Generic Name
Filgrastim
Brand Names
NYPOZI txid, Releuko, Neupogen, Granix, Nivestym, Zarxio
FDA approval date: April 07, 1997
Classification: Leukocyte Growth Factor
Form: Injection
What is NYPOZI txid (Filgrastim)?
ZARXIO 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
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)
Summary: The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment effect.
A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
Summary: This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexat...
Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida/RIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1/2 Study
Summary: This phase I/II trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (...
Related Latest Advances
Brand Information
NYPOZI (filgrastim-txid)
1DOSAGE FORMS AND STRENGTHS
NYPOZI is a clear, colorless to slightly yellowish, preservative-free solution available as:
Prefilled syringe:
- Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard
- Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe with BD UltraSafe Passive™ Needle Guard
2CONTRAINDICATIONS
NYPOZI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products
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
Patients in the BMT studies received up to 138 mcg/kg/day without toxic effects, although there was a flattening of the dose response curve above daily doses of greater than 10 mcg/kg/day.
5DESCRIPTION
Filgrastim-txid, a leukocyte growth factor, is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim-txid is produced by
NYPOZI (filgrastim-txid) injection is a sterile‚ clear‚ colorless to slightly yellowish‚ preservative-free liquid containing filgrastim-txid at a specific activity of 1.3 ± 0.3 × 10
6HOW SUPPLIED/STORAGE AND HANDLING
NYPOZI (filgrastim-txid) injection is a clear, colorless to slightly yellowish, preservative-free solution supplied as prefilled syringes:
Single-dose‚ preservative-free, prefilled syringes with 29 gauge, half inch needle with a BD UltraSafe Passive™ Needle Guard, containing 300 mcg/0.5 mL of filgrastim-txid.
- Carton of 1 prefilled syringe (NDC 72374-101-01)
- Carton of 10 prefilled syringes (NDC 72374-101-10)
Single-dose‚ preservative-free, prefilled syringes with 29 gauge, half inch needle with a BD UltraSafe Passive™ Needle Guard, containing 480 mcg/0.8 mL of filgrastim-txid.
- Carton of 1 prefilled syringe (NDC 72374-102-01)
- Carton of 10 prefilled syringes (NDC 72374-102-10)
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 Instructions for Use of NYPOZI prefilled syringe with BD UltraSafe Passive™ Needle Guard, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of NYPOZI
Advise patients of the following risks and potential risks with NYPOZI:
- 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 patient 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 products 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
Instruct patients who self-administer NYPOZI using the prefilled syringes 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 NYPOZI prefilled syringe.
8Instructions for Use NYPOZI™ (ni-poz-ee) (filgrastim-txid) injection 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 NYPOZI before using these Instructions for Use.
Before you use a NYPOZI prefilled syringe, read this important information.
Storing your NYPOZI prefilled syringe
- Store the NYPOZI prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Do not freeze NYPOZI prefilled syringes.
- Keep the prefilled syringe in the original carton to protect it 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 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 NYPOZI left in the prefilled syringe.
- Keep the NYPOZI prefilled syringe 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.
- Make sure the name NYPOZI appears on the carton and prefilled syringe label.
- Do not inject a dose of NYPOZI less than 0.3 mL (180 mcg) from a NYPOZI prefilled syringe. A dose less than 0.3 mL cannot be accurately measured using the NYPOZI 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.
- 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. Use another prefilled syringe that has not been activated and is ready to use.
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 blister pack from the carton. On a clean, well-lit, flat surface, place the syringe blister pack 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.
- Keep the prefilled syringe in the blister pack until you are ready to use it.
- Do not leave the prefilled syringe in direct sunlight.
- Do not shake the prefilled syringe.
Open the blister pack by peeling away the cover. Grab the transparent needle guard to remove the prefilled syringe from the blister pack.
For safety reasons:
- Do not grab the plunger rod.
- Do not grab the gray needle cap.
B Inspect the medicine and prefilled syringe.
Turn the prefilled syringe so you can see through the viewing window and dose markings. Make sure the medicine in the prefilled syringe is clear and colorless to slightly yellowish.
Check to make sure that the plastic transparent needle guard is covering the barrel of the glass syringe. If the transparent needle guard is covering the gray needle cap (shown below), the needle guard has already been activated.
