Prolia (denosumab) May Increase the Risk of Hypocalcemia in Dialysis Patients
A preliminary FDA study suggests an increased risk of hypocalcemia in dialysis patients treated with osteoporosis medicine Prolia (denosumab). Physicians should consider the risks of using Prolia in patients on dialysis. When Prolia is used in such patients, calcium and Vit D supplementation may help decrease the severity. Advise patients to seek help if they have hypocalcemia symptoms.
Rezvoglar Received FDA Approval as the Biosimilar Insulin Product to Lantus
FDA has approved Rezvoglar (insulin glargine-aglr) as the 2nd interchangeable biosimilar insulin product to Lantus (insulin glargine). Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes. The injection is available as a clear solution containing 100 units/mL (U-100) in 3mL KwikPen single-use prefilled pens.
First Drug That Can Delay Onset of Type 1 Diabetes
On Nov 17, FDA approved Tzield injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients ≥8 yrs who have stage 2 T1D. Tzield binds to and deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response. Tzield is administered by intravenous infusion once daily for 14 consecutive days.
Impella RP Flex with SmartAssist Receives FDA Approval to Treat Right Heart Failure
Impella RP Flex with SmartAssist has received FDA pre-market approval for acute right heart failure. It is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.
