PORTRAZZA Rx

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PORTRAZZA

Respiratory and thoracic cancers
Only 4 drugs may be compared at once

Generic Name and Formulations:

Necitumumab 800mg/50mL; soln for IV infusion after dilution; preservative-free.

Select therapeutic use:

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:

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:

Not established.

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 8 weeks after last dose; withhold for Grade 3/4 electrolyte abnormalities and may resume once improved to Grade ≤2. 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).

Pharmacological Class:

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 Availability:

NO

How Supplied:

Single-use vial—1

PORTRAZZA 50ml of 16mg/ml vials (Qty:1)

appx. price $4305.00