.Insulin Aspart Protamine and Insulin Aspart

.INSULIN ASPART PROTAMINE AND INSULIN ASPART- insulin aspart injection, suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in patients with diabetes mellitus.

Limitations of Use:

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Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 is not recommended for the treatment of diabetic ketoacidosis.

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The proportions of rapid-acting and long-acting insulins in Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

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Always check insulin labels before administration [see Warnings and Precautions (5.4)].

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Inject Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 subcutaneously in the abdominal region, buttocks, thigh, or upper arm.

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Administer the dose within 15 minutes before meal initiation. For patients with type 2 diabetes, the dose may also be given after meal initiation.

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Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 , 6.3 )].

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During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )].

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Inspect Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 visually before use. It should appear uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles.

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Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature.

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When using the vial, roll the vial gently in hands in a horizontal position 10 times until the suspension appears uniformly white and cloudy. Inject immediately.

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When using Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen, roll Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen gently between hands in a horizontal position 10 times. Then, turn Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen upside down so that the glass ball moves from one end of the reservoir to the other 10 times until the suspension appears uniformly white and cloudy. Inject immediately.

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The Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen dials in 1-unit increments.

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Use Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.

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Do not administer Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 intravenously or use in insulin infusion pumps.

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Do not mix Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 with any other insulins.

2.2 Dosage Information

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Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack).

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Individualize and adjust the dosage of Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal.

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Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6, 8.7)].

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Dosage adjustment may be needed when switching from another insulin to Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 [see Warnings and Precautions (5.2)].

2.3 Dosage Adjustment Due to Drug Interactions

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Dosage adjustment may be needed when Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 is co-administered with certain drugs [see Drug Interactions (7)].

3 DOSAGE FORMS AND STRENGTHS

Injectable suspension: 100 units per mL (U-100) of Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30, 70% insulin aspart protamine and 30% insulin aspart, is a white and cloudy suspension available as:

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10 mL multiple-dose vial

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3 mL single-patient-use Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen

4 CONTRAINDICATIONS

Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 is contraindicated

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During episodes of hypoglycemia [see Warnings and Precautions (5.3)]

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In patients with hypersensitivity to Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 or one of its excipients [see Warnings and Precautions (5.5)]

5 WARNINGS AND PRECAUTIONS

5.1 Never Share Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen Between Patients

Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 FlexPen should never be shared between patients, even if the needle is changed. Patients using Insulin Aspart Protamine and Insulin Aspart Injectable Suspension Mix 70/30 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

​ Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3) ​ ] ​ or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions ( 6.1 ​ , 6.3 ​ )]. ​ Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.