Applies to gadoterate meglumine: intravenous solution.
Warning
Intravenous route (Solution)
Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. The risk for NSF appears highest among patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73m(2)), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, older than 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
Serious side effects
Along with its needed effects, gadoterate meglumine 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 while taking gadoterate meglumine:
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
Other side effects
Some side effects of gadoterate meglumine 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
For Healthcare Professionals
Applies to gadoterate meglumine: intravenous solution.
General
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