What is Filergim?
Filergim injection is used to treat neutropenia (low white blood cells) that is caused by cancer medicines. It is a synthetic (man-made) form of a substance that is naturally produced in your body called a colony stimulating factor. Filergim helps the bone marrow to make new white blood cells.
When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Filergim is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. Filergim is also used to help the bone marrow recover after a bone marrow transplantation, for a process called peripheral blood progenitor cell collection in cancer patients, and to improve survival in cancer patients who have been exposed to radiation.
Filergim is available only with your doctor's prescription.
Filergim indications
Established Cytotoxic Chemotherapy: Filergim is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Peripheral Blood Progenitor Cell Mobilization (PBPC): Filergim is indicated for the mobilization of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy in order to accelerate hematopoetic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. The safety and efficacy of Filergim are similar in adults and children receiving cytotoxic chemotherapy. Filergim is indicated for the mobilization of peripheral blood progenitor cells in normal volunteers for use in allogeneic peripheral blood progenitor cell transplantation.
Severe Chronic Neutropenia (SCN): In patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an ANC of ≤0.5x109/L, and a history of severe or recurrent infections, long-term administration of Filergim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
HIV Infection: Filergim is indicated for the treatment of persistent neutropenia (ANC ≤1.0 x 109/L) in patients with advanced HIV infection, in order to reduce risk of bacterial infections, when other options to manage neutropenia are inappropriate.
Patients with Acute Myeloid Leukemia (AML): Filergim is indicated to reduce the duration of neutropenia and related clinical sequelae in patients undergoing induction or consolidation chemotherapy.
How should I use Filergim?
Use Filergim as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Filergim. Talk to your pharmacist if you have questions about this information.
- Do not shake Filergim. Shaking may damage Filergim. If the vial or syringe has been shaken, the solution may appear foamy and should not be used.
- Filergim is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Filergim at home, a health care provider will teach you how to use it. Be sure you understand how to use Filergim. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Filergim if it contains particles, is cloudy or discolored, or if the vial or syringe is cracked or damaged.
- Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them in a puncture-proof container as instructed by your health care provider.
- Choose a new site each time you inject Filergim. Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks.
- Discard any unused portion of medicine left in the vial or syringe.
- Continue to use Filergim for the full course of treatment. Do not miss any doses.
- Filergim works best if it is used at the same time each day.
- If you use Filergim because you also receive chemotherapy, the last dose of Filergim should be used at least 24 hours before your next dose of chemotherapy.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Filergim, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Filergim.
Uses of Filergim in details
Use: Labeled Indications
Chemotherapy-induced myelosuppression in nonmyeloid malignancies:
Filergim and Filergim biosimilars: To decrease the incidence of infection (neutropenic fever) in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a significant incidence of severe neutropenia with fever
Tbo-Filergim: To decrease the duration of severe neutropenia in adult and pediatric patients ≥1 month of age with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant incidence of neutropenic fever
Acute myeloid leukemia (AML) following induction or consolidation chemotherapy (Filergim and Filergim biosimilars): To reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy in adults with AML
Bone marrow transplantation (Filergim and Filergim biosimilars): To reduce the duration of neutropenia and neutropenia-related events (eg, neutropenic fever) in patients with nonmyeloid malignancies receiving myeloablative chemotherapy followed by marrow transplantation
Hematopoietic radiation injury syndrome, acute (Filergim only): To increase survival in patients acutely exposed to myelosuppressive doses of radiation
Peripheral blood progenitor cell collection and therapy (Filergim and Filergim biosimilars): Mobilization of autologous hematopoietic progenitor cells into the peripheral blood for apheresis collection
Severe chronic neutropenia (Filergim and Filergim biosimilars): Long-term administration to reduce the incidence and duration of neutropenic complications (eg, fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital, cyclic, or idiopathic neutropenia
Note: Filergim (Filergim-aafi) and Zarxio (Filergim-sndz) are approved as biosimilars to Filergim (Filergim). In Canada, Grastofil is a biosimilar to Filergim (Filergim).
Off Label Uses
Alcoholic hepatitis (severe)
Data from a small randomized, non-blinded pilot study suggest Filergim may be safe and effective therapy and may improve liver function as well as survival in patients with severe alcoholic hepatitis.
Filergim description
Each powder for injection contains Filgrastim 30 MU and 48 MU.
It also contains the following excipients: Sodium acetate trihydrate, mannitol and polysorbate 80.
Filergim 30 MU Lyophilized Powder for Injection: Each vial of solvent contains benzyl alcohol 9 mg/mL.
Filergim 48 MU Lyophilized Powder for Injection: Each vial of solvent contains benzyl alcohol 14.4 mg/1.6 mL.
The reconstituted preparation with 1 mL solvent (containing benzyl alcohol 0.9%) results in a clear, colorless solution.
