FDA: Prolia Use in Dialysis Patients May Cause Severe Hypocalcemia
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis.
Diagnosis & Disease Information
Prophylactic Steroids May Prevent Complications of Thyroidectomy
Rates of postoperative hypocalcemia and voice dysfunction lower with single preoperative dose of dexamethasone versus placebo
Etelcalcetide Shows Efficacy in Clinical Practice
Patients on hemodialysis who have secondary hyperparathyroidism experienced a 40% reduction in PTH levels over 12 months of etelcalcetide treatment, investigators reported.
CKD-Mineral and Bone Disorder Treatment Recommendations Updated
In addition, for adult patients with CKD G3a-G5 not on dialysis, the new guideline indicates that calcitriol and vitamin D analogs should not be routinely used.
First New Drug for Secondary HPT in Over a Decade Gets FDA Approval
Amgen announced that the Food and Drug Administration (FDA) has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis.
Rayaldee Available for Treating Secondary Hyperparathyroidism
Opko Health announced that Rayaldee (calcifediol) extended-release capsules will be available in pharmacies as early as Wednesday, November 30.
Dr. Reddy’s Launches Generic Zemplar Injection
Dr. Reddy’s Laboratories announced the launch of Paricalcitol Injection, the generic version of AbbVie’s Zemplar.
Rayaldee Approved for Secondary Hyperparathyroidism in Adults with CKD
Opko Health announced that the Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended-release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with Stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D <30ng/mL.
Rayaldee Approval Process Halted Due to Third-Party Manufacturer Issues
The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Rayaldee (calcifediol; Opko) as a treatment for secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Rayaldee NDA Accepted for SHPT in Stage 3 or 4 CKD and Vitamin D Deficiency
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Rayaldee (calcifediol modified-release capsules, Opko) for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
