Neulasta

Pregnancy Category: C

Lactation: not known if excreted in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

When using the On-body Injector: Avoid traveling, driving, or operating machinery while wearing the device.

Other drugs may interact with pegfilgrastim, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

The maximum amount of Neulasta that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum absolute neutrophil count (ANC) of 55 x 109/L, with a corresponding mean maximum WBC of 67 x 109/L. The absolute maximum ANC observed was 96 x 109/L with a corresponding absolute maximum WBC observed of 120 x 109/L. The duration of leukocytosis ranged from 6 to 13 days. The effectiveness of leukapheresis in the management of symptomatic individuals with Neulasta-induced leukocytosis has not been studied.

Neulasta is part of the drug class:

• Colony stimulating factors

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Neulasta there are no specific foods that you must exclude from your diet when receiving Neulasta.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Neulasta  can get into human breast milk.

Pegfilgrastim is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Pegfilgrastim is usually given once per chemotherapy cycle. This medication should not be given within 14 days before or 24 hours after you receive chemotherapy.

Do not shake the prefilled syringe. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

The Neulasta On-body Injector is a special device placed on the skin that delivers your pegfilgrastim dose at a specific time. Read and carefully follow all instructions for using this product. You will need to wear the device for 27 hours before the dose begins. The timed dose will then be released from the device slowly over a 45-minute period. While wearing the On-body Injector, you or a caregiver will need to check the device to make sure it is working properly.

Each prefilled syringe or On-body Injector is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

You may need frequent medical tests to help your doctor determine how long to treat you with pegfilgrastim.

Store this medicine in the refrigerator, do not freeze. Protect from light and do not shake.

Take the medicine out of the refrigerator and allow it to reach room temperature before injecting your dose. Do not leave the medicine at room temperature for longer than 48 hours.

Throw away any unused syringes after the expiration date on the label has passed.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In the U.S.

• Neulasta

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Colony Stimulating Factor

Pegfilgrastim injection is used to treat neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony stimulating factor. Pegfilgrastim helps the bone marrow to make new white blood cells.

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Pegfilgrastim is used to reduce the risk of infection while you are being treated with cancer medicines.

This medicine is available only with your doctor's prescription.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bone pain.
• Muscle pain.
• Pain and redness may happen where the shot was given. If you have a lump, swelling, or bruising that does not go away, call your doctor.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

      Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of Neulasta.  Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.

      Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta.  Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS.

      Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment.  Permanently discontinue Neulasta in patients with serious allergic reactions.  Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

      Allergies to Acrylics

The On-body Injector for Neulasta uses acrylic adhesive.  For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

        Use in Patients with Sickle Cell Disorders

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

        Glomerulonephritis

Glomerulonephritis has occurred in patients receiving Neulasta. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy.  Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of Neulasta.  If glomerulonephritis is suspected, evaluate for cause.  If causality is likely, consider dose-reduction or interruption of Neulasta. 

        Leukocytosis

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim.  Monitoring of complete blood count (CBC) during pegfilgrastim therapy is recommended.

        Capillary Leak Syndrome

Capillary leak syndrome has been reported after G-CSF administration, including Neulasta, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.  Episodes vary in frequency, severity and may be life-threatening if treatment is delayed.  Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.

        Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

No formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results.

Neulasta single-dose prefilled syringe for manual use 

Neulasta is supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard.

The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).

Neulasta is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 55513-190-01).

Neulasta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration.  Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe.

Store refrigerated between 36° F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake.  Discard syringes stored at room temperature for more than 48 hours.  Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

Neulasta OnproTM kit

Neulasta Onpro kit is provided in a carton containing one sterile prefilled syringe and one sterile On-body Injector for Neulasta (NDC 55513-192-01).

The single-dose prefilled syringe contains 0.64 mL of solution that delivers 6 mg/0.6 mL of pegfilgrastim when used with the On-body Injector for Neulasta.  The prefilled syringe is supplied with a 27-gauge, 1/2-inch needle.  The syringe does not bear graduation marks and is only to be used with the On-body Injector for Neulasta.

The needle cap of the prefilled syringe contains dry natural rubber (a derivative of latex).

Store Neulasta Onpro kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until ready for use. Because the On-body Injector for Neulasta is at room temperature during the period of use, Neulasta Onpro kit should not be held at room temperature longer than 12 hours prior to use. Discard Neulasta Onpro kit if stored at room temperature for more than 12 hours.

Do not use the On-body Injector for Neulasta if its packaging has been previously opened.  

