See Supplemental Patient Information
- Increased risk of NSF has been reported with GBCAs in patients with acute or chronic severe renal insufficiency (GFR <30 mL/min/1.73 m2) and in patients with acute renal insufficiency due to hepato-renal syndrome or in the perioperative hepatic transplantation period. Avoid use in such patients unless diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs [US Black Box Warning]
- Screen all patients for renal dysfunction. Do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to re-administration [US Black Box Warning]
- Hypersensitivity reactions, including anaphylactoid and anaphylactic reactions with cardiovascular, respiratory and cutaneous manifestations rarely resulting in death may occur with GBCAs. Discontinue therapy if such reaction occurs and initiate appropriate medical therapy, including resuscitation
- Carefully monitor patients with a history of drug reactions, allergy or other hypersensitivity disorders, during and up to several hours after injection
- Acute renal failure requiring dialysis or worsening renal function may occur in patients with renal insufficiency, within 48 hrs of administration; this risk is higher with increasing dose of contrast. Use the lowest possible dose, monitor renal function in patients with renal insufficiency, and allow sufficient time for contrast elimination before re-administration
- Rare cases of skin and soft tissue necrosis, thrombosis, fasciitis, and compartment syndrome requiring surgical intervention have been reported at the site of contrast injection or the dosed limb
- Phlebitis and thrombophlebitis may occur usually within 24 hours after administration and resolve with supportive treatment. Patency and integrity of the intravenous line should be determined before administration of therapy. Monitor the dosed limb for the development of injection site reactions
- Product might impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when gadopentetate MRI scans are interpreted without a companion non-contrast MRI scan
- Transitory changes in serum iron, bilirubin and transaminase levels were observed with therapy
Cautions: Use cautiously in
- Renal impairment
- Breastfeeding
- Hx of cardiac disease
Supplemental Patient Information
- Instruct patients to inform their physicians if they are pregnant, breastfeeding, or have a history of renal insufficiency, asthma or allergic respiratory disorders prior to initiation of therapy
Pregnancy Category:C
Breastfeeding: Early investigators recommended withholding breastfeeding following administration of gadopentetate. A more recent and much larger study indicated that the amounts of gadolinium excreted into breastmilk are <1% of the amount allowed to be given to infants. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives a gadolinium-containing contrast medium. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 28 July 2011). Manufacturer advises caution.
