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warnings and cautions
5 WARNINGS AND PRECAUTIONS Extravasation during intravenous administration may cause necrosis or sloughing of tissue ( 5.3 ) Severe bradycardia and decreased cardiac output ( 5.4 ) Allergic-type reactions: Sulfite ( 5.5 ) Concomitant use with oxytocic drugs: Pressor effect of sympathomimetic pressor amines is potentiated ( 5.8 ) 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its increasing blood pressure effects, VAZCULEP can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. 5.2 Peripheral and Visceral Ischemia VAZCULEP can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease. 5.3 Skin and Subcutaneous Necrosis Extravasation of VAZCULEP can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of VAZCULEP. 5.4 Bradycardia VAZCULEP can cause severe bradycardia and decreased cardiac output. 5.5 Allergic Reactions VAZCULEP contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. 5.6 Renal Toxicity VAZCULEP can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function. 5.7 Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction The increasing blood pressure response to adrenergic drugs, including VAZCULEP, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries. 5.8 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including VAZCULEP [see Drug Interactions ( 7.1 )] , with the potential for hemorrhagic stroke.
6 ADVERSE REACTIONS Adverse reactions to VAZCULEP are primarily attributable to excessive pharmacologic activity. Adverse reactions reported in published clinical studies, observational trials, and case reports of VAZCULEP are listed below by body system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiac disorders: Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias Gastrointestinal disorders: Epigastric pain, vomiting, nausea Nervous system disorders: Headache, blurred vision, neck pain, tremors Vascular disorders: Hypertensive crisis Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and subcutaneous tissue disorders: Pruritis Most common adverse reactions during treatment: nausea, vomiting, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avadel Legacy Pharmaceuticals, LLC at 1-877-622-2320 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .