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Necitumumab

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What is Necitumumab?

  • Necitumumab (PORTRAZZA) is an epidermal growth factor receptor (EGFR) antagonist used to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.


Necitumumab EGFR 6B3S.png

What are the uses of this medicine?

This medicine is used in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer.

How does this medicine work?

  • Necitumumab (ne" si toom' ue mab) is a recombinant human monoclonal IgG1 antibody to the epidermal growth factor (EGF) receptor.
  • The engagement of EGF with its receptors results in activation of cellular pathways that promote cell growth and angiogenesis.
  • EGF receptors are often overexpressed in cancer cells, particularly squamous non-small cell lung cancer.
  • Inhibition of EGF receptor signaling decreases cell growth and proliferation and decreases formation of new blood vessels, which plays an important role in growth and spread of cancer cells.
  • When used in combination with other antineoplastic agents, necitumumab was shown to extend recurrence-free survival in several forms of advanced cancer.

Who Should Not Use this medicine ?

  • This medicine have no usage limitations.

What drug interactions can this medicine cause?

  • No clinically important drug interactions have been observed with PORTRAZZA.

Is this medicine FDA approved?

  • It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage:

  • Recommended dose of PORTRAZZA is 800 mg (absolute dose) as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle.

Administration

  • Visually inspect the diluted solution for particulate matter and discoloration prior to administration.
  • If particulate matter or discoloration is identified, discard the solution.
  • Administer diluted PORTRAZZA infusion via infusion pump over 60 minutes through a separate infusion line.
  • Flush the line with 0.9% Sodium Chloride Injection, USP at the end of the infusion.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • As Injection: 800 mg/50 mL (16 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

  • PORTRAZZA

What side effects can this medication cause?

The most common side effects of this medicine include:

PORTRAZZA may cause serious side effects, including:

  • Cardiopulmonary Arrest
  • Venous and Arterial Thromboembolic Events
  • Dermatologic Toxicities
  • Infusion-Related Reactions
  • Non-Squamous NSCLC

What special precautions should I follow?

  • Cardiopulmonary arrest or sudden death occurred in 15 (3%) of 538 patients treated with PORTRAZZA plus gemcitabine and cisplatin. Closely monitor serum electrolytes during and after PORTRAZZA.
  • Hypomagnesemia occurred in patients with available laboratory results treated with PORTRAZZA. 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 ≤2. Replete electrolytes as necessary.
  • Venous and arterial thromboembolic events (VTE and ATE), some fatal, were observed with PORTRAZZA in combination with gemcitabine and cisplatin. Discontinue PORTRAZZA for severe VTE or ATE.
  • Dermatologic toxicities, including rash, dermatitis acneiform, acne, dry skin, pruritus, generalized rash, skin fissures, maculo-papular rash and erythema, occurred in 79% of patients receiving PORTRAZZA. Monitor for dermatologic toxicities and withhold or discontinue PORTRAZZA for severe toxicity. Limit sun exposure.
  • Infusion-related reactions may occur. Monitor for signs and symptoms during and following infusion. Discontinue PORTRAZZA for severe reactions.
  • PORTRAZZA is not indicated for the treatment of patients with non-squamous NSCLC. Non-Squamous NSCLC - Increased toxicity and increased mortality.
  • PORTRAZZA Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

  • headache
  • vomiting
  • nausea

Management of overdosage:

  • There is no known antidote for PORTRAZZA overdose.

Can this medicine be used in pregnancy?

  • Based on animal data and its mechanism of action, PORTRAZZA can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

  • The safety and effectiveness of PORTRAZZA have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

  • Active ingredient:

necitumumab

Inactive ingredients:

  • Anhydrous Citric Acid
  • Glycine
  • Mannitol
  • Polysorbate 80
  • Sodium Chloride
  • Trisodium Citrate Dihydrate
  • Water

Who manufactures and distributes this medicine?

What should I know about storage and disposal of this medication?

  • Store vials in a refrigerator at 2° to 8°C (36° to 46°F) until time of use.
  • Keep the vial in the outer carton in order to protect from light.
  • DO NOT FREEZE OR SHAKE the vial.

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