Pharmacy Diabetes

lesson 1 test 2

Glucagon-like peptide-1 receptor (GLP1R) agonists, (also known as GLP-1 receptor agonists or incretin mimetics) activates the GLP receptors in the beta cells in the pancreas (they are also found on neurons in the brain).

  • When activated GLP1R regulated blood glucose levels by increasing insulin secretion.

Exenatide

  • Byetta 5 micrograms solution for injection. Byetta 5 microgram pre-filled pen contains 60 doses of sterile, preserved isotonic solution (approximately 1.2 mL). Each dose contains 5 microgram exenatide in 20 microlitres (0.25 mg synthetic exenatide per mL).
  • Byetta 10 micrograms solution for injection. Byetta 10 microgram pre-filled pen contains 60 doses of sterile, preserved isotonic solution (approximately2.4 mL). Each dose contains 10 microgram exenatide in 40 microlitres (0.25 mg synthetic exenatide per mL).
  • Bydureon powder for injection in pre-filled pen (Bydureon pen). Each pre-filled pen contains 2 mg of exenatide. After suspension, each pen delivers a dose of 2 mg in 0.65 mL.
    Bydureon powder for injection in vial with diluent syringe (Bydureon kit). Each vial contains 2 mg of exenatide. After suspension, a dose of 2 mg in 0.65 mL is delivered. Bydureon is an extended-release microspheres formulation of exenatide. When the product is prepared as instructed, the resulting suspension contains 2 mg exenatide. The suspension is intended for subcutaneous use only, once per week.

  • Exenatide is indicated as adjunctive therapy to improve glycaemic management in individuals with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but are not achieving adequate glycaemic targets.

Exenatide is thought to have a positive effect on glucose levels in five ways.

  • Increases insulin secretion in response to food.
  • Suppress pancreatic release of glucagon in response to food.
  • Slows gastric emptying, which in turn delays how quickly the glucose is absorbed into the blood stream.
  • Reduces appetite (due to the satiety effect of delayed gastric emptying)
  • Has a positive effect on fatty liver disease.

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

Exenatide therapy (Byetta) should be initiated at 5 microgram exenatide per dose (start with the 5mcg pen device). Inject twice a day for at least one month. If there are little or no side effects, dose can then be increased to 10 micrograms twice a day if needed for glucose improvement (person centred care). This requires the 10-mcg pen device. Doses higher than 10 micrograms twice a day are not recommended. It is recommended exenatide be injected before the two carbohydrates containing main meals of the day (at least 6 hours or more apart). Exenatide should not be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose.
Each dose of Byetta should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. Exenatide is not recommended to be administered by intravenous or intramuscular injection. If insulin is administered, exenatide can be injected at the same time, but each should be given as two separate injections. (Diabetes Medscheck counselling on how to use Byetta pen)

The recommended Bydureon dose is 2 mg exenatide once weekly at any time of the day without regard to meals. There is no need to titrate the dose. After suspension, Bydureon should be administered immediately in the abdomen as a subcutaneous injection. Do not administer intravenously or intramuscularly.
Changing weekly dosing schedule: The day of weekly administration can be changed if the last dose was administered 3 or more days before.
Note: Diabetes MedsCheck is useful with counselling on what to do with missed doses.
Missed dose:
If a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, the weekly schedule can resume.
Note: Diabetes MedsCheck is useful with counselling on what to do with missed doses.
If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the dose should be missed. Resume Bydureon with the next regularly scheduled dose. Note: Diabetes MedsCheck is useful with counselling on what to do with missed doses.

  • Renal Impairment - In Individuals with moderate renal impairment (creatinine clearance: 30 to 50 mL/min), dose increases from 5 microgram to 10 micrograms should proceed with caution.
  • Exenatide should not be used with end-stage renal disease or severe renal impairment (creatinine clearance < 30 mL/min)
  • Bydureon is not recommended for use with end stage renal disease or severe renal impairment (creatinine clearance < 30 mL/min)
  • Liver dysfunction: Exenatide is cleared predominately by the kidney. Hepatic dysfunction is not expected to affect blood concentrations of exenatide.

