Neulasta
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Neulasta - Instructions for Use

Manufacture: Amgen
Country: United States
Condition: Neutropenia Associated with Chemotherapy, Neutropenia
Class: Colony stimulating factors, Hematopoietic stem cell mobilizer
Form: Subcutaneous (SC), Skin patch (transdermal)
Ingredients: pegfilgrastim, acetate, polysorbate 20, sodium, sorbitol in water for Injection

Pegfilgrastim

Information for Patients and Caregivers

This patient package insert provides information and instructions for people who will be receiving Neulasta or their caregivers. This patient package insert does not tell you everything about Neulasta. You should discuss any questions you have about treatment with Neulasta with your doctor.

What is Neulasta?

Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria Escherichia coli. G-CSF is a substance produced by the body. It stimulates the growth of neutrophils (nu-tro-fils), a type of white blood cell important in the body’s fight against infection.

Who should not take Neulasta?

Do not take Neulasta if you have had:

  • A serious allergic reaction to Neulasta®(pegfilgrastim) or to Neupogen®(filgrastim).

What important information do I need to know about receiving Neulasta?

Occasionally, pain and redness may occur at the injection site. If there is a lump, swelling, or bruising at the injection site that does not go away, talk to the doctor.

Neulasta should only be injected on the day the doctor has determined and should not be injected until approximately 24 hours after receiving chemotherapy.

The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.

What should I tell my healthcare provider before taking Neulasta?

If you have a sickle cell disorder, make sure that your doctor knows about it before you start using Neulasta. If you have a sickle cell crisis after getting Neulasta, tell your doctor right away.

If you have any questions, talk to your doctor.

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. The spleen is located in the upper left section of your stomach area. 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 doctor or seek emergency care right away if you have shortness of breath, trouble breathing, or a fast rate of breathing.
  • Serious Allergic Reactions. Neulasta can cause serious allergic reactions. These reactions can cause shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. If you start to have any of these symptoms, call your doctor or seek emergency care right away. If you have an allergic reaction during the injection of Neulasta, stop the injection. Call your doctor right away.
  • Sickle Cell Crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and take Neulasta. Serious and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, a medicine similar to Neulasta (pegfilgrastim). Call your doctor right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

What are the most common side effects of Neulasta?

The most common side effect you may experience is aching in the bones and muscles. If this happens, it can usually be relieved with a non-aspirin pain reliever, such as acetaminophen.

What about pregnancy or breastfeeding?

Neulasta has not been studied in pregnant women, and its effects on unborn babies are not known. If you take Neulasta while you are pregnant, it is possible that small amounts of it may get into your baby’s blood. It is not known if Neulasta can get into human breast milk. If you are pregnant, plan to become pregnant, think you may be pregnant, or are breastfeeding, you should tell your doctor before using Neulasta. If you become pregnant during Neulasta treatment, you are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. You should call 1-800-77-AMGEN (1-800-772-6436) to enroll.

How to prepare and give a Neulasta injection

Neulasta is provided in a prefilled syringe. Neulasta should be stored in its carton to protect from light until use. If you are giving someone else Neulasta injections, it is important that you know how to inject Neulasta. Before getting your Neulasta injection, always check to see that:

  • The name Neulasta appears on the carton and prefilled syringe label.
  • The expiration date on the prefilled syringe has not passed. You should not use a prefilled syringe after the date on the label.
  • The Neulasta liquid should always be clear and colorless. Do not use Neulasta if the contents of the prefilled syringe appear discolored or cloudy, or if the prefilled syringe appears to contain lumps, flakes, or particles.

Important: to help avoid possible infection, you shoud follow these instructions.

Setting up for an injection

Note: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance.

