insulin-Novomix 30

• Treatment of diabetes mellitus.

For the latest PBS indications for glargine please see

https://www.pbs.gov.au/pbs/search?term=novomix

• The aspart (rys) component of Novomix has a faster onset and a shorter duration of action than soluble human insulin. Injections should therefore be given just before a meal or, if needed, immediately after the beginning of a meal.
• The dose of Novomix is determined by the physician according to individualized needs (usually between 0.5 and 1.0 Units/kg/day in adults). The recommended starting dose of NovoMix products in combination with metformin is 0.2 Units/kg/day and should be adjusted depending on individual requirements based on blood glucose response
• Method of administration – Noxomix 30 is administered by subcutaneous injection in the abdominal wall, the thigh, the deltoid region, or the gluteal region.
• Injection sites should be rotated within the same region to reduce the risk of lipodystrophy and cutaneous amyloidosis.
• When injected subcutaneously into the abdominal wall, the onset of action for Novomix 30 will occur within 10-20 minutes of injection. The maximum effect is exerted between 1 and 4 hours after the injection, and the duration of action is up to 24 hours.
• NovoMix Penfill 3mL cartridge is made of glass, and contains a glass ball within the cartridge to facilitate resuspension. It is recommended to allow the insulin to reach room temperature before resuspending.
• Renal Impairment – As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.
• Liver Impairment – As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

• As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

• Safety and effectiveness of Novomix 30 in children and adolescents under the age of 18 has not been established.

• Hyperglycaemia: Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and ketoacidosis. The first symptoms of hyperglycaemia usually developed gradually, over a period of hours or days. They include nausea, vomiting, drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst, and loss of appetite as well as acetone breath. Untreated hyperglycaemic events maybe life threatening. Note: Diabetes MedsCheck referral to healthcare team for sick day management plan.
• Hypoglycaemia: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Individuals whose blood glucose management is greatly improved, e.g., by intensified insulin therapy, may also experience a change in their usual warning symptoms of hypoglycaemia, and should be advised accordingly. Usual warning symptoms may disappear in those with longstanding diabetes. Concomitant illness, especially infections and feverish conditions, usually increases a person’s insulin requirements. Renal or hepatic impairment, or concomitant diseases in the kidney or liver or affecting the adrenal, pituitary or thyroid gland, can require changes in the insulin dose. Care should be taken to match insulin doses with food intake, physical activities and current blood glucose levels in order to minimise the risk of hypoglycaemia. Note: Diabetes MedsCheck referral to healthcare team for hypoglycaemias and diabetes education.
• Injection site reactions: As with any insulin therapy, injection site reactions may occur and include pain, redness, itching, hives, bruising, swelling and inflammation. Continuous rotation of the injection site within a given area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few weeks. On rare occasions, injection site reactions may require discontinuation of NovoMix due to the fact it contains metacresol which on rare occasions may cause allergic reactions. Note: Diabetes MedsCheck referral to healthcare team for review education regarding injection technique.
• Skin and subcutaneous tissue disorders: Individuals must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and destabilisation of diabetes management following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered. Note: Diabetes MedsCheck referral to healthcare team for review education regarding injection technique.
• Insulin antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia. Note: Diabetes MedsCheck referral to healthcare team for review of glucose levels.
• Transfer between insulin types: Transferring an individual to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type, origin (human insulin, insulin analogue) and/or method of manufacture may result in the need for a change in dosage. Individuals transferred to NovoMix from another type of insulin may require an increased number of daily injections or a change in dosage from that used with their usual insulin products. If an adjustment is needed, it may occur with the first dose or during the first few weeks or months. Note: Diabetes MedsCheck referral to healthcare team for review of glucose levels
• Combination of thiazolidinediones and insulin: Cases of congestive heart failure have been reported when thiazolidinediones were used in combination with insulin, especially in those with risk factors for development of congestive heart failure. This should be kept in mind if treatment with the combination of thiazolidinediones and insulin medicinal products is considered. If the combination is used, individuals should be observed for signs and symptoms of congestive heart failure, weight gain and oedema. Thiazolidinediones should be discontinued if any deterioration in cardiac symptoms occurs. Note: Diabetes MedsCheck referral to healthcare team for review. Consider annual cycle of care for ECG a weight review.

• Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified blood glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes. Note: Diabetes MedsCheck with counselling on hypoglycaemia, BG monitoring and side effect profile. May need referral back to prescriber for dose adjustment.
• Injection site and allergic reactions: As with any insulin therapy, lipodystrophy may occur at the injection site and delay insulin absorption. Other injection site reactions with insulin therapy include redness, pain, itching, hives, swelling and inflammation. Note: Diabetes MedsCheck with education about side effects with referral to healthcare team to establish correct injection technique.
• Insulin antibodies: Insulin administration may cause insulin antibodies to form. In rare cases, the presence of insulin antibodies may necessitate adjustment of the insulin dose to correct a tendency to hyper- or hypoglycaemia. Note: Diabetes MedsCheck referral to healthcare team for education.
• Generalised hypersensitivity reactions Symptoms may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and reduction in blood pressure. Generalised hypersensitivity reactions are potentially life-threatening Note: Diabetes MedsCheck referral to appropriate healthcare team for immediate care if this is suspected.
• Skin and subcutaneous tissue disorders: Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the particular area may help to reduce or prevent these reactions. Note: Diabetes MedsCheck referral to appropriate healthcare team for injection technique education and possible hypoglycaemia education when new injection site is identified.

• Hypersensitivity to insulin aspart or any active ingredient.
• Hypoglycaemia.
• Insulin pump therapy- Novomix 30 is not to be used in insulin infusion pumps.