  • No dose adjustment is required in the elderly.

  • Exenatide has not been studied in individuals with any form of severe gastrointestinal disease, including gastroparesis.
  • Exenatide should not be sed to treat type 1 diabetes.
  • Exenatide should be used with caution in those individuals > 70 years. Doses above 5 micrograms should be considered on an individual basis.
  • There have been reported cases of increased INR with concomitant use of warfarin and exenatide, sometimes associated with bleeding.
    Note: Diabetes MedsCheck with referral back to GP for screening due to possible interaction.
  • Rapid weight loss at a rate of > 1.5 kg per week has been reported in some individuals treated with exenatide. Weight loss of this rate may have harmful consequences.
    Note: Diabetes MedsCheck. Enrolment in weight loss program to help maintain weight. Referral to appropriate allied health. Referral back to GP due to side effect profile.
  • Increased risk of pancreatitis- Recognised risk factors for pancreatitis include a history of pancreatitis, gallstones, alcoholism, and severe hypertriglyceridemia. Clinical judgement should be exercised.
    Note: Diabetes MedsCheck to explain signs and symptoms and what to do if such an event should occur.
  • Should not be used in children under the age of 18 years.
  • Bydureon - There have been post market reports of serious injection site reactions, including abscesses, cellulitis, ulcers, and necrosis.

Nausea, abdominal distension and pain, belching, constipation, flatulence, this is usually dose dependent.
Note: Diabetes MedsCheck for side effect profile.

Exenatide does not cause hypoglycaemia on its own. However, when used in conjunction with sulfonylureas or insulin hypoglycaemia can occur.
Note: Diabetes Medscheck forside effect for link to hypoglycaemia

dehydration, usually associated with nausea, vomiting, and/or diarrhoea and feeling full so often individuals will forget to drink.
Note: Diabetes MedsCheck for side effect profile, prevention of complications and referral to appropriate allied health care team.

Injection site reactions were higher in exenatide once weekly treated individuals (16%) (Bydureon) compared to exenatide twice daily treated individuals (2-7%).

  • Hypersensitivity to exenatide or any active ingredient
  • end-stage renal disease or severe renal impairment (creatinine clearance < 30 mL/min)

Metformin is absorbed through the entire gastrointestinal mucosa. Studies have shown there is a lack of dose proportionally with increasing doses thought to be due to a reduction of absorption. It is therefore thought that metformin absorption is saturable and incomplete. 

Plasma protein binding of metformin is negligible.

Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. Dosage adjustment should therefore occur in those with renal dysfunction and ceased in renal failure. 

For more detailed information on this product please consult the product information. 

For more detailed information on this product please consult the product information. 

Dulaglutide

Trulicity contains dulaglutide (rch) 1.5 mg per 0.5 mL solution.

  • Trulicity should be administered once weekly on the same day. It can be given at any time of the day, without regard to meals. Trulicity should be injected subcutaneously in the abdomen, thigh, or upper arm.Do not inject Trulicity intravenously or intramuscularly.
  • Renal impairment: No dose adjustment is required in individuals with renal impairment. However, there is limited experience in end-stage renal disease (creatinine clearance < 15 mL/min requiring dialysis treatment). Therefore, Trulicity cannot be recommended in this population.
  • Use in Hepatic Impairment
  • No dose adjustment is required based on hepatic impairment.

  • No dose adjustment is required based on age.

Use in children and adolescents. The safety and effectiveness of Trulicity have not been established in children and adolescents under 18 years of age.

Dulaglutide has not been studied in individuals with any form of severe gastrointestinal disease, including gastroparesis.
Note: Diabetes MedsCheck side effect profile, prevention of complications, referral to appropriate allied health care team.

Pancreatitis has been reported with use of all GLP-1 receptor agonists, including dulaglutide. individuals should be informed of the symptoms of acute pancreatitis. If acute pancreatitis is suspected Trulicity should be discontinued until evaluation is completed.

