Pharmacy Diabetes

insulin-semglee

Insulin glargine

  • Semglee [insulin glargine injection {rDNA origin}] is a recombinant human insulin analogue produced by DNA technology.
  • The Semglee injector pen provides insulin glargine for subcutaneous injection.
  • The 3 mL cartridge inside the injector pen contains 100 IU/mL (3.64 mg/mL) of insulin glargine as the active ingredient.

  • Insulin glargine is for once-daily subcutaneous administration in the treatment of type 1 diabetes in adults and children and type 2 diabetes in adults who require insulin for the management of hyperglycaemia.

For the latest PBS indications for glargine please see
https://www.pbs.gov.au/medicine/item/9039R

  • Semglee is an insulin analogue, equipotent to human insulin, with a prolonged duration of action that allows once daily dosing. It should be given subcutaneously once a day. It, at the same time every day (without regard to food).
  • Semglee is not intended for intravenous administration.
  • Although absorption of Semglee does not differ between abdominal, thigh or deltoid subcutaneous injection sites, as with all insulins, injection sites must be rotated from one injection to the next.
    Note: Diabetes MedsCheck with counselling on rotation of injection site and referral to healthcare team if lipodystrophy develops.
  • Paediatric use. Semglee can be safely administered to paediatric individuals > 6 years of age.
  • Renal impairment: Insulin requirements may be reduced due to impaired insulin metabolism. This may inn turn lead to a decrease in insulin requirements.
    Note: Diabetes MedsCheck with referral for annual cycle of care to check renal function.
  • Hepatic impairment: Although no studies have been performed, insulin requirements maybe diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
    Note: Diabetes MedsCheck with referral for annual cycle of care to check liver function.

• There is no data available for this age group.

  • Hypersensitivity to glargine or any active ingredient

  • Semglee must not be diluted or mixed with any other insulin or solution.
  • Semglee is not intended for intravenous administration. The prolonged duration of activity of insulin glargine is dependent on subcutaneous injection.
  • Semglee should not be administered intravenously.
  • Semglee is not the insulin of choice for the treatment of diabetic ketoacidosis.
  • As with all insulins, Semglee may differ in its duration of action in each individual. This is dependent on many factors including (but not limited to) blood supply, temperature, physical activity, age, and length of diabetes.
    Note: Diabetes MedsCheck with referral to healthcare team for education on diabetes, injection technique etc.
  • Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbance, or stress.
    Note: Diabetes MedsCheck with referral to healthcare team for sick day management.

  • 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.
    The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
    Note: Diabetes MedsCheck with counselling that hypoglycaemia is part information of the side effect profile. Referral for blood glucose monitoring. If hypoglycaemia is occurring regularly consider referral to healthcare team for dose adjustment.
  • Eyes: A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens. As with all insulin regimens, intensification of insulin therapy with abrupt improvement in glycaemic management maybe associated with temporary visual impairment or worsening of diabetic retinopathy. However, long-term improved glycaemic management decreases the risk of progression of diabetic retinopathy.
    Note: Diabetes MedsCheck with referral to healthcare for education.
  • 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.

After subcutaneous injection of insulin glargine in healthy subjects and diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the beta-chain with formation of two active metabolites M1 (21 -gly-insulin) and M2 (21 -gly-des-30 -thr-insulin). In plasma, the principal circulating compound is the metabolite M1.

For more detailed information on this product please consult the product information
file:///E:/knowdiabetes/FPI-Semglee-Semglee.pdf