BRAND INFORMATION
Active ingredients: Semaglutide
Schedule: 4
Manufacturer: Novo Nordisk Pharmaceuticals Pty Ltd
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
This medicine carries a boxed warning concerning the probable risk of thyroid cancer. This is the most severe Therapeutic Goods Administration (TGA) warning. A boxed warning advises physicians and patients about pharmacological effects that may be hazardous.
- Ozempic may boost the risk of thyroid cancers in animals. It is uncertain whether Ozempic has this impact on humans. If you or a close family member has had thyroid cancer in the past, or if you have multiple endocrine neoplasia syndrome type 2, you should not use Ozempic.
- If you are taking Ozempic and suffering thyroid tumour symptoms, consult your doctor immediately. A tumour or lump in your neck, trouble swallowing or breathing, and a hoarse voice are all serious concerns.
What is Ozempic? What it is used for
Ozempic is often prescribed for type 2 diabetes.
Ozempic is used for:
- controlling blood sugar levels in adults with type 2 diabetes, along with lifestyle improvements in diet and exercise.
- lowering certain risks in adults who have both heart disease and diabetes. A heart attack and a stroke are among the dangers.
Ozempic isn’t recommended for type 1 diabetes, diabetic ketoacidosis, or pancreatitis. For further details, see the “What is Ozempic used for?” section that follows.
A pre-filled disposable pen containing Ozempic has a solution of Ozempic. You’ll administer the medicine under your skin.
Semaglutide is Ozempic’s primary component. It is a member of the glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Only the Ozempic brand of semaglutide is available for purchase. It doesn’t come in a generic version.
TGA approval
Ozempic was approved by the Therapeutic Goods Administration (TGA) in August 2019.
It is important to note that Ozempic does not come in tablet form.
Ozempic generic
There is no generic version of Ozempic. These pills include a medication called semaglutide, which is not yet accessible in generic form.
Do I need a prescription?
This drug may only be purchased from a pharmacy with a valid prescription. A prescription is required for this Schedule 4 medication.
Is this medicine subsidised?
This medicine was verified as available on the PBS (Pharmaceutical Benefits Scheme) on July 1, 2022. Visit the Pharmaceutical Benefits Scheme (PBS) website to learn more about this subsidy.
Precautions
See warnings.
Notify your doctor or pharmacist if you have a severe adverse reaction to semaglutide. It is possible that the inactive substances in this product might cause allergic reactions or other problems. It’s possible that your pharmacist can assist you.
Please let your doctor know if you have a history of diabetes, retinopathy, liver disease, gallbladder illness, kidney issues, or stomach/intestinal disorders.
If your blood sugar is too high or too low, it might cause blurred vision, dizziness, and tiredness. Do not drive, operate machinery, or engage in any other activity that requires alertness or clear vision until you can do so without risk.
When using this medication, it’s possible that alcohol might raise your risk of low blood sugar.
Blood sugar regulation might be hampered by stress (such as due to fever, infection, injury, or surgery). This might impact your treatment plan, medications, or blood sugar testing.
Before surgery, notify your doctor about all of your current medicines (including prescription, nonprescription, and herbal products).
If you’re thinking about, or already are, or suspect of becoming pregnant, talk to your doctor about the benefits and risks of taking this medication. The manufacturer suggests ceasing usage 2 months before pregnancy.
What should be considered before taking Ozempic?
Discuss the advantages and disadvantages of taking Ozempic with your physician before beginning treatment with it. If you have any medical problem, you should also discuss it.
Ask your doctor if Ozempic is safe for you to take if you:
- have a family history of thyroid cancer
- have problems with your kidneys
- have diabetic retinopathy (damage to your eyes that’s caused by diabetes)
- are pregnant or plan to become pregnant
- are breastfeeding
Interactions
The way a medicine works may be affected by the use of other drugs, vaccinations, diets, and so on. These effects are called interactions.
Medication administered in combination might increase or decrease impact due to interactions.
Before using Ozempic, be careful to inform your doctor of any other drugs you are currently taking (including prescription and over-the-counter types). List all of the supplements you take and what they are for. Ozempic may interact with these medications, and your doctor or pharmacist can inform you if this is the case.
Taking Ozempic with other drugs
Your doctor may prescribe Ozempic with other medications to help manage your blood sugar levels or lower your risk of cardiovascular problems.
Some examples of other diabetes medications that may be prescribed with Ozempic include:
Talk to your doctor if you’d like to know more about taking other drugs with Ozempic.
