CONSENT FOR TREATMENT TO USE OZEMPIC WITH UNREGISTERED INDICATION (OFF LABEL) 

Medication: Ozempic (Semaglutide SC) 
Rationale for off-label prescribing: Weight loss in context of elevated BMI and metabolic complications that may include hyperlipidaemia, insulin resistance, impaired glucose tolerance, non-alcoholic fatty liver disease. 
Alternative on label medication: Saxenda is licensed for weight loss. This is a daily injection with long term safety data. 
Cost of off-label Ozempic: $132 per month Cost of on-label Saxenda: $387 per month 
Follow up plan: Review at 4 weeks, 12 weeks and then every 12 weeks. Phone rooms if any concerns or significant side effects. 

We discussed the available GLP-1 agonists. I have explained that the agent Saxenda (Liraglutide) is approved by the Therapeutic Goods Association (TGA) for weight loss in Australia. It is not subsidised by the Pharmaceutical Benefits Scheme (PBS) but is available on private prescription. 

In contrast, Ozempic has only been TGA approved for use in type II diabetes. It is also subsidised by the PBS for this. Therefore, Ozempic is considered ‘Off Label’ when it is used for weight loss. 

The US Food and Drug Administration (FDA) has approved a similar agent to Ozempic called Wegovy for chronic weight management in adults with obesity (BMI >30 kg/m2) or overweight BMI (>27 kg/m2) and at least 1 other weight-related condition. Wegovy contains the same ingredient as Ozempic called Semaglutide. However, Wegovy contains a higher dose of Semaglutide of 2.4 mg weekly compared to Ozempic which has a maximum dose of 1.0 mg weekly. 

The largest placebo-controlled trial of Wegovy in adults without diabetes (average age 46 years, 74% female, average BMI 38 kg/m2) showed the mean change in body weight from baseline to week 68 was −14.9% in the Semaglutide group as compared with −2.4% with placeboi. 

Ozempic is given according to the following dose schedule: 
• 0.25 mg SC weekly for 4 weeks 
• 0.5 mg SC weekly for at least 4 weeks 
• 1.0 mg SC weekly (if advised to increase to this dose by physician) 

Semaglutide has been shown to reduce major cardiovascular disease events in adults with type 2 diabetes and established cardiovascular disease or chronic kidney disease. Trials on adults without diabetes are ongoing. 
Ozempic should be used with caution in the following situations: 
• Personal history of pancreatitis or gallstones 
• Diabetic retinopathy 

It is not recommended in: 
• Grade 4 congestive heart failure 
• End stage renal failure 
• During or 2 months prior to pregnancy (category D) 
• Allergy to Semaglutide or any of the excipients including propylene glycol, phenol, hydrochloric acid, sodium              hydroxide 
• Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B 

The most common side effects of Semaglutide (Ozempic) include nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, indigestion, dizziness, abdominal distension, belching, hypoglycaemia low blood in patients with type 2 diabetes, flatulence, gastroenteritis and gastroesophageal reflux disease. These can be minimized by eating food low in saturated fats, only eating if you are hungry, eating smaller portions, drinking plenty of fluids to avoid dehydration especially if you have any vomiting or diarrhoea, increasing fibre intake. 

In the STEP 1 trial, in terms of major adverse events, this included: 
• 0.2 vs 0 events of pancreatitis per 100 person-years 
• 2.5 vs 1.0 events of gallbladder complications (e.g. gallstones) per 100 person-years 

	STATEMENT OF CONSENT BY PATIENT 

I confirm that I am aware of the following: 

	  Ozempic is being given for an indication that is not included in the Australian Therapeutic Goods 	
	  Administration (TGA) indications for use. 	
		
	  I have discussed the purpose, mechanism, benefits, side effects, risks and out of pocket costs of Ozempic. 	
		
	  I understand that efficacy and safety has not yet been demonstrated for this specific indication. 	
		
	  I have been given information regarding alternative treatments. 	
		
	  I agree to see my prescribing physician regularly so they can monitor the benefits and any potential adverse 	
	  events	
		
	  I have been given the opportunity to ask questions to clarify any issues I did not understand related to	
	  Ozempic	
		
	  I do not have any of the contraindications to using Ozempic listed above and I have notified my prescribing	
	  physician of any potential precautions. 	
		
	  I am aware of the potential side effects and agree to read the full product information on Ozempic for further 	
	  information.	

	
Patient name:	<PtFullName>	

Patient Signature:		
Date:	<TodaysDate>	

i Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, et al. Once-weekly Semaglutide in adults with overweight or obesity. N Engl J Med. 2021;384:989–1002