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise patients of the following risks and potential risks with Neulasta:

• Splenic rupture and splenomegaly
  
• Acute Respiratory Distress Syndrome
  
• Serious allergic reactions
  
• Sickle cell crisis
  
• Glomerulonephritis
  
• Capillary Leak Syndrome

Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) that efficacy studies of Neulasta for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals [see Clinical Studies (14.2)].

Instruct patients who self-administer Neulasta using the single-dose prefilled syringe of the:

• Importance of following the Instructions for Use.
  
• Dangers of reusing syringes.
  
• Importance of following local requirements for proper disposal of used syringes.

Advise patients on the use of the On-body Injector for Neulasta: 

• Review the Patient Information and Patient Instructions for Use with the patient and provide the instructions to the patient. 
  
• Refer the patient to the dose delivery information written on the Patient Instructions for Use.
  
• Tell the patient when their dose delivery of Neulasta will begin and when their dose delivery should be completed.  
  
• Advise the patient that serious allergic reactions can happen with Neulasta. Patients should have a caregiver nearby for the first use. Patients should plan to be in a place where they can appropriately monitor the On-body Injector for Neulasta during the approximately 45 minute Neulasta delivery and for an hour after the delivery. Advise the patient to avoid traveling, driving, or operating heavy machinery during hours 26-29 following application of the On-body Injector for Neulasta.  
  
• If the On-body Injector for Neulasta is placed on the back of the arm, remind the patient that a caregiver must be available to monitor the On-body Injector for Neulasta.
  
• If a patient calls the healthcare provider regarding any On-body Injector for Neulasta problems, the healthcare provider is advised to call Amgen at 1-800-772-6436.
  
• Advise the patient:
  • to call their healthcare provider immediately if the status light on the On-body Injector for Neulasta is flashing red (see the Patient Instructions for Use).
    
  • to inform their healthcare provider if the adhesive on the On-body Injector for Neulasta becomes saturated with fluid, or there is dripping, as this may be evidence of significant product leakage, resulting in inadequate or missed dose (see the Patient Instructions for Use).
    
  • to keep the On-body Injector for Neulasta dry for approximately the last 3 hours prior to the dose delivery start to better enable potential leak detection.
    
  • that the On-body Injector for Neulasta should only be exposed to temperatures between 41°F and 104°F (5°C-40°C).
    
  • to 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.  Failure to keep the On-body Injector for Neulasta at least this recommended distance may interfere with operation and can lead to a missed or incomplete dose of Neulasta.
    
  • that if the needle is exposed after On-body Injector for Neulasta removal, place the used On-body Injector for Neulasta in a sharps disposal container to avoid accidental needle stick and call their healthcare provider immediately.
    
  • to remove the On-body Injector for Neulasta after the green light shines continuously and to place the used On-body Injector for Neulasta in a sharps disposal container (see the Patient Instructions for Use).

• Advise the patient:
  • do not reapply the On-body Injector for Neulasta if the On-body Injector for Neulasta comes off before full dose is delivered and instead call their healthcare provider immediately.
    
  • avoid bumping the On-body Injector for Neulasta or knocking the On-body Injector for Neulasta off the body.
    
  • do not expose the On-body Injector for Neulasta to medical imaging studies, e.g. X-ray scan, MRI, CT scan, ultrasound, and oxygen rich environments such as hyperbaric chambers to avoid On-body Injector for Neulasta damage and patient injury.

• Advise the patient to avoid:
  • airport X-ray scans and request a manual pat down instead; remind patients who elect to request a manual pat down to exercise care to avoid having the On-body Injector for Neulasta dislodged during the pat down process.
    
  • sleeping on the On-body Injector for Neulasta or applying pressure on the On-body Injector for Neulasta as this may affect On-body Injector for Neulasta performance.
    
  • getting body lotions, creams, oils, and cleaning agents near the On-body Injector for Neulasta as these products may loosen the adhesive.
    
  • using hot tubs, whirlpools, or saunas and avoid exposing the On-body Injector for Neulasta to direct sunlight as these may affect the drug.
    
  • peeling off or disturbing the On-body Injector for Neulasta adhesive before delivery of full dose is complete.

