FDA Adds Boxed Warning to Denosumab for Hypocalcemia Risk in CKD Patients

1. FDA Adds Boxed Warning to Denosumab for Increased Risk of Hypocalcemia in Patients With Chronic Kidney Disease
2. Denosumab Boxed Warning for Hypocalcemia in CKD Patients – FDA Review.

FDA Adds Boxed Warning to Denosumab for Increased Risk of Hypocalcemia in Patients With CKD

The US Food and Drug Administration (FDA) has recently announced the addition of a boxed warning to the label of denosumab (Prolia; Amgen), a medication used in the treatment of osteoporosis. This warning highlights the increased risk of severe hypocalcemia, or very low calcium levels, in patients with advanced chronic kidney disease (CKD), particularly those who are undergoing dialysis. The decision comes after a thorough review of available data, which revealed that patients with CKD, especially those with mineral and bone disorder (MBD), are more susceptible to experiencing severe hypocalcemia when taking denosumab.

Denosumab, a monoclonal antibody, was initially developed for postmenopausal women with osteoporosis who are at high risk of fracture or who have not responded well to or cannot tolerate other treatment options. By blocking the receptor activator of nuclear factor kappa beta (RANK) protein, denosumab helps prevent the breakdown of bones by osteoclasts, a type of bone cell. This medication is administered by a healthcare professional via subcutaneous injection every 6 months.

Over time, denosumab received FDA approval for various other indications. It is now used to increase bone mass in men with osteoporosis and to treat men at high risk of fracture who are receiving androgen deprivation therapy for prostate cancer. Additionally, denosumab is prescribed for women at high risk of fracture who are receiving aromatase inhibitor therapy for breast cancer. It is also effective in treating both men and women with glucocorticoid-induced osteoporosis.

By adding a boxed warning to the label of denosumab, the FDA aims to ensure that healthcare providers and patients are fully aware of the potential risk of severe hypocalcemia associated with this medication. This warning will help guide treatment decisions and ensure that appropriate monitoring and management strategies are implemented for patients with CKD, especially those undergoing dialysis.

It is crucial for healthcare professionals to closely monitor patients receiving denosumab for any signs or symptoms of hypocalcemia, such as muscle cramps, numbness or tingling in the fingers or toes, or seizures. In cases where hypocalcemia is suspected, prompt intervention and calcium supplementation may be necessary to prevent complications.

The addition of the boxed warning to the label of denosumab serves as a reminder of the importance of individualized treatment plans and close monitoring in patients with CKD. By being vigilant and proactive in managing the potential risks associated with denosumab therapy, healthcare providers can ensure the safety and well-being of their patients.

In conclusion, the FDA’s decision to add a boxed warning to the label of denosumab highlights the increased risk of severe hypocalcemia in patients with advanced CKD, particularly those who are undergoing dialysis. This warning serves as a valuable tool for healthcare providers, enabling them to make informed treatment decisions and implement appropriate monitoring and management strategies. By prioritizing patient safety and well-being, healthcare professionals can optimize the use of denosumab in the management of osteoporosis while minimizing the risk of complications..

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