Active ingredient: Insulin Lispro
28B-L-Lysine-29B-L-proline insulin
Molecular formula: C257H383N65O77S6
Excipient: Protamine sulfate, Zinc oxide(0.715 mg/ml), M-cresol (1.76 mg/ml), Glycerol, Sodium phosphate dibasic anhydrous, Hydrochloric acid (for pH adjustment), Sodium hydroxide (for pH adjustment), Water for injections.
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 minutes before).
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak blood levels 30 to 70 minutes following subcutaneous injection.
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with renal impairment. In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic differences between insulin lispro and soluble human insulin were generally maintained and shown to be independent of renal function. Insulin lispro maintains more rapid absorption and elimination when compared to soluble human insulin in patients with hepatic impairment.
The following content is intended to answer your questions only and is not intended to be used for promotional purposes or as a clinical medication guidance.
※ Product Characteristics
● What is the basic information about Prandilin®25?
The generic name of Prandilin®25 is Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection (25R). It consists of two active ingredients: 25% insulin lispro and 75% insulin lispro protamine zinc. It is intended for the treatment of people with diabetes who require insulin therapy and was launched in China in 2014. Prandilin®25 is a unique insulin formulation designed for flexible dosing. Patients can inject once or twice daily, depending on their blood glucose levels. This insulin product can be administered just before meals and can also be used immediately after meals if required. As a biosimilar, Prandilin®25 closely matches the approved reference medicine (originator) in terms of quality, safety, and efficacy.
● Will Prandilin®25 cause liver and kidney problems like some oral hypoglycemic drugs?
Prandilin®25 is not associated with liver or kidney problems. The liver and kidney are involved in the elimination of the body's own insulin. The introduction of exogenous insulin does not place an additional burden on these organs. In cases of liver or kidney dysfunction, the need for insulin may be reduced due to the reduced breakdown of endogenous insulin. Therefore, people using insulin should continue to monitor their blood glucose levels and adjust their dose if necessary.
● Is injecting Prandilin®25 addictive? Could higher doses lead to dependence?
Prandilin®25 is not associated with addiction or dependence. Addiction is when an individual develops an intense craving for a substance to obtain psychological or physiological effects, leading to uncontrollable and compulsive use. Unlike addictive substances, Prandilin®25 is a form of insulin, a natural hormone that is essential for metabolic processes and the maintenance of life. The use of insulin is determined by factors such as blood glucose control and the functioning of the body's β cells. It is not addictive and its necessity is dictated by medical considerations rather than addictive tendencies.
● What are the precautions for the use of Prandilin®25 in special populations? Are there efficacy and safety data?
Pregnant and breastfeeding women: Use with caution. Clinical trial experience with insulin lispro in pregnant patients is very limited, therefore close monitoring of the patient's blood glucose is required throughout pregnancy if insulin is required (as stated in the prescribing information).
Children: Use with caution. The safety and effectiveness of this medicine in children under 12 years of age have not been established (as stated in the prescribing information).
Older people: No special instructions. Please refer to the [Dosage] in the prescribing information, or follow the doctor's advice.
※ Clinical Appication
● How does the glucose-lowering efficacy and safety of Prandilin®25 compare with that of the original insulin lispro 25 reference drug?
A multi-center Phase 3 clinical trial led by the General Hospital of the People's Liberation Army (PLA) enrolled 514 patients with diabetes. They were randomized to receive either Prandilin®25 (n=386) or the original reference insulin lispro25 (n=128) for a 12-week treatment period. The study was designed to evaluate the efficacy and safety of Prandilin®25 compared to the imported original reference product for treating both type 1 and type 2 diabetes mellitus. The results showed that Prandilin®25 demonstrated a similar level of efficacy and safety as the original reference drug insulin lispro 25 (Pan et al., 2019).
● Does Prandilin®️25 require a higher dosage than the original insulin lispro to achieve equivalent efficacy?
The Phase 3 clinical trial of Prandilin®25 conducted in China showed that there were no statistically significant differences (P>0.05) in the average total daily insulin dose and changes in daily insulin dose between Prandilin®25 and the original insulin lispro 25 in achieving comparable glycaemic control (Pan et al., 2019).
● Can Prandilin®25 be used with an insulin pump?
Prandilin®️25 cannot be used in insulin pumps.
● What are the advantages of Prandilin®25 over premixed human insulin?
Unlike premixed human insulin, Prandilin®️25 offers a reduced risk of postprandial hyperglycemia. Its mealtime component has a faster onset of action, allowing it to be injected either with or immediately after a meal without waiting for 30 minutes. This feature improves patient compliance. In addition, Prandilin®️25 has a higher peak concentration and shorter duration, resulting in improved postprandial glucose control.
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