.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 Mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus.

Limitations of Use:

Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is not recommended for the treatment of diabetic ketoacidosis.
The proportions of rapid-acting and long-acting insulins in Insulin Aspart Protamine and Insulin Aspart Mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments.

2 DOSAGE AND ADMINISTRATION

2.1 Important Preparation and Administration Instructions

Always check insulin labels before administration. This product is NovoLog Mix 70/30 (insulin aspart protamine and insulin aspart) [see Warnings and Precautions (5.4)].
Inspect Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart) visually before use. It should appear uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles.
Insulin Aspart Protamine and Insulin Aspart must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature.
When using the:
o
Vial, roll the vial gently in hands in a horizontal position 10 times until the suspension appears uniformly white and cloudy. Inject immediately.
o
Insulin Aspart Protamine and Insulin Aspart FlexPen, roll Insulin Aspart Protamine and Insulin Aspart FlexPen gently between hands in a horizontal position 10 times. Then, turn Insulin Aspart Protamine and Insulin Aspart 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.
The Insulin Aspart Protamine and Insulin Aspart FlexPen dials in 1-unit increments.
Use Insulin Aspart Protamine and Insulin Aspart FlexPen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
Inject Insulin Aspart Protamine and Insulin Aspart subcutaneously in the abdominal region, buttocks, thigh, or upper arm.
Administer the dose within 15 minutes before meal initiation. For patients with type 2 diabetes, the dose may also be given after meal initiation.
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)].
Do not administer Insulin Aspart Protamine and Insulin Aspart intravenously or use in insulin infusion pumps.
Do not mix Insulin Aspart Protamine and Insulin Aspart with any other insulins.

2.2 Dosage Recommendations

Insulin Aspart Protamine and Insulin Aspart is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack).
Individualize the dosage of Insulin Aspart Protamine and Insulin Aspart based on the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.
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)].
When switching from another insulin to Insulin Aspart Protamine and Insulin Aspart, a different dosage of Insulin Aspart Protamine and Insulin Aspart may be needed [see Warnings and Precautions (5.2)].
During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].

2.3 Dosage Modifications for Drug Interactions

Dosage modification may be needed when Insulin Aspart Protamine and Insulin Aspart is used concomitantly with certain drugs [see Drug Interactions (7)].

3 DOSAGE FORMS AND STRENGTHS

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

10 mL multiple-dose vial
3 mL single-patient-use FlexPen prefilled pen

4 CONTRAINDICATIONS

Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is contraindicated:

During episodes of hypoglycemia [see Warnings and Precautions (5.3)]
In patients with hypersensitivity to Insulin Aspart Protamine and Insulin Aspart 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 Mix 70/30 FlexPen Between Patients

Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart) FlexPen should never be shared between patients, even if the needle is changed. Patients using Insulin Aspart Protamine and Insulin Aspart 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.

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction of all insulins, including Insulin Aspart Protamine and Insulin Aspart. Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)] , or in patients who experience recurrent hypoglycemia.

Risk Factors for Hypoglycemia

The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Insulin Aspart Protamine and Insulin Aspart may vary in different individuals or at different times in the same individual and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature [see Clinical Pharmacology (12.2)]. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitantly administered medication [see Drug Interactions (7)]. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use in Specific Populations (8.6, 8.7)].

Risk Mitigation Strategies for Hypoglycemia

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia; increased frequency of blood glucose monitoring is recommended. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

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