Necitumumab is a monoclonal antibody that blocks a certain protein in the body that can affect tumor cell growth. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Necitumumab is used to treat a certain type of non-small cell lung cancer. Necitumumab is usually given in combination with other cancer medications.

Necitumumab may also be used for purposes not listed in this medication guide.

Necitumumab can cause your electrolytes to become unbalanced. This can lead to serious heart problems, including cardiac arrest. You will need frequent blood tests to check your electrolytes (calcium, potassium, and magnesium).

Necitumumab is injected into a vein through an IV. A healthcare provider will give you this injection. This medicine must be injected slowly, and the IV infusion can take at least 1 hour to complete.

Necitumumab is given in a 21-day treatment cycle. You may need to use the medicine only on days 1 and 8 of each cycle. Your doctor will determine how long to treat you with necitumumab.

You may be given medication to prevent certain side effects while you are receiving necitumumab.

Necitumumab can cause your electrolytes to become unbalanced. This can lead to serious heart problems, including cardiac arrest. You will need frequent blood tests to check your electrolytes (calcium, potassium, and magnesium).

Your doctor may recommend that you take mineral supplements to keep your electrolytes from getting too low. Follow your doctor's dosing instructions very carefully.

Necitumumab can have long-lasting effects on your body. You may need frequent medical tests for at least 8 weeks after you stop using this medicine.

Usual Adult Dose for Non-Small Cell Lung Cancer:

800 mg IV over 60 minutes on Days 1 and 8 of each 3-week cycle prior to gemcitabine and cisplatin infusion

Duration of therapy: Continue until disease progression or unacceptable toxicity.

Comments:
-For patients who have experienced a previous Grade 1 or 2 infusion-related reaction (IRR), premedicate with diphenhydramine (or equivalent) prior to all infusions of this drug.
-For patients who have experienced a second Grade 1 or 2 occurrence of IRR, premedicate for all subsequent infusions, with diphenhydramine (or equivalent), acetaminophen (or equivalent), and dexamethasone (or equivalent) prior to each infusion of this drug.

Use: For first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin

You should not be treated with necitumumab if you are allergic to it.

To make sure necitumumab is safe for you, tell your doctor if you have:

• coronary artery disease (hardened arteries);

• high blood pressure;

• chronic obstructive pulmonary disease (COPD);

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• a history of heart attack or stroke.

Using necitumumab during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are using necitumumab and for at least 3 months after your last dose.

It is not known whether necitumumab passes into breast milk or if it could harm a nursing baby. Do not breast-feed while you are being treated with necitumumab, and for at least 3 months after your last dose.

Call your doctor for instructions if you miss an appointment for your necitumumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, nausea, or vomiting.

Avoid exposure to sunlight or tanning beds. Necitumumab can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel chilled or feverish, or if you have trouble breathing.

Necitumumab may cause serious side effects. Call your doctor at once if you have:

• acne-like skin rash;

• thickened skin or a hard lump where the medicine was injected;

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

• chest pain or pressure, pain spreading to your jaw or shoulder;

• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, sudden cough, wheezing, coughing up blood, pain or swelling in an arm or leg; or

• symptoms of an electrolyte imbalance--numbness or tingling, irregular heartbeats, muscle tightness, tremors, muscle weakness or limp feeling, leg cramps, increased thirst or urination, behavior changes, seizure (convulsions).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of necitumumab may include:

• vomiting, diarrhea;

• skin rash; or

• low levels of magnesium in your blood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with necitumumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.