Each vial of 1 mL and 1.6 mL solution for injection contains Filgrastim 30 MU and 48 MU, respectively.
It also contains the following excipients: Sodium acetate trihydrate, polysorbate 80, benzyl alcohol and water for injection.
Each pre-filled syringe of 0.5 mL and 0.8 mL contains Filgrastim 30 MU and 48 MU, respectively.
It also contains the following excipients: Sodium acetate trihydrate, polysorbate 80, benzyl alcohol and water for injection.
Filergim (recombinant human granulocyte-colony stimulating factor, rH G-SCF) is produced by r-DNA technology in Escherichia coli.
Filergim dosage
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection:
Filergim: Filergim 300 mcg/mL (1 mL); Filergim 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]
Solution, Injection [preservative free]:
Filergim: Filergim-aafi 300 mcg/mL (1 mL); Filergim-aafi 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]
Solution, Subcutaneous [preservative free]:
Granix: tbo-Filergim 300 mcg/mL (1 mL); tbo-Filergim 480 mcg/1.6 mL (1.6 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Injection [preservative free]:
Filergim: Filergim 300 mcg/0.5 mL (0.5 mL); Filergim 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Filergim: Filergim-aafi 300 mcg/0.5 mL (0.5 mL); Filergim-aafi 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Zarxio: Filergim-sndz 300 mcg/0.5 mL (0.5 mL); Filergim-sndz 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Granix: tbo-Filergim 300 mcg/0.5 mL (0.5 mL); tbo-Filergim 480 mcg/0.8 mL (0.8 mL) [contains polysorbate 80]
Dosing: Adult
Note: Do not administer in the period 24 hours before to 24 hours after cytotoxic chemotherapy. May round the dose to the nearest vial size for convenience and cost minimization (ASCO [Ozer 2000]). Filergim (Filergim-aafi) and Zarxio (Filergim-sndz) are approved as biosimilars to Filergim (Filergim). In Canada, Grastofil is a biosimilar to Filergim (Filergim). International considerations: Dosages below expressed as micrograms; 1 mcg = 100,000 units (Hoglund 1998).
Acute myeloid leukemia (AML) following induction or consolidation chemotherapy (Filergim and Filergim biosimilars): SubQ, IV: 5 mcg/kg/day; doses may be increased by 5 mcg/kg (for each chemotherapy cycle) according to the duration and severity of the neutropenia; continue for up to 14 days until the ANC reaches 10,000/mm (Díaz 2000; Wagner 2001).
Filergim interactions
See also:
What other drugs will affect Filergim?
The safety and efficacy of Filergim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established. In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, the use of Filergim is not recommended in the period from 24 hrs before to 24 hrs after chemotherapy. Preliminary evidence from a small number of patients treated concomitantly with Filergim and 5-fluorouracil indicate that the severity of neutropenia may be exacerbated. Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Since lithium promotes the release of neutrophils, lithium is likely to potentiate the effect of Filergim. Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results.
Incompatibilities: Filergim should not be diluted with saline solutions. If required, Filergim may be diluted in 5% glucose.
Diluted Filergim may be adsorbed to glass and plastic materials. However, when diluted in 5% glucose solution, Filergim is compatible with glass and a variety of plastic including PVC, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Filergim side effects
See also:
What are the possible side effects of Filergim?
Filergim usually does not cause serious or life-threatening adverse effects and it only rarely has required discontinuance. Because most patients who receive Filergim have recently undergone cytotoxic chemotherapy, many of the adverse effects reported with Filergim therapy may actually result from the actions of the previously administered antineoplastic agents.
The most frequent adverse effect reported during Filergim therapy is deep, throbbing medullary bone pain, most often in the lower back, pelvis, ribs or sternum (eg, sites containing bone marrow). Sternal pain can imitate the pain of an acute myocardial infarction. The severity of the pain usually is increased in patients with more extensive leukocytosis. Non-opiate analgesics can alleviate this effect, and bone pain may spontaneously resolve with continued therapy.
Dose- or route-dependent, Filergim-induced leukocytosis (leukocyte count >100,000/mm3) can occur during therapy, and the drug should be discontinued if the absolute neutrophil count (ANC) rises >10,000/mm3 after the nadir is achieved. An ANC >10,000/mm3 will not increase the effectiveness of the drug, but can increase its toxicity.
Splenomegaly has been observed in both children and adults during therapy with Filergim, but is not common.
Filergim contraindications
See also:
What is the most important information I should know about Filergim?
You should not use this medication if you are allergic to Filergim or to other medicines that contain the E. coli bacteria.
Before using Filergim, tell your doctor if you have a blood cell disorder (such as sickle cell anemia), chronic myeloid leukemia, myelodysplasia (also called "preleukemia"), or if you are receiving chemotherapy or radiation treatment.
Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.
To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with Filergim. Your liver function will also need to be tested, and you may need bone density scans. Visit your doctor regularly.
Stop using Filergim and call your doctor at once if you have a serious side effect such as sudden or severe pain in your left upper stomach spreading up to your shoulder, rapid breathing or feeling short of breath, or signs of infection (fever, chills, sore throat, flu symptoms, easy bruising or bleeding, loss of appetite, nausea and vomiting, mouth sores, or unusual weakness).
Active ingredient matches for Filergim:
Filgrastim in Russian Federation.
List of Filergim substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| FILCAD | |
| FILCAD 300MG INJECTION 1 vial / 1 injection each (Cadila Pharmaceuticals Ltd) | $ 33.02 |
| Filgen (Argentina, Ecuador, Thailand) | |
| Filgen / vial 300 mcg/1 mL x 1's (Chandra Bhagat Pharma Pvt. Ltd.) | |
| Filgen / pre-filled syringe 300 mcg/1 mL x 1's (Chandra Bhagat Pharma Pvt. Ltd.) | |
| Filgen / vial 480 mcg/1.6 mL x 1's (Chandra Bhagat Pharma Pvt. Ltd.) | |
| Filgen 300mcg Syringe / 1 (Chandra Bhagat Pharma Pvt. Ltd.) | $ 30.11 |
| 300 mcg x 1's (Chandra Bhagat Pharma Pvt. Ltd.) | $ 30.11 |
| Filgen 300 mcg Injection (Chandra Bhagat Pharma Pvt. Ltd.) | $ 0.02 |
| FILGEN 300MG PREFILLED SYRINGE 1 packet / 1 prefilled syringe each (Chandra Bhagat Pharma Pvt. Ltd.) | $ 30.11 |
| Filgen inj 300 mcg/mL / vial 1's (Chandra Bhagat Pharma Pvt. Ltd.) | |
| Filgen inj 300 mcg/mL / pre-filled syringe 1's (Chandra Bhagat Pharma Pvt. Ltd.) | |
| Filgen inj 480 mcg/1.6 mL / vial 1's (Chandra Bhagat Pharma Pvt. Ltd.) | |
| FILGEN inj 300 mcg x 1ml (Chandra Bhagat Pharma Pvt. Ltd.) | $ 30.11 |
| Filgen 300mg Prefilled Syringe (Chandra Bhagat Pharma Pvt. Ltd.) | $ 30.11 |
| Filgrastim (Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia & Herzegowina, Bulgaria, Canada, Chile, Colombia, Croatia (Hrvatska), Cuba, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Jamaica, Kazakhstan, Kenya, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Turkey, Ukraine, United Kingdom, United States, Uruguay, Uzbekistan, Venezuela) | |
| Injectable; Injection; Filgrastim 0.3 mg / ml (Hexal) | |
| Injectable; Injection; Filgrastim 0.48 mg / ml (Hexal) | |
| Filgrastim 75 mcg/0.3 mL x 10's (Hexal) | |
| Filgrastim 150 mcg/0.6 mL x 10's (Hexal) | |
| Filgrastim 300 mcg/0.7 mL x 10's (Hexal) | |
| Filgrastim BS (Japan) | |
| Filgrastim BS F (Japan) | |
| Filgrastim BS Mochida (Japan) | |
| Filgrastim BS NK (Japan) | |
| Filgrastim BS Teva (Japan) | |
| Filgrastim Duncan (Argentina) | |
| Filgrastim fu (Uruguay) | |
| Filgrastim Hexal (Germany, Latvia, Lithuania, Luxembourg, Netherlands) | |
| Filgrastim HEXAL 30 Mio. E./0,5ml (Germany) | |
| Filgrastim HEXAL 48 Mio. E./0,5ml (Germany) | |
| Filgrastim Labot (Peru) | |
| Filgrastim ratiopharm (Lithuania) | |
| Filgrastim Roemmers (Colombia) | |
| Filgrastim Sedico (Egypt) | |
| Filgrastim-Mepha (Switzerland) | |
| Filgrastim-Teva (Switzerland) | |
| Filgrastim-Teva 30 Mio E/0.5ml (Switzerland) | |
| Filgrastim-Teva 48 Mio E/0.8ml (Switzerland) | |
| Filgrastima (Brazil) | |
| Filgrastine (Brazil) | |
| Filgratech (Peru) | |
| Fillif (India) | |
| Fillif 300mcg/mL INJ / 1 (Torrent) | $ 32.46 |
| FILLIF 300MCG PREFILLED SYRINGE 1 packet / 1 ML prefilled syringe each (Torrent) | $ 14.01 |
| FILLIF inj 300 mcg x 1 mL x 1ml (Torrent) | $ 32.46 |
See 410 substitutes for Filergim | |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