  1. Find a clean, flat working surface, such as a table.
  2. Remove the carton containing the prefilled syringe of Neulasta from the refrigerator. Allow Neulasta to reach room temperature (this takes about 30 minutes). Remove the syringe from the carton before injection. Each prefilled syringe should be used only once. DO NOT SHAKE THE PREFILLED SYRINGE. Shaking may damage Neulasta. If the prefilled syringe has been shaken vigorously, the solution may appear foamy and it should not be used.
  3. Assemble the supplies you will need for an injection:
    • Neulasta prefilled syringe with transparent (clear) plastic blue needle guard attached
    • An alcohol swab and a cotton ball or gauze
    • Puncture-proof disposal container
  4. Wash your hands with soap and warm water.
  5. How to prepare for injection of Neulasta

  6. Remove the prefilled syringe from the package and the tray. Check to see that the plastic blue needle guard is covering the barrel of the glass syringe. DO NOT push the blue needle guard over the needle cover before injection. This may activate or lock the needle guard. If the blue needle guard is covering the needle that means it has been activated. DO NOT use that syringe. Dispose of that syringe in the puncture-proof disposal container. Use a new prefilled syringe. Do not activate the needle guard prior to injection.
  7. Hold the syringe barrel through the needle guard windows with the needle pointing up. Holding the syringe with the needle pointing up helps to prevent medicine from leaking out of the needle. Carefully pull the needle cover straight off.
  8. Check the syringe for air bubbles. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.
  9. Gently place the prefilled syringe with the window flat on your clean working surface so that the needle does not touch anything.
  10. Selecting and preparing the injection site

  11. Choose an injection site. Four recommended injection sites for Neulasta are:
    • The outer area of the upper arms
    • The abdomen, except for the two-inch area around the navel
    • The front of the middle thighs
    • The upper outer areas of the buttocks
  12. Clean the injection site with an alcohol swab.
  13. Injecting the dose of Neulasta

  14. Pick up the prefilled syringe from your clean, flat working surface by grabbing the sides of the needle guard with your thumb and forefinger.
  15. Hold the syringe in the hand you will use to inject Neulasta. Use the other hand to pinch a fold of skin at the cleaned injection site. Note: Hold the syringe barrel through the needle guard windows when giving the injection.
  16. Holding the syringe like a pencil, use a quick “dart-like” motion to insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degrees) into the skin.
  17. Inject the prescribed dose subcutaneously as directed by your doctor, nurse, or pharmacist.
  18. When the syringe is empty, pull the needle out of the skin and place a cotton ball or gauze over the injection site and press for several seconds.
  19. Use a prefilled syringe with the needle guard only once.
  20. Activating the Needle Guard after the injection has been given

  21. After injecting Neulasta from the prefilled syringe, do not recap the needle. Keep your hands behind the needle at all times. While holding the clear plastic finger grip of the syringe with one hand, grasp the blue needle guard with your free hand and slide the blue needle guard over the needle until the needle is completely covered and the needle guard clicks into place. NOTE: If an audible click is not heard, the needle guard may not be completely activated.
  22. Place the prefilled syringe with the activated needle guard into a puncture-proof container for proper disposal as described below.
  23. Disposal of prefilled syringes and needle guards

    You should always follow the instructions given by your doctor, nurse, or pharmacist on how to properly dispose of containers with used syringes and needle guards. There may be special state and local laws for disposal of used needles and syringes.

    • Do not throw the container in the household trash. Do not recycle.
    • DO NOT put the needle cover (the cap) back on the needle.
    • Place all used needle covers and syringes in a hard plastic container with a screw-on cap or in a metal container with a plastic lid such as a coffee can labeled “used syringes.” If a metal container is used, cut a small hole in the plastic lid and tape the lid to the metal container. If a hard plastic container is used, always screw the cap on tightly after each use.
    • Do not use glass or clear plastic containers.
    • When the container is full, tape around the cap or lid to make sure the cap or lid does not come off.
    • Always keep the container out of the reach of children.
    • How should Neulasta be stored?

      Neulasta should be stored in the refrigerator at 2??to 8?C (36??to 46?F), but not in the freezer. Neulasta should be protected from light, so you should keep it in its carton until you are ready to use it. Avoid shaking Neulasta. If Neulasta is accidentally frozen, allow it to thaw in the refrigerator before injecting. However, if it is frozen a second time, do not use. Neulasta can be left out at room temperature for up to 48 hours. Do not leave Neulasta in direct sunlight. For all questions about storage, contact your doctor, nurse, or pharmacist.

      What are the ingredients in Neulasta?

      Each syringe contains pegfilgrastim in a sterile, clear, colorless, preservative-free solution containing acetate, sorbitol, polysorbate 20, and sodium.

