BRIEF SUMMARY OF PATIENT PACKAGE INSERT Neulasta® (pegfilgrastim)

This brief summary of the Patient Information for the on-body injector for Neulasta® provides information and instructions for people who will be receiving Neulasta® or their caregivers. This brief summary does not tell you everything about Neulasta®. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I need to know about receiving Neulasta® with the on-body injector for Neulasta®?

• See the Instructions for Use for the on-body injector for Neulasta® for detailed information about the on-body injector for Neulasta® and important information about your dose delivery that has been written by your healthcare provider.

• Know the time that delivery of your dose of Neulasta® is expected to start.

• Avoid traveling, driving, or operating heavy machinery during hour 26 through hour 29 after the on-body injector for Neulasta® is applied. Avoid activities and places that may interfere with monitoring during the 45-minute period that Neulasta® is expected to be delivered by the on-body injector for Neulasta®, and for 1 hour after delivery.

• A caregiver should be with you the first time that you receive Neulasta® with the on-body injector for Neulasta®.

• If placed on the back of the arm, a caregiver must be available to monitor the status of the on-body injector.

• 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 for Neulasta®. Get emergency medical help right away.

• You should only receive a dose of Neulasta® on the day your healthcare provider tells you.

• You should not receive your dose of Neulasta® any sooner than 24 hours after you finish receiving your chemotherapy. The on-body injector for Neulasta® is programmed to deliver your dose about 27 hours after your healthcare provider places the on-body injector for Neulasta® on your skin.

• Do not expose the on-body injector for Neulasta® to the following because the on-body injector for Neulasta® may be damaged and you could be injured: diagnostic imaging (e.g., CT Scan), MRI, Ultrasound, X-ray, radiation treatment, or oxygen rich environments, such as hyperbaric chambers.

• Avoid airport X-ray scans. Request a manual pat down instead. Use care during a manual pat down to help prevent the on-body injector for Neulasta® from being accidentally removed.

• Keep the on-body injector for Neulasta® at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves, and other common appliances. If the on-body injector for Neulasta® is too close to electrical equipment, it may not work correctly and can lead to a missed or incomplete dose of Neulasta®.

• The on-body injector is for adult patients only.

• If your on-body injector is not working properly, you may miss your dose or you may not receive your full dose of Neulasta®. If you miss your dose or do not receive your full dose of Neulasta®, you may have an increased risk of developing fever or infection.

• Call your healthcare provider right away, as you may need a replacement dose, if any of the following occur:

• On-body injector for Neulasta® comes off before or during a dose delivery. Do not re-apply it.

• On-body injector for Neulasta® is leaking.

• Adhesive on your on-body injector for Neulasta® becomes noticeably wet (saturated) with fluid, or there is dripping. This may mean that Neulasta® is leaking out of your on-body injector for Neulasta®. If this happens you may only receive some of your dose of Neulasta®, or you may not receive a dose at all.

• On-body injector for Neulasta® status light is flashing red.

What is Neulasta®?

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

Before you receive Neulasta®, tell your healthcare provider about all of your medical conditions, including if you:

• have a sickle trait or sickle cell disorder

• have had severe skin reactions to acrylic adhesives

• are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex).

• have kidney problems

• 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.

How will I receive Neulasta®?

See the Instructions for Use for detailed information about how you will receive a dose of Neulasta® with the on-body injector for Neulasta®, and how to remove and dispose of the on-body injector for Neulasta®. What are the possible serious side effects of Neulasta®? Neulasta® may cause serious side effects, including:

• Spleen rupture. Your spleen may become enlarged or may rupture during treatment with Neulasta®. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder.

• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have: fever, shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.

• Serious allergic reactions. Neulasta® can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate and sweating. 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 for Neulasta®. Get emergency medical help right away.

• Sickle cell crises. You may have a serious sickle cell crisis, which could lead to death, if you have a sickle cell disorder and receive Neulasta®.

• Kidney injury (glomerulonephritis). Neulasta® can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms: swelling of your face or ankles, blood in your urine or dark colored urine, or you urinate less than usual.

• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Neulasta®.

• Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with Neulasta®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with Neulasta®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.

• 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 than usual

• trouble breathing

• swelling of your stomach-area (abdomen) and feeling of fullness

• dizziness or feeling faint

• a general feeling of tiredness

• Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when Neulasta® is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Neulasta®.

• Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported in patients who received Neulasta®. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms. The most common side effect of Neulasta® is pain in your bones, and in your arms, and legs. These are not all the possible side effects of Neulasta®. For more information, ask your healthcare provider or pharmacist.

What are the ingredients in Neulasta®?

Active ingredient: pegfilgrastim Inactive ingredients: acetate, polysorbate 20, sodium and sorbitol in Water for Injection