Nausea, vomiting and diarrhoea- typically mild or moderate in severity. These usually occurred in the first two weeks of starting the medication and settled in the 4-6 weeks of continuation.

Rash, erythema-usually mild.

Atrial fibrillation was experienced in trials compared to placebo.
Note: Diabetes MedsCheck for side effect profile with referral to GP if symptoms of this occur.

Dulaglutide does not cause hypoglycaemia on its own. However, when used in conjunction with sulfonylureas or insulin hypoglycaemia can occur.

Trulicity 1.5 mg was associated with sustained weight reduction over the duration of studies (0.35 kg to -2.88 kg). While the weight loss was seen to be grater in the group with nausea, there was still a significant loss in those who reported little to no feeling of nausea.

  • Hypersensitivity to dulaglutide or any active ingredient

  • Following subcutaneous injection, dulaglutide reaches peak plasma concentrations in 48 hours.
  • Steady state plasma concentrations were achieved after 2 to 4 weeks of once weekly administration of dulaglutide 1.5 mg.

The mean volume of distribution after subcutaneous administration of dulaglutide 1.5 mg to steady state in individuals approximately 17.4 L.

Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.

The mean apparent clearance of dulaglutide in humans at steady state was 0.107 L/h with an elimination half-life of 4.7 days.

There does not seem to be any significantly relevant dose adjustment in this population.

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-2015-PI-01412-1

Liraglutide

  • Saxenda is a solution for injection in a pre-filled pen. One mL contains 6 mg salt-free anhydrous liraglutide. One pre-filled pen contains 18 mg liraglutide in 3 mL
  • Therapeutic indications:
  • Please note Saxenda is NOT PBS or TGA approved for treatment of type 2 diabetes. Instead, it is TGA (not PBS listed) approved as a product for weight management.
  • Saxenda is indicated as an adjunct to a reduced calorie eating plan and increased physical activity for weight management in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m (obese) or ≥ 27 kg/m to < 30 kg/m (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

  • Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese) or≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.
  • Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.
  • Long term use should be informed by the following: Therapeutic Goods Administration AusPAR VICTOZA, SAXENDA liraglutide Novo Nordisk Pharmaceuticals Pty. Ltd. - PM-2016-003931- 1-5 - FINAL 29 April 2019 -Page 8 of 51 Long term safety data are limited. Adverse reactions that are uncommon (frequency < 1/100) and/or are associated with prolonged use (> 12 months) might not have been identified in the clinical development program. (refer Clinical Trials).

  • The starting dose is 0.6 mg once daily. The dose should be increased to 3.0 mg daily in increments of 0.6 mg with at least one-week intervals to improve gastrointestinal side effects. If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment. Daily doses higher than 3.0 mg are not recommended.
  • The need for continued treatment should be re-evaluated whenever a new prescription is written and at least yearly.
  • Elderly (> 65 years old): No dose adjustment is required based on age. Caution should be exercised for individuals aged 65-74 years. It is not recommended that Saxenda be used for those over the age of 75 due to the lack of data.
  • Hepatic impairment: Saxenda is not recommended in hepatic impairment.
  • Renal impairment: No dose adjustment is required for those with mild or moderate renal impairment. Saxenda is currently not recommended for use in severe renal impairment including end-stage renal disease.
  • Saxenda and Victoza both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda should also not be used in combination with another GLP-1 receptor agonist.

Hypersensitivity to liraglutide or any active ingredient.