      Neulasta® (pegfilgrastim) Delivery Kit

      Healthcare Provider Instructions for Use

      Guide to Parts


      On-body Injector for Neulasta


      Important

      Read the following instructions before using the before using the on-body injector

      Warning: Do not use the Neulasta Delivery Kit (the Kit) to deliver any other drug product.

      • See Prescribing Information for information on Neulasta.
      • Store the Kit in the refrigerator at 36?F to 46?F (2?C to 8?C) until ready for use. If the Kit is stored at room temperature for more than 12 hours, do not use. Start again with a new Kit.
      • Keep the prefilled syringe in the Kit carton until use to protect from light.
      • For patients who have had severe skin reactions to acrylic adhesives, consider the benefit:risk profile before administering pegfilgrastim via the On-body Injector for Neulasta.
      • The On-body Injector should be applied to intact, non-irritated skin on the abdomen or back of the arm. The back of the arm may only be used if there is a caregiver available to monitor the status of the On-body Injector.

      DO NOT:

      • freeze the Kit.
      • shake the prefilled syringe.
      • separate the components of the Kit until ready for use.
      • modify the On-body Injector.
      • warm the Kit components using a heat source.
      • use Kit if expiry date on the Kit or any of the Kit components has passed.
      • use if the name Neulasta does not appear on the Kit.
      • attempt to reapply On-body Injector.
      • use if either the On-body Injector or prefilled syringe is dropped. Start again with a new Kit.

      For all questions, call Amgen at 1-800-772-6436. If a patient calls you regarding any On-body Injector problems, call Amgen at 1-800-772-6436.

      Step 1: Prepare

      Remove the Kit from refrigerator. Check to make sure it contains:

      • One Neulasta prefilled syringe
      • One On-body Injector for Neulasta
      • Neulasta package insert
      • Instructions for use:
        • for patient
        • for healthcare provider
      • Reference guide

      DO NOT use On-body Injector if its packaging has been previously opened.

      Wash hands thoroughly. Prepare and clean On-body Injector application site.


      Choose the flattest site for On-body Injector application. Consult with your patient regarding their ability to remove and monitor the entire On-body Injector.

      You can use:

      • Left or right side of abdomen, except for a 2-inch area right around navel.
      • Back of upper arm, only if there is a caregiver available to monitor the status of the On-body Injector.

      Choose an area larger than the adhesive pad, and clean it with an alcohol swab. Allow skin to completely dry.

      DO NOT touch this area again before attaching On-body Injector.

      You should avoid:

      • Areas with scar tissues, moles, or excessive hair. In case of excessive hair, carefully trim hair to get On-body Injector close to skin.
      • Areas where belts, waistbands, or tight clothing may rub against, disturb, or dislodge On- body Injector.
      • Surgical sites.
      • Areas where On-body Injector will be affected by folds in skin.

      The following is an overview of On-body Injector preparation steps. Read this section first.When ready, proceed to Step 2: Get Ready Section.

      Before you apply On-body Injector to your patient, locate medicine port on blue needle cover to fill the On-body Injector with Neulasta.

      Please note: During filling, beeping will sound and the On-body Injector will be activated.

      After activation, you will have 3 minutes to:

      1. Completely empty syringe contents into medicine port.
      2. Remove syringe from port and pull down needle safety guard over the exposed needle.
      3. Remove blue needle cover from back of On-body Injector.
      4. Peel away the two pieces of white adhesive backing from the back of the On-body Injector.
      5. Attach On-body Injector to back of patient’s upper arm or abdomen.

      On-body Injector will deploy cannula in 3 minutes, even if not applied to patient. If not on patient’s body in 3 minutes, do not use the On-body Injector. Start again with a new Kit.

      When you feel you are ready, please continue…

      Step 2: Get Ready

      Remove Neulasta prefilled syringe from tray.


      For safety reasons:

      • DO NOT grasp gray needle cap.
      • DO NOT put the gray needle cap back onto syringe.
      • DO NOT grasp clear plunger.

      Inspect medicine and Neulasta prefilled syringe. The Neulasta liquid should always be clear and colorless.


      DO NOT use Neulasta prefilled syringe if:

      • Liquid contains particulate matter or discoloration is observed prior to administration.
      • Any part appears cracked or broken.
      • The gray needle cap is missing or not securely attached.
      • The expiration date printed on the label has passed.

