Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: Cardiopulmonary Arrest [see Boxed Warning and Warnings and Precautions ( 5.1 )] .
Hypomagnesemia [see Boxed Warning and Warnings and Precautions ( 5.2 )] .
Venous and Arterial Thromboembolic Events [see Warnings and Precautions ( 5.3 )] .
Dermatologic Toxicities [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.4 )] .
Infusion-Related Reactions [see Dosage and Administration ( 2.2 , 2.3 ) and Warnings and Precautions ( 5.5 )] .
Non-Squamous NSCLC - Increased Toxicity and Increased Mortality [see Warnings and Precautions ( 5.6 ) and Clinical Studies ( 14.2 )] .
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 .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of PORTRAZZA was evaluated in two randomized, open-label trials comparing PORTRAZZA plus gemcitabine and cisplatin to gemcitabine and cisplatin alone in patients with squamous NSCLC (Study 1), and PORTRAZZA plus pemetrexed and cisplatin to pemetrexed and cisplatin alone in patients with non-squamous NSCLC (Study 2).
5 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 ≤
Replete electrolytes as necessary.
Like all medications, Portrazza can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: