NOVORAPID FLEXPEN
Generic Name: Insulin Aspart
Strength & Packaging: 100 U/mL, 5 x 3 mL pre-filled pens
Dosage Form: Solution for injection in a pre-filled pen
Category: Rapid-acting insulin analogue for glycaemic control in diabetes mellitus. Official product information identifies NovoRapid FlexPen as insulin aspart 100 units/mL, with each pre-filled pen containing 3 mL (300 units), and carton presentations including 5 x 3 mL pre-filled pens.

Product Name & Packaging

Product Name: NovoRapid FlexPen
Generic Name: Insulin Aspart
Strength: 100 U/mL
Presentation: 3 mL pre-filled multidose disposable pen
Pack Size: 5 x 3 mL pre-filled pens
Pen Use Note: Needles are not included. The FlexPen is designed for use with NovoFine or NovoTwist disposable needles up to 8 mm and is intended for subcutaneous use.

Description

NovoRapid FlexPen contains insulin aspart, a rapid-acting insulin analogue used to help control blood glucose in patients with diabetes mellitus. Compared with soluble human insulin, NovoRapid has a faster onset and shorter duration of action, supporting mealtime glucose control as part of an individualized insulin regimen.

Indications

Indicated for: treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and above.

Dosage & Administration

Administration: NovoRapid dosing is individualized according to the patient’s needs. It is normally used in combination with an intermediate-acting or long-acting insulin in a basal-bolus regimen. The usual total daily insulin requirement in adults and children is approximately 0.5 to 1.0 unit/kg/day, with about 50% to 70% of that requirement potentially provided by NovoRapid in basal-bolus therapy.

For subcutaneous injection, insulin aspart should generally be injected within 5 to 10 minutes before a meal into the abdomen, thigh, buttocks, or upper arm. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. FlexPen delivers 1 to 60 units in 1-unit increments and is suitable for subcutaneous injections only.

Mechanism of Action

The glucose-lowering effect of insulin aspart is due to facilitated uptake of glucose after insulin binds to receptors on muscle and fat cells, together with simultaneous inhibition of hepatic glucose output. NovoRapid produces a more rapid onset of action than soluble human insulin; when injected subcutaneously, onset generally occurs within 10 to 20 minutes, peak effect occurs at 1 to 3 hours, and duration of action is approximately 3 to 5 hours.

Precautions

Important precautions:
NovoRapid is contraindicated in patients with hypersensitivity to insulin aspart or any excipient. The most important safety risk is hypoglycaemia, which may be severe and can lead to unconsciousness, convulsions, or death. Patients should also be monitored for hyperglycaemia if doses are missed or regimens are changed, and for hypokalaemia, since all insulins can shift potassium intracellularly.

Patients must never share a FlexPen, even if the needle is changed, because of the risk of transmitting blood-borne pathogens. They should also check the insulin label before each injection to avoid accidental product mix-ups. Repeated injections into areas affected by lipodystrophy or cutaneous amyloidosis may alter insulin absorption and worsen glycaemic control.

Side Effects

Most common adverse reaction:

Hypoglycaemia

Other reported adverse effects may include:

Injection site reactions such as pain, redness, swelling, itching, bruising, hives, or inflammation
Lipodystrophy and localized cutaneous amyloidosis at the injection site
Rash, urticaria, and other hypersensitivity reactions
Oedema
Rare but serious anaphylactic reactions.

Storage

Storage:

Before opening: Store in a refrigerator at 2°C to 8°C. Do not freeze.
During use / when carried as a spare: Store for a maximum of 4 weeks below 30°C. The pen may also be kept refrigerated at 2°C to 8°C during use according to the NovoRapid FlexPen SmPC. Keep the pen cap on to protect from light, and discard the needle after each injection.