      DO NOT remove gray needle cap until ready to fill On-body Injector.

      DO NOT pull needle safety guard down over the needle until filling is complete.


      In all the above cases, start again with a new Kit. Call Amgen at 1-800-772-6436.

      The prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex.

      Carefully remove gray needle cap straight out from the syringe and away from your body. Check syringe, and remove air bubbles.

      Take care to expel air only and not medicine.A small droplet at the tip of the needle during air purging is normal.

      DO NOT recap syringe.

      Using blue needle cover, to avoid bending the needle and spilling medicine, insert syringe needle at 90 degrees all the way into medicine port. Slowly empty the entire syringe contents. Remove empty syringe from the medicine port.


      When beeping sounds and the status light flashes amber, the 3-minute countdown begins.

      DO NOT insert needle into medicine port at other than a 90 degree angle

      DO NOT insert needle more than once.

      DO NOT remove blue needle cover before filling the On-body Injector.

      Pull needle safety guard down until it clicks and covers needle. Dispose of empty syringe in a sharps container.

Check to see if the On-body injection is full

You should see:

  • amber status light flashing.
  • black line next to FULL on the fill indicator

If this is not the case, do not use. Start again with a new Kit, and call Amgen at 1-800-772-6436.

Step 3: Apply

 Firmly lift and remove blue needle cover away from On-body Injector.


A drop of medicine may be visible on needle tip when blue needle cover is removed.

To expose the adhesive pad, use both pull tabs, one at a time, to peel the two pieces of white adhesive backing away from On-body Injector.


DO NOT touch or contaminate automatic needle area.

DO NOT pull off adhesive pad or fold it.

DO NOT use if the needle or cannula is extended past the adhesive or is extended before the On-body Injector is placed on patient.

In all cases, start again with a new Kit. Call Amgen at 1-800-772-6436.

Apply On-body Injector securely to patient with entire On-body Injector visible so it can be monitored by patient or caregiver. Before cannula deploys, place On-body Injector on your selected site, and run your finger around entire adhesive pad to make sure it is securely attached.



STOP! Do not worry if On-body Injector is quiet. When 3 minutes are up, On-body Injector will beep.

Beeping will tell you the cannula is about to insert. You may hear a series of clicks. This is okay.

A long beep will sound, and the status light will turn to green. This means the cannula insertion is complete.


If the adhesive folds over near the cannula window or there are folds anywhere that prevent the On-body Injector from securely adhering, remove the On-body Injector. Start again with a new Kit and call Amgen at 1-800-772-6436.

Step 4: Finish

A Fill in the Dose Delivery Information section in the patient instructions. Be sure to include when the On-body Injector was applied, when the dose will begin, and your contact information. Review this information with the patient.

Review each step in the patient instructions with your patient. Give your patient the instructions, and reference guide to take home.

Before your patient goes home, make sure your patient understands

  • The On-body Injector will always flash a slow green light to let them know it is working properly.
  • After approximately 27 hours, beeps will signal that the dose delivery will begin in 2 minutes.
  • When the dose delivery starts it will take about 45 minutes to complete. During this time, the On-body Injector will flash a fast green light.
  • The patient should remain in a place where they can monitor the On-body Injector for the entire dose delivery. The patient should avoid activities and settings that may interfere with monitoring during the dosing of Neulasta administered by the On-body Injector. For example, avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the On-body Injector (this includes the approximately 45-minute delivery period plus an hour post-delivery).
  • If the patient has an allergic reaction during the delivery of Neulasta, the patient should remove the On-body Injector and call his or her healthcare provider or seek emergency care right away.
  • If placed on the back of the arm, remind the patient that a caregiver must be available to monitor the On-body Injector.
  • When the dose delivery is complete, the patient or caregiver will hear a beep and see a solid green light.
  • Always dispose of the empty On-body Injector in a sharps disposal container as instructed by your healthcare provider or by state or local laws.
  • Keep the On-body Injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the On-body Injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.
  • Attention!

    What to do if you hear beeping or when you look at status light and it is flashing red.


    If at any time the On-body Injector beeps continuously for 5 minutes, and the status light is flashing red, take the On-body Injector off of the patient.

