Helping Reduce the Risk of Infection During Strong Chemotherapy

Opportunity to Receive Support at Home

Having cancer is a journey. In addition to scheduling time for a doctor’s visit to receive strong chemotherapy, some people may need to return the next day to receive a white blood cell count-boosting medicine that helps reduce the risk of infection.

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Neulasta® (pegfilgrastim) is a prescription medicine used to help reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid), who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count.

Important Safety Information

Who should not take Neulasta®?

Do not take Neulasta® if you have had a serious allergic reaction to Neulasta® (pegfilgrastim) or NEUPOGEN® (filgrastim).

What should I tell my health care provider before taking Neulasta®? Tell your healthcare provider if you:

  • Have sickle cell trait or sickle cell disease
  • Have had severe skin reactions to acrylic adhesives
  • Are allergic to latex
  • Have problems with your kidneys
  • Have any other medical problems
  • Are pregnant or plan to become pregnant. It is not known if Neulasta® may harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if Neulasta® passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements.

Patients receiving strong chemotherapy may develop a weakened immune system, leaving them at a higher risk of infection. Neulasta® has been shown to reduce the risk of infection or febrile neutropenia (an infection with a fever) – a medical emergency that can lead to hospitalization. Neulasta® Onpro® offers another way for people to receive Neulasta®, at home or in another appropriate setting.

I’ve been working in oncology for 14 years, and while at times it can be emotionally challenging, I find my job very fulfilling. I feel good when I have the opportunity to offer appropriate patients receiving strong chemotherapy an innovative delivery option like Neulasta® Onpro®.

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– Linda Buck, Registered Nurse Practitioner

The Neulasta® Onpro® kit is comprised of a single dose of Neulasta® and a single-use On-body Injector. The On-body Injector is applied the same day as chemotherapy administration and is designed to automatically deliver the dose of Neulasta® the next day, so that you may not have to return to the doctor just for a shot of Neulasta®.

The On-body Injector (a small, lightweight delivery system) is filled with the co-packaged Neulasta® prefilled syringe and applied to the skin (arm or abdomen) by a healthcare provider during the chemotherapy appointment – designed to allow people who are undergoing strong chemotherapy treatment for certain types of cancer to receive Neulasta® any day of the week, including weekends or holidays.

Learn more about how the Neulasta® Onpro® kit may offer the possibility of fewer doctor visits. For information about the Neulasta® Onpro® kit, and patient support tools such as:

  • Questions for the doctor
  • Patient brochure
  • Patient video

Visit https://www.neulasta.com/onpro/

Important Safety Information, continued

What are possible serious side effects of Neulasta®?

  • Spleen Rupture. Your spleen may become enlarged and can rupture while taking Neulasta®. A ruptured spleen can cause death. Call your doctor right away if you have pain in the left upper stomach area or left shoulder tip area. This pain could mean your spleen is enlarged or ruptured.
  • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of ARDS: fever, shortness of breath, trouble breathing, or a fast rate of breathing.
  • Serious Allergic Reactions. Get emergency medical help right away if you get any of these symptoms of a serious allergic reaction with Neulasta®: shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives.

If you have an allergic reaction during the delivery of Neulasta®, remove the On-body Injector for Neulasta® by grabbing the edge of the adhesive pad and peeling off the On-body Injector. Get emergency medical help right away.

To provide additional support, patients and caregivers can download the companion app. The On-body Injector Digital Companion (Apple® and Android™ available), which is an optional resource for patients who have been prescribed the Neulasta® Onpro® kit. The app:

  • Generates optional notifications to guide the patient through the Neulasta® dose delivery process;
  • Provides easy access to Patient Instructions for Use, and Neulasta® Patient Prescribing Information and Important Safety Information;
  • Has the ability to share the Neulasta® dose delivery process by “connecting” the app with a friend or family member; and
  • Includes one-touch phone access to Neulasta® Patient Support Services.

Important Safety Information, continued

  • Sickle Cell Crises. Severe sickle cell crises, and sometimes death, can happen in people with sickle cell trait or disease who receive filgrastim, a medicine similar to Neulasta®.
  • Kidney injury (glomerulonephritis). Kidney injury has been seen in patients who received Neulasta®. You should notify your healthcare provider right away if you experience puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.
  • Increased white blood cell count (leukocytosis). Your doctor will check your blood during treatment with Neulasta®.
  • Capillary Leak Syndrome. Neulasta® can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
    • swelling or puffiness and are urinating less often
    • trouble breathing
    • swelling of your stomach area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness

The most common side effect of Neulasta® is pain in the bones and in your arms and legs.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Neulasta®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1.800.FDA.1088 (1.800.332.1088).

For more information about Neulasta®, talk with your healthcare provider or pharmacist; go to www.neulasta.com, or call 1.844.696.3852 (1.844.MYNEULASTA).

Please see Neulasta® Patient Information.

USA-003-035023

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