  • Saxenda must not be used as a substitute for insulin. Saxenda has not been studied in individuals taking insulin. Therefore, Saxenda and insulin should not be used together. However, if Saxenda is prescribed with insulin or insulin secretagogues (such as sulfonylureas), consider reducing the dose of insulin or sulfonylureas to reduce the risk of hypoglycaemia. Note: MedsCheck to check for clinical interactions with referral to healthcare team, provide hypoglycaemia information, assess side effect profile, refer for blood glucose monitoring.
  • Saxenda is not indicated for the treatment of type 2 diabetes mellitus.
  • Saxenda is not indicated in individuals with obesity secondary to endocrinological or eating disorders or in conjunction with treatment with medicinal products that may cause weight gain.
  • Saxenda is not recommended in combination with other medicinal products intended for weight loss, including prescription medicines, over-the-counter medicines, and complementary medicines or herbal preparations. Note: MedsCheck to check for clinical interactions-refer to heath care professionals if appropriate.
  • Cardiovascular events: An increase in heart rate with Saxenda was observed in clinical trials. For those who experience a sustained increase in resting heart rate, Saxenda should be discontinued.
  • Dehydration, renal impairment, and acute renal failure: Individuals treated with Saxenda should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. In those treated with GLP-1 receptor agonists, including liraglutide, there have been reports of acute renal injury/failure and worsening of chronic renal failure. Note: MedsCheck to counsel on possible side effects and complications, referral to appropriate health care professional for review.
  • Pancreatitis: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. After initiation of Saxenda, observe carefully for signs and symptoms of pancreatitis. Do not restart Saxenda if pancreatitis is confirmed. Note: MedsCheck to counsel on side effect profile and how to manage if it happens.
  • Gastrointestinal disease: Saxenda has not been studied in individuals with any form of severe gastrointestinal disease, including gastroparesis. Note: MedsCheck for side effect profile, prevention of complications, referral to appropriate allied health care team.
  • Hypoglycaemia with concomitant use of diabetes therapy: The risk of serious hypoglycaemia is increased when Saxenda is used in combination with insulin secretagogues (e.g., sulfonylureas) in individuals with type 2 diabetes. The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea.
  • Thyroid disease: Saxenda should be used with caution in patients with thyroid disease.
  • Suicide behaviour and ideation: Individuals treated with Saxenda should be monitored for the emergence of depression, suicide thoughts or behaviour, or any unusual changes in mood or behaviour. Discontinue Saxenda in those that experience suicidal thoughts or behaviours or who develop other symptoms of depression referral to appropriate allied health Note: MedsCheck for referral to appropriate health care team.

  • Gastrointestinal adverse reactions: Nausea, diarrhoea, constipation, vomiting, dyspepsia, abdominal pain, dry mouth, gastritis, gastroesophageal reflux, flatulence, eructation, and abdominal distension.
    Note: MedsCheck, referral to allied health professional due to side effect profile.
  • Hypoglycaemia in individuals with type 2 diabetes
  • Thyroid C-cell tumours: Liraglutide causes thyroid C-cell tumours at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumours has not been determined.
    Note: MedsCheck to ensure relevant referral pathways for screening.
  • Malignancies: In the clinical development program for weight loss, there was no imbalance for all neoplasms, combined. However, when subgroup analyses were done by individual types of cancer, imbalances were identified, including invasive breast cancer in women and colorectal neoplasms (mainly adenomas). For further information please see the full product information.
  • Injection site reactions: Injection site reactions have been reported in individuals treated with Saxenda. These reactions have usually been mild and transient.
    Note: MedsCheck, referral to allied health professional due to side effect profile.
  • Suicidal behaviour and ideation:
    Note: MedsCheck side effect profile referral to GP
  • Cardiac disorders: Increased heart rate.</li.
  • Gastrointestinal disorders. Acute pancreatitis, haemorrhagic and necrotising pancreatitis.
    Note: MedsCheck, inform about side effect profile, what symptoms to be aware of for and what to do should any of these side effects occur.

The absorption of liraglutide following subcutaneous administration is slow, reaching maximum concentration approximately 11 hours post dosing.

The mean apparent volume of distribution after subcutaneous administration of a liraglutide 3.0 mg is 20-25 L (for a person weighing approximately100 kg). The mean volume of distribution after intravenous administration of liraglutide is 0.07 L/kg. Liraglutide is extensively bound to plasma protein (> 98%).

