Neupogen is 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 [see Clinical Studies (14.1)] Neupogen (filgrastim) is a man-made form of a protein that stimulates the growth of white blood cells in your body. White blood cells help your body fight against infection. Neupogen is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions
NEUPOGEN is 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 [see Clinical Studies (14.1)] Used to reduce the duration of neutropenia and incidence of infection in patients receiving myelosuppressive chemotherapy or myeloablative chemotherapy followed by bone marrow transplant; also used for the mobilization of peripheral blood progenitor cells for leukapheresis, for the treatment of severe chronic neutropenia, and to improve survival following acute radiation exposur
NEUPOGEN ® (filgrastim) 1,2 Patients with Cancer Receiving Myelosuppressive Chemotherapy ZARXIO is 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 Neupogen, Zarxio, Nivestym Indicated for long-term administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic.. 1 INDICATIONS NEUPOGEN® (filgrastim for injection) is indicated for: • Cancer Patients Receiving Myelosuppressive Chemotherapy NEUPOGEN (filgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies (see Patients with Acut
A. FDA-Approved Indications Neupogen 1. Patients with Cancer Receiving Myelosuppressive Chemotherapy Neupogen is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated wit Mortality in both the 10.0 Gy and 11.0 Gy cohorts suggested that early administration of Neupogen® at day 1 post exposure may affect acute GI-ARS mortality, while Neupogen® appeared to mitigate mortality due to the H-ARS. However, the study was not powered to detect statistically significant differences in survival Nivestym (filsgrastim-aafi) are biosimilars to Neupogen and approved for most indications as Neupogen. The FDA defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product (1-5). References 1. Neupogen [package insert]
Neupogen ® (filgrastim) is a drug that has been used successfully for cancer patients to stimulate the growth of the white blood cells, making patients less vulnerable to infections, it is expected to help patients who have bone marrow damage from very high doses of radiation in much the same way Indications for rG-CSF only (J1440/J1441, J2505) • In adult and pediatric cancer patients receivin g myelosuppressive chemotherapy • Decreasing the duration of neutropenia and fever after the completion of AML induction or consolidation chemotherapy in adult patients . Indications for G-CSF only (J1440/J1441 Neupogen 480 mcg vial: 90 vials per 30 days Neupogen 480 mcg SingleJect: 90 syringes per 30 days B. Max Units (per dose and over time) [Medical Benefit]: Severe Chronic Neutropenia: 1380 billable units per day BMT or PBPC or Radiation: 1200 billable units per day All other indications: 600 billable units per day III Purpose: Filgrastim (NEUPOGEN ®) is the originator recombinant human granulocyte colony-stimulating factor widely used for preventing neutropenia-related infections and mobilizing hematopoietic stem cells
Filgrastim/Neupogen An indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but i Neupogen is being used in combination with epoetin or Aranesp (darbepoetin), AND Diagnosis is not an auto immune disorder, patient is not a burn patient, chronic myeloid leukemia (CML), or a chronic infection, AND Dose does not exceed 10mcg/kg/day. 5) For prevention or reduction of radiation-induced neutropenia Giving Yourself an Injection of Filgrastim (Neupogen®) or Pegfilgrastim (Neulasta®) With a Prefilled Syringe - Last updated on December 11, 2018 All rights owned and reserved by Memorial Sloan Kettering Cancer Cente
markets, G-CSF is commercially available as filgrastim (Neupogen) and lenograstim (Granocyte, Neutrogin, Myelostim); a biosimilar form of filgrastim (filgrastim-sndz, Zarxio) was approved in the United States Coverage Indications, Limitations, and/or Medical Necessity White blood cell growth factors, also known as granulocyte colony stimulating factors (G-CSF), are administered to enhance recovery of blood related functions in neutropenia (low white blood count) including febrile neutropenia (FN)
Neupogen, Granix, and Leukine brands of short-acting CSFs are more costly to Aetna than other short-acting CSFs, Zarxio and Nivestym, for certain indications. There is a lack of reliable evidence that Neupogen, Granix, and Leukine are superior to Zarxio and Nivestym short-acting CSFs for medically necessary indications listed below The supply of Neupogen will remain in Amgen's rotating inventory, and would be sold and administered for other indications. The value of Neupogen's new indication to Amgen—or any other company—is unclear. In 2013, an FDA Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee USES: This medication stimulates the blood system (bone marrow) to make white blood cells, helping you fight infections. This medication is given to those whose ability to make white blood cells has been reduced
