NOVOMIX 30 FLEXPEN 100/UNITS/ML 5×3ML/PENFILL @

Indications

Approved Uses

Treatment of type 2 diabetes mellitus in adults, treatment of type 1 diabetes mellitus in adults

Off-Label Uses

No specific off-label use should be asserted; insulin aspart mixtures may be used in pregnancy/gestational diabetes when clinically indicated, but this is jurisdiction- and product-label-dependent.

Dosage & Administration

Dosing by Condition

Individualize dosing for both type 1 and type 2 diabetes based on SMBG and glycaemic targets; typical total daily insulin needs are often ~0.5-1.0 units/kg/day (varies widely), and premixed regimens are commonly started and titrated (e.g., once or twice daily with meals) rather than using a fixed universal starting dose.

Initial Dose

0.5 units/kg/day for the protamine product; 6 IU twice daily administered with main meals (type 2 diabetes); individualised for type 1 diabetes

Maintenance Dose

Individualised; typically 0.5 units/kg/day divided into 2 doses before meals, with 70% of the daily dose before breakfast and 30% of the daily dose before dinner

Maximum Dose

No defined maximum dose; dose is individualised to glycaemic targets and patient needs.

Children's Dosage

Approved for children aged 10 years or older.

Dose Adjustment Notes

Titrate based on self-monitored blood glucose; dose needs may change with intercurrent illness/infection, stress, diet or activity changes; renal or hepatic impairment can reduce insulin requirements; switching from other insulin regimens requires close glucose monitoring and possible dose adjustment.

How to Take

For subcutaneous use only (do not give IV/IM). Inject into the subcutaneous tissue of the abdomen, thigh, upper arm, or buttock; rotate injection sites within the same region to reduce lipodystrophy. Because it is a suspension, resuspend before each dose by rolling the pen between the palms and inverting repeatedly until uniformly white/cloudy. Administer subcutaneously with a meal as directed by the prescriber.

How to Prepare

Allow to reach room temperature before first use if refrigerated; resuspend by rolling the pen 10 times and inverting 10 times until uniformly white and cloudy; do not use if clumps/particles remain; attach a new needle each time and perform a safety/air shot per pen-use instructions

Side Effects

Common Side Effects

Hypoglycaemia; injection-site reactions (pain, redness, swelling, itching); lipodystrophy (lipoatrophy/lipohypertrophy); weight gain; oedema.

Safety & Warnings

Contraindications

Hypoglycemia, Hypersensitivity to insulin aspart or any of the excipients.

Warnings & Precautions

Key precautions: high risk of hypoglycaemia (requires correct dose/timing with meals, exercise and interacting drugs); do not stop abruptly (risk hyperglycaemia/DKA); rotate injection sites to reduce lipodystrophy/amyloidosis; avoid product mix-ups; do not share pens; ensure proper resuspension of premix before each dose; not for IV use or pump use; caution in hypoglycaemia unawareness and monitor for hypokalaemia.

Age Restriction

Approved for adults, adolescents, and children aged 10 years or older.

Drug Interactions

Drug Interactions

Glucose-lowering effect may be increased by: other antidiabetics, ACE inhibitors, salicylates, MAO inhibitors, some beta-blockers; may be reduced by: corticosteroids, thiazide diuretics, thyroid hormones, sympathomimetics, oral contraceptives; beta-blockers can mask hypoglycaemia symptoms; alcohol may potentiate/prolong hypoglycaemia; octreotide/lanreotide may increase or decrease insulin requirement.

Interaction Severity

MAJOR: Pioglitazone/other thiazolidinediones with insulin (increased risk of fluid retention/heart failure); alcohol can increase hypoglycaemia risk (clinically significant). MODERATE: Beta-blockers (mask hypoglycaemia), ACE inhibitors/salicylates (may enhance glucose-lowering), corticosteroids/thiazides/thyroid hormones/sympathomimetics/oral contraceptives (may raise glucose and increase insulin needs), MAO inhibitors (may enhance hypoglycaemia). VARIABLE: Octreotide/lanreotide (may increase or decrease insulin requirements).

