Alvograstim

Alvograstim Dosage/Direction for Use

filgrastim

Manufacturer:

MR Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Dosage/Direction for Use
Established cytotoxic chemotherapy: The recommended daily dose of Alvograstim is 0.5 MIU (5 µg)/kg. The first dose of Alvograstim should not be administered less than 24 hours following cytotoxic chemotherapy.
This medicine may be given as a daily subcutaneous injection. Daily dosing with Alvograstim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Following established chemotherapy for solid tumours, lymphomas and lymphoid leukaemia, it is expected that the duration of treatment required to fulfill these criteria will be up to 14 days.
Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 to 2 days after initiation of therapy. However, for a sustained therapeutic response, Alvograstim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range. Premature discontinuation of therapy, prior to the time of the expected neutrophil nadir, is not recommended.
In patients treated with myeloablative therapy followed by bone marrow transplantation: The recommended starting daily dose of Alvograstim is 1.0 MIU (10 µg)/kg given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 µg)/kg given by continuous 24 hour subcutaneous infusion.
Alvograstim should be diluted in 20 ml of 5% glucose solution (see Cautions for Usage).
The first dose should not be administered less than 24 hours following cytotoxic chemotherapy and within 24 hours of bone marrow infusion.
Once the neutrophil nadir has been passed, the daily dose should be titrated against the neutrophil response as shown in Table 2.

Click on icon to see table/diagram/image

For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation: The recommended daily dose for PBPC mobilisation when used alone is 1.0 MU (10 µg)/kg as a 24 hour subcutaneous continuous infusion or a single daily subcutaneous injection for 5 to 7 consecutive days.
For infusions, Alvograstim should be diluted in 20 ml of 5% glucose solution (see Cautions for Usage). Timing of leukapheresis: one or two leukapheresis on days 5 and 6 are often sufficient. In other circumstances, additional leukapheresis may be necessary. Alvograstim dosing should be maintained until the last leukapheresis.
The recommended daily dose for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 µg)/kg given by subcutaneous injection from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range. Leukapheresis should be performed during the period when the ANC rises from <0.5 x 109/L to >5.0 x 109/L. For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient. In other circumstances, additional leukapheresis are recommended.
For the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation: For PBPC mobilisation in normal donors, Alvograstim should be administered at 10 µg/kg/day subcutaneously for 4 to 5 consecutive days. Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
In patients with severe chronic neutropenia (SCN): Congenital neutropenia: The recommended daily starting dose is 1.2 MIU (12 μg)/kg subcutaneously as a single dose or in divided doses.
Idiopathic or cyclic neutropenia: The recommended daily starting dose is 0.5 MIU (5 µg)/kg subcutaneously as a single dose or in divided doses.
Dose adjustments: Chronic daily administration is required to maintain clinical benefit.
Absolute neutrophil count should not be used as the sole indication of efficacy. The dose should be individually adjusted based on the patients' clinical course as well as ANC.
In the SCN post-marketing surveillance study, the reported median daily doses of Alvograstim were: 6.0 mcg/kg (congenital neutropenia), 2.1 mcg/kg (cyclic neutropenia) and 1.2 mcg/kg (idiopathic neutropenia). In rare instances, patients with congenital neutropenia have required doses of Alvograstim ≥100 mcg/kg/day.
Dilution: If required, Alvograstim may be diluted in 5% dextrose. The medicine diluted to concentrations between 5 and 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL.
When diluted in 5% glucose or 5% glucose plus Albumin (Human), Alvograstim is compatible with glass bottles, PVC and polyolefin IV bags, and polypropylene syringes.
Dilution of the medicine to a final concentration of less than 5 mcg/mL is not recommended at any time. Do not dilute with saline at any time; product may precipitate.
Other particulars: Alvograstim therapy should only be given in collaboration with an oncology centre which has experience in G-CSF treatment and haematology and has the necessary diagnostic facilities. The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
In patients with HIV infection: For reversal of neutropenia: The recommended daily starting dose is 0.1 MIU (1 µg)/kg given daily by subcutaneous injection with titration up to a maximum of 0.4 MU (4 µg)/kg until a normal neutrophil count is reached and can be maintained (ANC >2.0 x 109/L). In clinical studies, >90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days. In a small number of patients (<10%), doses up to 1.0 MU (10 µg)/kg daily were required to achieve reversal of neutropenia.
For maintaining normal neutrophil counts: When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established. Initial dose adjustment to alternate day dosing with 30 MIU (300 µg)/day by subcutaneous injection is recommended. Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at >2.0 x 109/L.
In clinical studies, dosing with 30 MIU (300 µg)/day on 1 to 7 days per week was required to maintain the ANC >2.0 x 109/L, with the median dose frequency being 3 days per week. Long-term administration may be required to maintain the ANC >2.0 x 109/L.
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