Portrazza ® (necitumumab) injection

800 mg/50 mL vial

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

PORTRAZZA® (necitumumab):RASH MANAGEMENT

Skin rash, a class effect of EGFR inhibitors, has been observed with PORTRAZZA® (necitumumab) use. Numerous guidelines are published regarding rash management.

See important safety information, including boxed warning, in the attached prescribing information.

Skin toxicity appears to be a class effect of epidermal growth factor receptor (EGFR) inhibitors (Burtness, 2009). Rash is the most common skin toxicity reported with anti-EGFR monoclonal antibody treatment, with nearly 90% of patients experiencing a rash (Lucchini, 2014). Skin toxicity usually occurs early in treatment, tends to be mild to moderate in severity, and tends to occur on the face and upper body, as well as other areas that may be exposed to the sun (Melosky, 2009).

Management of Skin Toxicity in SQUIRE Trial

The SQUamous non-small cell lung cancer (NSCLC) treatment with the Inhibitor of EGF REceptor (SQUIRE) study was a randomized, multicenter, open-label, phase 3 study of necitumumab plus gemcitabine‑cisplatin chemotherapy vs gemcitabine-cisplatin chemotherapy alone in the first-line treatment of patients with stage IV squamous NSCLC, with the primary endpoint of overall survival (Thatcher, 2015). Preemptive treatment with skin moisturizers, topical steroids, doxycycline, or sunscreen was permitted as clinically appropriate to patients receiving necitumumab after completing cycle 1 (Data on file). Reactive treatment of skin rash was based on Canadian recommendations for the management of EGFR-mediated skin rash (Melosky, 2009).

Necitumumab Dosing With Skin Toxicity (Portrazza Package Insert, 2015)

Necitumumab is indicated in combination with gemcitabine and cisplatin for the treatment of patients with metastatic squamous NSCLC who have not received prior chemotherapy for their metastatic disease.

Withhold necitumumab for grade 3 rash or acneiform rash until symptoms resolve to grade ≤2:

  • Resume necitumumab at reduced dose of 400 mg for at least 1 treatment cycle.

  • If symptoms do not worsen, may increase dose to 600 mg and 800 mg in subsequent cycles.

Permanently discontinue necitumumab for any of the following:

  • grade 3 rash or acneiform rash that does not resolve to grade ≤2 within 6 weeks

  • reactions that worsen or become intolerable at a dose of 400 mg

  • patient experiences grade 3 skin induration/fibrosis, or

  • patient experiences grade 4 dermatologic toxicity.

Although Eli Lilly and Company cannot make recommendations for treatment or prevention of skin toxicity, the following resources are provided for consideration:

NCCN task force report: management of dermatologic and other toxicities associated with EGFR inhibition in patients with cancer (Burtness, 2009).

An interdisciplinary consensus on managing skin reactions associated with human epidermal growth factor receptor inhibitors (Eaby, 2008).

Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities (Lacouture, 2011).

Management of skin rash during EGFR-targeted monoclonal antibody treatment for gastrointestinal malignancies: Canadian recommendations (Melosky, 2009).

Enclosed Prescribing Information

GEMZAR® (gemcitabine for injection), for intravenous use, Lilly

PORTRAZZA® (necitumumab) injection, for intravenous use, Lilly

The published references below are available by contacting 1‑800-LillyRx (1-800-545-5979).

References

Burtness B, Anadkat M, Basti S, et al. NCCN task force report: management of dermatologic and other toxicities associated with EGFR inhibition in patients with cancer. J Natl Compr Canc Netw. 2009;7(suppl 1):S5-S21.

Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Eaby B, Culkin A, Lacouture ME. An interdisciplinary consensus on managing skin reactions associated with human epidermal growth factor receptor inhibitors. Clin J Oncol Nurs. 2008;12(2):283-290.

Lacouture ME, Anadkat MJ, Bensadoun RJ, et al. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 2011;19(8):1079-1095.

Lucchini E, Pilotto S, Spada E, et al. Targeting the epidermal growth factor receptor in solid tumors: focus on safety. Expert Opin Drug Saf. 2014;13(5):535-549.

Melosky B, Burkes R, Rayson D, Alcindor T, Shear N, Lacouture M. Management of skin rash during EGFR-targeted monoclonal antibody treatment for gastrointestinal malignancies: Canadian recommendations. Curr Oncol. 2009;16(1):14-24.

Portrazza [package insert]. Indianapolis, IN: Eli Lilly and Company; 2015.

Thatcher N, Hirsch FR, Luft AV, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non‑small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015;16(7):763-774.

Additional related information

Date of Last Review: November 26, 2017

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