When basal insulin is no longer enough
Step up with NovoMix®
(biphasic insulin aspart) 30
Prescribing Information NovoMix® NovoMix®
®
30 Biphasic insulin aspart. . NovoMix®
biphasic human insulin and should generally be given immediately before a meal. When necessary NovoMix®
30 FlexPen® . All presentations contain soluble insulin
aspart/protamine-crystallised insulin aspart 100 U/ml in the ratio 30/70. Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 10 to 17 years. Posology and administration: Potency of insulin analogues is expressed in units (U). In patients with type 2 diabetes, NovoMix®
30 can be given in monotherapy or in combination
with oral antidiabetic drugs (OADs) when blood glucose is inadequately controlled with these OADs alone. The recommended starting dose is 6 U at breakfast and 6 U at the evening meal. Titration is according to pre-meal blood glucose levels (pre-breakfast glucose for adjustment of evening dose and pre-evening meal glucose for adjustment of breakfast dose). NovoMix® can also be initiated once daily with 12 U at the evening meal. When using NovoMix®
30 30
once daily it is generally recommended to move to twice daily when the daily dose reaches 30 U; this can be done by splitting the dose into equal breakfast and dinner doses. If twice daily dosing results in recurrent daytime hypoglycaemic reactions the morning dose can be split into morning and lunchtime doses and thrice daily dosing instituted. Only consider combination of NovoMix®
®
with increased physical activity, changes in diet or during concomitant illness. NovoMix® can be used in the elderly; limited experience of NovoMix®
30 with pioglitazone following clinical evaluation of the patient’s 30
cautiously, titrating to the lowest dose required to obtain glycaemic control. In patients with type 1 diabetes the individual insulin requirement is usually between 0.5 and 1.0 U/kg/day and may be fully or partially supplied with NovoMix®
30. Adjustment of dose may be necessary 30
30 in combination with OADs in
patients older than 75 years. Renal or hepatic impairment may reduce insulin requirements. adjusted accordingly. NovoMix®
30 can be used in children and adolescents aged 10 years
and above; limited clinical data for children aged 6–9 years. No studies in children under the age of 6 years; only use in this age group under careful medical supervision. When transferring a patient from biphasic human insulin to NovoMix®
30, start with the same dose
and regimen, then titrate according to individual needs. For subcutaneous administration only; not to be used in infusion pumps. NovoMix®
30 has a faster onset of action than
® with NovoFine®
and NovoTwist®
® and FlexPen®
designed to be used are designed to be used
needles. Contraindications: Hypersensitivity to active
substance/excipients. Special warnings and precautions for use: Use of dosages which are inadequate or discontinuation of treatment may lead to hyperglycaemia and ketoacidosis which are potentially lethal. Travelling between time zones may require change in the applied insulin regimen. Too much insulin, omission of a meal or strenuous exercise may lead to hypoglycaemia. Compared with biphasic human insulin NovoMix®
30 may
have a more pronounced glucose-lowering effect up to 6 hours after injection. This may need to be compensated for through adjustment of dose and/or food intake. Reduction of early warning symptoms of hypoglycaemia may be seen upon tightening control and symptoms may disappear with longstanding diabetes. Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention a delayed absorption of food might be expected. Concomitant disease in kidney, liver, adrenal, pituitary or thyroid gland may require change in dose. Transferring to a new type or brand of insulin should be done under strict medical supervision; may require changes in dose/number of injections. Injection site reactions, usually transitory, may occur; rotation of injection sites within an area may help reduce or prevent these reactions. Rarely injection site reactions may require discontinuation of NovoMix®
reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. If the combination of pioglitazone and NovoMix®
30 is used, patients should be observed for signs and symptoms of heart
failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Hypoglycaemia may constitute a risk when driving or operating machinery. Fertility, pregnancy and lactation: Limited clinical experience in pregnancy. No restrictions on use during breast-feeding. No differences in animal studies between insulin aspart and human insulin regarding fertility. Undesirable effects:
from the available data). Very common: hypoglycaemia; Uncommon: urticaria, rash, eruptions; refraction anomalies, oedema and local hypersensitivity reactions on instituting result in temporary worsening; lipodystrophy; Rare: peripheral neuropathy – acute painful neuropathy, usually reversible, may occur with rapid improvement in glycaemic control; Very rare: anaphylactic reactions – generalised hypersensitivity reactions are potentially life- threatening. The Summary of Product Characteristics should be consulted for a full list of side effects. MA numbers: NovoMix®
® EU/1/00/142/004; NovoMix®
EU/1/00/142/009. Legal Category: POM. Basic NHS Price:® 5 x 3 ml FlexPen®
30 FlexPen® £28.84,
£30.98. Further prescribing information can be obtained from:
Date created/last revised: May 2011
Adverse events should be reported. Reporting forms and information can be found at
www.yellowcard.gov.uk. Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0845 6005055). Calls may be monitored for training purposes.
NovoMix® , FlexPen® ® , NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S. The Apis bull logo is a registered trademark of Novo Nordisk A/S
References 1. Qayyum R et al. Systematic review: comparative effectiveness and safety of premixed insulin analogues in type 2 diabetes. Ann Intern Med 2008; 149(8): 549–559. 2. Unnikrishnan A et al. Practical guidance on intensification of insulin therapy with BIAsp 30: a consensus statement. Int J Clin Pract 2009; 63(11): 1571–1577.
APROM ID#3054; approval date: June 2011 Date of preparation: June 2011
UK/NM30/0411/0015i
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