Neulasta® (pegfilgrastim)
Manufactured by:
Amgen Inc.
One Amgen Center Drive      
Thousand Oaks, California 91320-1799
U.S. License No. 1080

Patent: http://pat.amgen.com/Neulasta/

© 2002-2016 Amgen Inc. All rights reserved.
www.Neulasta.com
1-800-77-AMGEN (1-800-772-6436)

10/2016
v19

This Patient Information has been approved by the U.S. Food and Drug Administration.       Revised: 4/2016

Patient Information

Neulasta® (nu-las-tah)

(pegfilgrastim)
injection

On-body Injector for Neulasta

Read this Patient Information before you receive Neulasta and each time you receive Neulasta with the On-body Injector for Neulasta. There may be new information. 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 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:
  •   MRI
  •   X-ray
  •   CT-Scan
  •   Ultrasound
  •   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.
  
• Call your healthcare provider right away if the:
  •   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.

Who should not take Neulasta?

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

What should I tell my healthcare provider before receiving Neulasta?

Before you receive 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.
  
  Pregnancy Registry: There is a pregnancy registry for women who become pregnant during treatment with Neulasta. The purpose of this registry is to collect information about the health of you and your baby. You are encouraged to enroll in this registry. Your healthcare provider may enroll you, or you may enroll by calling 1-800-AMGEN (1-800-772-6436).        
      
  
• 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.

• See the section “What is the most important information I need to know about receiving Neulasta with the On-body Injector for Neulasta?”
  
• Neulasta is given as an injection under the skin (subcutaneous). Your healthcare provider will use a prefilled syringe with Neulasta to fill the On-body Injector prior to applying it. The prefilled syringe with Neulasta and the On-body Injector are provided to your healthcare provider as part of Neulasta OnproTM kit. The On-body Injector for Neulasta will be applied to the stomach area (abdomen) or back of your arm by your healthcare provider.  If the On-body Injector for Neulasta was placed on the back of your arm, a caregiver must be available to monitor the On-body Injector for Neulasta.
  
• Your healthcare provider should place the On-body Injector for Neulasta on an area of your skin that does not have swelling, redness, cuts, wounds, or abrasions. Tell your healthcare provider about any skin reactions that happen in the On-body Injector for Neulasta application area after it has been applied.
  
• 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.
  
• The dose of Neulasta will be delivered over about 45 minutes. During dose delivery and for 1 hour after delivery, it is best to stay in a place where you or a caregiver can monitor the On-body Injector for Neulasta to make sure you receive your full dose of Neulasta and watch for symptoms of an allergic reaction.
  
• Keep the On-body Injector for Neulasta dry for about the last 3 hours before the dose delivery is expected to start. This will help you to better detect possible leaking from the On-body Injector for Neulasta.
  
• Only expose the On-body Injector for Neulasta to temperatures between 41°F to 104°F (5°C to 40°C).

What should I avoid while the On-body Injector for Neulasta is in place?

While the On-body Injector for Neulasta is in place you should avoid:

• traveling, driving or operating heavy machinery during hour 26 through hour 29 after the On-body Injector for Neulasta is applied.
  
• sleeping on the On-body Injector for Neulasta or applying pressure on the On-body Injector for Neulasta. The On-body Injector for Neulasta may not work properly.
  
• bumping the On-body Injector for Neulasta or knocking it off your body.
  
• getting body lotion, creams, oils, and skin cleansing products near the On-body Injector for Neulasta. These products may loosen the adhesive that holds the On-body Injector for Neulasta onto your body.
  
• using hot tubs, whirlpools, or saunas, and direct sunlight. These may affect Neulasta.
  
• peeling off or disturbing the On-body Injector for Neulasta adhesive before you receive your full dose of Neulasta.

What are possible side effects of Neulasta?

Neulasta can 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 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 for Neulasta. Get emergency medical help right away.
  
• 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 (pegfilgrastim).
  
• 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. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Neulasta

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information about Neulasta, talk with your healthcare provider or pharmacist. You can ask your pharmacist for information about Neulasta that is written for health professionals.

For more information, go to www.Neulasta.com or call 1-844-696-3852 (1-844-MYNeulasta).

What are the ingredients in Neulasta?

Active ingredient: pegfilgrastim

Inactive ingredients: acetate, polysorbate 20, and sodium, sorbitol in Water for Injection.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Neulasta® (pegfilgrastim)

Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License No. 1080

Patent: http://pat.amgen.com/Neulasta/

© 2002 to 2015 Amgen Inc. All rights reserved.

www.Neulasta.com

1-844-MYNeulasta (1-844-696-3852)
Issued: 11/2015
v3

• Do not use if the liquid contains particulate matter or discoloration is observed prior to administration.
  
• Do not use if any part appears cracked or broken.
  
• Do not use if the gray needle cap is missing or not securely attached.
  
• Do not use if the expiration date printed on the label has passed.
  
• Do not remove the gray needle cap until ready to fill the On-body Injector.

