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What is Fylnetra®?

Fylnetra from Amneal Biosciences

FYLNETRA 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.4

How to Use

Guide to parts

Before use

After use

diagram

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 FYLNETRA before using these Instructions for Use.

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

Storing the prefilled syringe

  • Store FYLNETRA in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze.
  • Keep the prefilled syringe in the original pack 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 FYLNETRA that has been at left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 72 hours.
  • Keep the FYLNETRA 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 FYLNETRA appears on the pack and prefilled syringe label.
  • Check the pack and prefilled syringe label to make sure the dose strength is 6 mg/0.6 mL.
  • You should not inject a dose of FYLNETRA to children weighing less than 45 kg from a FYLNETRA prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the FYLNETRA 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 pack 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 attempt to activate the needle safety guard prior to injection.

Call your healthcare provider if you or your caregiver have any questions.

A. Remove the prefilled syringe pack from the refrigerator. Put the original pack with any unused prefilled syringes back in the refrigerator. Remove the syringe tray from the pack. On a clean, well-lit surface, place the syringe tray at room temperature for 30 minutes before you give an injection.

B. Inspect the medicine and prefilled syringe.

For safety reasons:

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

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

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

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

Recommended Injection Sites

You can use:

  • Thigh
  • Stomach area (abdomen), except for a 2-inch area 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 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.

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 and the plunger head is completely between the needle guard wings.

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.

I.

Before you finish!

  • While you continue to hold the syringe, slowly let go of the plunger head.
  • As you let go of the plunger head, the needle will automatically slide into the clear safety guard until the needle is completely covered.
Important: If the clear safety guard does not activate after Step I., remove the needle from the skin and throw away (discard of) the used prefilled syringe as instructed in Step J. right away.

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:
    o made of a heavy-duty plastic,
    o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    o upright and stable during use,
    o leak-resistant, and
    o 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 the household trash.

Important: If the clear safety guard does not activate after Step I., remove the needle from the skin and throw away (discard of) the used prefilled syringe as instructed in Step J. right away.

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:
Kashiv BioSciences, LLC
Piscataway, NJ 08854
US License No. 2131

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 05-2022-00

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What is Fylnetra®?

Tips to Prevent and Manage Infection and Sepsis

It is important that patients do all they can to protect themselves against infection during chemotherapy. Read more about why this is and what you can to help prevent unnecessary exposure.

What is an infection and why am I at risk?

An infection is when germs such as bacteria, viruses, or fungi get into your body and multiply, causing you to feel ill or damage your organs. The immune system within your body is normally able to prevent and fight infections. Chemotherapy impairs your immune system by reducing the number of infection-fighting cells called neutrophils that are able to protect you from getting sick.

What is sepsis?

Sepsis is a life-threatening complication where the body is unable to fight infection. Patients with cancer who get an infection are at risk for developing sepsis.

What are the signs and symptoms of sepsis?4
Use this handy acronym to of the word sepsis itself to help remember the signs.

S – Shivering, fever, or very cold
E – Extreme pain or general discomfort (“worst ever”)
P – Pale or discolored skin
S – Sleepy, difficult to rouse, confused
I – “I feel like I might die”
S – Short of breath

How can I prevent infection?1,2

The following precautions are suggested as preventative measures:

  • Try to avoid crowded areas and people who you know are sick.
  • Do not share eating utensils, cups, plates, your toothbrush, or other personal care items with anyone.
  • Wash your hands with soap and water regularly, especially before you cook or eat, after you use the bathroom, after cleaning up after your pet, and after being in a public place.
  • Bathe or shower daily, and use an unscented moisturizer to prevent dry and cracked skin.
  • Brush your teeth with a soft bristle toothbrush only.
  • Use an electric shaver, not a razor.
  • Carefully wash raw fruits and vegetables.
  • Make sure that meat and eggs are cooked all the way through.
    Wear gloves when gardening and doing yard work.
  • Protect yourself from your pet’s urine and fecal waste by wearing gloves when cleaning up after your pet; better yet, have someone else do it.
  • Keep household surfaces as clean as you can.
  • Ask your doctor for permission to get the seasonal flu shot as soon as it is available.

What are the signs and symptoms of an infection?2,3

  • A fever that is 100.5⁰F (38⁰F) or higher
  • Chills
  • Sore throat
  • Cough
  • Sores or a white coating in your mouth
  • Ear pain
  • Headache
  • Nasal congestion or sinus pain
  • Stiff or sore neck
  • Skin rash, redness, or soreness
  • Pain or burning during urination
  • Bloody or cloudy urine
  • Unusual vaginal discharge or irritation
  • Diarrhea or vomiting

When should I call my doctor?2,3

  • If you suspect sepsis, see a doctor urgently, call 911, or go to a hospital and say, “I am concerned about sepsis.”
  • If you have cancer, getting an infection is a medical emergency that must be taken care of as soon as possible. When you speak with a doctor, make sure you say, “I HAVE CANCER AND AM CONCERNED ABOUT INFECTION AND SEPSIS.”
  • Make sure you ask your doctor before taking any medications, including acetaminophen (such as Tylenol®), NSAID drugs (such a Motrin®, Advil®, and Aleve®), or aspirin.
  • Ask your doctor before receiving any shot or vaccine.

References:

1. Fylnetra® Summary Basis of Approval – Drug Approval Package https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm
2. Food and Drug Administration, FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry, 2015.
3. Food and Drug Administration, FDA. Draft Guidance: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations, 2019.
4. Fylnetra® Full Prescribing Information – https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03

Important Safety Information
Indications and Usage

Indication: FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use: FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Contraindications: Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before taking FYLNETRA, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

Warnings and Precautions:

  • Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
  • Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue FYLNETRA in patients with ARDS.
  • Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA in patients with serious allergic reactions.
  • Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving FYLNETRA. Discontinue FYLNETRA if sickle cell crisis occurs.
  • Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on FYLNETRA. Consider dose-reduction or interruption of FYLNETRA in patients with kidney injury.
  • White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during FYLNETRA therapy is recommended.
  • Decreased platelet count (thrombocytopenia) has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
  • Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.
  • The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
  • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using FYLNETRA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
  • Aortitis has been reported in patients receiving pegfilgrastim products.
  • Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.

Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

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