During the 24 hours following administration of a single liraglutide dose to healthy individuals, the major component in plasma was intact liraglutide. Two minor plasma metabolites were also detected.

Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination. The elimination half-life is approximately 13 hours.
For more detailed information on this product please consult the source product information.
https://www.novonordisk.com.au/content/dam/australia/affiliate/www-novonordisk-au/Health%20Care%20Professionals/Documents/Saxenda%20pi3.pdf

Liraglutide

Victoza is a solution for injection in a pre-filled pen. One mL solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide. Each pen contains 3 mL of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.

  • Please note Victoza is not PBS listed - private prescription.
  • As an adjunct to healthy eating and physical activity to improve glycaemic management in individuals 10 years and older with type 2 diabetes mellitus.
  • To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

  • VICTOZA® can be injected subcutaneously in the abdomen, thigh, or upper arm once daily (at approximately the same time each day) at any time of day, without regard to meals.
  • Insulin and Victoza can be injected at the same time of the day in the same region of the body but must never be mixed. Inject separately.
  • Missed dose: If a dose is missed, resume the once-daily regimen as soon the dose is remembered (at the same time), Do not take an extra dose to make up for any missed doses. If more than 3 days have been missed restart VICTOZA® at 0.6 mg and titrate as per initial starting schedule to reduce chances of gastrointestinal side effects. Note: Diabetes MedsCheck for missed doses.
  • Adult Dosage: Initiate VICTOZA® with a dose of 0.6 mg daily for one week to help reduce the likelihood of gastrointestinal symptoms. After one week at 0.6 mg per day, increase the dose to 1.2 mg daily. If additional glycaemic management is required, increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. Note: Diabetes MedsCheck on how to use pen delivery device.
  • Paediatric Dosage: Inject VICTOZA® with a dose of 0.6 mg daily. After at least one week at 0.6 mg daily, the dose may be increased to 1.2 mg daily if additional. glycaemic management is required. Further adjustment to 1.8mg after at least one week can then occur if needed.
  • Victoza and Saxenda both contain the same active ingredient, liraglutide, and therefore should not be used together. Saxenda should also not be used in combination with another GLP-1 receptor agonist.

  • Hypersensitivity to liraglutide or any active ingredient.
  • Medullary Thyroid Carcinoma VICTOZA® is contraindicated in those with a personal or family history of medullary thyroid carcinoma (MTC) or in individuals with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  • Thyroid C-cell tumours: Liraglutide causes thyroid C-cell tumours at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumours has not been determined.
    Note: Diabetes MedsCheck to ensure relevant referral pathways and screening occurs.
  • Pancreatitis: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. After initiation of Victoza, observe carefully for signs and symptoms. Do not restart Victoza if pancreatitis is confirmed.
    Note: MedsCheck to counsel on side effect profile and how to manage if it happens.
  • Hypoglycaemia with concomitant use of diabetes therapy: The risk of serious hypoglycaemia is increased when Victoza is used in combination with insulin secretagogues (e.g., sulfonylureas) in individuals with type 2 diabetes. The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea.
    Note: Diabetes MedsCheck, counselling to ensure individual understands hypoglycaemia signs and symptoms, blood glucose monitoring, referral pathways to allied health.
  • Dehydration, renal impairment, and acute renal failure: Individuals treated with Victoza should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. In those treated with GLP-1 receptor agonists, including liraglutide, there have been reports of acute renal injury/failure and worsening of chronic renal failure.
    Note: MedsCheck to counsel on possible side effects and complications, referral to appropriate health care professional for review.
  • Acute Gallbladder Disease: In the LEADER 3.1% of VICTOZA®-treated individuals versus 1.9% of placebo-treated individuals reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis. Most events required hospitalization or cholecystectomy.
    Note: MedsCheck to counsel on possible side effects and complications, referral to appropriate health care professional for review.

