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Do I Need A Prescription For Insulin Syringes – The R U-500 KwikPen is a dedicated device 1 for the unique dosing needs of high volume patients (more than 200 units per day).
It can deliver 300 units per injection, and it holds 1500 units of insulin in every pen – the equivalent of five U-100 KwikPens.
Do I Need A Prescription For Insulin Syringes
Although the R U-500 KwikPen has more units of insulin, it is the same size as other KwikPens.
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The R U-500 differs from other KwikPens in that it is a single pen that calls out 5 units.
R U-500 is a concentrated human insulin that has been shown to improve glycemic control in adults and children with diabetes who require more than 200 units of insulin per day.
Description: Limitations of use: The safety and efficacy of R U-500 used in combination with other insulins, or when delivered by continuous subcutaneous infusion, have not been determined.
Description: R U-500 is contraindicated during episodes of hypoglycemia and in patients who are allergic to R U-500 or any of its components.
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Narrator: The R U-500 initiative trial was conducted to compare the efficacy and safety of U-500 dosed TID or BID in adult patients not controlled on high doses of U-100 insulins.
Caption: May be life-threatening. If overdoses occur due to dispensing, prescribing, or administration errors, attention to detail at all levels is necessary to prevent these errors.
Description: Patients should be prescribed U-500 for use with R U-500 vials. Do not use any other type of syringe to administer R U-500.
Note: Do not make dose changes when using the R U-500 KwikPen or the U-500 insulin syringe.
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Narrator: In these patients who require more than 200 units of insulin per day, will U-500 improve glycemic control with just two or three daily injections?
Description: This trial included a 4-week lead-in period. This is followed by a 24-week treatment period divided into:
Description: Intensive dose titration phase for 12 weeks (visit every week for 6 weeks, then every 2 weeks for 6 weeks)
Subjects: Randomization was stratified by baseline A1C (≤8% or >8%) and total daily insulin dose (TDD; ≤300 or >300 units).
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[Light music accompanies chapter transitions; The R U-500 logo appears on the screen; Dr. Ralph Goodman talks to the camera]
Dr. Goodman: In my practice, patients who come in with a lot of injections a day and a lot of insulin a day are frustrated because they are taking a lot of medicine and their A1C may stick or rise, despite everything. That they feel they are doing.
Dr. Lajara: Patients who may benefit from U-500 are often patients who use high-dose insulin, meaning above 200 units per day in total daily dose.
Dr. Lajara: In addition, their A1C is not controlled and their blood sugar readings are not controlled, they may also have a higher body mass index and have signs and symptoms consistent with insulin resistance.
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R U-500 – Do not use KwikPen or U-500 syringes between patients, even when changing needles, to avoid the risk of blood-borne pathogens.
Dr. Schmeltz: These are patients who are doing all the diabetic behaviors, checking their blood sugar, watching their diet, and taking all the shots they should be, but still not reaching the glycemic goals that we set. them.
Caption: Lowell Schmeltz, MD, FACE; Assistant Professor, Oakland University William Beaumont School of Medicine; Head, Department of Endocrinology and Metabolism; Detroit Huron Valley Medical Center-Sinai Hospital
Dr. Goodman: Patients really want to see their A1C improve. They know this is a sign of overall control. They know it reflects the risk of complications, and they’re really improving now to ask about their A1C at every visit, and they want feedback that it’s improving.
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Description: Serious, life-threatening, general allergic reactions, including allergic reactions, can occur with insulin products, including R U-500. If a hypersensitivity reaction occurs, discontinue R U-500; Treat according to the standard of care and monitor until signs and symptoms resolve.
Dr. Lajara: As an endocrinologist, one of the biggest sources of frustration is that I have an indicator that I measure in terms of the success of treatment recommendations, which is A1C.
