Tresiba and Ryzodeg get FDA’s approval

The U.S. Food and Drug Administration has approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

In annoucmen issued on Friday, FDA explained that Tresiba is a long-acting insulin analog indicated to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Dosing of Tresiba should be individualized based on the patient’s needs. Tresiba is administered subcutaneously once daily at any time of day. Ryzodeg 70/30 is a mixture of insulin degludec, a long-acting insulin analog, and insulin aspart, a rapid-acting human insulin analog. It is indicated to improve glycemic control in adults with diabetes mellitus.

Tresiba and Ryzodeg should not be used in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Patients or caregivers should monitor blood glucose in all patients treated with insulin. Insulin regimens should be modified cautiously and only under medical supervision. Tresiba and Ryzodeg may cause low blood sugar (hypoglycemia), which can be life-threatening. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin.

The most common adverse reactions associated with Tresiba and Ryzodeg in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema, and weight gain.