Alternate Name(s):
G-CSF: NEUPOGEN®, GRASTOFIL® (filgrastim biosimilar), NIVESTYM ® (filgrastim biosimilar)
Classification:
Hematopoietic colony stimulating factor
Original Date:
August 2005
Revised Date:
February 2021
Indications:
- To decrease incidence of febrile neutropenia and its sequelae in patients with
• Non-myeloid malignancies receiving myelosuppressive chemotherapy
• Following induction and consolidation treatment for acute myeloid leukemia
• Myeloablative chemotherapy followed by bone marrow transplantation (BMT) - For chronic administration to increase neutrophil counts and to reduce the incidence and duration of infection in patients with a diagnosis of congenital, cyclic or idiopathic neutropenia
- For patients with HIV infection for the prevention and treatment of neutropenia, to maintain a normal ANC
Grastofil and Nivestym are subsequent entry biologic drugs. Comparability has been established with the reference product, Neupogen; however Grastofil and Nivestym are not interchangeable with the reference product
Reconstitution and Stability:
- Different filgrastim products are not interchangeable
- Refrigerate. Protect from light. Avoid vigorous shaking.
- Freezing should be avoided. For information regarding accidental one-time exposure to temperatures greater than 25ºC or exposure to freezing temperatures, please consult individual product monograph
Neupogen (filgrastim) and Nivestym (filgrastim biosimilar)
- Available as 300 mcg/1 mL and 480 mcg/1.6 mL single-use (preservative free) vials (concentration of 300 mcg/mL) as well as 300 mcg/0.5 mL and 480 mcg/0.8 mL single-use (preservative free) prefilled syringes (concentration of 600 mcg/mL)
- Neupogen (filgrastim) may be kept at room temperature for a maximum of 14 days prior to use. Prefilled syringe system contains natural rubber (a derivative of latex).
- Nivestym (filgrastim biosimilar) may be allowed to reach room temperature for a maximum of 15 days. Vials are single use; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration
- Grastofil (filgrastim biosimilar)
- Available as 300mcg/0.5 mL and 480 mcg/0.8 mL single-use (preservative free) prefilled syringes (concentration of 600 mcg/mL). Prefilled syringe system contains natural rubber (a derivative of latex).
- Can be removed from the refrigerator and stored at room temperature for one single period up to 15 days.
Compatibility:
- Solutions Compatible: D5W ONLY
- Y-site Compatible:
- Incompatible: SALINE SOLUTIONS
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | YES, preferred route, biologic activity is extended |
| IM | NO |
| IV Push |
NO |
| IV Intermittent Infusion | YES (vials only)
May be used for oncology patients, but only in exceptional circumstances Flush line with 20 mL D5W prior to infusing filgrastim Usual dilution: 5 - 15 mcg/mL
Infusion time: over 15 minutes |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- Chemotherapy-induced neutropenia (including post-stem cell transplant):
- Usual Dose: 5 mcg/kg/day for up to 2 weeks, until the ANC has reached 10 x 109/L (or protocol specific target) following the expected chemotherapy-induced neutrophil nadir.
- If patient cannot achieve this ANC count by the time the next course of chemotherapy is due OR the patient continues to require admission for febrile neutropenic episodes (despite filgrastim) the dosage may be increase up to 10 mcg/kg/day.
- Peripheral Blood Progenitor Cell (PBPC) mobilization:
- 10 mcg/kg/day, given for at least 4 days before the first leukapheresis and continued to the day of the last leukapheresis
** Dosage may differ according to protocol; refer to specific treatment protocol.
** Different filgrastim products are not interchangeable
Potential hazards of parenteral administration:
- Minor bruising or inflammation at subcutaneous injection sites
- Transient bone pain, most commonly in sternum, pelvis and/or lower back (can be treated with acetaminophen)
- Allergic-type reactions; dyspnea, wheezing, hypotension, syncope, urticaria, facial edema and anaphylaxis have occurred (rare)
- Mild to moderate, reversible increases in LDH, alkaline phosphatase and uric acid (rare)
- Glomerulonephritis, cutaneous vasculitis, splenomegaly, acute respiratory distress syndrome (possibly due to the influx of neutrophils to the inflammation sites on the lungs) and Capillary leak syndrome have occurred (rare)
Notes:
- Filgrastim should be started at least 24 hours after the last chemotherapy dose and discontinued at least 24 hours before chemotherapy. Do not discontinue filgrastim until patient has passed the neutrophil nadir (at least 7-10 days post start of chemotherapy)
- Filgrastim will cause initial marrow egress and demargination of neutrophils and neutrophil counts 1-4 days after starting filgrastim may be as high as 30-40 x 109 cells/L. Filgrastim may be stopped for one or two days during this period but will have to be restarted shortly thereafter.
- ANC can drop by approximately 50% within 1 or 2 days after stopping filgrastim
References:
- Amgen Canada. "Neupogen (filgrastim)" product monograph. Version January 8, 2021
- Lexicomp. "Neupogen". Accessed 31Oct2018, 11Feb2021
- Apotex Inc. Grastofil. Product monograph. Version. December 27, 2019
- Pfizer Canada. Nivestym. Product Monograph. Version. April 16, 2020