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Safety Information and Boxed Warnings Prescribing Information
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See Indication

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.

SUPPORT Resources FOR YOUR LUNG CANCER JOURNEY

Lilly Oncology is grateful to work with leading patient advocacy and medical organizations to help raise awareness about cancer, educate the public, support cancer research, and influence change in public policy. Above all, Lilly Oncology is determined to support those who face cancer every day—those who are fighting the disease and those who care for them.

Below is a list of websites that will provide you with more information about lung cancer, living with cancer, and patient and family support organizations:

  • Lung Cancer Alliance®
  • American Lung Association®/
    Lung Force
  • LUNGevity®
  • Bonnie J. Addario
    Lung Cancer Foundation

Lung Cancer Alliance®

Lung Cancer Alliance is a nonprofit organization solely dedicated to saving lives and advancing research by empowering those living with and at risk for lung cancer. They offer personalized, professional support, advocate for increased lung cancer research funding, and conduct nationwide education campaigns.

American Lung Association®/
Lung Force

The American Lung Association® is the leading organization working to save lives by improving lung health and preventing lung disease through education, advocacy, and research. The Lung Association is committed to defeating lung cancer and supporting those affected by it. Through our strategic cause initiative, LUNG FORCE, we have three priorities: 1) Make lung cancer a cause that people care about—and act on; 2) Educate and empower patients and healthcare providers; and 3) Raise critical funds for lung cancer research.

LUNGevity®

LUNGevity Foundation® is focused on changing outcomes for people living with lung cancer through research, education, and support. LUNGevity strategically funds a robust portfolio of translational research to find lung cancer early and treat it more effectively. The organization also provides a community of empowerment, support, and hope for everyone affected by lung cancer through their extensive educational resources, online peer-to-peer support, and in-person survivorship programs.

Bonnie J. Addario
Lung Cancer Foundation

The Bonnie J. Addario Lung Cancer Foundation (ALCF) is a nonprofit organization that actively works with physicians, organizations, and people affected by lung cancer. To reach our goal of making lung cancer a chronically managed disease by 2023, we empower and educate patients via patient services and programs, work with physicians via our Community Hospital Center of Excellence program, fund cutting-edge research, build strategic collaborations, and raise public awareness.

This information has been provided by the listed organizations, and Lilly is not responsible for the content. Its use on this site is not intended to serve as an endorsement of the listed organizations. All third-party names, logos, brands, and other trademarks are the property of their respective trademark owners. Those trademark owners are not affiliated with Lilly and they do not sponsor or endorse this website.

Learn more about additional cancer and lung cancer support groups.

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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