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 reactions are discussed in greater detail in other sections of the label: Infusion reactions [see Warnings and Precautions ( 5.1 )] .
Cardiopulmonary arrest [see Warnings and Precautions ( 5.2 )] .
Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] .
Dermatologic toxicity [see Warnings and Precautions ( 5.4 )] .
Hypomagnesemia and Electrolyte Abnormalities [see Warnings and Precautions ( 5.6 )] .
The most common adverse reactions (incidence ≥25%) with Erbitux as a single-agent or in combination with radiotherapy or chemotherapy (FOLFIRI, Irinotecan and 5-Fluorouracil/Platinum) are: cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection.
( 6 ) The most common adverse reactions (>25%) for ERBITUX, in combination with encorafenib, are fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash.
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 data described in Warnings and Precautions reflect exposure to ERBITUX in 1373 patients with SCCHN or CRC enrolled in clinical trials and treated at the recommended dosage for a median of 7 to 14 weeks [see Clinical Studies ( 14.1 , 14.2 )] .
5 WARNINGS AND PRECAUTIONS Infusion Reactions: Monitor patients following infusion.
Immediately stop and permanently discontinue ERBITUX for serious infusion reactions.
( 2.5 , 5.1 ) Cardiopulmonary Arrest: Monitor serum electrolytes during and after ERBITUX.
( 5.2 , 5.6 ) Pulmonary Toxicity: Interrupt or permanently discontinue for acute onset or worsening of pulmonary symptoms.
( 2.5 , 5.3 ) Dermatologic Toxicity: Monitor for dermatologic toxicities or infectious sequelae.
Like all medications, Erbitux 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: