📋 Indications & Clinical Dosage
*Reduction in the duration of neutropenia following bone-marrow transplantation or peripheral stem cells transplantation for non-myeloid malignancy:*
BY SC INJ OR IV INF: Adult: 150 mcg/m2 daily until neutrophil count stable in acceptable range (max. 28 days), to be started the day after transplantation.
*Reduction in the duration of neutropenia following treatment with cytotoxic chemotherapy associated with a febrile neutropenia:*
BY SC INJ: Adult: 150 mcg/m2 daily until neutrophil countstable in acceptable range (max. 28 days), to be started on the day after completion of chemotherapy.
*Mobilization of peripheral blood progenitor cells for harvesting and subsequent INF:*
BY SC INJ: Adult: 10 mcg/kg daily for 4-6 days.
*Mobilisation of peripheral blood progenitor cells, used following adjunctive myelosuppressive chemotherapy:*
BY SC INJ: Adult:150 mcg/m2 daily until neutrophil count stable in acceptable range, to be started 1-5 days after completion of chemotherapy, (for treatment of leucopheresis, consult product literature).
💊 Mode of Administration
For IV infusion, give intermittently over 30 min in Sodium chloride 0.9%; initially reconstitute with 1ml water for injection provided (do not shake vigorously) then dilute with up to 50ml infusion fluid for each vial of 263 mcg; give over 30 minutes.
⛔ Contraindications
Severe congenital neutropenia (Kostmanns syndrome) with abnormal cytogenetics.
⚠️ Precautions & Warnings
Tumours with myeloid characteristics (risk of tumour growth), pre-malignant myeloid conditions; reduced myeloid precursors; monitor leucocyte count (discontinue) treatment if leukocytosis); 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.
⚠️ Adverse Reactions / Side Effects
Mucositis, splenic rupture, toxic epidermal necrolysis, musculoskeletal pain, transient hypoten-sion, disturbances in liver enzymes and serum uric acid; thrombocytopenia; urinary abnormalities including dysuria; allergic reactions (more common after intravenous infusion), proteinuria, haematuria, and transient decrease in blood glucose; on long-term use cutaneous vasculitis, splenic enlargement, hepatomegaly, headache, diarrhoea, anaemia, epistaxis, alopecia, osteoporosis, and rash.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Risk cannot be ruled out.
Lactation / Breastfeeding:
Caution advised or effect undetermined.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.