necitumumab

What is the most important information I should know about necitumumab?

What is necitumumab?

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.

What should I discuss with my healthcare provider before receiving necitumumab?

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.

How is necitumumab given?

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.

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.

What happens if I miss a dose?

What happens if I overdose?

Overdose symptoms may include headache, nausea, or vomiting.

What should I avoid while receiving necitumumab?

What are the possible side effects of necitumumab?

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.

• 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 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.

What other drugs will affect necitumumab?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about necitumumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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