Portrazza (necitumumab)

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Portrazza (necitumumab)

Portrazza (necitumumab) is a medication used for the treatment of metastatic squamous non-small cell lung cancer.

Oncology Lung Cancer
Marketing Authorisation Holder Eli Lilly Nederland B.V.
Mode of Action Epidermal Growth Factor (EGFR) Antagonist (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Strength 800 / 50 milligram / millilitre
Package 1 Vials

What is Portrazza (necitumumab) for?

Portrazza (necitumumab) is a monoclonal antibody indicated for the treatment of people with metastatic squamous non-small cell lung cancer in combination with gemcitabine and cisplatin — two widely approved medicines1,2.

How does Portrazza (necitumumab) work?

The active substance in Portrazza, necitumumab, is an epidermal growth factor receptor (EGFR) antagonist1, a type of protein designed to recognise and attach to EGFR on the surface of the cancer cells. EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing the cells to divide uncontrollably. By attaching to and blocking EGFR, necitumumab helps to reduce the growth and spread of the cancer2.

Where has Portrazza (necitumumab) been approved?

Portrazza (necitumumab) was approved for the first line treatment of advanced squamous NSCLC by:

  • Food and Drug Administration (FDA), USA, November 11, 20154
  • European Medical Agency (EMA), European Union, March 4, 20162.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Portrazza (necitumumab) taken?

The standard dosage is:

  • 800 mg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle1,3

Administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by necitumumab as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity3
Administer necitumumab prior to gemcitabine and cisplatin infusion1

Warning: Closely monitor serum electrolytes: cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with Portrazza in combination with gemcitabine and cisplatin.

Complete information about Portrazza (necitumumab)  dosage and administration can be found in the official prescribing information listed in our resources section1,3.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects of Portrazza (necitumumab)?

Common side effects

The most common side effects listed in the prescribing information include1,3:

  • skin reactions (rash)
  • hypomagnesemia
  • venous thromboembolic events.

Serious side effects

The serious side effects listed in the prescribing information include1,3:

  • skin reactions
  • venous thromboembolic events: cardiopulmonary arrest and/or sudden death occurred in 3% of patients
  • hypomagnesemia occurred in 83% of patients and was severe in 20%.

Use in a specific population

Portrazza (necitumumab) can be fatal for a fetus, it is advised to avoid pregnancies and breast feeding1,3.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,3.

More Information
Working ingredient necitumumab
Shipping method Cold chain (temperature controlled)
Package 1
Therapeutic Area Oncology
Oncology Lung Cancer
Indication Squamous NSCLC
Administration Intravenous
Mode of Action Epidermal Growth Factor (EGFR) Antagonist (immunotherapy)
Strength 800 / 50
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Eli Lilly Nederland B.V.

The approvals were based on a study (SQUIRE) involving 1,093 patients with advanced squamous non-small cell lung cancer who received the chemotherapies gemcitabine and cisplatin with or without Portrazza (necitumumab). Patients treated with necitumumab in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months (95% CI 10.4, 12.6) versus 9.9 months (95% CI 8.9, 11.1))3,1. The 1-year overall survival rate was 47.7% with necitumumab and 42.8% without3. The median progression free survival (PFS) was 5.7 months (95% CI 5.6, 6.0) when necitumumab was added to the therapy and 5.5 months (95% CI 4.8, 5.6) without necitumumab's addition3,1.

Necitumumab was not found to be an effective treatment in patients with non-squamous NSCLC2,4.

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.