WebMD provides common contraindications for Neupogen injection. Find out what health conditions may be a health risk when taken with Neupogen injectio A. FDA-Approved Indications Neupogen 1. Patients with Cancer Receiving Myelosuppressive Chemotherapy Neupogen is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated wit
Filgrastim (Neupogen ®) and its biosimilars, filgrastim-sndz (Zarxio ®), filgrastim-aafi (Nivestym ™), ®and tbo-filgrastim (Granix), are human granulocyte colony-stimulating factors. FDA Approved Indication(s) Granix is indicated to reduce the duration of severe neutropenia in adult and pediatric patients The use of NEUPOGEN to increase survival in pediatric patients acutely exposed to myelosuppressive doses of radiation is based on studies conducted in animals and clinical data supporting the use of NEUPOGEN in other approved indications [see Dosage and Administration ( 2.1 to 2.4 ) and Clinical Studies ( 14.6 )] . 8.5 Geriatric Use Among 855. Does NEUPOGEN Interact with other Medications? Severe Interactions . These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in. Neupogen, Neulasta, Nivestym, Fulphila, Udenyca, Ziextenzo, Zarxio, or Leukine: May also be considered medically necessary for any of the following: 2. Secondary Prophylaxis - prevention of FN when a previous cycle of chemotherapy resulted in a neutropenic complication and for which primary prophylaxis was not received, and a dose reduction wil
Filgrastim (Neupogen ®) and its biosimilars, filgrastim-sndz (Zarxio ®) and tbo-filgrastim (Granix ®), are human granulocyte colony-stimulating factors. FDA Approved Indication(s) Granix is indicated for reduction in the duration of severe neutropenia in patients with non-myeloi Neulasta is a peglated version of Neupogen which is also know as filgrastim. It's used to stimulate production of neutrophils, a component of whilte blood cells. It can be taken less often than regular 'ol Neupogen. I found it rougher than Neupgen in that it had some side effects, mainly bone pain. I found Neupogen to be side-less
Amgen's biologic is often used off-label in healthy stem cell donors; advisory committee members distinguished between some Neupogen indications in discussing whether extrapolation was appropriate In the U.S., NIVESTYM is indicated: 2 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 The specific dosing depends on the indication for use. In the outpatient setting, it is much more common to administer peg-filgrastim (Neulasta). It is administered as a single 6mg subcutaneous injection. Only a single dose per cycle of chemotherapy is necessary. A newer formulation of peg-filgrastim, the Neulasta OnPro is another convenient.
Neupogen and Zarxio are used to increase white blood cell counts to help reduce the risk of infection, as in patients receiving chemotherapy. For more information on Neupogen see the manufacturer website here. Can Zarxio be used for all the same indications as Neupogen? Yes. Zarxio can be used for the same indications as Neupogen The first FDA approved biosimilar for distribution in the United States is now available! Zarxio is an alternative to Neupogen (its reference biologic) and will be offered at a reduced cost.. Zarxio is considered a specialty medication but will be available for open distribution. Open distribution means that the medication can be dispensed by any licensed pharmacy—and you won't need. Neupogen (filgrastim), and approved for most indications as Neupogen. Zarxio and Nivestym are granulocyte colony-stimulating factors (G-CSF), which are made using the bacteria Escherichia coli. G-CSF is a substance naturally produced by the body. It stimulates the growt
Neupogen became the first FDA approved drug in March 2015 for the indication of radiation induced myelosuppression, following a nuclear incident, the hematopoietic syndrome of Acute Radiation. (Neupogen ®, Granix® For which of the following indications is the requested medication being prescribed? Primary prophylaxis of febrile neutropenia in a patient with a solid tumor or non-myeloid malignancy . Has the patient received, is currently receiving, or will be receiving myelosuppressive anti-cancer therapy that is expected to. Neulasta and neupogen for acute myeloid leukemia: An Update - pro. Myeloid growth factors granulocyte-colony stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) have been extensively studied in acute leukemias. Whether administered before, during, or after chemotherapy for acute myeloid and acute.
