Dotarem

Brand name:

Dotarem.

Gadoterate is used as a magnetic resonance imaging (MRI) contrast agent. The function of a contract agent is to allow the creation of clear pictures of the body when performing an MRI scan.

MRI scans is used as a special diagnostic procedure when there is need for getting clear and detailed images of parts of the body. The MRI machine uses a series of magnets and computers to allow the creation of images of the body areas being scanned. This is different from the X-rays since they do not apply the use of the ionizing radiations.

Gadoterate is a gadolinium bases contrast agent (GBCA). It is administered as an injection before MRI can be performed. MRI is important in diagnosis of problems in the brain, spine, head, neck, and other body parts. The use of Gadoterate is only allowed under the direct supervision of a trained MRI expert and a medical doctor.

Always weigh the risk of taking the medicine against the benefits of using the drugs. This is a decision that must be made with your doctor. Find out if have any form of allergies and inform your medical doctor in advance.

Inform your medical doctor if you have had any form of allergic reactions to medicines or any other form of medicine. Check also whether you have reactions to food, dyes, preservatives or animals. In case of non-prescription products, always read the information provided in the label for ingredients.

Pediatric specific problems that are a limitation on the usefulness of the drug in children 2 years of age and older. Similarly, safety and efficacy studies on children that are younger than 2 years of age have not been established. In addition, Geriatric studies have also not been performed and there are no geriatric specific problems that have been suggested to indicate the usefulness of gadoterate in the elderly. However, elderly patients are more prone to age related kidney problems.

There is little data on animal studies that demonstrate an adverse effect but there are no adequate studies in pregnant women. Similarly, no studies have been done to demonstrate the infant risk when their mothers are using this drug during breastfeeding. It is advisable to weight on the potential benefits against the risks before one can be allowed to use this medication while breastfeeding.

There is a possibility of drug interaction and certain medicines are not supposed to be used together. However, different medicines may be used together even with the drug interaction. In such cases, the medical professional will want to change the dose or ensure other precautions are observed very carefully.

Inform your healthcare profession if you are using any of the non-prescription or over the counter drugs. Other medicines may need to be avoid especially around times of eating since an interaction my occur.

Keep off completely from alcohol or tobacco. In case of other medical problems, inform your doctor in advance since they may affect the use of Gadoterate.

This is common in conditions of Asthma or allergies and even with the history of these conditions. Any prior reaction to use of contract media must be indicated to the doctor in advance and it must be used with caution. This is because it may increase the likelihood of allergic reaction.

It also needs to be used with caution in people suffering from diabetes or high blood pressure. It may also alter the function of the kidney or liver. Furthermore, it may lead to the other serious side effects such as acute or long term kidney problems. It is advisable not be used in patients suffering from kidney problems.

This drug is only given by a healthcare professional that is trained on the administration of this medicine. Gadoterate is administered through a needle placed in one of your veins just before an MRI scan can be performed.

Close monitoring of the progress by your doctor is very important for your or your child after receiving this medicine, during the scan and even after the MRI scan. This will enable the evaluation of the effectiveness of the medicine and whether unwanted effects are present.

It is known that in the presence of kidney disease, the risk of nephrogenic system fibrosis is increased. However, it will still be important that the medicine be used even with severe kidney disease.

In case of a:

• Burning or itching of the skin
• Red or dark patches on the skin
• Swelling
• Hardening
• Reddening of the skin
• Joint stiffness
• Rduced range of motion in the arms or legs
• Deep pain at the hip bone or ribs
• Muscles weakness

These are an indication of symptoms of the NSF.

Gadoterate may cause serious allergic reaction called anaphylaxis. Anaphylaxis can be life threatening and requires immediate medical attention.

In case of:

• Cold
• Clammy skin
• Confusion
• Dizziness
• Lightheadedness
• Skin rash
• Sweating
• Swelling of the face or tongue and throat or trouble with breathing and chest pain after receiving medicines

check with your medical doctor as soon as possible.

Sometimes, one may feel mild or burning pain, warmth or coldness, observe your skin peeling, redness or swelling at the site of injection.

It is possible that side effects may occur after administration with Gadoterate. If they occur, seek medical attention immediately by checking with your nurse or doctor.

Some of the side effect may include:

• Red and blurred vision
• Feeling dizziness
• Fact and irregular pounding of the heartbeat
• Pulse headache
• Nervousness and pounding in the ears
• Slow or fast heartbeat
• Some areas of the skin may also turn red or dark
• A blue color of the fingernails, lips, skin or palms must be observed
• Pain in the nail beds may increase
• Pain the hips, and or ribs
• Itching eye
• Cough that comes with a discomfort
• Difficulty in swallowing
• Excessive discharge or tearing
• Fainting
• Fever
• Increased sweating
• Itching
• Swelling of the eye lids, face, tongue, legs, hands or sex organs

Some of the side effects may go away during treatment or even as the body adjust to the medicines. The medical healthcare professional may also be able to lower or prevent some of the side effects. In case they become bothersome or continue, visit your healthcare professional.

In the event that needs immediate medical attention.:

• Rare bleeding
• Blistering
• Burning
• Coldness
• Discoloration of the skin
• Feeling pressure
• Hives infection
• Inflammation
• Itching
• Lumps
• Numbness
• Pain
• Redness
• Scarring
• Soreness
• Stinging
• Swelling
• Tenderness
• Ulceration or warmth at the site of injection
• Numbness
• Prickling
• Tingling feelings and change of taste
• Discomfort in the throat
• Nausea
• Cold sensation at the injection site
• Sleepiness
• Drowsiness
• Vomiting or unusual vomiting

Other side effects that are not listed here may also occur in some of the patients. Always check with a medical doctor or call for medical advice about the side effects. Side effects may also be reported to FDA directly through the number 1-800-FDA-1088.