Dear Healthcare Professional Letter on new risk minimisation measures for osteonecrosis of the jaw and hypocalcaemia in patients treated with denosumab 60 mg (Prolia)
11.09.2014
Amgen Europe B.V. has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) addressed a letter to healthcare professionals on the new risk minimisation measures for osteonecrosis of the jaw (ONJ) and hypocalcaemia in patients treated with Prolia.
Information summary on osteonecrosis of the jaw
- Doctors should judge the risk factors for ONJ in all patients before starting the treatment.
- Patients with risk factors should receive care by a dentist and undergo necessary preventive oral surgery.
- During Prolia treatment, patients should be advised to maintain a good hygiene of the oral cavity, have a regular care by dentist and to urgently report any symptom associated with the oral cavity, groin of the teeth, pain or swelling.
Information summary on hypocalcaemia
- The hypocalcaemia represents an identified risk in patients treated with Prolia that inceases with the extent of renal impairment
- Before starting the treatment with Prolia, the existing hypocalcaemia should be corrected.
- An adequate intake of calcium and vitamin D is essential in all patients, especially in those with severe renal impairment.
- Calcium level monitoring should be carried out:
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- before administration of every single dose of Prolia
- within two weeks after initial dose in patients with predisposition for hypocalcaemia (i.e. patients with heavy renal impairment, creatinine clearance ˂30 ml/min)
- if symptoms indicating hypocalcaemia occur or if this is indicated based on the patient clinical status
- patients should be advised to report symptoms of hypocalcaemia.
HALMED has not received any suspected adverse reaction report to Prolia that would be associated to the osteonecrosis of the jaw or hypocalcaemia. HALMED will continue to monitor closely the safe use of this medicine and will inform the public promptly about any new findings.
Here you may view 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 via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