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

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

Neulasta® (pegfilgrastim)

Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License No. 1080

Patent: http://pat.amgen.com/Neulasta/

© 2002 to 2016 Amgen Inc. All rights reserved.

www.Neulasta.com 1-844-MYNeulasta (1-844-696-3852)
Issued: 10/2016
v6

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.

{SIDE 1 Information}

Patient Instructions for Use

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 prefilled syringe with Neulasta and the On-body Injector are provided to your healthcare provider as part of Neulasta OnproTM kit. 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 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 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.

The On-body Injector is for adult patients only.

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.

Call your healthcare provider right away if you experience any of these symptoms of kidney injury (glomerulonephritis): puffiness in your face or ankles, blood in your urine or brown colored urine or you notice you urinate less than usual.

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.

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 one 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 three 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 four 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 Placement

Neulasta® (pegfilgrastim)

Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License No. 1080

Patent: http://pat.amgen.com/Neulasta/

© 2002 to 2016 Amgen Inc.  All rights reserved.

www.Neulasta.com

1-844-MYNeulasta (1-844-696-3852) Issued: 10/2016 v5

Instructions for Use

Neulasta (nu-las-tah)

(pegfilgrastim)

Injection, for subcutaneous use

Single-Dose Prefilled Syringe

Important: The needle is covered by the gray needle cap before use.

Important

Read the Patient Information for important information you need to know about Neulasta before using these Instructions for Use.

Before you use a Neulasta prefilled syringe, read this important information.

Storing the prefilled syringe

• Store Neulasta in the refrigerator between 36°F to 46°F (2°C to 8°C).
  
• Do not freeze.  
  
• Keep the prefilled syringe in the original carton to protect from light or physical damage.
  
• Take the prefilled syringe out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
  
• Throw away (dispose of) any Neulasta that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours. 
  
• Keep the Neulasta prefilled syringe out of the reach of children.  

Using the prefilled syringe

• It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
  
• Make sure the name Neulasta appears on the carton and prefilled syringe label.
  
• Check the carton and prefilled syringe label to make sure the dose strength is 6 mg.
  
• You should not inject a dose of Neulasta to children weighing less than 45 kg from a Neulasta prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Neulasta prefilled syringe. 
  
• Do not use a prefilled syringe after the expiration date on the label.
  
• Do not shake the prefilled syringe.
  
• Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
  
• Do not use the prefilled syringe if the carton is open or damaged.
  
• Do not use a prefilled syringe if it has been dropped on a hard surface. The prefilled syringe may be broken even if you cannot see the break. Use a new prefilled syringe.
  
• Do not slide the blue safety guard over the needle before you give the injection. This will “activate” or lock the blue safety guard. Use another prefilled syringe that has not been activated and is ready to use.
  
• The gray needle cap on the prefilled syringe contains dry natural rubber (made from latex). Tell your healthcare provider if you are allergic to latex. You should not give Neulasta using the prefilled syringe if you have latex allergies.

Call your healthcare provider if you have any questions.

Step 1: Prepare

A  Remove the prefilled syringe carton from the refrigerator. 

Put the original carton with any unused prefilled syringes back in the refrigerator.

Remove the syringe tray from the carton. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection.

• Do not use the prefilled syringe if the carton is damaged.
  
• Do not try to warm the prefilled syringe by using a heat source such as hot water or microwave.
  
• Do not leave the prefilled syringe in direct sunlight.
  
• Do not shake the prefilled syringe.

Open the tray by peeling away the cover. Grab the blue safety guard to remove the prefilled syringe from the tray.

For safety reasons:

• Do not grab the plunger rod.
  
• Do not grab the gray needle cap.

B  Inspect the medicine and prefilled syringe.

Make sure the medicine in the prefilled syringe is clear and colorless.

• Do not use the prefilled syringe if:
  • The medicine is cloudy or discolored or contains flakes or particles.
    
  • Any part appears cracked or broken.
    
  • The prefilled syringe has been dropped.
    
  • The gray needle cap is missing or not securely attached.
    
  • The expiration date printed on the label has passed.

In all cases, use a new prefilled syringe and call your healthcare provider.

C  Gather all materials needed for the injection.

Wash your hands thoroughly with soap and water.

On a clean, well-lit work surface, place the:

• Prefilled syringe
  
• Alcohol wipe
  
• Cotton ball or gauze pad
  
• Adhesive bandage
  
• Sharps disposal container

Step 2: Get ready

D  Prepare and clean the injection site(s).

