+BOXED WARNING

(WHAT IS THIS?)

WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA

  • Cardiopulmonary arrest and/or sudden death occurred in 3.0% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration [see Warnings and Precautions (5.1, 5.2)].
  • Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20% of patients. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of PORTRAZZA during treatment and for at least 8 weeks following completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate [see Warnings and Precautions (5.2)].

+HIGHLIGHTS OF PRESCRIBING INFORMATION

+FULL PRESCRIBING INFORMATION: CONTENTS*

+1 INDICATIONS AND USAGE

+2 DOSAGE AND ADMINISTRATION

+3 DOSAGE FORMS AND STRENGTHS

+4 CONTRAINDICATIONS

+5 WARNINGS AND PRECAUTIONS

+6 ADVERSE REACTIONS

+8 USE IN SPECIFIC POPULATIONS

+10 OVERDOSAGE

+11 DESCRIPTION

+12 CLINICAL PHARMACOLOGY

+13 NONCLINICAL TOXICOLOGY

+14 CLINICAL STUDIES

+16 HOW SUPPLIED/STORAGE AND HANDLING

+17 PATIENT COUNSELING INFORMATION