  • Risk of Thyroid C-cell Tumours
  • Pancreatitis
  • Hypoglycaemia
  • Renal Impairment
  • Hypersensitivity Reactions (especially at injection site)

Following subcutaneous administration, maximum concentrations of liraglutide are achieved at 8-12 hours post dosing.

The mean apparent volume of distribution after subcutaneous administration of VICTOZA® 0.6 mg is approximately 13 L. Liraglutide is extensively bound to plasma protein (>98%).

During the 24 hours following administration of a single liraglutide dose to healthy individuals, the major component in plasma was intact liraglutide. Two minor plasma metabolites were also detected.

Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination. The elimination half-life is approximately 13 hours.
For more detailed information on this product please consult the product information.
https://www.novo-pi.com/victoza.pdf

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

Transition from Byetta twice daily injections to Bydureon once a week injection. Following weekly administration of 2 mg exenatide once weekly, there is a gradual increase in the average plasma exenatide concentration over 6 to 7 weeks. Customers monitoring blood glucose levels may experience a rise in blood glucose due to the long-acting nature of Bydureon.

  • Counselling on what to expect is appropriate at this point.
  • Diabetes MedsCheck
  • Referral to appropriate health care team.

A rise in blood glucose may be seen when discontinuing Bydureon. In some individuals it may take up to 10 weeks after discontinuation of Bydureon before side effects have ceased.

  • Counselling of what to expect is appropriate at this point.
  • Diabetes MedsCheck
  • Referral to appropriate health care team

After suspension, Bydureon should be administered immediately into the abdomen as a subcutaneous injection. Do not administer intravenously or intramuscularly.

  • Diabetes MedsCheck with counselling on how to use Bydureon pen.
  • Referral to healthcare team if required.

GLP1 Analogues do not cause hypoglycaemia alone, however, when used in conjunction with sulfonylureas or insulin hypoglycaemia can occur.

  • Diabetes MedsCheck for side effect profile
  • Referral to healthcaqre team.
  • Education on managing hypoglycaemia.

Trulicity should be injected subcutaneously in the abdomen, thigh, or upper arm. Do not inject Trulicity intravenously or intramuscularly.

  • Diabetes MedsCheck and how to use pen.

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.

  • Diabetes MedsCheck with referral for annual cycle of care.
  • Referral to appropriate health care professionals including GP for EPC visit.

The use of Saxenda does not replace physical activity and healthy eating.

  • MedsCheck is useful; unless the individual has been diagnosed with diabetes and then a Diabetes MedsCheck can be activated to engage in consultation and referral for appropriate health care professionals.

Pancreatitis has been reported with use GLP-1 receptor agonists. Patients should be informed of the symptoms of acute pancreatitis. If acute pancreatitis is suspected, consider discontinuation until evaluation is completed.

  • Diabetes MedsCheck for side effect profile and prevention of complications.
  • Referral to appropriate allied healthcare team.

The delay of gastric emptying with GLP-1 Analogues may influence the absorption of many medications. All should be used with caution where medicinal products require rapid gastrointestinal absorption.

  • Diabetes MedsCheck
  • Referral to healthcare team

  • Trulicity is supplied with its own needles. There is no need therefore, to update the status of the NDSS.
  • Ozempic (both strengths) are supplied with their own needles. There is no need therefore, to update the status of the NDSS.
  • The Saxenda pen is designed to be used with NovoFine disposable needles up to a length of 8 mm. It is however generally recommended that NovoFine 6mm needles are used. Injection needles are not included. NovoNordisk supply needles free with the first prescription and the sixth prescription through the Saxenda program
    https://saxenda.pharmaprograms.com.au/home/
    Individuals should be advised to discard the injection needle after each injection and store the pen without a needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
  • Needles are not supplied with Victoza under the NDSS (due to Victoza being considered a private non-PBS prescription). Needles will need to be purchased from the pharmacy. NovoNordisk recommend 6mm or 4mm. A Diabetes MedsCheck can be useful with guidance on how to use Victoza pen, referral to Credentialled Diabetes Educator on injection technique.

  • Guidance - Safe disposal of needles.