insulin-Humulin R

The treatment of insulin-requiring diabetes

For the latest PBS indications for Humulin R please see

https://www.pbs.gov.au/pbs/search?term=humulin%20r&analyse=false&search-type=medicines

• The dosage should be determined by the physician, according to the requirements of the person.
• During changes to a person’s insulin regimen, increase the frequency of glucose monitoring.
• Subcutaneous administration, preferably by the individual, should be in the upper arms, thighs, buttocks, or abdomen.
• Use of injection sites should be rotated so that the same site is not used more frequently than once a month, in order to reduce the risk of lipodystrophy and localised cutaneous amyloidosis.
• Do not inject into areas of lipodystrophy or localised cutaneous amyloidosis.
• Care should be taken to ensure that a blood vessel has not been inadvertently entered.
• The injection site should not be massaged.
• Vials: HUMULIN R is a short acting insulin which may be administered by subcutaneous, intramuscular, or intravenous injection.
• HUMULIN R may be administered in combination with HUMULIN NPH, depending on individual metabolic requirements as determined by the physician. A mixture of HUMULIN R and NPH is usually administered as a twice-daily regimen.
• Mixing of Insulins: The shorter-acting (HUMULIN R) insulin should be drawn into the syringe first to prevent contamination of the vial by the longer-acting (HUMULIN NPH) preparation. It is advisable to inject immediately after mixing.
• Preparations of HUMULIN (unopened or new vials) should be stored in a refrigerator between 2°and 8°C. They should not be frozen or exposed to excessive heat or sunlight. Under these conditions, potency should be maintained for 24 months from the date of manufacture for HUMULIN R.
• Vials of HUMULIN preparations while in use may be kept at room temperature for up to 28 days without loss of potency.
• Insulin opened and stored at room temperature which has not been used for a month or more should be discarded.
• Insulin which is used only occasionally is best kept refrigerated.

• Cartridges: HUMULIN R is supplied as 3.0 mL Cartridges (100 IU/mL) for use in HumaPen.
• HUMULIN 3.0mL Cartridges are not designed to allow any other insulin to be mixed in the cartridge.
• HUMULIN R Cartridges should be used only for subcutaneous administration.
• To prevent the possible transmission of disease, each cartridge must be used by one person only, even if the needle on the delivery device is changed.
• Cartridges of HUMULIN R should be stored in a refrigerator between 2°C and 8°C.
• HUMULIN Cartridges have a 2-year shelf-life when stored between 2°C and 8°C.
• Do not allow the insulin to freeze.
• When inserted in HumaPen or when carried as a spare, HUMULIN R cartridges need not be refrigerated but should be kept cool (below 30°C) and away from excessive heat and direct sunlight.
• Unrefrigerated HUMULIN R cartridges should be discarded after 21 days even if the cartridges still contain insulin.
• Renal impairment. Insulin requirements may be reduced in the presence of renal impairment. Careful glucose monitoring and dose adjustments of insulin, including Humulin R, maybe necessary. Note: Diabetes Medscheck, annual cycle of care, referral to appropriate health care professional.
• Hepatic impairment. Insulin requirements may be reduced in the presence of hepatic impairment. Careful glucose monitoring and dose adjustments of insulin, including Humulin R, may be necessary. Note: Diabetes Medscheck, annual cycle of care, referral to appropriate health care professional.

