients with unhealed lesions from dental or surgery to ensure that treatment is not initiated when the patient is in this situation. A dental examination with preventive dentistry is recommended prior to treatment with Xgeva. The management plan of any patients who develop osteonecrosis of the jaw should be st up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in osteonecrosis of the jaw. The card will remind patients about important safety information that they need to be aware of before and during treatment with Xgeva. Xgeva is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastasis from solid tumours and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection to result in severe morbidity.
Here you may read the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
