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Apidra®
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Rapid-Acting Apidra®

The goal of insulin therapy is to mimic the secretion pattern of endogenous human insulin.1 The quick absorption and rapid action of RAIs are intended to be close to normal endogenous insulin secretion at mealtime.

Studies

  1. A fast onset of action2,5
  2. Low postmeal BG levels3,5
  3. Fast absorbtion regardless of weight4,5

Vs RHI and lispro: Onset of action5,6,7,a

  • The action profile of Apidra® was not affected by skin thickness or BMI2

For the purposes of this trial, references to lispro refer to Humalog® manufactured by Eli Lilly & Co.

Study Design
Becker study: The pharmacokinetics and pharmacodynamics of Apidra®, RHI, and lispro were examined in a single-dose, randomized, double-blind, 3-way crossover euglycemic clamp study of 18 obese, nondiabetic subjects. An SC injection of 0.3 U/kg of each insulin was administered in the abdominal area in predetermined sequences. The washout periods between the clamp procedures for each insulin were at least 7 days. After administration, infusion of a 20% glucose solution started when BG fell below 10% of mean baseline level. PD parameters were derived from the individual glucose infusion rate profiles.2,5 Point estimate vs Apidra® (95% CI): RHI: -36 min (-96; -20 min).

Vs aspart§ : During the first hour following a meal3

  • In a PK/PD study, Apidra® was associated with lower BG levels during the first hour after a standard meal in insulin naive, obese patients with T2DM3

§For the purposes of this trial, references to aspart refer to Novalog® manufactured by Novo Nordisk Inc.

Study Design
Bolli study: A multinational, randomized, double-blind, two-way crossover trial to compare the PK and PD properties of SC Apidra® and insulin aspart§ in 30 insulin-naive, obese, T2DM subjects. Patients fasted overnight and received a 0.2 U/kg SC dose of either Apidra® or aspart§ 2 minutes before starting a standardized meal. The procedure was repeated with the alternative insulin after a 7-day washout period. The primary objective was to assess the PD effect (as measured by AUC) of each insulin during the first hour after a standard meal.3

Faster absorption vs. Lispro regardless of weight4,a

Vs lispro: Absorption in non-diabetic patients4,a

  • The onset of action overall was faster for Apidra® in the first dosing hour (GIR-AUC0-1h with 0.2U/kg was 102.3+/-75.1 vs 83.1+/-72.8 mg/kg, P<0.05)

a There is no evidence to suggest that these PK/PD differences impact overall glycemic control.

For the purposes of this trial, references to lispro refer to Humalog® manufactured by Eli Lilly & Co.

Study Design
Heise study: A randomized, double-blind, single-center, 4-way crossover euglycemic clamp study examined the PD and PK of Apidra® and lispro. Eighty nondiabetic subjects (ages 18-65) were randomized to treatment groups and stratified by BMI into 4 classes as indicated on the graph, with 20 subjects in each group. Subjects fasted overnight prior to the day of receiving study medication. Insulin (0.2 or 0.4 U/kg) was administered by SC injection into the abdominal area. The euglycemic clamp device measured BG continuously and automatically adjusted and recorded the infusion rate of a 20% glucose solution each minute to maintain BG levels at 10% below the individual fasting BG concentration. PD parameters were derived from the individual glucose infusion rate profiles4

Help your patients take control of mealtime with Apidra® — the longest defined dosing window in the RAI category.5-7 Postmeal Dosing Info

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Indications and Usage for Apidra®
(insulin glulisine [rDNA origin] injection)

Apidra® is a rapid-acting insulin analog indicated to improve glycemic control in adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes.

When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal. Apidra® given by subcutaneous injection should normally be used in regimens that include a longer-acting insulin.

Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection)

CONTRAINDICATIONS

Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra® or any of its excipients.

WARNINGS AND PRECAUTIONS

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As with all insulin preparations, the time course of Apidra® action may vary by individual or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature.

Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®, which may be serious.

Severe life-threatening, generalized allergy, including anaphylaxis, can occur. All insulins, including Apidra®, can cause hypokalemia, which if untreated, may be serious.

A reduction in the Apidra® dose may be required in patients with renal or hepatic impairment.

Apidra® for subcutaneous injection should not be mixed with insulins other than NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous administration.

Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. Observe for signs and symptoms of heart failure. Consider dosage reduction or discontinuation of TZD if heart failure occurs.

DRUG INTERACTIONS

Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).

ADVERSE REACTIONS

Other adverse reactions commonly associated with Apidra® include injection site reactions, lipodystrophy, pruritus, and rash.

Important Safety Information for Apidra® (insulin glulisine [rDNA origin] injection) SoloSTAR®

Apidra® SoloSTAR® is a disposable prefilled insulin pen. To help ensure an accurate dose each time, patients should follow the steps in the Instruction Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin, which may affect their blood glucose.

Please click here for Full Prescribing Information for Apidra®.

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*Certain restrictions apply for the savings program. This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD, or TRICARE, or similar federal or state programs including any state medical pharmaceutical programs. Void where prohibited by law. The maximum savings is $100 off per monthly prescription for the duration of the program. Savings may vary depending on patient’s out-of-pocket costs. Upon registration, patient receives all program details. Sanofi US reserves the right to rescind, revoke, or amend the program without notice. As of September 2017.

Humalog savings card information. Available at: https://www.humalog.com/hcp/humalog-u200.aspx#savings-card-section. Accessed September 6, 2017.

NovoLog savings card information. Available at: https://www.novologpro.com/prescribing/prescription-savings.html . Accessed September 6, 2017.

Reference

  1. Sheldon B, Russel‑Jones D, Wright J. Diabetes Obes Metab. 2009;11:5‑9.
  2. Becker RHA, Frick AD, Burger F, Potgieter JH, Scholtz H. Exp Clin Endocrinol Diabetes. 2005;13:435‑443.
  3. Bolli GB, Luzio S, Marzotti S, et al. Diabetes Obes Metab. 2011;13:251‑257.
  4. Heise T, Nosek L, Spitzer H, et al. Diabetes Obes Metab. 2007;9:746‑753.
  5. Apidra® Prescribing Information. February 2015
  6. NovoLog® Prescribing Information. April 2017
  7. Humalog® Prescribing Information. August 2017

Apidra® is a rapid-acting insulin analog indicated to improve glycemic control in adults with type 2 diabetes or adults and children (4 years and older) with type 1 diabetes.

When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes before or within 20 minutes after starting a meal. Apidra® given by subcutaneous injection should normally be used in regimens that include a longer-acting insulin.

Important Safety Information for Apidra®

Contraindications

Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Apidra® or any of its excipients.

Warnings and Precautions

Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.

Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As with all insulin preparations, the time course of Apidra® action may vary by individual or at different times in the same individual and is dependent on many conditions, including the site of injection, local blood supply, or local temperature.

Click here for additional Important Safety Information.

Click here for full prescribing information for Apidra®.

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