Necitumumab Brand Name– PORTRAZZA
What is Necitumumab
Necitumumab (Portrazza, IMC-11F8, LY3012211) is a recombinant human lgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands.
It carries a black box warning for cardiopulmonary arrest and hypomagnesemia; patients receiving necitumumab should be closely monitored for hypomagnesemia, hypokalemia, and hypocalcemia; dermatologic toxicities are also common after treatment with necitumumab, and may become worse with sun exposure.
Necitumumab is indicated for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC), in combination with gemcitabine and cisplatin, after demonstrating a significant improvement in overall survival (11.5 months vs. 9.9 months; p = 0.01) in patients treated with necitumumab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone.
Progression free survival was slightly improved (5.7 vs. 5.5 months; p = 0.02) in necitumumab-treated patients; however, the overall response rate was not significantly different (31% vs. 29%; p = 0.4).
It is not indicated for the treatment of non-squamous NSCLC due to an increased incidence of serious and fatal toxicities as well as an increased incidence of death within 30 days of the last dose of study drug in a randomized clinical trial in patients who received necitumumab plus pemetrexed and cisplatin compared to patients treated with pemetrexed and cisplatin alone.
Necitumumab was approved by the FDA in November 2015.
Indications
- non-small cell lung cancer (NSCLC)
For the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), in combination with gemcitabine and cisplatin
NOTE: The FDA has designated necitumumab as an orphan drug for the treatment of squamous NSCLC.
Side Effects
- acne vulgaris
- acne vulgaris
- acneiform rash
- acneiform rash
- antibody formation
- blepharitis
- blurred vision
- cardiac arrest
- conjunctival hyperemia
- conjunctivitis
- conjunctivitis
- diarrhea
- diarrhea
- dysphagia
- erythema
- headache
- hemoptysis
- hemoptysis
- hypocalcemia
- hypocalcemia
- hypokalemia
- hypokalemia
- hypomagnesemia
- hypomagnesemia
- hypophosphatemia
- hypophosphatemia
- lacrimation
- maculopapular rash
- myocardial infarction
- ocular hemorrhage
- ocular infection
- ocular irritation
- ocular pain
- ocular pruritus
- pruritus
- pruritus
- pulmonary embolism
- pulmonary embolism
- rash
- rash
- stomatitis
- stomatitis
- stroke
- thromboembolism
- thromboembolism
- thrombosis
- visual impairment
- vomiting
- vomiting
- weight loss
- weight loss
- xerophthalmia
- xerosis
Monitoring Parameters
- serum electrolytes
Contraindications
- breast-feeding
- cardiac arrest
- cardiac arrhythmias
- chronic obstructive pulmonary disease (COPD)
- contraception requirements
- coronary artery disease
- electrolyte imbalance
- geriatric
- heart failure
- human anti-human antibody (HAHA)
- hypertension
- hypocalcemia
- hypokalemia
- hypomagnesemia
- infusion-related reactions
- myocardial infarction
- pregnancy
- reproductive risk
- serious rash
- sunlight (UV) exposure
- thromboembolic disease
Interactions
- Palifermin
- Penicillamine
- Tuberculin Purified Protein Derivative, PPD
Palifermin: (Moderate) Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents.
Penicillamine: (Major) Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity.
Tuberculin Purified Protein Derivative, PPD: (Moderate) Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD. This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Consider deferring the skin test until completion of the immunosuppressive therapy
