May 28, 2016
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Neulasta

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Neulasta




PATIENT INFORMATION

Neulasta®
(nu-las-tah)
(pegfilgrastim) Injection

What is Neulasta?

Neulasta is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection. Acute Radiation Syndrome: The effectiveness of Neulasta for this use was only studied in animals, because it could not be studied in people.

Do not take Neulasta if you have had a serious allergic reaction to human G-CSFs such as pegfilgrastim or filgrastim products.

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

  • have a sickle cell disorder.
  • have kidney problems.
  • are allergic to latex. The needle cap on the prefilled syringe contains dry natural rubber (derived from latex). You should not give Neulasta using the prefilled syringe if you have latex allergies.
  • are pregnant or plan to become pregnant. It is not known if Neulasta will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Neulasta passes into your breast milk.

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

How will I receive Neulasta?

  • Neulasta is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed “Instructions for Use” that comes with your Neulasta for information on how to prepare and inject a dose of Neulasta.
  • You and your caregiver will be shown how to prepare and inject Neulasta before you use it.
  • You should not inject a dose of Neulasta to children weighing less than 45kg from a Neulasta prefilled syringe. A dose less than 0.6 mL (6mg) cannot be accurately measured using the Neulasta prefilled syringe.
  • If you are receiving Neulasta because you are also receiving chemotherapy, the last dose of Neulasta should be injected at least 14 days before and 24 hour after your dose of chemotherapy.
  • If you miss a dose of Neulasta, talk to your healthcare provider about when you should give your next dose.

What are possible side effects of Neulasta?

Neulasta may cause serious side effects, including:

  • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
  • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency care right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
  • Serious allergic reactions. Neulasta can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Neulasta and call your healthcare provider or get emergency medical help right away.
  • Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receive Neulasta. Serious sickle cell crises have happened in people with sickle cell disorders receiving Neulasta that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
  • Kidney injury (glomerulonephritis). Neulasta can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
    • swelling of your face or ankles
    • blood in your urine or dark colored urine
    • you urinate less than usual
  • Increased white blood cell count (leukocytosis). Your healthcare provider 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 than usual
    • 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 effects of Neulasta are pain in the bones, arms, and legs.

These are not all the possible side effects of Neulasta.

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

How should I store Neulasta?

  • 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.
  • Do not shake the prefilled syringe.
  • Take Neulasta 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.

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. Do not use Neulasta for a condition for which it was not prescribed. Do not give Neulasta to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Neulasta that is written for health professionals.

What are the ingredients in Neulasta?

Active ingredient: pegfilgrastim

Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in water for injection.

Instructions for Use

Neulasta
(nu-las-tah)
(pegfilgrastim) Injection, for subcutaneous use

Single-Dose Prefilled Syringe

Guide to parts

Guide to parts - Illustration

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 yourcaregiver 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 (6mg) 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 credit 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.

remove the prefilled syringe - Illustration

For safety reasons:

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

B. Inspect the medicine and prefilled syringe.

Inspect the medicine and prefilled syringe - Illustration

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

Materials needed for the injection - Illustration

Step 2: Get ready

D. Prepare and clean the injection site(s).

Injection sites - Illustration

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.

NEULASTA® (pegfilgrastim) Figure 6 Illustration

  • 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

Pinch the injection site - Illustration

Important: Keep skin pinched while injecting.

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

Insert the needle into the skin - Illustration

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.

Push the plunger rod - Illustration

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

Caution - Illustration

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

Pull the blue safety guard - Illustration

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

Discard (throw away) the used prefilled syringe - Illustration

  • 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.

Neulasta®
(pegfilgrastim)

Onpro™ kit
Healthcare Provider Instructions for Use

Guide to Parts

Neulasta Prefilled Syringe with Manual Needle Guard

Neulasta Prefilled Syringe with Manual Needle Guard - Illustration

On-body Injector for Neulasta

On-body Injector for Neulasta - Illustration

Important

READ THE FOLLOWING INSTRUCTIONS BEFORE USING THE ON-BODY INJECTOR

Warning: Do not use Neulasta Onpro kit to deliver any other drug product.

