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.
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.
Rates of postoperative hypocalcemia and voice dysfunction lower with single preoperative dose of dexamethasone versus placebo
Patients on hemodialysis who have secondary hyperparathyroidism experienced a 40% reduction in PTH levels over 12 months of etelcalcetide treatment, investigators reported.
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.
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.
Opko Health announced that Rayaldee (calcifediol) extended-release capsules will be available in pharmacies as early as Wednesday, November 30.
Dr. Reddy’s Laboratories announced the launch of Paricalcitol Injection, the generic version of AbbVie’s Zemplar.
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.
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.
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.