You can use:

• Thigh
  
• Stomach area (abdomen), except for a 2-inch area right around the navel (belly button)
  
• Upper outer area of the buttocks (only if someone else is giving you the injection)
  
• Outer area of upper arm (only if someone else is giving you the injection)

Clean the injection site with an alcohol wipe. Let the skin dry.

• Do not touch this area again before injecting.
  
• If you want to use the same injection site, make sure it is not the same spot on the injection site you used for a previous injection.
  
• Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.

E Hold the prefilled syringe by the syringe barrel. Carefully pull the gray needle cap straight off and away from the body.

• Do not remove the gray needle cap from the prefilled syringe until you are ready to inject.
  
• Do not twist or bend the gray needle cap.
  
• Do not hold the prefilled syringe by the plunger rod.
  
• Do not put the gray needle cap back onto the prefilled syringe. 

Important: Throw the gray needle cap into the sharps disposal container.

Step 3: Subcutaneous (under the skin) injection

F Pinch the injection site to create a firm surface.

Important: Keep skin pinched while injecting.

G Hold the pinch. Insert the needle into the skin at 45 to 90 degrees.

H Using slow and constant pressure, push the plunger rod until it reaches the bottom.

When done, gently pull the syringe off of the skin.

Important: When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your healthcare provider right away.

Step 4: Finish

I   

For your safety, pull the blue safety guard until it clicks and covers the needle.

Once extended, the blue safety guard will lock into position and will not slide back over the needle.

Keep your hands away from the needle at all times.

J Discard (throw away) the used prefilled syringe.

• Put the used prefilled syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in the household trash.
  
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
    
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    
  • upright and stable during use,
    
  • leak-resistant, and
    
  • properly labeled to warn of hazardous waste inside the container.
  
  
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal

• Do not reuse the prefilled syringe.
  
• Do not recycle the prefilled syringe or sharps disposal container or throw them into household trash.

Important: Always keep the sharps disposal container out of the reach of children.

K Examine the injection site. 

If there is blood, press a cotton ball or gauze pad on the injection site. Do not rub the injection site.  Apply an adhesive bandage if needed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
U.S. License No. 1080
© 2002-2016 Amgen Inc. All rights reserved.
1xxxxxx
Revised: 4/2016 v1

Principal Display Panel

NDC 55513-190-01

1 - 0.6 mL Single Dose Prefilled Syringe

AMGEN®

Neulasta ®

(pegfilgrastim) injection

Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor

(PEG-r-metHuG-CSF) derived from E Coli

6 mg

6 mg in 0.6 mL Single Dose Prefilled Syringe

For Subcutaneous Use Only

This Product Contains Dry Natural Rubber

Sterile Solution – No Preservative

Rx Only

Manufactured by Amgen Inc.

Thousand Oaks, CA 91320-1799 U.S.A.

U.S. License No. 1080

Principal Display Panel

NDC 55513-192-01

1 - Single Dose Neulasta Prefilled Syringe

1 - Sterile On-body Injector for Neulasta

AMGEN®

Neulasta® Onpro™ kit

(pegfilgrastim) injection

Pegylated Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor

(PEG-r-metHuG-CSF) derived from E Coli

6 mg/0.6 mL*

6 mg/0.6 mL*

*Prefilled syringe contains 0.64 mL to deliver 6 mg/0.6 mL when used with on-body injector

For Subcutaneous Use Only

Carton Contents (intended to be dispensed as a unit):

• 1 sterile On-body Injector for Neulasta
  
• 1 Neulasta prefilled syringe labeled for use with on-body injector only
  
• 1 patient instructions for use
  
• 1 healthcare provider instructions for use, 1 package insert
  
• 1 reference guide

This Product Contains Dry Natural Rubber

Store at 2° to 8°C (36° to 46°F).

Do Not Freeze or Shake. Keep in Carton to Protect from Light.

See package insert for full prescribing information and Instructions for Use

Enhanced Features see enclosed instructions

Rx Only

You should not use Neulasta if you are allergic to pegfilgrastim or filgrastim (Neupogen).

To make sure you can safely use Neulasta, tell your doctor if you have any of these other conditions:

• sickle cell disorder;

• kidney disease;

• chronic myeloid leukemia;

• myelodysplasia (also called "preleukemia"); or

• a latex allergy.

It is not known whether Neulasta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Neulasta on the baby.

It is not known whether pegfilgrastim passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

When using the On-body Injector: Avoid traveling, driving, or operating machinery while wearing the device.

Common side effects of Neulasta include: ostealgia. See below for a comprehensive list of adverse effects.