SUMMARY CMI
DOTAREM®
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.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
1. Why am I given DOTAREM?
DOTAREM contains the active ingredient gadoteric acid. DOTAREM is a contrast agent used during a magnetic resonance imaging (MRI) examination.
For more information, see Section 1. Why am I given DOTAREM? in the full CMI.
2. What should I know before I am given DOTAREM?
You must not be given DOTAREM if you have ever had an allergic reaction to DOTAREM or any of the ingredients listed at the end of the CMI. You must not be given DOTAREM if you have any metallic foreign objects in your body such as pacemakers or vascular clips. Talk to your doctor, radiographer or nurse if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am given DOTAREM? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with DOTAREM and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How am I given DOTAREM?
DOTAREM is injected into your vein by a doctor immediately before or during your MRI examination.
More instructions can be found in Section 4. How am I given DOTAREM? in the full CMI.
5. What should I know while receiving DOTAREM?
Things you should do | Tell your doctor, radiographer or nurse if:
|
Driving or using machines | Nausea may incidentally occur; you should wait for this to resolve before driving or operating machines. |
Looking after your medicine | The MRI clinic will store DOTAREM as recommended by the manufacturer. |
For more information, see Section 5. What should I know while receiving DOTAREM? in the full CMI.
6. Are there any side effects?
Serious side effects can include severe allergic reactions, which may result in swelling of the face, mouth or throat, swelling of hands or feet, lightheadedness (low blood pressure), breathing difficulties, whistling respiration, coughing, itching, sneezing, skin rash, and nephrogenic systemic fibrosis (NSF), which can cause hardening of the skin and may affect also soft tissue and internal organs. Common side effects can include headache, dizziness, changes to taste, tingling sensation, sensation of warmth or cold and/or pain at the injection site, nausea, vomiting, high blood pressure, low blood pressure, abdominal pain and mild allergic reactions (usually affecting the skin such as rash and itchiness).
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NFS) in patients with:
• acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2
• acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
FULL CMI
DOTAREM®
Active ingredient(s): gadoteric acid
Consumer Medicine Information (CMI)
This leaflet provides important information about using DOTAREM. You should also speak to your doctor, radiographer or nurse if you would like further information or if you have any concerns or questions about using DOTAREM.
Where to find information in this leaflet:
1. Why am I given DOTAREM?
2. What should I know before I am given DOTAREM?
3. What if I am taking other medicines?
4. How am I given DOTAREM?
5. What should I know while receiving DOTAREM?
6. Are there any side effects?
7. Product details
1. Why am I given DOTAREM?
DOTAREM contains the active ingredient gadoteric acid, which is made from gadolinium oxide (a magnetic agent) and DOTA, which binds with the gadolinium oxide.
DOTAREM is a contrast agent which enhances the images obtained during a magnetic resonance imaging (MRI) examination.
DOTAREM is indicated in adults and children for use with MRI to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging.
2. What should I know before I am given DOTAREM?
Warnings
Do not use DOTAREM if:
- you are allergic to gadoteric acid, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- You have any metallic foreign objects in your body such as a pacemaker or vascular clips. Before the examination, remove all metallic objects that you wear. This is very important because metals could cause serious disorders, since MRI machines use very strong magnetic fields.
Check with your doctor, radiographer or nurse if you:
- have any other medical conditions such as:
- asthma
- very poor kidney function or severe kidney problems
- have had or will soon have a liver transplant
- a low threshold for seizures
- severe heart and circulatory disorders - have any allergies (e.g. seafood allergy, hay fever, hives)
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor, radiographer or nurse if you are pregnant or intend to become pregnant.
DOTAREM should not be used during pregnancy unless necessary.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is advisable that breastfeeding women discard their milk for the 24 hours following administration.
3. What if I am taking other medicines?
Tell your doctor, radiographer or nurse if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with DOTAREM and affect how it works.
4. How am I given DOTAREM?
How much is given
- The dosage for DOTAREM is based on your weight. The doctor will determine the lowest effective dose that you will receive and will supervise the inejction.
- The usual dose for adults, children and infants is 0.2 mL/kg.
When to take / use DOTAREM
- DOTAREM will be given immediately before or during your MRI examination.
How DOTAREM is given
- DOTAREM will be given to you as a single intravenous injection.
- You will be monitored for any side effects for at least 30 minutes after the injection.
The use of DOTAREM is not recommended in patients with severe kidney problems and in patients in the perioperative liver transplantation period. However, if it is required, you should only receive one dose of DOTAREM (not exceeding 0.2 mL/kg) during scan and you should not receive a second injection for at least 7 days.
If you are given too much DOTAREM
It is highly unlikely that you will receive too much DOTAREM, as it will be given to you by a trained healthcare professional.
If you think that you have been given too much DOTAREM, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while receiving DOTAREM?
Things you should do
Follow carefully the directions given you by your doctor and other medical staff.
Call your doctor straight away if you notice any of the following:
- Swelling of the face, mouth, or throat
- Lightheadedness (low blood pressure)
- Breathing difficulties
- Skin rash and itching
Each sign may be a warning of the start of a shock reaction.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DOTAREM affects you.
DOTAREM may incidentally cause nausea in some patients.
Looking after your medicine
The MRI clinic will store DOTAREM as recommended by the manufacturer.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, radiographer, or nurse if you have any further questions about side effects.
Most side effects occur during injection or during the first hour after the injection. Some side effects may appear several days after the injection of DOTAREM.
Less serious side effects
Less serious side effects | What to do |
General disorders:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Hypersensitivity reactions: Signs of the start of a shock reaction:
| Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Nephrogenic Systemic Fibrosis
There have been reports of nephrogenic systemic fibrosis (NSF) with other contrast agent containing gadolinium-based contrast agents (GBCAs). NSF can cause hardening of the skin and may affect also soft tissue and internal organs.
Seizures
As with other gadolinium-containing contrast agents, special caution is necessary in patients with a lowered threshold for seizures.
Tell your doctor, radiographer, or nurse if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
7. Product details
This medicine is only available at an MRI clinic.
What DOTAREM contains
Active ingredient (main ingredient) | Gadoteric acid |
Other ingredients (inactive ingredients) | Meglumine Water for injections |
Do not take this medicine if you are allergic to any of these ingredients.
What DOTAREM looks like
DOTAREM is a clear, colourless to yellow solution.
DOTAREM is available in a glass vial or glass or plastic pre-filled syringes (PFS) of various sizes.
DOTAREM is registered in:
- Packs of 1 glass vial, with volume fill of 5 mL, 10 mL, 15 mL, and 20 mL
- Packs of 1 glass pre-filled syringe, with volume fill of 10 mL, 15 mL, and 20 mL
- Packs of 10 plastic pre-filled syringes, with volume fill of 10 mL, 15 mL, and 20 mL
The Australian Registration numbers are:
20 mL vial - AUST R 76923
15 mL vial - AUST R 76924
10 mL vial - AUST R76925
5 mL vial - AUST R 76926
20 mL PFS - AUST R 160800
15 mL PFS - AUST R 160799
10 mL PFS - AUST R 160798
Who distributes DOTAREM
Guerbet Australia Pty Ltd
166 Epping Road,
Lane Cove West NSW 2066
Australia
This leaflet was prepared in February 2025.
Published by MIMS May 2025