Alternate Name(s):
PEG-GCSF: NEULASTA®, FULPHILA™ (peg-filgrastim biosimilar), NYVEPRIAT® (peg-filgrastim biosimilar) , LAPELGA (peg-filgrastim biosimilar) Ziextenzo® (peg-filgrastim biosimilar)
Classification:
Hematopoietic colony stimulating factor
Original Date:
February 2021
Indications:
- Decrease the incidence of infection (i.e. febrile neutropenia) in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic drugs.
- Fulphila, Lapelga, Nyvepriat, and Ziextenzo are subsequent entry biologic drugs. Comparability has been established with the reference product, Neulasta; however Fulphila, Lapelga, Nyvepriat, and Ziextenzo are not interchangeable with the reference product
Reconstitution and Stability:
- Different pegfilgrastim products are not interchangeable
- Commercially available as a pre-filled syringe (6 mg/0.6 mL); preservative free.
- Protect from light. Store in refrigerator. Do NOT shake vigorously.
- 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
- Neulasta® (peg-filgrastim): Stable at room temperature for up to 72 hours. Needle cover on the single-use prefilled syringe contains dry natural rubber (a derivative of latex)
- Fulphila (peg-filgrastim biosimilar): Stable at room temperature for up to 72 hours.
- Nyvepria (peg-filgrastim biosimilar): Stable at room temperature for up to 15 days (single period). Syringe plunger stopper and needle cover are not made with natural rubber latex.
- Lapelga (peg-filgrastim biosimilar): Stable at room temperature for up to 15 days (single period). Needle cover on the single-use prefilled syringe contains dry natural rubber (a derivative of latex)
- Ziextenzo (peg-filgrastim biosimilar): Stable at room temperature room temperature for up to 120 hours (single period)
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 |
| IM | NO |
| IV Push | NO |
| IV Intermittent Infusion | NO |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Give subcutaneously once per chemotherapy cycle, beginning at least 24 hours after completion of chemotherapy.
- Patients < 10 kg: 0.1 mg/kg
- Patients 10 to 20 kg: 1.5 mg
- Patients 21 to 30 kg: 2.5 mg
- Patients 31 to 44 kg: 4 mg
- Patients > 45 kg: 6 mg
** Dosage may differ according to protocol
Different filgrastim products are not interchangeable
Potential hazards of parenteral administration:
Common (>9%):
- 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)
Rare (<1%):
- Allergic-type reactions; dyspnea, wheezing, hypotension, syncope, urticaria, facial edema and anaphylaxis have occurred
- Glomerulonephritis, splenomegaly and splenic rupture, acute respiratory distress syndrome (possibly due to the influx of neutrophils to the inflammation sites on the lungs), antibody development and Capillary leak syndrome have occurred
Notes:
- Do not administer pegfilgrastim within 14 days of next course of chemotherapy.
References:
- Amgen Canada. "Neulasta (pegfilgrastim)" product monograph. Version January 8, 2021
- Lexicomp. "Neulasta". Accessed 31Oct2018: 11Feb2021
- BGP Pharma ULC. Fulphila (pegfilgrastim) product monograph. Version June 7th 2019
- Apotex Inc. Lapelga. Product Monograph. Version April 5th 2018
- Pfizer. Nyvepria Product Monograph. Version October 28th 2020
- Sandoz. ZIEXTENZ. Product Monograph. Version October 19th 2020