Necitumumab

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(Redirected from Portrazza)

What is Necitumumab?[edit | edit source]

  • 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.


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What are the uses of this medicine?[edit | edit source]


How does this medicine work?[edit | edit source]

  • 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 ?[edit | edit source]

  • This medicine have no usage limitations.


What drug interactions can this medicine cause?[edit | edit source]

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


Is this medicine FDA approved?[edit | edit source]

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


How should this medicine be used?[edit | edit source]

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?[edit | edit source]

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?[edit | edit source]

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?[edit | edit source]

  • 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?[edit | edit source]

Symptoms of overdosage may include:

Management of overdosage:

  • There is no known antidote for Portrazza overdose.


Can this medicine be used in pregnancy?[edit | edit source]

  • 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?[edit | edit source]

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


What are the active and inactive ingredients in this medicine?[edit | edit source]

  • Active ingredient:

necitumumab

Inactive ingredients:

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


Who manufactures and distributes this medicine?[edit | edit source]


What should I know about storage and disposal of this medication?[edit | edit source]

  • 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.
Necitumumab Resources
Wikipedia


Necitumumab Resources
Wikipedia
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