Clinical Pharmacology Details


Filgrastim (Granulocyte Colony-Stimulating Factor, G-CSF)


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Indications & Dose:

Cytotoxic-induced neutropenia:



Prefer-ably by SC inj, or by IV infusion (over 30 minutes).


Adults & Children


500,000 units/kg daily started not less than 24 hours after cytotoxic chemotherapy, continued until neutrophil count in normal range, usually for up to 14 days.


Myeloablative therapy followed by bone-marrow transplantation: 



By IV infusion over 30 minutes or over 24 hours or by SC infusion over 24 hours. 1 million units/kg daily, started not less than 24 hours following cytotoxic chemotherapy (and with 24 hours of bone marrow infusion), then adjusted according to absolute neutrophil count.


Mobilisation of peripheral blood progenitor cells:



Used alone, by SC inj or by SC infusion over 24 hours. 1 million units/kg daily for 6 days; used following adjunctive myelosuppressive chemotherapy (to improve yeild), by Sc inj. 500,000 units/kg daily, started the day after completion of chemotherapy and continued until neutrophil count in normal range, for timing of leukapheresis.


Severe chronic neutropenia:


By SC inj.


Adults & Children



In severe congenital neutropenia,


initially 1.2 million units/kg daily in single or divided doses (initially 500,000 units/kg daily in idiopathic or cyclic neutropenia), adjusted according to response.


Reversal of neutropenia in advanced HIV infection:



By Sc inj. initially 100,000 units/kg daily  adjusted according to response up to a max. of 400,000 units/ kg daily until neutrophil count in normal range; maintenance of normal neutrophil count initially 30 million units three times a week then adjusted according to absolute neutrophil count; reduce dose and then stop filgrastim if myelosuppressive therapy discontinued and there is no recurrence of neutropenia.

Contraindications:

Severe congenital neutropenia (Kostman’s syndrome) with abnormal cytogenetics. 

Side Effects:

Cautions:

Precautions:

Tumours with myeloid characteristics (risk of tumour growth), pre-malignant myeloid conditions; reduced myeloid precursors; monitor leucocyte count (discontinue treatment if leucocy-tosis); monitor platelet count and haemoglobin; regular morphological and cytogenetic bone marrow examinations recommended in severe congenital neutropenia (possible risk of myelodysplastic syndromes or leukaemia); monitor spleen size, osteoporotic bone disease (monitor bone density if given for more than 6 months); does not prevent other toxic effects of high-dose chemotherapy; pregnancy & breast-feeding. 

Interaction:

Drug-drug.


Chemotherapy drugs: May cause rapidly dividing myeloid cells to be sensitive to cytotoxic drugs. Don’t give filgrastim within 24 hours before or after a chemotherapy drug.


Lithium: May potentiate myeloproliferative effects of filgrastim. Use cautiously in patients taking lithium


BREAST-FEEDING PATIENTS


• It isn’t known whether drug appears in breast milk. Use cautiously.


PEDIATRIC PATIENTS


• Efficacy hasn’t been established, but there’s no evidence of greater toxicity in children than in adults.


GERIATRIC PATIENTS


• No age-related problems have been reported. 

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: fatigue, fever, headache, weakness.
CV: arrythmias, chest pain, MI, transient hypotention.
GI: constipation, diarrhoea, mucositis, nausea, stomatitis, vomiting.
Hematologic: leukocytosis, thrombocytopenia.


Musculoskeletal; skeletal pain.
Respiratory: cough, dyspnea.
Skin: alopecia, cutaneous vasculitis, rash.
Other: hypersensitivity reactions. 

Patient And Carer Advice: