Rx Item-PORTRAZZA NECITUMUMAB 16MG/ML SINGLEDOSE PRESRV FREE VIAL 1X50 ML by Tak

For: Non-Small Cell Lung Cancer

Portrazza (necitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated in combination with gemcitabine and cisplatin for the treatment of patients with metastatic squamous non-small cell lung cancer. These highlights do not include all the information needed to use PORTRAZZA safely and effectively. See full prescribing information for PORTRAZZA.

PORTRAZZA (necitumumab) injection, for intravenous use
Initial U.S. Approval: 2015
WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA PORTRAZZA is supplied in single-dose vials as a sterile, preservative-free solution:

800 mg/50 mL (16 mg/mL) NDC 0002-7716-01

16.2 Storage and Handling

Store vials in a refrigerator at 2� to 8�C (36� to 46�F) until time of use. Keep the vial in the outer carton in order to protect from light. DO NOT FREEZE OR SHAKE the vial.

See full prescription information for complete boxed warning

Cardiopulmonary arrest and/or sudden death occurred in 3% 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. (5.1, 5.2)
Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20%. 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. (5.2)

INDICATIONS AND USAGE

PORTRAZZA� is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. (1.1)

Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. (1.2, 5.6, 14.2)
DOSAGE AND ADMINISTRATION

Recommended dose of PORTRAZZA is 800 mg (absolute dose) as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle. (2.1)
DOSAGE FORMS AND STRENGTHS

Injection: 800 mg/50 mL (16 mg/mL) solution in a single-dose vial. (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

Cardiopulmonary Arrest: Closely monitor serum electrolytes during and after PORTRAZZA. (5.1)
Hypomagnesemia: Monitor prior to each infusion and for at least 8 weeks following the completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities; subsequent cycles of PORTRAZZA may be administered in these patients once electrolyte abnormalities have improved to Grade ?2. Replete electrolytes as necessary. (5.2)
Venous and Arterial Thromboembolic Events (VTE and ATE): Discontinue PORTRAZZA for severe VTE or ATE. (5.3)
Dermatologic Toxicities: Monitor for dermatologic toxicities and withhold or discontinue PORTRAZZA for severe toxicity. Limit sun exposure. (2.3, 5.4)
Infusion-Related Reactions: Monitor for signs and symptoms during and following infusion. Discontinue PORTRAZZA for severe reactions. (2.3, 5.5)
Increased Toxicity: Non-Squamous NSCLC - Increased toxicity and increased mortality. (5.6)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.7, 8.1, 8.3)

ADVERSE REACTIONS

The most common adverse reactions (all grades) observed in PORTRAZZA-treated patients at a rate of ?30% and ?2% higher than gemcitabine and cisplatin alone arm were rash and hypomagnesemia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS

Lactation: Do not breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 11/2015

Rx Item-PORTRAZZA NECITUMUMAB 16MG/ML SI
RX00002-7716-01

Rx Item-PORTRAZZA NECITUMUMAB 16MG/ML SI
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