Product Information
Registration Status: ActiveFULPHILA™ SOLUTION FOR INJECTION IN PREFILLED SYRINGE 6MG/0.6ML is approved to be sold in Singapore with effective from 2020-09-21. It is marketed by MYLAN PHARMACEUTICALS PTE LTD, with the registration number of SIN16012P.
This product contains Pegfilgrastim 6mg/0.6 ml in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Biocon Limited in INDIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Pegfilgrastim is a modified form of filgrastim which has been PEGylated at the N terminus. It is a form of human G-CSF (Granulocyte colony stimulating factor) consisting of 175 residues and is produced from E. coli via bacterial fermentation. The first biosimilar was approved in June 2018 by Mylan NV as Fulphila (pegfilgrastim-jmdb).
Indication
Pegfilgrastim is indicated for use in patients receiving myelosuppressive chemotherapy for non-myeloid malignancies to reduce the incidence of infection.
Mechanism of Action
Pegfilgrastim binds to the G-CSF receptor. As a G-CSF analog, it controls proliferation of committed progenitor cells and influences their maturation into mature neutrophils. Pegfilgrastim also stimulates the release of neutrophils from bone marrow storage pools and reduces their maturation time. Pegfilgrastim acts to increase the phagocytic activity of mature neutrophils. In patients receiving cytotoxic chemotherapy, pegfilgrastim can accelerate neutrophil recovery, leading to a reduction in duration of the neutropenic phase.
Pharmacokinetics
- Absorption
- Pegfilgrastim has an absolute bioavailability of 60-70% [A29]. It is slowly absorbed following subcutaneous administration with a time to peak concentration of about 1-2 days. It is thought that the lymphatic system plays a large role in absorption due to the large size of the protein and attached PEG group.
- Distribution
- Pegfilgrastim appears to have a volume of distribution of approximately 170L [A33290].
- Metabolism
- Pegfilgrastim is thought to be broken down into amino acids similarly to endogenous proteins.
- Elimination
Clearance
Clearance is not well characterized as pegfilgrastim is primarily cleared by granulocytes as part of a negative feedback system [A29]. Clearance increases as the number of granulocytes increases.
Toxicity
The most common adverse events experienced included bone pain and extremity pain [FDA Label]. Rarely, leukocytosis was observed after pegfilgrastim administration. As a protein, pegfilgrastim has the potential for immunogenicity but this was observed in less than 1% of studied patients.
Active Ingredient/Synonyms
Granulocyte colony-stimulating factor pegfilgrastim | Peg-filgrastim | pegfilgrastim-jmdb | Pegfilgrastim |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.