    • DO NOT apply On-body Injector to patient if red error light is on.
    • DO NOT leave On-body Injector on patient if red error light is on.

    In all cases, do not use. Start over with a new Kit, and call Amgen at 1-800-772-6436.

    What to do if the adhesive becomes saturated with fluid or the On-body Injector is dripping.


    If patient reports an On-body Injector leak, they might not have received full dose. Schedule a follow- up appointment, and report the incident to Amgen at 1-800-772-6436.

    Do not expose the On-body Injector for Neulasta to the following environments as the On-body Injector may be damaged and the patient could be injured:

    • MRI
    • X-ray
    • CT-Scan
    • Ultrasound
    • Oxygen rich environments such as hyperbaric chambers

    Electromagnetic Compatibility

    The information contained in this section (such as separation distances) is, in general, specifically written in regard to the On-body Injector for Neulasta. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.

    General Notes:

    Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC), and needs to be installed and put into service according to the EMC information provided in this document.

    Portable and mobile RF communications equipment can affect medical electrical equipment.

    Cables and accessories not specified within the instructions for use are not authorized. Using cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity).

    Care should be taken if the On-body Injector for Neulasta is used adjacent to other electrical equipment; if adjacent use is inevitable, the On-body Injector for Neulasta should be observed to verify normal operation in this setting.

    Electromagnetic Emissions
    The On-body Injector for Neulasta is intended for use in the electromagnetic environment

    specifie below. The user of the On-body Injector for Neulasta should ensure that it is used in such an

    environment.

    Emissions Compliance according to Electromagnetic environment
    CISPR B

    Emissions Classification

    Class B
    Electromagnetic Emissions
    The On-body Injector for Neulasta is intended for use in the electromagnetic environment

    specifie below. The user of the On-body Injector for Neulasta should ensure that it is used in such an environment.

    Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic

    Environment –

    Guidance

    ESD

    IEC 610000-4-2

    ±6kV Contact

    ±8kV Air

    6kV Contact

    ±8kV Air

    Floors should be wood,

    concrete or ceramic tile.

    If floors are synthetic,

    the r/h should be at

    least 30%.

    Power Frequency

    50/60 Hz

    Magnetic Field IEC

    61000-4-8

    3A/m 3A/m Power frequency

    magnetic fields should

    be that of typical

    commercial or hospital

    environment.

    Radiated RF Fields

    61000-4-3

    3 V/m

    80 MHz to 2.5 GHz

    (E1)=3V/m Portable and mobile

    communications

    equipment should be

    separated from the

    On-body Injector for

    Neulasta by no less

    than the distances

    calculated/listed

    below:

    D=(3.5/V1)(vP)150

    kHZ to 80 MHz

    D=(3.5/E1)(vP)80 to

    to 800 MHz

    D=(7/E1)(vP)800 MHz

    to 2.5 GHz

    Where P is the max

    power in watts

    and D is the

    recommended

    separation distance

    in meters. Field

    strengths from fixed

    transmitters, as

    determined by an

    electromagnetic site

    survey, should be less

    than the compliance

    levels (V1 and E1).

    Interference may

    occur in the vicinity

    of equipment containing a

    transmitter.

    Recommended separation distances between portable and mobile RF

    communications equipment and the On-body Injector for Neulasta

    You can help prevent electromagnetic interference by maintaining a minimum distance

    between portable and mobile RF communications equipment (transmitters) and the On-body Injector for

    Neulasta, as recommended below, according to the maximum power of the communication equipment.

    Rated maximum

    output power of

    transmitter, in watts

    Separation distance according to frequency of transmitter, in meters
    150 kHz to 80 MHz

    D=(3.5/V1)( vP)

    80 to 800 MHz

    D=(3.5/E1)( vP)

    800 MHz to 2.5 GHz

    D=(7/E1)(vP)

    0.01 0.11667 0.11667 0.23333
    0.01 0.36894 0.36894 0.73785
    1 1.1667 1.1667 2.3333
    10 3.6894 3.6894 7.3785
    100 11.667 11.667 23.333

    {SIDE 1 Information}

    On-body Injector for Neulasta Description

    The On-body Injector for Neulasta is intended for delivery of Neulasta. The On-body Injector is small, for one-time use, lightweight, battery-powered, and waterproof up to 8 feet for 1 hour. Your healthcare provider will use a prefilled syringe with Neulasta to fill the On-body Injector prior to applying it. The On- body Injector is applied directly to your skin using a self-adhesive backing. The On-body Injector informs you of its status with sounds and lights.

    The On-body Injector contains electronic components as well as: a plastic housing, acrylic adhesive, batteries, a cannula introducer (needle) and a cannula. The On-body Injector is approximately: 2.4 in long, 1.6 in wide, 0.7 in height (62 mm long, 41 mm wide, 17 mm height).

    Warnings

    • Before you receive Neulasta, tell your healthcare provider if you:
      • Have sickle cell trait or sickle cell disease
      • 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 breastmilk.
    • DO NOT take Neulasta if you have had a serious allergic reaction to pegfilgrastim (Neulasta®) or to filgrastim (Neupogen®).
    • Tell your healthcare provider if you are allergic to latex. A prefilled syringe is used to fill the On-body Injector by your healthcare provider prior to applying the On-body Injector. The prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex. Latex may be transferred to your skin.
    • Tell your healthcare provider if you have had severe skin reactions to acrylic adhesives.
    • Avoid activities and places that may interfere with monitoring during the dosing of Neulasta administered by the On-body Injector. For example, AVOID traveling, driving, or operating heavy machinery during hours 26-29 following application of the On-body Injector for Neulasta (this includes the 45-minute dose delivery period plus an hour post-delivery). If you must travel by airplane before the approximately 45-minute dose delivery period with the On-body Injector, 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 from being accidentally removed. For more information go to http://www.tsa.gov/traveler-information/travelers-disabilities-and-medical-conditions If you have an allergic reaction during the delivery of Neulasta, remove the On-body Injector by grabbing the edge of the adhesive pad and peeling off the On-body Injector. Get emergency medical help right away.
    • Call your healthcare provider immediately if you have severe pain or skin discomfort around your On-body Injector.
    • Call your healthcare provider right away if you have pain in your left upper stomach area or left shoulder area. This pain could mean your spleen is enlarged or ruptured.
    • Call your healthcare provider or get emergency medical help right away if you get any of these symptoms of acute respiratory distress syndrome (ARDS): fever, shortness of breath, trouble breathing, or a fast rate of breathing.
    • Keep children away from the used On-body Injector.
    • 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 on your skin.
    • It is not known if Neulasta is safe and effective in children.
    • DO NOT expose the On-body Injector to the following because the On-body Injector may be damaged and you could be injured:
      • MRI
      • X-ray
      • CT-Scan
      • Ultrasound
      • Oxygen rich environments, such as hyperbaric chambers
    • DO NOT use hot tubs, whirlpools, or saunas while wearing the On-body Injector. This may affect your medicine.
    • DO NOT expose the On-body Injector to direct sunlight. If the On-body Injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. Wear the On-body Injector under clothing.
    • DO NOT sleep on the On-body Injector or apply pressure during wear, especially during dose delivery. This may affect the On-body Injector performance.
    • DO NOT peel off or disturb the On-body Injector’s adhesive before your full dose is complete. This may result in a missed or incomplete dose of Neulasta.

    Precautions

    Environmental:

    • Keep the On-body Injector dry for the last 3 hours prior to the dose delivery start.
    • Only expose the On-body Injector to temperatures between 41°F and 104°F (5°C-40°C).
    • Keep the On-body Injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the On-body Injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.

    Activity Related:

    • Avoid getting body lotions, creams, oils or cleaning agents near the On-body Injector as these products may loosen the adhesive.
    • Be careful not to bump the On-body Injector or knock the On-body Injector off your body.

    Biohazard:

    Properly dispose of the On-body Injector:

    • The On-body Injector contains batteries, electronics, and a needle. The On-body Injector should be placed in a sharps disposal container, with an appropriate sized opening, regardless of whether or not the needle is exposed. Follow instructions provided by your healthcare provider or by state or local laws.
    • To participate in Amgen’s voluntary disposal program, please call 1-844-MYNEULASTA (1-844- 696-3852) or visit www.neulasta.com to enroll.
    • For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDA’s website at: http://www.fda.gov/safesharpsdisposal.