[Patient sitting in doctor’s office at table, talking to their health care provider; The HCP is explaining the pen, which the patient is holding in their hand; Dr. Laza talks to the camera]
Dr. Lajara: And if the A1C does not decrease, despite the increase in their daily amount of insulin, I begin to talk about what may be the factors that influence these numbers. I’m talking technique. I correct the following. I deal with issues of getting insulin, co-pays, access, different things that might be Effects on blood sugar control, including stress, illness, new medications. There are many possibilities.
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Dr. Goodman: The frustration that patients feel and their doctors who refer them feel is something that I really see. They are on several units of insulin a day and their A1C may not be going anywhere.
Dr. Lajara: When I recommend U-500 to patients, it’s usually in situations where you’re not doing well in terms of your A1C readings and your blood glucose readings, and I see that you’re injecting multiple times a day and. That your total amount of insulin per day is quite high.
Dr. Goodman: I don’t wait to start a patient on U-500 if they’re not well controlled on a high dose of U-100 because they can tolerate the change. They accept a simpler regimen, and when they start on U-500 and see the improvement and control possible, I think it makes them more active in their diabetes management efforts.
Description: U-500 may reduce the number of daily injections compared to standard insulin U-100. Most patients will need 2-3 injections of U-500 per day. Patients can inject up to 80% liquid and still get the volume they need.
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Narrator: The primary results of the trial confirmed that R U-500 produced similar reductions in A1C levels when administered TID or BID. In both cases, the average decrease was more than 1% at the end point.
Descriptive clues: This graph presents the primary end point of a similar reduction in A1C between the 3 times a day (n = 162) and 2 times a day (n = 161) regimen for R U-500. The mean A1C at baseline in both groups was 8.7%. At 24 weeks, patients in the 3 times a day arm of the study had a least squares mean change in A1C of -1.1% (A1C of 7.5%) and patients in the 2 times a day arm had a least squares mean change. in A1C of -1.2% (A1C of 7.4%). The least squares mean change from baseline in A1C between treatment groups was -0.10%. The 95% confidence interval (-0.33% to 0.12%) fell within the bounds set by the non-destructive margin of 0.4%, indicating clinical equivalence of the 2 treatments. All efficacy analyzes were performed using the full analysis set, which defined that all randomized patients received at least 1 dose of the baseline study drug. The study was conducted with insulin syringes U-100 and R U-500 vials. The R U-500 Initiative Trial was an open-label, randomized, 24-week trial to compare the efficacy and safety of 2 doses (3 times daily, n = 162 vs. 2 times daily, n = 163) of U-500 insulin as a high-dose insulin replacement U-100 (greater than 200 units daily) with or without oral antihyperglycemic agents in adult patients with uncontrolled type 2 diabetes. These regimens were found to be equivalent in A1C reduction over 24 weeks, and both were effective.
Caption: LS = least squares; MMRM = mixed repeated measures; TID = three times a day; BID = twice a day.
Caption: The difference in least square mean (LSM) A1C change from baseline between treatment groups (BID vs TID) was -0.10%. The 95% CI (-0.33% to 0.12%) fell within the range set by the non-inferiority margin (0.4%), indicating clinical equivalence of the two treatments.
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Caption: All efficacy analyzes were performed using the full analysis set, which defined that all randomized patients received at least one dose of the baseline study drug.
Commentary: Care must be taken when measuring R U-500 because an unintended overdose may result in serious or life-threatening adverse reactions.
Narrator: In addition, the number of trial participants who reached glycemic targets was measured. About 70% of patients are below 8%, about 50% are below 7.5%, and about 30% are below 7% at the end point.
Descriptive clues: This bar graph presents the percentage of patients who met glycemic goals at endpoint (24 weeks for those who were not at goal at randomization). The mean A1C for patients at baseline (TID and BID) was 8.7%. The percentage of patients at the baseline target was approximately 1.9% (A1C less than 7.0%), approximately 9.9% (A1C less than 7.5%), and approximately 24.8% (A1C less than 8.0%). About 70% of patients taking R U-500 3 times a day and 69% of patients taking R U-500 2 times a day achieved an A1C of less than 8.0%. About 55% of patients take R U-500 3 times a day and 47% of patients take R U-500 2.
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