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Generic Name
Filgrastim
Brand Names
Filkri, Granix, Neupogen, Nivestym, Nypozi, NYPOZI txid, Releuko, Zarxio
FDA approval date: April 07, 1997
Classification: Leukocyte Growth Factor
Form: Injection
What is Filkri (Filgrastim)?
FILKRI is a leukocyte growth factor indicated to Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
Approved To Treat
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Brand Information
FILKRI (filgrastim-laha)
1DOSAGE FORMS AND STRENGTHS
FILKRI is a clear, colorless, preservative-free solution available as:
2CONTRAINDICATIONS
FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products [see Warnings and Precautions (5.3)].
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Splenic Rupture
- Acute Respiratory Distress Syndrome
- Serious Allergic Reactions
- Sickle Cell Disorders
- Glomerulonephritis
- Alveolar Hemorrhage and Hemoptysis
- Capillary Leak Syndrome
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Thrombocytopenia
- Leukocytosis
- Cutaneous Vasculitis
- Aortitis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of filgrastim products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- splenic rupture and splenomegaly (enlarged spleen)
- acute respiratory distress syndrome
- anaphylaxis
- sickle cell disorders
- glomerulonephritis
- alveolar hemorrhage and hemoptysis
- capillary leak syndrome
- leukocytosis
- cutaneous vasculitis
- Sweet's syndrome (acute febrile neutrophilic dermatosis)
- decreased bone density and osteoporosis in pediatric patients receiving chronic treatment with filgrastim products
- myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with breast and lung cancer receiving chemotherapy and/or radiotherapy
- aortitis
- extramedullary hematopoiesis
4OVERDOSAGE
The maximum tolerated dose of filgrastim products has not been determined. In filgrastim clinical trials of patients with cancer receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm
5DESCRIPTION
Filgrastim-laha, a leukocyte growth factor, is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-laha is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim-laha has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because filgrastim-laha is produced in E coli‚ the product is non-glycosylated and thus differs from G-CSF isolated from a human cell.
FILKRI (filgrastim-laha) injection is a sterile‚ clear‚ colorless‚ preservative-free liquid containing filgrastim-laha at a specific activity of 1.0 ± 0.6 x 10
6HOW SUPPLIED/STORAGE AND HANDLING
FILKRI (filgrastim-laha) injection is a clear, colorless, preservative-free solution supplied as:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Review the steps for direct patient administration with patients and caregivers. Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the
Advise patients of the following risks and potential risks with FILKRI:
- Rupture or enlargement of the spleen may occur. Symptoms include left upper quadrant abdominal pain or left shoulder pain. Advise patients to report pain in these areas to their physician immediately
- Dyspnea, with or without fever, progressing to Acute Respiratory Distress Syndrome, may occur. Advise patients to report dyspnea to their physician immediately
- Serious allergic reactions may occur, which may be signaled by rash‚ facial edema‚ wheezing‚ dyspnea‚ hypotension‚ or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur
- In patients with sickle cell disease, sickle cell crisis and death have occurred. Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of human granulocyte colony-stimulating factors
- Glomerulonephritis may occur. Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately
- There may be an increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with congenital neutropenia who receive filgrastim products and in patients with breast and lung cancer who receive filgrastim products in conjunction with chemotherapy and/or radiation therapy. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Advise patients to report to their physician signs and symptoms of MDS/AML
- Cutaneous vasculitis may occur, which may be signaled by purpura or erythema. Advise patients to report signs or symptoms of vasculitis to their physician immediately
- Aortitis may occur. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Advise patients to report signs and symptoms of aortitis to their physician immediately
Advise patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) that efficacy studies of filgrastim 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
Instruct patients who self-administer FILKRI using the prefilled syringe of the:
- Importance of following the applicable Instructions for Use.
- Dangers of reusing needles or syringes.
- Importance of following local requirements for proper disposal of used syringes and needles.
- Importance of informing the healthcare provider if difficulty occurs when measuring or administering partial contents of the FILKRI prefilled syringe.
8Instructions for Use
FILKRI
Single-Dose Prefilled Syringe
Single-Dose Prefilled Syringe
Guide to parts
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 FILKRI before using these Instructions for Use.
Before you use a FILKRI prefilled syringe, read this important information.
Storing your prefilled syringe
- Store the prefilled syringe in the refrigerator between 36˚F to 46˚F (2˚C to 8˚C).
- Do not freeze. If FIKRI is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
- Do not use a FILKRI prefilled syringe that has been frozen more than 1 time. Throw it away and use a new prefilled syringe.
