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FULPHILA™ SOLUTION FOR INJECTION IN PREFILLED SYRINGE 6MG/0.6ML [SIN16012P]
Active ingredients: FULPHILA™ SOLUTION FOR INJECTION IN PREFILLED SYRINGE 6MG/0.6ML
Last updated 26 October 2025
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Product Info
FULPHILA™ SOLUTION FOR INJECTION IN PREFILLED SYRINGE 6MG/0.6ML
[SIN16012P]
Product information
Active Ingredient and Strength | PEGFILGRASTIM - 6 MG/0.6 ML |
Dosage Form | INJECTION, SOLUTION |
Manufacturer and Country | BIOCON BIOLOGICS INDIA LIMITED - INDIA |
Registration Number | SIN16012P |
Licence Holder | ZUELLIG PHARMA PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L03AA13 |
THERAPEUTIC INDICATIONS
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Posology and Method of Administration
Fulphila™ therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Posology
One 6 mg dose (a single pre-filled syringe) of Fulphila™ is recommended for each chemotherapy cycle, given at least 24 hours (not above 30°C) after cytotoxic chemotherapy.
Special Populations
Paediatric population
The safety and efficacy of Fulphila™ in children has not yet been established. Currently available data are described below but no recommendation on a posology can be made.
Patients with renal impairment
No dose change is recommended in patients with renal impairment.
Method of administration
Fulphila™ is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, refer to section "special warnings and precautions for use" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.