Insulin-Humalog U200

• For use in type 1 and type 2 diabetes mellitus.

For the latest PBS indications for Humalog please see
https://www.pbs.gov.au/pbs/search?term=humalog&analyse=false&search-type=medicines

• HUMALOG KwikPen is available in two strengths. HUMOLOG U200 has a concentration of 200 units/mL in a 3 mL prefilled insulin delivery device. HUMALOG U100 has a concentration of 100 units/mL in a 3 mL prefilled insulin delivery device. For both, the dose is dialled in units.
• Both prefilled pens, the HUMALOG U200 KwikPen and the HUMALOG KwikPen deliver 1 – 60 units in steps of 1 unit in a single injection. The dose counter shows the number of units regardless of strength and no dose conversion should be done when transferring a person to a new strength. HUMALOG U200 takes effect rapidly and has a shorter duration of activity (2 to 5 hours). HUMALOG U200 can be given by subcutaneous injection. It may also be administered intravenously. In adults, HUMALOG U200, can be given immediately (up to 15 minutes before a meal). When necessary, HUMALOG U200 can be given soon after meals. (Within 20 minutes of the start of the meal).
• In individuals with type 2 diabetes HUMALOG U200 may be administered in combination therapy with oral sulfonylurea agents.
• Subcutaneous administration should be in the abdomen or thighs. The injection sites should be rotated so that the same site is not used more than approximately once a month in order.to reduce the risk of lipodystrophy and localised cutaneous amyloidosis.
• After injection, the site of injection should not be massaged. Note: Diabetes MedsCheck with referral to healthcare team for education on injection technique and managing hypoglycaemia.
• Use in renal impairment: HUMALOG U200 can be used in renal impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.
• Use in liver impairment: HUMALOG U200 can be used in hepatic impairment. As with all insulins, glucose monitoring should be intensified, and dosage adjustment should occur on an individual basis.

• There is no data available.

• There have been no studies of HUMALOG U200 in children.

• Hypoglycaemia.
• Hypersensitivity to insulin lispro or one of its excipients.

• HUMALOG U200 solution for injection must not be transferred from the prefilled KwikPen to a syringe. The markings on the insulin syringe will not measure the dose correctly. Overdose can result causing severe hypoglycaemia. HUMALOG U200 solution for injection must not be transferred from the KwikPen to any other insulin delivery device, including insulin infusion pumps.
• HUMALOG U200 should be reserved for the treatment of individuals with diabetes requiring daily doses of more than 20 units of rapid-acting insulin. The HUMALOG U200 solution should not be withdrawn from the KwikPen, or mixed with any other insulin, or diluted.
• Do not use HUMALOG U200 solution for injection in an insulin infusion pump.
• Do not use HUMALOG U200 solution for injection intravenously.
• 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 with referral to healthcare team for sick day management plan and education.
• 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.
• Individuals who have experienced hypoglycaemic reactions after transfer from animal source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin. Note: Diabetes MedsCheck with counselling on side effect profile and how hypoglycaemia is part of side effect profile. If happening regularly consider referral to healthcare team for adjustment of dose. Referral for blood glucose monitoring.

• 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 side effect profile and how hypoglycaemia is part of side effect profile. If happening regularly consider referral to healthcare team for adjustment of dose. Referral for blood glucose monitoring.
• 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 counselling on side effect profile and referral to healthcare team to establish correct 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 worsened glycaemic control 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. Note: Diabetes MedsCheck with referral to healthcare team for correct injection technique.
• Lipodystrophy: Administration of insulin subcutaneously can result in lipoatrophy or lipohypertrophy. A change in injection technique may help alleviate the problem. Localised cutaneous amyloidosis at the injection site have also 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 healthcare team for correct injection technique and managing hypoglycaemia.