necitumumab (Rx)

Brand and Other Names:Portrazza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 800mg/50mL (16mg/mL)

Non-small Cell Lung Cancer

Indicated for first-line treatment of metastatic squamous NSCLC in combination with gemcitabine and cisplatin

800 mg IV infused over 1 hr on days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion

Continue therapy until disease progression or unacceptable toxicity

Dosage Modifications

Infusion-related reactions

  • Grade 1: Reduce the infusion rate by 50%
  • Grade 2: Stop the infusion until signs and symptoms have resolved to grade 0 or 1; resume infusion at 50% reduced rate for all subsequent infusions
  • Grade 3 or 4 IRR: Permanently discontinue
  • Also see Administration

Dermatologic toxicity

  • Grade 3 rash or acneiform rash: Withhold until symptoms resolve to grade ≤2, then resume infusion at reduced dose of 400 mg for at least 1 treatment cycle; if symptoms do not worsen, may increase dose to 600 mg and 800 mg in subsequent cycles
  • Permanently discontinue if
    • Grade 3 rash or acneiform rash do not resolve to grade ≤2 within 6 wk
    • Reactions worsen or become intolerable at a dose of 400 mg
    • Patient experiences grade 3 skin induration/fibrosis
    • Grade 4 dermatologic toxicity

Dosing Considerations

Limitations of use: Not indicated for treatment of nonsquamous NSCLC

Safety and efficacy not established

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Adverse Effects

Percentages listed below are for all grades of toxicity unless otherwise noted

>10%

Hypomagnesemia (83%)

Hypocalcemia (45%)

Rash (44%)

Hypocalcemia (albumin corrected) (36%)

Hypophosphatemia (31%)

Vomiting (29%)

Hypokalemia (28%)

Hypomagnesemia, grade 3-4 (20%)

Diarrhea (16%)

Dermatitis acneiform (15%)

Weight decreased (13%)

Stomatitis (11%)

Headache (11%)

1-10%

Hemoptysis (10%)

Venous thromboembolic events (9%)

Acne (9%)

Hypophosphatemia, grade 3-4 (8%)

Paronychia (7%)

Conjunctivitis (7%)

Pruritus (7%)

Dry skin (7%)

Hypocalcemia, grade 3-4 (6%)

Hypokalemia, grade 3-4 (5%)

Skin fissures (5%)

Pulmonary embolism (5%)

Venous thromboembolic events, grade 3-4 (5%)

Hypocalcemia (albumin corrected), grade 3-4 (4%)

Vomiting, grade 3-4 (3%)

Diarrhea, grade 3-4 (2%)

Stomatitis, grade 3-4 (1%)

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Warnings

Black Box Warnings

Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with necitumumab in combination with gemcitabine and cisplatin

Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after necitumumab (administer drug through dedicated IV line; do not mix with electrolyte or dextrose solutions) (see Administration)

Hypomagnesemia occurred in 83% of patients receiving necitumumab in combination with gemcitabine and cisplatin, and was severe in 20% of patients

Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose during treatment and for at least 8 weeks following completion

Withhold drug for grade 3 or 4 electrolyte abnormalities

Replete electrolytes as medically appropriate

Contraindications

None

Cautions

Cardiopulmonary arrest reported in 3% of patients with necitumumab plus gemcitabine and cisplatin compared with 0.6% with gemcitabine and cisplatin; closely monitor serum electrolytes during and after dose

Monitor for hypomagnesemia (see Black Box Warnings)

Discontinue if severe venous or arterial thrombosis occurs

Dermatologic toxicities, including rash, dermatitis acneiform, acne, dry skin, pruritus, generalized rash, skin fissures, maculopapular rash and erythema, occurred in 79% of patients, typically within the first 2 weeks of therapy; limit sun exposure and discontinue for severe toxicity (see Dosage Modifications)

Infusion-related reactions may occur; discontinue for severe reactions (see Dosage Modifications)

Not indicated for nonsquamous NSCLC; increased toxicity and increased mortality occurred when necitumumab was added to pemetrexed and cisplatin therapy for these patients

Based on animal data and its mechanism of action, can cause fetal harm when administered to a pregnant woman (see Pregnancy)

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Pregnancy

Pregnancy

Based on animal data and its mechanism of action, can cause fetal harm when administered during pregnancy

Contraception

  • Advise females of reproductive potential to use effective contraception during treatment and for 3 months following the final dose

Animal studies

  • Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development, including effects on placental, lung, cardiac, skin, and neural development
  • The absence of EGFR signaling has resulted in embryolethality as well as postnatal death in animals

Lactation

Unknown if distributed in human breast milk

Advise a nursing woman not to breastfeed during treatment and for 3 months following the final dose

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Epidermal growth factor receptor (EGFR) inhibitor; monoclonal antibody that binds to the human EFGR and blocks interaction between EGFR and its ligands

Expression and activation of EGFR has been correlated with malignant progression, induction of angiogenesis, and inhibition of apoptosis

Pharmacokinetics

Time to steady state: ~100 days

Total systemic clearance at steady-state: 14.1 mL/hr

Vd: 7 L

Half-life: ~14 days

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Administration

IV Compatibilities

0.9% NaCl

IV Incompatibilities

Dextrose-containing solutions

Electrolyte-containing solutions

IV Preparation

Inspect vial contents for particulate matter and discoloration prior to dilution

Discard vial if particulate matter or discoloration is identified

Dilute the required dosage volume with 0.9% NaCl in an IV infusion container to a final volume of 250 mL

Do not use solutions containing dextrose

Do not dilute with other solutions or coinfuse with other electrolytes or medication

Gently invert the container to ensure adequate mixing (do not shake)

IV Administration

Administer diluted solution via infusion pump over 1 hr through a separate infusion line

Flush line with 0.9% NaCl at the end of the infusion

Premedication

  • For patients who have experienced a previous grade 1 or 2 infusion-related reaction (IRR), premedicate with diphenhydramine (or equivalent) prior to all subsequent necitumumab infusions
  • For patients who have experienced a second grade 1 or 2 occurrence of IRR, premedicate for all subsequent infusions with diphenhydramine (or equivalent), acetaminophen, and dexamethasone (or equivalent) prior to each necitumumab infusion
  • Also see Dosage Modifications

Storage

Unopened vials

  • Store vials in a refrigerator at 2-8°C (36-46˚F) until time of use
  • Keep the vial in the outer carton in order to protect from light

Diluted drug

  • Do not freeze
  • Do not shake the infusion solution
  • Store diluted infusion solution for no more than 24 hr at 2-8°C (36-46°F), or no more than 4 hr at room temperature (up to 25°C [77°F])
  • Discard vial with any unused portion of necitumumab
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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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