Pharmacy Diabetes

G-5.6 GLP-1 Analogues- formulation(semaglutide)

Semaglutide

  • Ozempic 0.25 mg, 0.5 mg/dose. One mL of solution contains 1.34 mg of semaglutide. One pre-filled pen contains 2 mg semaglutide in 1.5 mL solution.
  • Ozempic 1 mg/dose. One mL of solution contains 1.34 mg semaglutide. One pre-filled pen contains 4 mg semaglutide in 3 mL solution.

  • Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
    • as monotherapy when metformin is not tolerated or contraindicated.
    • in addition to other medicinal products for the treatment of type 2 diabetes.

For the latest PBS indications for Semaglutide please see
https://www.pbs.gov.au/medicine/item/12075M-12080T

  • Ozempic starting dose is 0.25 mg once weekly. This is with the Ozempic 0.25 mg, 0.5 mg/dose delivery pen. After 4 weeks, the dose should be increased to 0.5 mg once weekly. This is with the Ozempic 0.25 mg, 0.5 mg/dose delivery pen. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly if blood glucose levels require improvement (person centred care). The Ozempic 1 mg/dose prefilled pen is required for this dose.
  • Ozempic 0.25 mg is not a maintenance dose.
  • Ozempic is administered once a week, on the same day each week, at any time of the day, without regard to meals.
  • Ozempic should be injected subcutaneously in the abdomen, in the thigh or in the upper arm.
  • Changing weekly dosage schedule: The day of week can be changed if the time between two doses is at least 3 days.
  • Missed dose: If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped and the next dose should be administered on the regular scheduled dose.
  • Hepatic impairment: No dose adjustment is required for this population. However, caution should be exercised when treating individuals with severe hepatic dysfunction due to the limited data.
  • Renal impairment. No dose adjustment is required with renal impairment. However, experience with severe (Cr <30 mL/min) renal impairment is limited. Therefore
  • semaglutide is not recommended for use in individuals with end-stage renal disease.
  • Gender. No dose adjustment is required based on gender.

  • No dose adjustment is required based on age.

GLP1 agonists are not a substitute for insulin and should be used with caution in type 1 diabetes or for the treatment of diabetic ketoacidosis.

Pancreatitis has been reported with use of all GLP-1 receptor agonists, including semaglutide. Patients should be informed of the symptoms of acute pancreatitis. Do not restart if confirmed.

In individuals with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Caution should be used.

There is no therapeutic experience in patients with congestive heart failure. It is therefore not recommended.

Semaglutide does not cause hypoglycaemia on its own. However, when Ozempic is added to existing therapy of a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia.

Semaglutide is not recommended in children under the age o 18 years.

  • Gastrointestinal adverse reactions: Nausea, vomiting and diarrhoea .
    Note: Diabetes MedsCheck for side effect profile.
  • Diabetic retinopathy complications
  • Injection site reactions: injection site rash, erythema
  • Fatigue, dysgeusia and dizziness

Hypersensitivity to semaglutide or any active ingredient.

Maximum concentration was reached 1 to 3 days post dose. Steady-state exposure was achieved following 4-5 weeks of once weekly administration.

Semaglutide is primarily excreted through the via urine and faeces. With an elimination half-life of approximately 1 week, semaglutide will be present in the circulation for about 5 weeks after the last dose.
Note: It is important to note how long the medication lasts in the system if an individual has side effects. Diabetes MedsCheck with counselling on medication clearance.

For more detailed information on this product please consult the product information.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2019-PI-01881-1