BRAND INFORMATION
Brand name: Ozempic [‘əʊzɛ:mpɪk]
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 drug has a warning about the possible risk of thyroid cancer. This is the most serious Therapeutic Goods Administration (TGA) warning. This warning alerts doctors and patients about drug effects that may be dangerous.
Contents
Ozempic may raise the risk of thyroid tumours in animals. It is unknown if Ozempic has this effect on people. 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 take Ozempic.
If you are taking Ozempic and experiencing thyroid tumour symptoms, call your doctor immediately. A tumour or lump in your neck, difficulty swallowing or breathing, and a raspy voice are all alarming symptoms.
What is Ozempic? What it is used for
Ozempic is often prescribed for type 2 diabetes.
Ozempic is a prescription drug that’s used to:
✓ Manage blood sugar levels in adults with type 2 diabetes, along with lifestyle improvements in diet and exercise.
✓ Lower certain risks in adults who have both heart disease and diabetes. These risks include heart attack and stroke.
Ozempic isn’t used for type 1 diabetes, diabetic ketoacidosis, or in people who’ve had pancreatitis. See the “What is Ozempic used for?” section below for more information.
Ozempic comes as a liquid solution inside prefilled, disposable pens. You’ll inject the drug under your skin.
Ozempic’s active ingredient is semaglutide. It belongs to a class of drugs called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Semaglutide comes only as the brand-name drug Ozempic. There isn’t a generic form of it available.
TGA approval
Ozempic was approved by the Therapeutic Goods Administration (TGA) in 2019.
Note: Ozempic is not currently available in an oral pill 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?
A prescription is required to get this medication from a pharmacy. It is Schedule 4 : Prescription Only Medicine.
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.
If you’re allergic to semaglutide, notify your doctor or pharmacist. Inactive chemicals in this product may cause allergic reactions or other issues. Your pharmacist can help.
Tell your doctor or pharmacist your medical history, particularly of: diabetic retinopathy, pancreatitis, gallbladder disease, renal difficulties, and stomach/intestinal diseases (such as gastroparesis and digestion problems).
Low or high blood sugar may cause blurred vision, dizziness, and sleepiness. Do not drive, operate equipment, or undertake any activity requiring alertness or clear eyesight until you can do so safely.
Alcohol might increase your risk of low blood sugar when taking this medicine.
Stress might make blood sugar control tougher (such as due to fever, infection, injury, or surgery). This may affect your treatment strategy, medicines, or blood sugar tests.
Always tell your doctor about all your medications before surgery (including prescription, nonprescription, and herbal products).
Discuss with your doctor the advantages and dangers of taking this medicine during pregnancy if you intend, become, or suspect pregnancy. The manufacturer suggests ceasing usage 2 months before pregnancy.
What should be considered before taking Ozempic?
✓ 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
Using medications, vaccines, foods, and other things with a certain drug can affect how the drug works. These effects are called interactions.
Interactions can raise or lower the effect of medications taken together.
Before taking Ozempic, be sure to tell your doctor about all medications you take (including prescription and over-the-counter types). Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Ozempic.
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:
✓ glipizide (Glucotrol)
✓ glyburide (Diabeta, Glynase Prestabs)
✓ metformin (Glucophage, Glumetza, Riomet)
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?”.
These recommendations may help direct your debate.
What will Ozempic do to my body, mind, and lifestyle?
Bring a friend if it would help you relax.
If you’re new to self-injections, ask your doctor to explain how it’s done. Ask to demonstrate the method again until you understand it.
Never be scared to ask questions or provide feedback on your treatment.
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
It’s unknown if Ozempic is safe to use during pregnancy or while breastfeeding.
Talk with your doctor about the benefits and risks of Ozempic if you’re pregnant, planning to become pregnant, or breastfeeding.
Do not use Ozempic® if:
- Уou or any of your family have ever had Medullary thyroid cancer (MTC) or if you have Multiple endocrine neoplasia type 2 (MEN 2).
- Уou 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
Always read the label. If symptoms persist, see your healthcare professional.
What should be done in case of overdose?
Don’t take more Ozempic than your doctor prescribes. Doing so can lead to serious side effects.
