Pronunciation:

ne-si-TOOM-oo-mab

Brand Names:

• Portrazza

Dosage Forms:

• Solution

Warnings:

Cardiopulmonary arrest and/or sudden death have been reported with necitumumab in combination with gemcitabine and cisplatin. Monitor serum electrolytes, including serum magnesium, potassium, and calcium. Hypomagnesemia has been reported with necitumumab plus gemcitabine and cisplatin. Monitor for hypomagnesemia, hypocalcemia, and hypokalemia prior to each necitumumab dose and for at least 8 weeks after discontinuation. Withhold treatment if grade 3 or 4 electrolyte abnormalities occur .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Necitumumab injection is used in combination with gemcitabine and cisplatin to treat squamous non-small cell lung cancer that has spread.

Necitumumab interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by necitumumab, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Some unwanted effects, such as a skin rash, may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of necitumumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of necitumumab injection in the elderly. However, elderly patients are more likely to have blood clots (eg, pulmonary embolism), which may require caution in patients receiving necitumumab injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots (eg, deep vein thrombosis, pulmonary embolism) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle will remain in place for 60 minutes and the infusion will be given on Day 1 and 8 of each 3-week cycle.

You may also receive medicines to help prevent possible allergic reactions to the injection.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Hypomagnesemia may occur while you are receiving this medicine. Tell your doctor right away if you have drowsiness, mood or mental changes, muscle spasms or twitching, seizures, or unusual tiredness or weakness after receiving this medicine.

Blood clots may occur while you are receiving this medicine. Call your doctor if you have chest pain that may spread to your arms, jaw, back, or neck, coughing up blood, nausea, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking, trouble breathing, or unusual sweating.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Infusion-related reactions may occur while you are receiving this medicine. Tell your doctor right away if you have the following symptoms: back pain, chest tightness, chills, fever, flushing, headache, nausea and vomiting, weakness, or trouble breathing.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Abdominal or stomach cramps

confusion

convulsions

decreased urine

difficulty with breathing

drowsiness

dry mouth

increased thirst

irregular heartbeat

loss of appetite

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

muscle pain or muscle spasms (tetany) or twitching

nausea or vomiting

numbness and tingling around the mouth, fingertips, or feet

tremor

unusual tiredness or weakness

Less common

Anxiety

back pain

chest pain or discomfort

chest tightness

chills

cough

difficulty with speaking

dizziness or lightheadedness

double vision

fainting

fast heartbeat

fever

flushing

headache

heart stops

inability to move the arms, legs, or facial muscles

no breathing

no pulse or blood pressure

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

pains in the chest, groin, or legs, especially the calves of the legs

severe headaches of sudden onset

slow speech

sudden loss of coordination

sudden onset of slurred speech

sudden shortness of breath or troubled breathing

sudden vision changes

sweating

trouble breathing

unconscious

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blemishes on the skin

burning, dry, or itching eyes

decreased weight

diarrhea

discharge or excessive tearing

dry skin

itching skin or rash

loosening of the fingernails

pimples

rash with flat lesions or small raised lesions on the skin

redness or soreness around the fingernails

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.