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Safety Information and Boxed Warnings Prescribing Information
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Portrazza® (necitumumab) is a prescription medicine used with a combination of 2 chemotherapy drugs (gemcitabine and cisplatin) for the initial treatment of a type of lung cancer that has spread called metastatic squamous non-small cell lung cancer (NSCLC).

Limitation of Use: Portrazza is not for use to treat a different type of cancer called nonsquamous NSCLC.

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INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Portrazza® (necitumumab) is a prescription medicine used with a combination of 2 chemotherapy drugs (gemcitabine and cisplatin) for the initial treatment of a type of lung cancer that has spread called metastatic squamous non-small cell lung cancer (NSCLC).

Limitation of Use: Portrazza is not for use to treat a different type of cancer called nonsquamous NSCLC.

WARNING: CARDIAC ARREST AND LOW MAGNESIUM IN THE BLOOD

Cardiac arrest and/or sudden death occurred in 3% of patients treated with Portrazza plus gemcitabine and cisplatin in a clinical trial. Most of these patients had other health problems, like a history of heart disease, low magnesium in their blood, a lung problem called chronic obstructive pulmonary disease (COPD), and/or high blood pressure. The risk of cardiac arrest or sudden death in patients with these health problems is not known. Your healthcare provider will do blood tests to check your magnesium, potassium, and calcium during and after your Portrazza treatment. You may receive treatment for low levels of these in your blood. Take medicines to replace electrolytes exactly as prescribed by your physician.

Low magnesium in the blood occurred in 83% of patients treated with Portrazza. It was severe in 20% of patients.

Before beginning treatment, you should discuss the potential benefits and risks of Portrazza with your doctor. Some side effects of Portrazza can be serious and may include:

  • Blood Clots
  • Blood clots in the veins occurred in 9% of people and blood clots in the arteries occurred in 5% of people who took Portrazza plus gemcitabine and cisplatin in a clinical trial; some of these caused people to die.
  • The risk of blood clots may be higher if you have already had a blood clot in the past.
  • Your doctor will observe you and stop your treatment if you develop a serious or life-threatening blood clot.
  • Skin Reactions
  • Skin reactions occurred in 79% of the people who took Portrazza in a clinical trial. Skin reactions were severe in 8% of people. These reactions ranged from a rash, a rash that looks like acne, itchy or dry skin, cracks in the skin, red and swollen skin, and/or a skin infection around fingernails or toenails.
  • Reactions usually began during the first 2 weeks of treatment and got better about 4 months after they started.
  • If you have a skin reaction, your doctor may change your dose of Portrazza.
  • If your reactions are serious enough, your treatment may need to be stopped right away and not started again.
  • Time in the sun may worsen skin reactions; limit sun exposure with protective clothing and use sunscreen.
  • Allergic Reactions
  • Portrazza can cause allergic reactions in some people when going through the vein. This occurred in 1.5% of the people who were given Portrazza plus gemcitabine and cisplatin in a clinical trial, and was severe in 0.4%. Most of these allergic reactions happened during the first or second dose of Portrazza.
  • Symptoms can include trouble breathing, wheezing, fever, and chills.
  • A member of your healthcare team will give you the infusion and watch for signs of allergic reactions. They may give you medicine before giving you Portrazza to help prevent these reactions. Or they may give you Portrazza more slowly.
  • If your reactions are serious or life threatening, your treatment may need to be stopped right away and not started again.
  • Harmful Effects if Used for a Different Type of Lung Cancer
  • Portrazza is not for use in patients who have a type of lung cancer that is different than yours (called nonsquamous non-small cell lung cancer).
  • Serious and fatal side effects have happened in people who took Portrazza with a different chemotherapy combination (pemetrexed and cisplatin) for this type of lung cancer.
  • Harmful Effects to Unborn Babies
  • Portrazza can harm your unborn baby. You should avoid getting pregnant and use adequate contraception (birth control) while receiving Portrazza and for at least 3 months after stopping Portrazza.

What are the most common side effects of Portrazza?

  • The most common side effects in patients treated with Portrazza were:
  • Low levels of magnesium (83%) and/or other electrolytes (calcium, potassium, and phosphate) in the blood
  • Rash (44%)
  • Vomiting (29%)
  • Diarrhea (16%)
  • Acne-like rash (15%)
  • The most common severe side effects in patients treated with Portrazza were:
  • Low levels of magnesium (20%) and/or other electrolytes (calcium, potassium, and phosphate) in the blood
  • Blood clots (5%)
  • Rash (4%)
  • Vomiting (3%)

These are not all of the possible side effects with Portrazza. Tell your doctor about any side effect you have and/or any change in the way you feel. For more information, ask a member of your healthcare team.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-10881-800-FDA-1088.

What should I tell my doctor before taking Portrazza?

  • Tell your doctor about all of your health conditions, including if you:
  • Have a history of heart problems
  • Have a history of high blood pressure
  • Have a history of lung problems (COPD)
  • Have had or are at high risk for blood clots
  • Are pregnant or may become pregnant, as Portrazza may harm your unborn baby. You should avoid getting pregnant and use adequate contraception (birth control) while receiving Portrazza and for at least 3 months after stopping Portrazza.
  • Are breastfeeding. You should not breastfeed while receiving Portrazza and for at least 3 months after stopping Portrazza.

Tell your doctor about all the medications you are taking, including prescription and over-the-counter medications, herbal remedies, and vitamin supplements.

Portrazza is available by prescription only.

Please see full Prescribing Information for additional information about Portrazza, including Boxed Warnings for cardiac arrest and low magnesium in the blood.

NE DTC ISI 12MAY2016