    Risks

    You can avoid most risks related to using the On-body Injector for Neulasta by following the Patient Instructions for Use. Immediately call your healthcare provider if any of the following occur:

    • The adhesive becomes noticeably wet (saturated) with fluid, or you see dripping
    • If the On-body Injector fill indicator is not at the empty position after On-body Injector removal (You should see a black line next to the EMPTY indicator.)
    • The On-body Injector comes off from the skin before or during a dose delivery (DO NOT re- apply it.)
    • Status light is flashing red
    • Allergic reaction
    • Persistent or worsening redness or tenderness at the application site (may be a sign of infection)
    • Severe pain or skin discomfort around your On-body Injector
    • Any concern about your medication
    • If the needle is exposed after On-body Injector removal
    • {SIDE 2 Information}

      On-body Injector for Neulasta® (nu-las-tah) (pegfilgrastim) Injection

      Dose Delivery Information

      Day Time AM / PM
      Your dose delivery will start around:
      Day Time AM / PM
      Name of Healthcare Provider:
      Last, First

      Healthcare Provider contact number:

      AM / PM

      On-body Injector lot number:

      Important Information

      • This On-body Injector delivers Neulasta with an under-the-skin (subcutaneous) injection. See Patient Information for medicine information.
      • f you have concerns about your medication, call your healthcare provider immediately. Serious allergic reactions can happen with Neulasta. Ask your caregiver to be nearby for the first use.
      • Plan to be in a place where you or your caregiver can appropriately monitor the On-body Injector for Neulasta during the approximately 45 minute Neulasta delivery and for an hour afterthe delivery.
      • Avoid activities and places that may interfere with monitoring during the dosing of Neulasta administered by the On-body Injector (hours 26-29).
      • If you have an allergic reaction during the delivery of Neulasta, remove the On-body Injector by grabbing the edge of the adhesive pad and peeling off the On-body Injector. Get emergency medical help right away.
      • The On-body Injector should be applied to intact, non-irritated skin on the stomach area (abdomen) or back of the arm. The back of the arm may only be used if there is a caregiver available to monitor the status of the On-body Injector.
      • Call your healthcare provider immediately if you have severe pain or skin discomfort around your On-body Injector.
      • Be careful not to bump the On-body Injector or knock the On-body Injector off your body.
      • Avoid getting body lotions, creams, oils or cleaning agents near the On-body Injector as these products may loosen the adhesive.
      • Keep the On-body Injector dry for the last 3 hours prior to the dose delivery start.
      • Only expose the On-body Injector to temperatures between 41°F and 104°F (5°C and 40°C).
      • After On-body Injector removal, properly dispose of it in a sharps disposal container as instructed by your healthcare provider or by state or local laws.
      • Keep the On-body Injector at least 4 inches away from electrical equipment such as cell phones, cordless telephones, microwaves and other common appliances. Failure to keep the On-body Injector at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.

      DO NOT:

      • use hot tubs, whirlpools, or saunas while wearing the On-body Injector. This may affect your medicine.
      • expose the On-body Injector to direct sunlight. If the On-body Injector is exposed to direct sunlight for more than 1 hour, it may affect your medicine. Wear the On-body Injector under clothing.
      • sleep on the On-body Injector or apply pressure during wear, especially during dose delivery. This may affect On-body Injector performance.
      • peel off or disturb the On-body Injector adhesive before your full dose is complete. This may result in a missed or incomplete dose of Neulasta.

      A healthcare provider who is familiar with Neulasta should answer your questions. For general questions or support call 1-844-MYNEULASTA (1-844-696-3852) or visit www.neulasta.com.

      Guide to Parts for On-body Injector for Neulasta


      If at any time you hear beeping, check the status light. If it is flashing red, call your healthcare provider immediately.


      After your dose delivery is complete, check to see if the black line on your On-body Injector fill indicator is at empty.

      On-body Injector Placement


      Step 1: Monitor On-body Injector

      Check your status light occasionally for approximately 27 hours. Since it flashes slowly, watch for at least 10 seconds. If the status light is flashing green, it is okay.

      If at any time you hear beeping, check the status light. If it is flashing red, call your healthcare provider immediately.


