Polymyxin B for Injection, USP

500,000 units per vial | NDC 70860-103-10

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NDC 70860-103-10 500,000 units per vial

DESCRIPTION Glass Vial

500,000 units CONCENTRATION per vial

CLOSURE 20 mm

UNIT OF SALE 1 vial

BAR CODED Yes

STORAGE Room Temp.

• PRESERVATIVE-FREE • NOT MADE WITH NATURAL RUBBER LATEX • AP-RATED •

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POLYMYXIN B for Injection, USP ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN • Baseline renal function should be done prior to INDICATION AND USAGE PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR therapy, with frequent monitoring of renal function NEPHROTOXICITY. and blood levels of the drug during parenteral • Polymyxin B sulfate is a drug of choice in the treatment therapy. of infections of the urinary tract, meninges, and THE CONCURRENT OR SEQUENTIAL USE OF OTHER bloodstream caused by susceptible strains of NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH • Avoid concurrent use of a curaiform muscle relaxant Ps. aeruginosa. POLYMYXIN B SULFATE, PARTICULARLY BACITRACIN, and other neurotoxic drugs which may precipitate STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTA- respiratory depression. If signs of respiratory paralysis • It may also be used topically and subconjunctivally MICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, appear, respiration should be assisted as required, in the treatment of infections of the eye caused by PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD and the drug discontinued. susceptible strains of Ps. aeruginosa. BE AVOIDED. • As with other antibiotics, use of Polymyxin B for • It may be indicated in serious infections caused by THE NEUROTOXICITY OF POLYMYXIN B SULFATE Injection may result in overgrowth of nonsusceptible susceptible strains of H. influenzae, specifically in CAN RESULT IN RESPIRATORY PARALYSIS FROM organisms, including fungi. meningeal infections, Escherichia coli, specifically NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN in urinary tract infections, Aerobacter aerogenes , • If superinfection occurs, appropriate therapy should THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/ specifically in bacteremia andKlebsiella pneumoniae, be instituted. OR MUSCLE RELAXANTS. specifically in bacteremia, when less potentially ADVERSE REACTIONS toxic drugs are ineffective or contraindicated. USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED. • Nephrotoxic reactions: Albuminuria, cylinduria, IMPORTANT SAFETY INFORMATION azotemia may occur with use of Polymyxin B for CONTRAINDICATIONS WARNING Injection without any increase in dosage. Polymyxin B for Injection, USP is contraindicated CAUTION: WHEN THIS DRUG IS GIVEN • Neurotoxic reactions: Facial flushing, dizziness, in persons with a prior history of hypersensitivity INTRAMUSCULARLY AND/OR INTRATHECALLY, progressing to ataxia, drowsiness, peripheral reactions to polymyxins. IT SHOULD BE GIVEN ONLY TO HOSPITALIZED paresthesias (circumoral and stocking glove), PATIENTS, SO AS TO PROVIDE CONSTANT WARNINGS apnea due to concurrent use of curaiform muscle SUPERVISION BY A PHYSICIAN. • Clostridium difficile associated diarrhea (CDAD) has relaxant, other neurotoxic drugs or inadvertent overdosage and signs of meningeal irritation with RENAL FUNCTION SHOULD BE CAREFULLY been reported with use of nearly all antibacterial intrathecal administration may occur with use of DETERMINED AND PATIENTS WITH RENAL DAMAGE agents, including Polymyxin B for Injection, and may Polymyxin B for Injection. AND NITROGEN RETENTION SHOULD HAVE REDUCED range in severity from mild diarrhea to fatal colitis. DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO • If CDAD is suspected or confirmed ongoing, • Other reactions occasionally reported are drug POLYMYXIN B SULFATE USUALLY SHOW ALBUMINURIA, antibiotic use not directed at C. Difficile may need fever, urticarial rash, pain (severe) at intramuscular CELLULAR CASTS, AND AZOTEMIA. DIMINISHING to be discontinued. injection sites, and thrombophlebitis at intravenous URINE OUTPUT AND A RISING BUN ARE INDICATIONS injection sites. PRECAUTIONS FOR DISCONTINUING THERAPY WITH THIS DRUG. You are encouraged to report negative side • Prescribing polymyxin B in the absence of a NEUROTOXIC REACTIONS MAY BE MANIFESTED BY effects of prescription drugs to the FDA. proven or strongly suspected bacterial infection IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, Visit www.fda.gov/medwatch. Or call 1-800-FDA-1088. or a prophylactic indication is unlikely to provide PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, a benefit to the patient and increases the risk of Please see full prescribing information for POLYMYXIN AND BLURRING OF VISION. THESE ARE USUALLY the development of drug resistant bacteria. B for Injection, USP.