Note: For information about things that can interact with Ozempic, such as other drugs or foods, see the “What should be considered before taking Ozempic?”.
The Ozempic and therapy questions may interest you. Speak with your doctor about your concerns. These suggestions might help you focus your discussion.
- What would Ozempic do to my physical, mental, and social well-being?
- If it helps you relax, bring a friend along.
- Ask for clarification if you don't understand what your doctor is saying.
- Ask your doctor for instructions if you're a novice at self-injections. Request that the approach be shown a second time to ensure you comprehend it.
- Never be afraid to ask questions or provide comments on your care.
Use with alcohol
Drinking large amounts of alcohol with Ozempic can affect your blood sugar levels. This can also:
- affect your liver function
- cause dehydration
Ask your doctor for more information about the risks of drinking alcohol while you’re taking Ozempic.
Pregnancy and breastfeeding
Ozempic’s safety during pregnancy and nursing has not been established.
Your doctor may tell you about the advantages and drawbacks of Ozempic when you’re expecting or nursing.
Do not use Ozempic® if:
- You or any of your family have ever had Medullary thyroid cancer (MTC) or if you have Multiple endocrine neoplasia type 2 (MEN 2).
- You are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”.
How to take it
The way to take this medicine is subcutaneous. This medicine is injected into the fat just beneath the skin, usually with a short needle or pen-like device.
- Store at 2 to 8 degrees Celsius
- Protect from Light
- Refrigerate
- Do not Freeze
The product has a shelf life of three years. When it comes to pharmaceuticals, you should obtain medical advice and only take them as prescribed by a healthcare practitioner.
To be safe, always check the back of the package before opening anything. Consult a medical practitioner if your symptoms continue.
What should be done in case of overdose?
Take Ozempic only as directed by your doctor. If you choose not to do so, you might be in for significant consequences.
Overdosing on Ozempic may have long-lasting consequences due to the drug’s once-weekly administration schedule. The symptoms of an overdose of Ozempic will need to be treated by your doctor for as long as it takes for them to go away.
Call your doctor if you think you’ve taken too much Ozempic. If there are no symptoms, but you suspect poisoning, call 13 11 26 (Poisons Information Centre) to speak with a poison expert. You can call 24 hours a day from anywhere in Australia. But if you have severe symptoms, immediately call 000 or go to the nearest emergency room.
Symptoms of overdose
Ozempic overdose can cause severe low blood sugar levels.
Symptoms include:
- dizziness;
- jitteriness;
- mood changes;
- weakness;
- headache;
- shakiness;
- severe nausea;
- severe vomiting.
Ozempic side effects
Ozempic has side effects that range from mild to severe. The following side effects have been linked to Ozempic. The list of possible side effects does not cover all of them.
Ask your doctor or pharmacist about Ozempic’s adverse effects or how to manage them.
| More common side effects | Serious side effects |
| nausea headache vomiting diarrhea stomach pain stomach upset constipation flatulence (passing gas)+ | Thyroid cancer.* Pancreatitis (inflammation of the pancreas). Symptoms can include: pain in your back and belly, nausea, vomiting, unintended weight loss, fever, swollen belly. Hypoglycemia (low blood sugar). Symptoms can include: drowsiness, headache, confusion, weakness, hunger, irritability, sweating, feeling jittery, fast heartbeat. Diabetic retinopathy (diabetes-related eye problems). Symptoms can include: blurred vision, vision loss, seeing dark spots, poor night vision. Kidney damage. Symptoms can include: reduced urination, swelling in your legs or ankles, confusion, fatigue, nausea. Gallbladder disease. Symptoms can include: gallstones, which can cause pain in your belly, nausea, vomiting, and fever cholecystitis (inflammation in your gallbladder) Allergic reaction. |
A few days or a few weeks after taking a medication, the most typical side effects go away. If your symptoms intensify or don’t go away, speak to your doctor or pharmacist.
Ozempic may produce major side effects, however, they are very uncommon. You should seek quick medical attention if you notice any serious side effects. For life-threatening or medical emergencies in Australia, dial 000.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to TGA at 1300 134 237.
Allergic reaction
As with most drugs, some people can have an allergic reaction after taking Ozempic. Symptoms of a mild allergic reaction can include:
- skin rash;
- itchiness;
- flushing.
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
- swelling under your skin, typically in your eyelids, lips, hands, or feet;
- swelling of your tongue, mouth, or throat;
- trouble breathing.
It’s unknown how often allergic reactions may have occurred in people taking Ozempic in clinical trials. However, serious allergic reactions to Ozempic have been reported.
A severe allergic response to Ozempic should prompt you to seek emergency medical attention. If your symptoms are life-threatening or you suspect you have a medical emergency, dial 000 in Australia.
Dosage Forms & Strengths
injection, prefilled, single-dose pen (Ozempic)
| Strength | Dose given per injection |
| 2 mg/1.5 mL (this may also be written as 1.34 mg/mL) | 0.25 mg or 0.5 mg |
| 4 mg/3 mL (1.34 mg/mL) | 1 mg |
| 8 mg/3 mL (2.68 mg/mL) | 2 mg |
FAQ
A short Ozempic dosage guide is below.
When you recall, take Ozempic. Don’t take it until five days following the last time you took it. Do not take the missed dose if it has been more than 5 days since your last dose. Low blood sugar might occur if you take too many doses. Check your blood sugar levels frequently if you miss a dose. Make sure you don’t miss an injection by using Medisafe.
If Ozempic works for you, your doctor may prescribe it long-term. Ask your doctor about Ozempic’s long-term consequences, including side effects, before taking it.
After injection, Ozempic begins working immediately. Ozempic may take several weeks for your body to adjust and begin working properly. Your Ozempic dose may be modified by your doctor depending on how you respond. Don’t take Ozempic if you’re not supposed to.
Images
This medicine is a colourless, clear injection.
Color: colourless solution
Color: colourless solution
Color: colourless solution
Marketing authorisation holder
Novo Allé
DK-2880 Bagsværd
Denmark
References
- Ozempic Important Safety Information. Available from: [URL_Link]
- Diabetes Australia stands up for people with type 2 as the Ozempic shortage hits Australia. Available from: [URL_Link]
- Ozempic Pen Injector – Uses, Side Effects, and More. Available from: [URL_Link]
- All about Ozempic. Available from: [URL_Link]
- Novo Nordisk Australia contact form. Available from: [URL_Link]
- Joint statement: Prioritisation of semaglutide (Ozempic) supply for people with type 2 diabetes during a shortage. Available from: [URL_Link]
- Medical News Today. Ozempic (semaglutide). Available from: [URL_Link]
- Ozempic® Selected Important Safety Information. Available from: [URL_Link]
- Ahmann, A. J., et al. (2018). Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): A 56-weeks open-label, randomized clinical trial. Available from: [URL Link]
- Blundell, J., et al.. (2017). Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity. Available from: [URL Link]
- Davies, M., et al.. (2017). Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes. Available from: [URL Link]
- Dejgaard, T. F., et al.. (2016). Liraglutide for treating type 1 diabetes. Available from: [URL_Link]
- Doggrell, S. A. (2018). Do glucagon-like peptide-1 receptor (GLP-1R) agonists have potential as adjuncts in the treatment of type 1 diabetes? Available from: [URL_Link]
- TGA approves first oral GLP-1 treatment for type 2 diabetes Available from: [URL_Link]
- Lamos, E. M., et al.. (2017). GLP-1 receptor agonists in the treatment of polycystic ovary syndrome. Available from: [URL_Link]
- O’Neil, P., et al.. (2018). Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active-controlled dose-ranging, phase 2 trial. Available from: [URL_Link]
- Ozempic (semaglutide) injection for subcutaneous use. Available from: [URL_Link]
- Pratley, R. E., et al.. (2018). Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): A randomised, open-label, phase 3b trial. Available from: [URL_Link]
Never Give Up Team information isn’t for emergencies. Call triple zero (000) if you have an acute sickness, overdose, or emergency.
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I’m terrified because of that serious adverse reactions. Probably I will give up the whole idea of treatment.
Very effective medication. As a long-time diabetic, I can prove that Ozempic does his work perfectly.
Once I forgot, I already took Ozempic and made it for the second time the same day. Never felt more horrible in my entire life.
Very helpful facts, especially about side effects. Thanks a lot!
I really wonder what dose would be enough for me. Only time can show, I guess. I’m on 1 mg now.
My doctor told me how to do injections, and I still didn’t get it. I’m feeling so stupid…
I quit after a month cause my body couldn’t handle the adverse effects
Ozempic literally saved my life and showed me there could be another healthy way to live. Such a blessing! To all diabetics there… try it!