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Biphasic (Premixed) Insulin Analogue Pregnancy: UK SPC §4.6. Pregnancy: there is limited clinical experience with NovoMix 30 in pregnancy; animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity. In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters; after delivery they return rapidly to pre-pregnancy levels. Breast-feeding: there are no restrictions on treatment with NovoMix 30 during breast-feeding — insulin treatment of the nursing mother presents no risk to the baby, however the dose may need to be adjusted. Fertility: animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.

Biphasic Insulin Aspart

Brand names: NovoMix 30

Biphasic insulin aspart is a premixed insulin combining rapid-acting insulin aspart with a protamine-bound intermediate-acting component, used to manage diabetes mellitus.

Adult dose

Dose: DIABETES MELLITUS (the page's primary indication), given as a biphasic premix. TYPE 2 DIABETES — the recommended starting dose is 6 units at breakfast and 6 units at dinner (evening meal); NovoMix 30 can also be initiated once daily with 12 units at dinner (evening meal). When using it once daily it is generally recommended to move to twice daily on reaching 30 units, by splitting the dose into equal breakfast and dinner doses. If twice daily dosing results in recurrent daytime hypoglycaemic episodes, the morning dose can be split into morning and lunchtime doses (thrice daily dosing). TITRATION (adjust from the LOWEST of the three previous days' pre-meal blood glucose levels; do not increase if hypoglycaemia occurred in those days; adjust once a week until target HbA1c is reached): pre-meal glucose <4.4 mmol/l (<80 mg/dl) −2 units; 4.4–6.1 mmol/l (80–110 mg/dl) no change; 6.2–7.8 mmol/l (111–140 mg/dl) +2 units; 7.9–10 mmol/l (141–180 mg/dl) +4 units; >10 mmol/l (>180 mg/dl) +6 units. If a GLP-1 receptor agonist is added, a 20% dose reduction is recommended for patients with an HbA1c less than 8%, and a dose reduction should be considered for those with an HbA1c higher than 8%. TYPE 1 DIABETES — the SPC states only that the individual insulin requirement is usually between 0.5 and 1.0 unit/kg/day, which NovoMix 30 may fully or partially meet; it gives no separate NovoMix starting dose for type 1. TRANSFER from biphasic human insulin: start with the same dose and regimen, then titrate to individual needs with close glucose monitoring.
Route: Subcutaneous injection ONLY — into the thigh or the abdominal wall, or the gluteal or deltoid region if convenient, rotating injection sites within the same region to reduce the risk of lipodystrophy and cutaneous amyloidosis. §4.4: must not be administered intravenously (may result in severe hypoglycaemia), intramuscular administration should be avoided, and it is not to be used in insulin infusion pumps.
Frequency: Usually twice daily (breakfast and dinner); may be initiated once daily at dinner in type 2 diabetes, and may be split to three times daily if recurrent daytime hypoglycaemia occurs. Give immediately before a meal; when necessary it can be given soon after a meal.
SCOPE: this record is the biphasic (premixed) insulin aspart 30/70 regimen and nothing else. That hold was recorded because the bundle then held 'Fiasp 100 units/mL Penfill', a fast-acting MONO-COMPONENT mealtime insulin aspart whose bolus regimen must never be transferred to a premix. The bundle now holds the UK SPC for 'NovoMix 30 FlexPen 100 units/ml' — the exact brand this page names — which §4.2 describes as 'a biphasic suspension of the insulin analogue, insulin aspart. The suspension contains rapid-acting and intermediate-acting insulin aspart in the ratio 30/70', for subcutaneous administration only. NO MAXIMUM DOSE: §4.2 states no dose ceiling — insulin dosing is individual and determined by the patient's needs — so maxDose is deliberately left blank rather than invented. The FlexPen 'delivers 1–60 units in increments of 1 unit' is a DEVICE delivery range, not a therapeutic maximum, and must not be surfaced as one; if administration by syringe is necessary a vial should be used. POTENCY: the potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units. SPECIAL POPULATIONS — Elderly (≥65 years): NovoMix 30 can be used, but there is limited experience in combination with oral antidiabetic medicinal products in patients older than 75 years; intensify glucose monitoring and adjust the dose individually. Renal or hepatic impairment: may reduce the patient's insulin requirements; intensify glucose monitoring and adjust the dose individually. Adjustment may also be necessary with increased physical activity, a change in usual diet, or concomitant illness — infections and feverish conditions usually INCREASE insulin requirements, and concomitant kidney, liver, adrenal, pituitary or thyroid disease can require dose changes. PAEDIATRIC (recorded here because no numeric paediatric dose exists to place in paedDose): NovoMix 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred; there is limited clinical experience in children aged 6–9 years, and no data below 6 years of age. The label gives no paediatric unit/kg figure. COMBINATION: in type 2 diabetes NovoMix 30 can be given as monotherapy, or in combination with oral antidiabetic medicinal products and/or GLP-1 receptor agonists. ONSET: NovoMix 30 has a faster onset of action than biphasic human insulin and may have a more pronounced glucose-lowering effect up to 6 hours after injection, which may need to be compensated for by adjusting insulin dose and/or food intake.

