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.
What are the uses of this medicine?
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 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.
- 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
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:
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:
- Anhydrous Citric Acid
- Polysorbate 80
- Sodium Chloride
- Trisodium Citrate Dihydrate
Who manufactures and distributes this medicine?
- Packager: Eli Lilly and Company
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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Learn more about Necitumumab
- Dailymed label info
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- Drug portal Necitumumab
- toxicity info on Necitumumab
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