The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).
According to the Centers for Disease Control and Prevention, more than 30 million people in the U.S. have diabetes, a chronic disease that affects how the body turns food into energy and the body’s production of natural insulin. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage. Improvement in blood sugar control through treatment with insulin, a common treatment, can reduce the risk of some of these long-term complications.
The most common adverse reactions associated with Admelog in clinical trials was hypoglycemia, itching, and rash. Other adverse reactions that can occur with Admelog include allergic reactions, injection site reactions, and thickening or thinning of the fatty tissue at the injection site (lipodystrophy).
Admelog should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin lispro or one of its ingredients. Admelog SoloStar prefilled pens or syringes must never be shared between patients, even if the needle is changed.
Patients or caregivers should monitor blood glucose in all patients treated with insulin products. Insulin regimens should be modified cautiously and only under medical supervision. Admelog 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.
Accidental mix-ups between insulin products can occur. Patients should check insulin labels before injecting the insulin product.
Severe, life-threatening, generalized allergic reactions, including anaphylaxis, may occur.
Health care providers should monitor potassium levels in patients at risk of hyperkalemia, a serious and potentially life-threatening condition in which the amount of potassium in the blood is too high.
For more information, please visit: Admelog.
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