Description

Ficocyte (filgrastim) is indicated for treatment:

- Shorten the time decreased neutrophils and reduced rates lower febrile neutropenia in patients treated with cytotoxic chemotherapy due to malignant diseases (excluding leukemia and chronic myeloid Assembly marrow dysplasia).

- Shorten the time of the neutropenia in patients treated with immunosuppressive drugs after bone marrow transplantation have an increased risk due to low neutrophil serious stretching.

For pediatric patients or adults with reduced neutropenia (congenital, cyclic, or idiopathic) with the number of absolute neutrophil count ≤ 0.5 x 109/lit, and a history of infection recurrent or severe infections, long-term use Ficocyte increase the number of neutrophils and decrease the rate of time and stages of infection.

- Ficocyte have the effect of reducing prolonged neutropenia in patients with advanced HIV infection (the number of neutrophils ≤ 1.0 x 109/lit), to reduce the risk of infection for these patients when the choice choose other treatment is not appropriate.

Composition

Each vial lyophilized powder contains:

Active ingredient: Filgrastim ......... 30 MU

Excipients: sodium acetate trihydrate, Mannitol, Tween 80.

Each vial of solvent containing dissolved together with 9 mg Benzyl alcohol in 1 mL of distilled water for injection.

Each vial drug solution (1 mL) contains:

Active ingredient: Filgrastim ......... 30 MU

Excipients: sodium acetate trihydrate, Tween 80, Benzyl alcohol, distilled water for injection.

Each drug prefilled syringe (0.5 mL) contains:

Active ingredient: Filgrastim ......... 30 MU

Excipients: sodium acetate trihydrate, Benzyl alcohol, Tween 80, distilled water for injection.

Theraputic Indications

- FICOCYTE is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
- The safety and efficacy of FICOCYTE are similar in adults and children receiving cytotoxic chemotherapy.
- FICOCYTE is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
- In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an ANC of 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of FICOCYTE is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
FICOCYTE is indicated for the treatment of persistent neutropenia (Absolute neutrophil count (ANC) less than or equal to 1.0 x109/L) in patients with advanced HIV infection inappropriate.

Administration route: SC or IV injection

Contradications

FICOCYTE should not be administered to patients :
- Hypersensitivity to the active substance or to any of the excipients. FICOCYTE should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
- With severe congenital neutropenia (Kostman's syndrome) with abnormal cytogenetics.

STORAGE, SHELF-LIFE AND PACKING UNITS

Storage: Store at 2°C - 8°C. Do not freeze. Protect from light. The solution for injection should be inspected visually for particulate matter and discoloration before administration.
Shelf life: 24 months from manufacturing date.
Reconstituted solution was stable for 7 days at 2°C - 8°C.

Packing units:
Box of 01 or 05 vial(s) of FICOCYTE 30 MU/48 MU lyophilized powder and 1 vial solvent (1 mL)
Box of 01 or 05 vial(s) of FICOCYTE 30 MU/48 MU solution for injection (1 mL)
Box of 01, 06 or 12 prefilled syringe(s) of FICOCYTE 30 MU/48 MU solution for injection (0.5 mL)