Respiratory and thoracic cancers:

Indications for: PORTRAZZA

In combination with gemcitabine and cisplatin, for first-line treatment of metastatic squamous non-small cell lung cancer.

Limitations of Use:

Not for treatment of non-squamous non-small cell lung cancer.

Adult Dosage:

Give by IV infusion over 60 mins prior to gemcitabine and cisplatin infusion. 800mg on Days 1 and 8 of each 3-week cycle; continue until disease progression or unacceptable toxicity. May premedicate with diphenhydramine HCl (or equivalent) if previously experienced a Grade 1/2 infusion-related reaction. Dose modifications: see full labeling.

Children Dosage:

Not established.

Boxed Warning:

Cardiopulmonary arrest. Hypomagnesemia.

PORTRAZZA Warnings/Precautions:

Risk of cardiopulmonary arrest and/or sudden death, hypomagnesemia. History of coronary artery disease, CHF, or arrhythmias. Monitor serum electrolytes (eg, magnesium, potassium, calcium) prior to each infusion during therapy and for at least 8 weeks after last dose; withhold for Grade 3/4 electrolyte abnormalities and may resume once improved to Grade ≤2. Replete electrolytes as medically appropriate. Discontinue if serious or life-threatening venous/arterial thromboembolic events or infusion-related reactions occur. Discontinue if Grade 4 skin reactions or Grade 3 skin induration/fibrosis occurs. Limit sun exposure. Embryo-fetal toxicity. Pregnancy; avoid. Use effective contraception during treatment and for 3 months after last dose. Nursing mothers: not recommended (during therapy and for 3 months after last dose).

PORTRAZZA Classification:

Human epidermal growth factor receptor (EGFR) inhibitor.

Adverse Reactions:

Rash, dermatitis acneiform, vomiting, diarrhea, thromboembolic events, hypomagnesemia, hypocalcemia, hypokalemia; cardiopulmonary arrest, dermatologic toxicities, infusion reactions.

Generic Drug Availability:


How Supplied:

Single-use vial—1