      If the On-body Injector for Neulasta was placed on the back of your arm, a caregiver must be available to monitor the status of the On-body Injector.


      After approximately 27 hours, your On-body Injector will beep to let you know yourdose delivery will begin in 2 minutes. When the dose delivery starts, it will take about 45 minutes to complete. During this time, the On-body Injector will flash a fast green light.

      If at any time you hear beeping, check the status light. If it is flashing red, call your healthcare provider immediately.


      DO NOT remove the On-body Injector before the dose delivery is complete.

      Step 2: Monitor Dose Delivery

      For the next 45 minutes, monitor your On-body Injector frequently for leaks during dose delivery. If the On-body Injector was placed on the back of your arm, a caregiver must be available to monitor your On-body Injector.


      If the adhesive becomes noticeably wet (saturated) with fluid, or you see dripping, call your healthcare provider immediately.

      Your dose delivery will take around 45 minutes to complete.

      • You may hear a series of clicks. This is okay.
      • A beep will sound when the dose delivery is complete.

        Step 3: Remove On-body Injector When Dose Delivery Is Complete

        When beeping starts, check to see the color of the status light.


        Check to see if the status light is SOLID GREEN or has switched off. This means the dose is complete. Remember, any time you see a leak, call your healthcare provider immediately. If the dose is complete, go to the next step. If you see the status lightis flashing red, your On-body Injector is not functioning properly.Call your healthcare provider immediately, as you may not have received a full dose.

        Grab the edge of the adhesive pad. Slowly peel off the On-body Injector.

        • If medicine has leaked or the adhesive is noticeably wet (saturated), call your healthcare provider immediately as you may not have received your full dose.
        • Remove any extra adhesive using soap and water.

        DO NOT grasp the On-body Injector itself to try to pull it off of your body.

        Step 4: Finish

        Check to see if your On-body Injector is empty.

        • You should see a black line next to the EMPTY indicator. If the On-body Injector is not empty, call your healthcare provider immediately.
        • Check your status light again. Watch for at least 10 seconds. If the status light is solid green or it has switched off, it is okay.
        • If you hear beeping, or when you check the status light and it is flashing red, call your healthcare provider immediately.

        After On-body Injector removal, place the On-body Injector in a sharps disposal container whether the needle is exposed or not. If the needle is exposed, call your healthcare provider immediately.

        Record the end state of your On-body Injector.

        • Mark the box of the description that represents your On-body Injector after it has been used.

        - Status light is solid green or the status light has switched off. This means that the delivery is complete.

        - On-body Injector leaked, call your healthcare provider immediately.

        - Status light is red, call your healthcare provider immediately.

        Properly dispose of the On-body Injector.

        • The On-body Injector contains batteries, electronics, and a needle. Dispose of it in a sharps disposal container as instructed by your healthcare provider or by state or local laws.
        • To participate in Amgen’s voluntary disposal program, please call 1-844-MYNEULASTA (1-844-696-3852) or visit www.neulasta.com to enroll. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to FDA’s website at: http://www.fda.gov/safesharpsdisposal.

        Keep children away from the used On-body Injector.

        Attention!

        What to do if you hear beeping or when you look at the status light and it is flashing red.

        If the status light is flashing red, you may not have received your full dose. Call your healthcare provider immediately.

        What to do if the On-body Injector adhesive becomes noticeably wet (saturated) with fluid, or you see dripping.


            If the adhesive becomes saturated with fluid, or you see dripping, your medicine may have leaked out.

            Even with a leak, the status light may remain green and the fill indicator may be at EMPTY.

            Call your healthcare provider immediately as you may not have received your full dose.

            Note: It is normal to see a few drops of fluid at the application site, but not normal to see a noticeably wet (saturated) adhesive.

            What do I do if the On-body Injector comes off before the full dose is delivered?

            Call your healthcare provider immediately if the On-body Injector at any time comes away from your skin before your full dose delivery, DO NOT reapply it.

            What if there is blood at my application site after the On-body Injector has been removed?

            If there is blood, press a clean cotton ball or gauze pad on the application site. Apply an adhesive bandage if needed.

            What if my application site is red or tender after On-body Injector removal?

            Call your healthcare provider immediately if you experience persistent or worsening redness or tenderness at the application site, as this can be a sign of infection.