Necitumumab

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.

File:Necitumumab EGFR 6B3S.png

What are the uses of this medicine?

• Necitumumab (Portrazza) 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:

• rash
• hypomagnesemia

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?

• 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.

• Dailymed label info on Necitumumab
• FDA Necitumumab