FDA approves Myxredlin, first ready-to-use insulin for intravenous infusion

Written by Dr. Kamal Kant Kohli Kohli Published On 2019-07-24T19:05:15+05:30 | Updated On 12 Aug 2021 3:32 PM IST

Food and Drug Administration has approved Myxredlin, the first ready-to-use insulin for intravenous (IV) infusion for use in acute care settings under medical supervision.

The U.S. Food and Drug Administration (FDA) has granted approval of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection). Myxredlin (pronounced mix-RED-lin) is the first and only ready-to-use insulin for IV infusion, in the hospital and other acute care settings and features an extended shelf life of 30 days at room temperature (77 degrees F [25 degrees C]) or 24 months if refrigerated (36 degrees F to 46 degrees F [2 degrees C to 8 degrees C]) in the original carton to protect from light. Myxredlin is provided in a standardized concentration of 100 units/100 mL in a flexible plastic container. This innovative presentation helps ensure that Myxredlin delivers a consistent, stable and predictable concentration with every administration, which is a key consideration for patient safety.

Food and drug administration has granted approval to M/s Baxter for marketing the product.

"Insulin is in the top five drug classes involved with medication errors, and more than 30 percent of those errors result in patient harm,"¹ said Robert Felicelli, president, Pharmaceuticals, Baxter. "When a patient requires intravenous insulin in the hospital, pharmacists have to manually admix insulin for treatment. With the launch of Myxredlin, clinicians will have access to a convenient, reliable presentation of ready-to-use insulin that can help ensure faster delivery to patients, streamlined workflow for pharmacists and nurses, and less waste for hospitals."

Myxredlin is indicated for use as a short-acting human insulin to improve glycemic control in adults and pediatric patients with diabetes mellitus. Myxredlin is intended for use only in acute care settings under medical supervision.

Indication

Myxredlin is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Contraindications

During episodes of hypoglycemia

Hypersensitivity to insulin human or any of the excipients in Myxredlin

Warnings and Precautions

Administer Myxredlinintravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels. Hypokalemia may be life-threatening.

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Dr. Kamal Kant Kohli Kohli