Necitumumab

Necitumumab is used for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin.

Necitumumab is available under the following different brand names: Portrazza.

Dosages of Necitumumab:

Dosage Forms and Strengths

Intravenous (IV) solution

• 800 mg/50mL (16mg/mL)

Dosage Considerations – Should be Given as Follows:

Non-small Cell Lung Cancer

• Indicated for first-line treatment of metastatic squamous NSCLC in combination with gemcitabine and cisplatin
• 800 mg intravenously (IV) infused over 1 hour on days 1 and 8 of each 3-week cycle before 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 up to 2, then resume infusion at a reduced dose of 400 mg for at least 1 treatment cycle; if symptoms do not worsen, may increase the dose to 600 mg and 800 mg in subsequent cycles
• Permanently discontinue if:
  • Grade 3 rash or acneiform rash do not resolve to grade up to 2 within 6 weeks
  • 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 the treatment of non-squamous NSCLC
• Safety and efficacy not established in pediatric patients

Common side effects of Necitumumab include:

• Low magnesium (hypomagnesemia)
• Low calcium (hypocalcemia)
• Rash
• Low phosphates (hypophosphatemia)
• Vomiting
• Low potassium (hypokalemia)
• Diarrhea
• Weight loss
• Inflammation of the mouth and lips
• Headache
• Coughing up blood
• Blood clots
• Acne
• Infection around the fingernails or toenails
• Conjunctivitis
• Itching
• Dry skin
• Skin fissures
• Pulmonary embolism

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Necitumumab has no listed severe interactions with other drugs.
• Necitumumab has no listed serious interactions with other drugs.
• Necitumumab has no listed moderate interactions with other drugs.
• Necitumumab has no listed mild interactions with other drugs.

Warnings

This medication contains necitumumab. Do not take Portrazza if you are allergic to necitumumab or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

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 the drug through dedicated IV line; do not mix with electrolyte or dextrose solutions)
• 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 before 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

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Necitumumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Necitumumab?"

Cautions

• A cardiopulmonary arrest was 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
• 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 redness, occurred in 79% of patients, typically within the first 2 weeks of therapy; limit sun exposure and discontinue for severe toxicity
• Infusion-related reactions may occur; discontinue for severe reactions
• Not indicated for non-squamous 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

Pregnancy and Lactation

• Based on animal data and its mechanism of action, necitumumab can cause fetal harm when administered during pregnancy. Females of reproductive potential are advised to use effective contraception during treatment with necitumumab and for 3 months following the final dose.
• It is unknown if necitumumab is distributed in human breast milk. Nursing women are advised not to breastfeed during treatment with necitumumab and for 3 months following the final dose.