• Changes which impact diabetes management- Any change in an insulin or human insulin analogue regimen should be made cautiously and only under medical supervision with increased frequency of glucose monitoring. Changes in strength, brand (manufacturer), type species (animal, human, human insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in the need for a change in dosage. Prompt recognition and appropriate management of the complications of insulin therapy are essential for the safe and effective management of diabetes mellitus. The number and size of daily doses and the time of administration, as well as healthy eating and physical activity, require direct and continuous medical supervision. Insulin requirements may be increased during illness or emotional disturbances. In the event of infectious diseases such as colds, boils, etc., the insulin requirements increase, in which case the person should consult their physician in time to prevent the development of health consequences. Individuals whose glycaemic diabetes management is improved, e.g., by flexible insulin therapy, may lose some or all of the warning symptoms of hypoglycaemia and should be advised accordingly. Other conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include a long duration of diabetes, neuropathy or medications such as beta blockers. Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma or death. The presence of such diseases as acromegaly, Cushing’s syndrome, hyperthyroidism, and phaeochromocytoma complicate the management of diabetes. Note: Diabetes Medscheck with appropriate education on hypo and hyperglycaemic management and referral to allied health team.
• Thiazolidinediones (TZDs) in combination with insulin are associated with an increased risk of oedema and heart failure; especially in those with underlying cardiac disease. Note: Diabetes Medscheck for counselling and referral for appropriate allied health. Consider annual cycle of care and weight check.
• Visual disturbances: Refractive changes are reversed during the early phase of effective management. However, alteration in osmotic equilibrium between the lens and ocular fluids may not stabilise for a few weeks after initiating therapy. It is wise to postpone prescribing new corrective lenses for 3 to 6 weeks.
• Overseas travel: Those who are travelling overseas (or to destinations with substantially different time zones) should contact their doctor/ pharmacist/ credentialled diabetes educator for information on insulin and diabetes management. Note: Diabetes Medscheck for education.
• Severe Reactions: Individuals who receive insulin, which contains protamine, have an increased risk of severe reactions simulating anaphylaxis when protamine is used to reverse systemic heparinisation after cardiac catheterisation. Note: Diabetes Medscheck for education and referral if required.
• Injection technique: 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, and dose adjustment of medications may be considered. Note: Diabetes Medscheck and referral to credentialled diabetes educator regarding education for correct injection technique.

• Hypoglycaemia: Hypoglycaemia is the most common adverse effect of insulins. As with all insulins, particular caution (including intensified glucose monitoring) should be exercised in individuals who are at greater risk of clinically significant sequelae from hypoglycaemic episodes. These include (but are not restricted to) change in the injection area, improved insulin sensitivity (e.g., by removal of stress factors, weight loss); unaccustomed, increased, or prolonged physical activity, intercurrent illness (e.g., vomiting, diarrhoea); inadequate food intake; missed meals; and alcohol consumption. Note: Diabetes MedsCheck with counselling that hypoglycaemia is part of the side effect profile of insulin. Referral for glucose monitoring. If hypoglycaemia is occurring regularly consider referral to healthcare team for adjustment of dose.
• Local Allergy including pruritus, rash, erythema, induration. In individuals, local reactions occasionally occur as redness, swelling and itching at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or injection technique. Note: Diabetes Medscheck with referral to appropriate health care team.
• Systemic Allergy including anaphylactoid reaction and urticaria: Less common but potentially more serious, is a generalised allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse or sweating. Severe cases of generalised allergy may be life- threatening. Note: Diabetes Medscheck with urgent referral if this is suspected.
• Lipodystrophy: Rarely, administration of insulin subcutaneously can result in lipoatrophy or lipohypertrophy. A change in injection technique may help alleviate this. Note: Diabetes Medscheck and referral to credentialled diabetes educator for education on injection technique. Counselling regarding potential hypoglycaemia with injection site change.
• Oedema: Cases of oedema have been reported with insulin therapy, particularly if there is an improvement in diabetes management. Lipodystrophy and localised cutaneous amyloidosis at the injection site have occurred. Hyperglycaemia has been reported with repeated insulin injections into areas of lipodystrophy or localised cutaneous amyloidosis; hypoglycaemia has been reported with a sudden change to an unaffected injection site. Note: Diabetes Medscheck with referral to appropriate allied health. Counselling regarding potential hypoglycaemia with injection site change.

• Hypoglycaemia
• Hypersensitivity to human insulin or any of its excipients (unless used as part of a desensitisation program).