- 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, 68°F to 77°F (20°C to 25°C), before preparing an injection.
- Throw away (dispose of) any prefilled syringe that has been left at room temperature for longer than 24 hours.
- After you inject your dose, throw away (dispose of) any unused FILKRI left in the prefilled syringe.
- Keep FILKRI and all medicines out of the reach of children.
Using your 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.
- Do not inject a dose of FILKRI less than 0.3 mL (180 mcg) from a FILKRI prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the FILKRI prefilled syringe.
- Make sure the name FILKRI appears on the carton and prefilled syringe label.
- 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.
- The prefilled syringe has a needle guard that will be activated to cover the needle after the injection is given. The needle guard will help prevent needle stick injuries to anyone who handles the prefilled syringe.
- Avoid touching the syringe needle guard wings before use. Touching them may cause the syringe needle guard to be activated too early.
- 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 FILKRI 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
- 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 orange safety guard to remove the prefilled syringe from the tray (see Figure 2).
For safety reasons:
- Do not grab the plunger rod.
- Do not grab the gray needle cap.
B Inspect the medicine and prefilled syringe (see Figure 3).
Turn the prefilled syringe so you can see the medicine window and markings. 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.
- The needle guard is activated. Check to make sure that the plastic transparent needle guard is covering the barrel of the glass syringe. If transparent needle guard is covering the needle cap, the needle guard has already been activated (see Figure 4). Do not use the prefilled syringe if the needle guard has been activated. Get another prefilled syringe that has not been activated and is ready to use.
- In all cases, use a new prefilled syringe and call your healthcare provider.
C Gather all materials needed for your injection (see Figure 5).
Wash your hands thoroughly with soap and water.
- Prefilled syringe
- Alcohol wipe
- Cotton ball or gauze pad
- Adhesive bandage
- Sharps disposal container
Step 2: Get ready
D Prepare and clean your injection site (see Figure 6).
You can use:
- Thigh
- Stomach area (abdomen), except for a
- Upper outer area of your 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 your injection site with an alcohol wipe.
- Let your 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 area 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 your body (see Figure 7).
- 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 (see Figure 8).
F
Check your prescription before you inject your dose.
Check your prescription before you inject your dose.Your healthcare provider has prescribed either a “full” syringe dose or a “partial” syringe dose of FILKRI.
- If you are prescribed a full dose, you will inject all of the medicine from your prefilled syringe.
- If you are prescribed a partial dose of FILKRI, start with Step G below.
G Point the needle up and gently tap the syringe body with your fingers until the air bubble rises to the top of the syringe (See Figure 9).
H Slowly push the plunger rod up to the line on the syringe barrel that matches your prescribed dose (see Figure 10).
Be careful not to activate the needle guard before use.
As you push the plunger rod up, air and extra medication is removed. Check to make sure the end of the conical base (edge) of the plunger stopper lines up with the syringe markings for your prescribed dose. See Figure 10 for an example of a dose of 0.3 mL. Your dose may be different than example shown. If you remove too much medicine, get a new prefilled syringe and start again at Step 1.
- Call your healthcare provider if you have problems measuring your prescribed dose.
Step 3: Subcutaneous (under the skin) injection
I Pinch your injection site to create a firm surface (see Figure 11).
Important: Keep skin pinched while injecting.
J Hold the pinch. Insert the needle into the skin at 45 to 90 degrees (see Figure 12).
K Using slow and constant pressure, push the plunger rod until it reaches the bottom (see Figure 13).
- Do not pull back the plunger rod while the needle is inserted.
When done, gently pull the syringe off of your skin.
L When done, keep the plunger fully pressed down while you carefully pull the needle straight out from the injection site (Figure 14).
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.
M Slowly release the plunger and allow the needle guard to automatically cover the exposed needle (see Figure 15).
Step 4: Finish
N. Discard (throw away) the used prefilled syringe (see Figure 16).
N. Discard (throw away) the used prefilled syringe (see Figure 16).
- Put the used prefilled syringe in a FDA-cleared sharps disposal container right away after use.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- 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.
O Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply an adhesive bandage if needed.
If there is blood, press a cotton ball or gauze pad on your 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.
FILKRI
Manufactured by:
Accord BioPharma Inc.
Manufactured at:
Intas Pharmaceuticals Limited
Plot No. 423/P/A, Sarkhej-Bavla Highway,
Moraiya, Ahmedabad, Gujarat 382213, India
Intas Pharmaceuticals Limited
Plot No. 423/P/A, Sarkhej-Bavla Highway,
Moraiya, Ahmedabad, Gujarat 382213, India
Approved: 01/2026