Food Interaction

Give with a meal: usually immediately before (within ~10 minutes of starting a meal); if necessary, it may be administered soon after starting a meal-avoid injecting without ensuring carbohydrate intake to reduce hypoglycaemia risk.

Alcohol Interaction

Dangerous

Special Populations

Children

Approved for children aged 10 years or older.

Elderly

Start at lower doses; titrate slowly with careful blood glucose monitoring due to increased risk of hypoglycaemia and potential renal impairment

Kidney Impairment

No fixed adjustment; renal impairment may reduce insulin requirements-individualise dose with intensified glucose monitoring and reduce as needed.

Liver Impairment

No fixed adjustment; hepatic impairment may reduce insulin requirements-individualise dose with intensified glucose monitoring and reduce as needed.

Storage & Patient Advice

Preparation Instructions

Allow to reach room temperature before first use if refrigerated; resuspend by rolling the pen 10 times and inverting 10 times until uniformly white and cloudy; do not use if clumps/particles remain; attach a new needle each time and perform a safety/air shot per pen-use instructions

Stopping the Medicine

Do not discontinue without medical supervision; stopping insulin can cause severe hyperglycaemia and diabetic ketoacidosis (especially in type 1 diabetes).

Overdose

Overdose primarily causes hypoglycaemia; treat mild/moderate with oral fast-acting carbohydrate, and severe episodes with glucagon (IM/SC) or IV glucose with medical supervision and continued monitoring for recurrence.

Patient Counseling

Confirm the correct pen/label and dose; resuspend until uniformly white/cloudy before each injection; inject subcutaneously with site rotation and never share the pen; take with a meal (immediately before, or soon after starting if needed) and do not skip meals after dosing; recognize and treat hypoglycaemia and carry fast-acting carbohydrate; store unopened pens refrigerated (2-8°C per API data) and follow product guidance for in-use storage/time at room temperature; seek advice during illness, major diet/activity changes, or recurrent hypo/hyperglycaemia.

Monitoring Requirements

Regular SMBG (fasting and postprandial as appropriate) and periodic HbA1c (typically every ~3 months until stable, then individualized); monitor for hypoglycaemia and injection-site/lipodystrophy; consider serum potassium in high-risk situations (e.g., high doses, renal impairment) and periodic renal/hepatic assessment to guide dosing.

Pharmacology

Mechanism of Action

Binds insulin receptors to increase peripheral glucose uptake and decrease hepatic glucose output; the soluble insulin aspart provides rapid prandial effect while protamine-crystallised insulin aspart provides a slower, intermediate basal effect via delayed absorption from the SC depot (50/50 for this product).

Onset of Action

Approximately 10-20 minutes after subcutaneous injection.

Duration of Effect

Up to about 24 hours (dose- and patient-dependent).

Half-Life

Apparent terminal half-life after subcutaneous dosing is governed by absorption (‘flip-flop’) and is longer than the plasma elimination half-life; for insulin aspart alone it is ~81 minutes, but for biphasic aspart/protamine the apparent terminal phase is prolonged (hours) due to the protamine component

Metabolism

Degraded by proteolytic enzymes in peripheral tissues and in insulin-clearing organs (liver and kidney), similar to human insulin

Excretion

Primarily renal elimination of metabolites (no clinically meaningful unchanged urinary excretion); specific renal clearance value (e.g., 1.2 L/h/kg) is not a standard label parameter for this product

Protein Binding

Low (<10%)

Product Information

Available Dosage Forms

Suspension for injection in 3 ml cartridge (FlexPen pre-filled pen), suspension for injection in 3 ml Penfill cartridge

Composition per Dose

Each 1 ml: insulin aspart 50 IU + insulin aspart protamine 50 IU (total 100 IU/ml); each 3 ml cartridge contains 300 IU total (150 IU insulin aspart + 150 IU insulin aspart protamine)

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Both

Insulin Type

Pre-mixed

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