NEUPOGEN® is the Amgen Inc. trademark for Filgrastim, which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF). NEUPOGEN® is a 175 amino acid protein manufactured by recombinant DNA technology Amgen's Neupogen labeling carries a relatively broad adjunct cancer indication for the granulocyte-colony stimulating factor (G-CSF) product. The indication approved by FDA on Feb. 21 points toward use of the product by about 200,000 to 400,000 patients with febrile neutropenia resulting from myelosuppressive chemotherapy. Neupogen is indicated to decrease the incidence of infection, as. NIVESTYM is an FDA-approved biosimilar* to Neupogen® (ﬁlgrastim), brought to you by Pﬁzer1 • NIVESTYM is approved for all eligible indications of Neupogen1 • NIVESTYM has an identical dosing schedule and route of administration to Neupogen1 • NIVESTYM is highly similar to Neupogen, with no clinically meaningful differences in terms of safety
Neupogen: [ noo´po-jen ] trademark for a preparation of filgrastim , a granulocyte colony-stimulating factor that stimulates hematopoiesis and decreases neutropenia Complete the following questions if Granix, Zarxio, or Neupogen is being prescribed. If Nivestym is being . prescribed, skip to diagnosis section. 4. Is the product being requested for the treatment of one of the following indications? Neutropenia associated with myelosuppressive anti-cancer therap NEW YORK--Neupogen, Amgen's recombinant granulocyte colony-stimulatingfactor (G-CSF, filgrastim) has received FDA approval for use intreating severe chronic neutropenia. In 1991, the agent was approved for use in cancer patients onvarious chemotherapy regimens, and in 1994 it was licensed foruse in bone marrow transplants Neupogen is not considered medically necessary for indications other than those listed above due to insufficient evidence of therapeutic value. Applicable Procedure Codes J1442 Injection, filgrastim (g-csf), excludes biosimilars, 1microgram (1 mcg=1 billable unit Neupogen for all of the five currently approved indications held by US-licensed Neupogen. These include: decreasing the incidence of infections in patients with non-myeloid malignancie
Filgrastim (Neupogen®, Zarxio®, Nivestym®) is a Supportive Care Therapy to prevent or treat Neutropenic Fever. How does filgrastim work? Filgrastim is designed to lower risk of infection after chemotherapy. It is part of a family of drugs called granulocyte colony-stimulating factor (G-CSF), or growth factor Neupogen (filgrastim) can continue to receive Neupogen (filgrastim) for the duration of the EAP approval period. The ministry will also consider EAP renewal requests for Neupogen (filgrastim) for patients with existing EAP approvals. 3. What is difference between Grastofil (filgrastim) and Neupogen (filgrastim) iii. All of Neupogen's biosimilars are approved for the same indications as Neupogen with the exception of use to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). That indication is protected by Orphan Drug Exclusivity until March 30, 2022
Filgrastim 600mcg/mL; for SC inj or IV infusion; preservative-free Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies - CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, an Because NEUPOGEN® is produced in E coli‚ the product is nonglycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN® is a sterile‚ clear‚ colorless‚ preservative-free liquid for parenteral administration containing Filgrastim at a specific activity of 1.0 ± 0.6 x 10 8 U/mg (as measured by a cell mitogenesis assay.
• Filgrastim (Neupogen language and/or specific clinical indications for its use, please consult your physician. Policy BCBSNC will provide coverage for White Blood Cell Growth Factors when it is determined to be medically necessary because the medical criteria and guidelines shown below are met Neupogen, Neulasta, and Leukine are FDA-approved for the indication of acute exposure to myelosuppressive doses of radiation. If there are very significant shortages of medical countermeasures, including myeloid cytokines, senior medical incident managers may recommend modification of standard dosing schedules The use of NEUPOGEN for PBPC mobilization in healthy donors is not an approved indication. capillary leak syndrome Capillary leak syndrome (CLS) has been reported after G-CSF administration, including NEUPOGEN, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration Brand Names: Neupogen, Neupogen SingleJect, Nivestym, Zarxio Generic Name: filgrastim. What is filgrastim? What are the possible side effects of filgrastim? What is the most important information I should know about filgrastim? What should I discuss with my healthcare provider before using filgrastim? How should I use filgrastim The prescribing information for Neupogen lists its five indications as follows: cancer patients receiving myelosuppressive chemotherapy: Neupogen is indicated to decrease the incidence of. In the case of Neupogen, Amgen obtained approval for one indication in 1991 but did not have approval for all five of Neupogen's indications until 1998. On January 7, the Oncologic Drugs Advisory Committee met and agreed with FDA's finding that Sandoz's product is a biosimilar of Neupogen