Dose adjustments

Renal

§4.2 Renal and hepatic impairment, verbatim: 'Renal or hepatic impairment may reduce the patient's insulin requirements. In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.' No numeric adjustment is given.

Hepatic

§4.2 Renal and hepatic impairment, verbatim: 'Renal or hepatic impairment may reduce the patient's insulin requirements. In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin aspart dose adjusted on an individual basis.' No numeric adjustment is given.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 — this is the whole of §4.3; the label lists no other contraindication
  • Must NOT be administered intravenously — §4.4: 'NovoMix 30 must not be administered intravenously, as it may result in severe hypoglycaemia' (a §4.4 prohibition, not a §4.3 contraindication)
  • Intramuscular administration should be avoided (§4.4)
  • Not to be used in insulin infusion pumps (§4.4)
  • Must not be injected in case of hypoglycaemia or if hypoglycaemia is suspected — after stabilisation of blood glucose, adjustment of the dose should be considered (§4.4)
  • No data are available in children below 6 years of age; there is only limited clinical experience in children aged 6–9 years (§4.2)

Side effects

  • Very common — hypoglycaemia; the most frequently reported adverse reaction. It may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death; symptoms usually occur suddenly and may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness
  • Uncommon — urticaria, rash, eruptions
  • Very rare — anaphylactic reactions; generalised hypersensitivity reactions (generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure) are very rare but can potentially be life-threatening
  • Rare — peripheral neuropathy (painful neuropathy); fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible
  • Uncommon — refraction disorders, and diabetic retinopathy; intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression
  • Uncommon — lipodystrophy; not known — cutaneous amyloidosis (post-marketing). Rotate injection sites within the same region to reduce the risk of both
  • Uncommon — oedema, and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site). At the beginning of insulin treatment refraction anomalies, oedema and injection site reactions may occur and are usually transitory
  • Hyperglycaemia and diabetic ketoacidosis from inadequate dosing or discontinuation of treatment, especially in type 1 diabetes — symptoms develop gradually over hours or days and include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite and acetone odour of breath; untreated, this is potentially lethal (§4.4)
  • NOTE: §4.8 was cut at the source-fetch limit part-way through the hypoglycaemia description, so this list reproduces the tabulated reactions that were retrieved and may not be complete — confirm against the SPC

Monitoring

  • Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control (§4.2)
  • Pre-meal blood glucose levels should be used to evaluate the adequacy of the preceding dose; titrate from the LOWEST of the three previous days' pre-meal levels, and do not increase the dose if hypoglycaemia occurred within those days. Dose adjustments can be made once a week until target HbA1c is reached (§4.2)
  • Intensify glucose monitoring and adjust the dose individually in elderly patients and in renal or hepatic impairment (§4.2)
  • Close glucose monitoring during transfer from another insulin and in the initial weeks thereafter; transferring a patient to another type or brand of insulin should be done under strict medical supervision, and early warning symptoms of hypoglycaemia may change or become less pronounced after transfer (§4.2, §4.4)
  • Watch for loss of hypoglycaemia awareness — patients whose blood glucose control is greatly improved may experience a change in their usual warning symptoms and should be advised accordingly; usual warning symptoms may disappear in patients with longstanding diabetes. Tighter control increases the potential for hypoglycaemic episodes and requires special attention during dose intensification (§4.4)
  • Review the insulin dose during concomitant illness, especially infections and feverish conditions, which usually increase insulin requirements, and in concomitant kidney, liver, adrenal, pituitary or thyroid disease (§4.4)
  • Advise patients travelling between time zones to seek medical advice beforehand, since insulin and meals may have to be taken at different times (§4.4)
  • NOTE: §4.4 was cut at the source-fetch limit within the 'Transfer from other insulin medicinal products' paragraph — read the remainder from the SPC

Clinical monograph

How it works

The aspart fraction provides rapid postprandial glucose control while the protaminated fraction gives a more prolonged basal effect; insulin lowers glucose by promoting cellular uptake and inhibiting hepatic glucose output.

Prescribing in practice

  • Hypoglycaemia is the principal risk, and because it contains a rapid-acting component it should be given with or just before a meal to avoid early hypoglycaemia.
  • Insulin requirements change with illness, activity, weight and renal function, so doses need individualised adjustment.
  • The pen must be resuspended by gentle mixing before each injection, and brands or insulin preparations should not be switched without clinical supervision.

Monitoring

Monitor blood glucose regularly (including HbA1c) and review injection technique and site rotation to detect hypoglycaemia and lipohypertrophy.

Counselling the patient

  • A premixed insulin covering meals and providing background control.
  • Resuspend the pen by gentle mixing and inject with or just before meals.
  • Know how to recognise and treat low blood sugar and rotate injection sites.

Evidence & guidelines

Premixed biphasic insulin aspart is an established option in diabetes care, with administration timing and hypoglycaemia precautions detailed in NICE guidance and the SPC.

Reference: NICE NG28 (Type 2 DM); MHRA Insulin Safety Alert; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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