  • See Prescribing Information for information on Neulasta.
  • The On-body Injector is for adult patients only.
  • The On-body Injector is not recommended for patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome.
  • Store Neulasta Onpro kit in the refrigerator at 36°F to 46°F (2°C to 8°C) until ready for use. If Neulasta Onpro kit is stored at room temperature for more than 12 hours, do not use. Start again with a new Neulasta Onpro kit.
  • Keep the prefilled syringe in the Neulasta Onpro 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 Neulasta Onpro kit.
    • shake the prefilled syringe.
    • separate the components of Neulasta Onpro kit until ready for use.
    • modify the On-body Injector.
    • warm Neulasta Onpro kit components using a heat credit.
    • use Neulasta Onpro kit if expiry date on the carton or any of the Neulasta Onpro kit components has passed.
    • use if the name Neulasta does not appear on the Neulasta Onpro kit carton.
    • attempt to reapply On-body Injector.
    • use if either the On-body Injector or prefilled syringe is dropped. Start again with a new Neulasta Onpro 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

A Remove Neulasta Onpro 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 healthcare provider
    • for patient
  • 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.

On-body injector application site - Illustration

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.

Caution - Illustration

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 Neulasta Onpro kit.

When you feel you are ready, please continue...

Step 2: Get Ready

A. Remove Neulasta prefilled syringe from tray.

Remove Neulasta prefilled syringe from tray -  Illustration

For safety reasons:

DO NOT grasp gray needle cap.

DO NOT put the gray needle cap back onto syringe.

DO NOT grasp clear plunger.

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

Inspect medicine and Neulasta prefilled syringe - Illustration

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 Neulasta Onpro kit. Call Amgen at 1-800-772-6436.
  • The prefilled syringe gray needle cap contains dry natural rubber, which is derived from latex.

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

Carefully remove gray needle cap - Illustration

  • 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.

D. 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.

Insert syringe needle at 90 degrees all the way into medicine port - Illustration

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.

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

Pull needle safety guard down - Illustration

F. Check to see if the On-body Injector is full.

Check to see if the On-body Injector is full - Illustration

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 Neulasta Onpro kit, and call Amgen at 1-800-772-6436.

Step 3: Apply

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

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

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

B. 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.

Peel the two pieces of white adhesive backing away - Illustration

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 Neulasta Onpro kit. Call Amgen at 1-800-772-6436.

C. 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.

Back of Upper Arm

Apply On-body Injector securely - Illustration

Abdomen

Apply On-body Injector securely - Illustration

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

Caution - Illustration

D. 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.

Beeps and meaning - Illustration

  • 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 Neulasta Onpro 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.

What to do if you hear beeping - Illustration

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 Neulasta Onpro kit, and call Amgen at 1-800772-6436.

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

NEULASTA® (pegfilgrastim) Figure 30 Illustration

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:

Symbols & meanings -  Illustration

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 specified 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
RF Emissions (CISPR 11) Group 1 The On-body Injector for Neulasta uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby equipment.
CISPR B Emissions Classification Class B  

Electromagnetic Immunity

The On-body Injector for Neulasta is intended for use in the electromagnetic environment specified below. The user of this equipment 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)(√P)150 kHz to 80 MHz D=(3.5/E1)(√P)80 to 800 MHz D=(7/E1)(√P)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)( √P) 80 to 800 MHz D=(3.5/E1)( √P) 800 MHz to 2.5 GHz D=(7/E1)(√P)
0.01 0.11667 0.11667 0.23333
0.1 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

Last reviewed on RxList: 5/9/2016
This monograph has been modified to include the generic and brand name in many instances.

Neulasta - User Reviews

Neulasta User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Neulasta sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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