Label Changes for:
Ultravist (brand of iopromide) Injection
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012
5 WARNINGS AND PRECAUTIONS
5.1 Anaphylactoid Reactions
- Life-threatening or fatal, anaphylactoid reactions, may occur during or after ULTRAVIST administration. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Increased risk is associated with a history of previous reaction to a contrast agent (3-fold), a known sensitivity to iodine and known allergic disorders (that is, bronchial asthma, hay fever and food allergies) or other hypersensitivities (2-fold). Exercise extreme caution when considering the use of iodinated contrast agents in patients with these histories or disorders. Emergency facilities and personnel trained in the treatment of anaphylactoid reactions should be available for at least 30 to 60 minutes after ULTRAVIST administration.
5.2 Contrast Induced Acute Kidney Injury
- Acute kidney injury, including renal failure, may occur after intravascular administration of ULTRAVIST. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma / paraproteinemia, repetitive and/or large doses of ULTRAVIST. Use the lowest necessary dose of ULTRAVIST in patients with renal impairment. Adequately hydrate patients prior to and following ULTRAVIST administration.
5.3 Cardiovascular Reactions
- The administration of ULTRAVIST may cause pulmonary edema in patients with heart failure. Based upon published reports, deaths from the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Observe patients with preexisting cardiovascular disease for several hours following ULTRAVIST administration.
5.4 Thromboembolic Complications
- Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure including stroke, brachial plexus palsy, chest pain, myocardial infarction, sinus arrest, hepato-renal function abnormalities. For these reasons, meticulous angiographic .....
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- Musculoskeletal and connective tissue disorders: compartment syndrome in case of extravasation.
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions
- In patients with renal impairment, biguanides can cause lactic acidosis. ULTRAVIST appears to increase the risk of biguanide induced lactic acidosis, possibly as a result of worsening renal function [see Warnings and Precautions (5.2)].