Necitumumab, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by IV to treat squamous non-small cell lung cancer.
• Keep all appointments for tests to see how this medicine affects you.
• This is a very strong medicine and may cause serious and life-threatening heart problems, blood clots, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); EGFR antagonist; monoclonal antibody

Generic and brand names: necitumumab, injection; Portrazza

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat squamous non-small cell lung cancer that has spread to other parts of the body. It is usually given with 2 other medicines, gemcitabine and cisplatin.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Blood clots or bleeding problems
• Breathing problems such as COPD
• Heart disease, heart attack, heart failure, or irregular heartbeats
• High blood pressure
• Problems with low levels of magnesium, calcium, or potassium in your blood

Females of childbearing age: This medicine is not given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use effective birth control during treatment with this medicine and for 3 months after your final treatment. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine and for 3 months after your final treatment.

How do I use it?

The infusions are usually given by your healthcare provider on days 1 and 8 of each 3-week cycle. Be sure to keep all appointments for these infusions and for blood tests to find out how this medicine affects you. While you are receiving this medicine, your healthcare provider will carefully watch you for any serious side effects.

What should I watch out for?

Rarely, serious or life-threatening heart problems and sudden death have happened in people treated with this medicine along with gemcitabine and cisplatin. Call your healthcare provider right away if you feel faint, dizzy, have trouble breathing or chest pain, or if your heartbeat is fast, slow, or irregular while taking this medicine. These may be signs of a heart problem that may cause death.

This medicine may cause very low levels of magnesium in your blood that can be serious or life-threatening. It may also cause low levels of potassium and calcium in your blood. Contact your healthcare provider right away if you have seizures, muscle spasms or cramps, numbness, or muscle weakness.

You will need blood tests regularly during treatment and for up to 8 weeks after stopping treatment to see how this medicine affects you. Keep all appointments.

This medicine may cause severe or life-threatening blood clots. Tell your healthcare provider right away if you have any signs of blood clots, including new swelling or pain in your legs or abdomen, chest pain, shortness of breath, sudden headache or cough, numbness or weakness (especially on one side of your body), or problems with vision, speech, or balance.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

This medicine may cause serious or life-threatening infusion reactions while you are receiving this medicine or several hours after receiving this medicine. Tell your healthcare provider right away if you have any symptoms of an infusion reaction, such as fever, chills, itching, swelling (of the face, mouth, tongue, or throat), trouble breathing, anxiousness, dizziness, fainting, headache, nausea, or skin rash. Talk with your healthcare provider about this.

Skin problems are common with this medicine, including dry or cracked skin, acne, itching, redness, rash, or other skin problems. If these skin problems become severe or do not go away, contact your healthcare provider. Also, your skin may become more sensitive to sunlight while taking this medicine. While you are receiving treatment with this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. Ask your pharmacist for the most protective sunscreen lotion.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; chest pain, pain with breathing, shortness of breath, coughing up blood.

Serious (Report these to your healthcare provider right away.): Muscle pain, numbness, or weakness; severe or prolonged diarrhea; severe nausea and vomiting; severe dizziness or fainting; seizures; swelling, pain, or warmth in the calf; unusual mood changes or confusion; severe or continued skin rash, redness, or itching; vision problems or eye pain.

Other: Mild diarrhea, nausea, or vomiting; mouth sores; mild headache; mild skin rash, redness, or itching; dry or cracked skin; nail changes.

What products might interact with this medicine?

No significant drug interactions have been reported for this medicine. However, do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.