- 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 injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the:
- Prefilled syringe, and the following items, that are not included in the NYPOZI carton
- Alcohol wipe
- Cotton ball or gauze pad
- Adhesive bandage
- Sharps disposal container or other appropriate disposal container
Step 2: Get ready
D Prepare and clean your injection site
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 cleansed 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, scaly or hard. Avoid injecting into areas with scars or stretch marks.
E Hold the prefilled syringe by the syringe barrel (the clear plastic needle guard) with the needle pointing up. Carefully pull the gray needle cap straight off and away from your 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 away the gray needle cap into the sharps or other appropriate disposal container.
F
Check your prescription before you inject your dose
Check your prescription before you inject your doseYour healthcare provider has prescribed either a "full" syringe dose or a "partial" syringe dose of NYPOZI.
- 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 NYPOZI, start with Step G below.
G Check the syringe for an air bubble. Point the needle up and gently tap the syringe with your fingers until the air bubble rises to the top of the syringe.
H Hold the syringe as shown below and press slowly on the plunger to push out the excess medicine until the top edge of the conical base of the plunger stopper lines up with the syringe marking for your prescribed dose. As you push the plunger rod up, air and extra medication is removed. Check to make sure the plunger lines up with the syringe markings for your prescribed dose. If you remove too much medicine, get a new prefilled syringe and start again at Step 1.
- See the figure below (
- Call your healthcare provider if you have problems measuring your prescribed dose.
Step 3: Subcutaneous (under the skin) injection
I With one hand gently pinch the skin at the injection site to create a firm surface.
Important: Keep the skin pinched while injecting.
J Hold the pinch. With your other hand insert the needle into the skin at a 45 to 90 degree angle as shown.
K Using slow and constant pressure, slowly press down on the plunger rod as far as it will go so that the plunger head is completely between the needle guard wings.
- Do not pull back the plunger rod while the needle is inserted.
When done, keep the plunger fully pressed down while you carefully pull the needle straight out from the injection site
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
L
Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.
Keep your hands away from the needle at all times.
M Discard (throw away) your used prefilled syringe.
- Put the used prefilled syringe in a FDA-cleared sharps or other appropriate 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, syringes, and prefilled 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.
N Examine the injection site.
If there is blood, press a cotton ball or gauze pad on your injection site.
tanvex ™
(filgrastim-txid) Injection
(filgrastim-txid) Injection
Manufactured by:
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
9PRINCIPAL DISPLAY PANEL - (1) 0.5 mL Syringe Carton
1 x 300 mcg/0.5 mL Single-Dose Prefilled Syringe with a Needle Guard
NDC 72374-101-01
Rx Only
NYPOZI™
300 mcg/0.5 mL
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. Coli
If required for intravenous administration, dilute in 5% Dextrose Injection
Single-Dose Prefilled Syringe. Discard Unused Portion.
tanvex
10PRINCIPAL DISPLAY PANEL - (10) 0.5 mL Syringe Carton
10 x 300 mcg/0.5 mL Single-Dose Prefilled Syringes with a Needle Guard
NDC 72374-101-10
Rx Only
NYPOZI™
300 mcg/0.5 mL
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. Coli
If required for intravenous administration, dilute in 5% Dextrose Injection to a
Single-Dose Prefilled Syringe. Discard Unused Portion.
Manufactured by:
tanvex
11PRINCIPAL DISPLAY PANEL - (1) 0.8 mL Syringe Carton
1 x 480 mcg/0.8 mL Single-Dose Prefilled Syringe with a Needle Guard
NDC 72374-102-01
Rx Only
NYPOZI™
480 mcg/0.8 mL
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. Coli
If required for intravenous administration, dilute in 5% Dextrose Injection
Single-Dose Prefilled Syringe. Discard Unused Portion.
tanvex
12PRINCIPAL DISPLAY PANEL - (10) 0.8 mL Syringe Carton
10 x 480 mcg/0.8 mL Single-Dose Prefilled Syringes with a Needle Guard
NDC 72374-102-10
Rx Only
NYPOZI™
480 mcg/0.8 mL
A Recombinant Granulocyte Colony Stimulating Factor (rG-CSF) derived from E. Coli
If required for intravenous administration, dilute in 5% Dextrose Injection to a
Single-Dose Prefilled Syringe. Discard Unused Portion.
Manufactured by:
tanvex
