Necitumumab Injection

IMPORTANT WARNING:

Necitumumab injection may cause a serious and life-threatening problem of heart rhythm and breathing. Your doctor will order certain tests before your infusion, during your infusion, and for at least 8 weeks after your final dose to check your body's response to necitumumab. Tell your doctor if you have or have ever had lower than normal levels of magnesium, potassium, or calcium in your blood, chronic obstructive pulmonary disease (COPD), high blood pressure, heart rhythm problems, or other heart problems. If you experience any of the following symptoms, call your doctor immediately: chest pain; shortness of breath; dizziness; loss of consciousness; or fast, irregular, or pounding heartbeat.

Keep all appointments with your doctor and the laboratory.

Talk to your doctor about the risks of receiving necitumumab injection.

WHY is this medicine prescribed?

Necitumumab injection is used with gemcitabine (Gemzar) and cisplatin to treat a certain type of non-small-cell lung cancer (NSCLC) that has spread to other parts of the body. Necitumumab injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Necitumumab injection comes as a liquid to be given intravenously (into a vein) over 1 hour by a doctor or nurse in a medical facility. It is usually given on certain days every 3 weeks. The length of treatment depends on how well your body responds to the medication and the side effects that you experience.

Your doctor may need to stop or delay your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with necitumumab.

You may experience symptoms such as fever, chills, shortness of breath, or difficulty breathing while you are receiving or following a dose of necitumumab, especially the first or second dose. Tell your doctor or other healthcare provider if you experience these symptoms during your treatment. If you experience a reaction to necitumumab, your doctor may stop giving you the medication for a time or may give it to you more slowly. Your doctor may prescribe other medications to help prevent or relieve these symptoms. Your doctor will tell you to take these medications before you receive each dose of necitumumab.

What SPECIAL PRECAUTIONS should I follow?

Before receiving necitumumab injection,

• tell your doctor and pharmacist if you are allergic to necitumumab, any other medications, or any of the ingredients in necitumumab injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving necitumumab injection. You should use effective birth control to prevent pregnancy during your treatment with necitumumab injection and for at least 3 months after your final dose of medication. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving necitumumab injection, call your doctor immediately. Necitumumab injection may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving necitumumab and for 3 months after your final dose.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Necitumumab injection may make your skin sensitive to sunlight.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Necitumumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• acne
• dry or cracked skin
• diarrhea
• vomiting
• weight loss
• sores on lips, mouth, or throat
• vision changes
• red, watery, or itchy eye(s)
• redness or swelling around the fingernails or toenails
• itching

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• leg pain, swelling, tenderness, redness, or warmth
• sudden chest pain or tightness
• weakness or numbness in an arm or leg
• slurred speech
• rash
• difficulty swallowing
• coughing up blood

Necitumumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• headache
• vomiting
• nausea

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about necitumumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.