Clariscan

Generic name: Gadoterate
Drug class: Magnetic resonance imaging contrast media

Usage of Clariscan

Gadoterate injection is used to help diagnose or find problems in the brain, spine, head, neck, and other parts of your body. It is a gadolinium-based contrast agent (GBCA) used in magnetic resonance imaging (MRI) scans. Contrast agents are used to help create a clear picture of the different parts of the body during certain medical procedures, such as MRI scans. MRI scans use magnets and computers to create images or “pictures” of certain areas inside the body. Unlike x-rays, they do not involve ionizing radiation.

This medicine is to be given only by or under the direct supervision of your doctor.

Clariscan side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

  • Blurred vision
  • dizziness
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • Incidence not known

  • Areas of the skin that turned red or dark or feel tight
  • bluish color of the fingernails, lips, skin, palms, or nail beds
  • bone pain in the hips or ribs
  • burning, dry, or itching eyes
  • change in consciousness
  • chest pain or discomfort
  • cough
  • decreased or uncontrolled urination
  • difficulty with swallowing
  • discharge or excessive tearing
  • fainting
  • fever
  • hives or welts, itching, skin rash
  • increased sweating
  • lack or loss of strength
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness, dizziness, or fainting
  • loss of consciousness
  • muscle weakness
  • no blood pressure or pulse
  • no breathing
  • numbness, tingling, pain, or weakness in the hands or feet
  • paralysis or severe weakness of the legs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • shakiness in the legs, arms, hands, or feet
  • skin that burns or itches, swells, scales, or hardens
  • stiff joints or muscles
  • stopping of the heart
  • trembling or shaking of the hands or feet
  • trouble moving your arms or legs
  • uncontrolled bowel movements
  • uncontrolled movements of the body
  • unusual tiredness or weakness
  • Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Rare

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • discomfort in the throat
  • fear
  • loss of taste
  • nausea
  • pain in the arms or legs
  • sleepiness or unusual drowsiness
  • vomiting
  • Incidence not known

  • Transient, mild, pleasant aromatic odor
  • Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    Before taking Clariscan

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gadoterate injection in newborns to children 17 years of age. However, safety and efficacy have not been established in preterm newborns.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gadoterate injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving gadoterate.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or allergies, history of or
  • Patients who have had prior reactions to contrast media—Use with caution. May increase the likelihood of an allergic reaction.
  • Diabetes or
  • Hypertension (high blood pressure) or
  • Infection, severe—Use with caution. May increase your likelihood of having kidney problems (eg, reduced kidney function).
  • Kidney disease, mild or moderate—Use with caution. May increase the likelihood of serious side effects.
  • Kidney problems, severe (acute or long-term)—Should not be used in patients with this condition.
  • Relate drugs

    How to use Clariscan

    A doctor or other trained health professional will give you or your child this medicine. It is given through a needle placed into one of your veins just before you have an MRI scan.

    This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    Warnings

    It is very important that your doctor check you or your child's progress while you are receiving this medicine and during the MRI scan to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    The risk of having a very serious disease called nephrogenic systemic fibrosis (NSF) is increased in patients with severe kidney disease. Even if you have severe kidney problems, your doctor may decide that it is still important to receive this medicine. Check with your doctor right away if you or your child have burning, itching, swelling, hardening, or tightening of the skin, red or dark patches on the skin, joint stiffness, limited range of motion in the arms and legs, pain that is deep in the hip bone or ribs, or muscle weakness. These may be symptoms of NSF.

    This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

    This medicine contains a metal called gadolinium, which can stay in your body (including the brain, bones, skin) for a long time (several months to years). Talk to your doctor if you have concerns.

    This medicine may increase your risk of having acute kidney injury requiring dialysis. This is more likely in patients with a history of kidney problems or in patients receiving increasing doses of gadoterate injection. Talk to your doctor about this risk.

    Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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