Fulphila
Generic Name: Pegylated Granulocyte Colony Stimulating Factor Injection (PEG-GCSF injection) 6 mg/0.6 mL
Dosage Form: Injection
TG Name: Oncology
1. What is Fulphila®
Fulphila® (6 mg/ 0.6 ml prefilled syringe) is USFDA and EMA approved first Biosimilar Pegfilgrastim which is a granulocyte colony stimulating factor (GCSF) used as a supportive treatment of chemotherapy.
2. How Fulphila® works in our body?
Pegfilgrastim is a pegylated, recombinant from of endogenous granulocyte colony stimulating factor (GCSF) that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.
3. What is the indication of Fulphila®?
Fulphila is a leukocyte growth factor indicated to
- Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
4. What are the dosage & administration of Fulphila®?
Patients with cancer receiving myelosuppressive chemotherapy.
- 6 mg administered subcutaneously once per chemotherapy cycle.
- Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy.
- Use weight based dosing for pediatric patients weighing less than 45 kg; refer to following Table:
| Body Weight | Fulphila Dose | Volume to Administer |
| Less than 10 kg | 0.1 mg/kg | 0.01 mL/kg |
| 10 to 20 kg | 1.5 mg | 0.15 mL |
| 21 to 30 kg | 2.5 mg | 0.25 mL |
| 31 to 44 kg | 4 mg | 0.4 mL |
5. What are the contraindications of Fulphila®?
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as Pegfilgrastim or Filgrastim products.
6. What are the adverse effects of Fulphila®?
Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.
7. What would be the storage condition of Fulphila®?
Store Fulphila in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Take Fulphila out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an Injection.