Because Ozempic is injected once weekly, the effects of an overdose may last for a while. If you take too much Ozempic, your doctor will need to monitor you closely and treat your symptoms until they’ve resolved.
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
Symptoms include:
- dizziness;
- jitteriness;
- mood changes;
- weakness;
- headache;
- shakiness;
- severe nausea;
- severe vomiting.
Ozempic side effects
Ozempic has moderate to severe adverse effects. Ozempic may cause the adverse effects listed below. Not all adverse effects are included.
Ask your doctor or pharmacist about Ozempic’s adverse effects or how to manage them.
More common side effects
- nausea
- headache
- vomiting
- diarrhea
- stomach pain
- stomach upset
- constipation
- flatulence (passing gas)+
| Serious side effects | Symptoms |
|---|---|
| ✕ Thyroid cancer.* ✕ Pancreatitis (inflammation of the pancreas). | pain in your back and belly; nausea; vomiting; unintended weight loss; fever; swollen belly. |
| ✕ Hypoglycemia (low blood sugar). | drowsiness; headache; confusion; weakness; hunger; irritability; sweating; feeling jittery; fast heartbeat. |
| ✕ Diabetic retinopathy (diabetes-related eye problems). | blurred vision; vision loss; seeing dark spots; poor night vision. |
| ✕ Kidney damage | reduced urination; swelling in your legs or ankles; confusion; fatigue; nausea. |
| ✕ Gallbladder disease | gallstones, which can cause pain in your belly; nausea; vomiting; and fever cholecystitis (inflammation in your gallbladder). |
Within a few days or a few weeks, the most common adverse effects disappear. Consult your physician or pharmacist if symptoms worsen or don’t go away
It is possible that Ozempic might cause serious adverse effects; however, they are rare. If you have any severe side effects, you should immediately contact your doctor. 000 should be called in Australia if you have life-threatening symptoms or a medical emergency.
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.
Call your doctor immediately if you have a severe allergic reaction to Ozempic. Call 000 in Australia if your symptoms feel life-threatening or if you think you have a medical emergency.
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. Only do this 5 days after your previous dosage. If it’s been more than 5 days, omit the missing dosage. Too many dosages may cause low blood sugar. If you miss a dosage, check your blood sugar levels periodically. Keep track of your weekly injections with Medisafe.
Your doctor may prescribe Ozempic long-term if it helps your problem. Ask your doctor about long-term Ozempic use, including adverse effects.
Ozempic works quickly after injection. Your body may need several weeks to adjust to Ozempic and get its full effect. Your doctor may alter your Ozempic dosage based on your response. Take Ozempic precisely as prescribed.
Images
This medicine is a colourless, clear injection.
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]
- 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]
- 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.
When created, correct information was provided. This material shouldn’t be used to replace medical advice, diagnosis, or treatment. Please see our T&Cs.
I remember I missed my dose once. I was so nervous… I wish I knew it was OK to take the missed dosage within 5 days.
Good article. I found what I was interested in. Thanks!
i wish to know where i can purchase Ozempic i have a prescription but no one seems to be able to get it here do you have it in stock now i would like a true answer no or yes not we are getting it soon thanks Lynn
Actually, I’ve heard they use Ozempic for type 1 diabetes. And you say it’s only for type 2. Where is truth?
Ozempic makes me soooo sleepy. I guess I’m the only one with this side effect. Most people can’t fall asleep after taking it. And I can’t even drive cause I’m too sleepy.
I needed to wait for a month to feel Ozempic full effect. And you say “several weeks”. Interesting.
What’s the point of telling my doctor what supplements I take? Can my vitamins really interact with the drug? It sounds ridiculous.
I’ve just read about severe side effects. Totally shocked. I thought this medicine was not that toxic.
Thanks for the detailed description of allergic reaction symptoms. It helped me understand things are wrong.
Never would have guessed that alcohol might increase your risk of low blood sugar when taking Ozempic. Good to know.
Thanks for the poisons information centre contacts. Heard about it for the first time.
It’s harmful to me to read about side effects… Now I’m really worried and doubt taking the drug.