Other safety alerts
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| The United States: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) |
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The US Food and Drug Administration (FDA) announces that based on a completed review of available information, it was concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis. Severe hypocalcemia appears to be more common in patients with CKD who also have a condition known as mineral and bone disorder (CKD-MBD). In patients with advanced CKD taking Prolia, severe hypocalcemia resulted in serious harm, including hospitalization, life-threatening events, and death. As a result, FDA is revising the Prolia prescribing information to include a new Boxed Warning, its most prominent warning, communicating this increased risk.
FDA is adding a Boxed Warning to the Prolia prescribing information about the significant risk of developing severe hypocalcemia in patients with advanced CKD. This warning and new labeling contains information to help reduce this risk, including appropriate patient selection for Prolia treatment, increased monitoring of blood calcium levels, and other strategies. FDA is also adding this updated information to the patient Medication Guide and the Prolia Risk Evaluation and Mitigation Strategy (REMS), a drug safety program required by FDA to help ensure that Prolia’s benefits outweigh its risks.
It is important that the appropriateness of Prolia treatment in patients with advanced CKD be determined by a health care professional with expertise in the diagnosis and management of CKD-MBD including renal osteodystrophy, a complication that weakens bone. Treating bone disease in patients with advanced and dialysis-dependent CKD is challenging because of the difficulty in diagnosing and confirming the underlying altered bone metabolism responsible for the low bone mass and increased fracture risk, and the complex benefit-risk considerations of approved osteoporosis treatments in this population.
Before prescribing Prolia, health care professionals should assess their patients’ kidney function. For patients with advanced CKD, particularly those on dialysis, health care professionals should consider the risk of severe hypocalcemia with Prolia in the context of other available treatments for osteoporosis. If Prolia is still being considered for these patients, for initial or continued use, check their calcium blood levels and assess them for evidence of CKD-MBD.
Treatment with Prolia in patients with advanced CKD, including those on dialysis, and particularly patients with diagnosed CKD-MBD should involve a health care provider with expertise in the diagnosis and management of CKD-MBD. Proper management of CKD-MBD, correction of hypocalcemia, and supplementation with calcium and activated vitamin D prior to Prolia treatment is expected to decrease the risk of developing severe hypocalcemia and any associated complications. Following Prolia administration, close monitoring of blood calcium levels and prompt management of hypocalcemia is essential to prevent complications such as seizures or arrhythmias. Advise patients to promptly report symptoms that could be consistent with hypocalcemia.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease
In Hong Kong, Prolia Solution For Injection In Pre-filled Syringe 60mg/ml (USA) (HK-60588) is a pharmaceutical product containing 60mg of denosumab which is registered by Amgen Hong Kong Limited. The product is a prescription-only medicine. So far, the Department of Health (DH) has received 64 cases of adverse drug reaction related to denosumab, of which 3 cases were related to hypocalcemia/serum calcium decreased. Related news on the risk of hypocalcemia associated with the use of Xgeva (containing 120mg of denosumab) and Prolia was previously issued by Health Canada, Singapore Health Sciences Authority and US FDA, and was posted on the Drug Office website on 1 Jun 2012, 8 Oct 2014 and 23 Nov 2022. Letters to inform local healthcare professionals were issued by the DH on 1 Jun 2012. In Dec 2012, the Registration Committee of the Pharmacy and Poisons Board discussed the matter for Xgeva and Prolia, and the sales pack label and/or package insert of denosumab products have included safety information about the risk of hypocalcemia (including in patients with severe renal impairment or receiving dialysis). The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Jan 20, 2024
Issued at HKT 12:00
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