Lenograstim- recombinant human granulocyte- colony stimulating factor (rHuG-CSF). Each vial contains 33.6 million units (263mcg) as powder for reconstitution in 1ml water for injection, lnd: Reduction in duration of neutropenia and associated complications in patients undergoing bone-marrow transplantation or cytotoxic chemo¬therapy with febrile neutropenia, & mobilisation of peripheral blood progenitor cell (PBPCs).

C/I: Known hypersensitivity to product or constituents. Not to be used for intensification of cytotoxic chemotherapy beyond established regimens. Not to be administered concurrently with cytotoxic chemotherapy or to patients suffering from myeloid malignancy. Not recomm-ended in pregnancy & nursing women. S/E: Musculoskeletal pain (alleviated by standard analgesics); asthenia; abdominal pain & generalised pain reported in healthy donors. Urinary abnormalities (predominantly dysuria). Reversible dose-dependent elevations of lactate dehydrogenase, alkaline phosphatase, serum uric acid, and gammaglutamyl transpeptidase. There have been occasional reports of decrease of blood pressure, but not requiring clinical treatment. Precautions: Safety and efficacy have not been established in myelodysplasia, acute myeloge¬nous leukemia, or chronic myelogenous leukemia. Exercise caution in any malignant or premalignant myeloid condition. Leucocytosis (WBO 100 xl09/L) has been seen at doses seen above 0.3 million units (3mcg)/kg/day in less than 5% of patients. In addition, as higher doses of chemotherapy may be administered, resulting in an increased risk of thrombocytopenia and anemia, regular hematological monitoring is recommended.

For sustained response, lenograstim should be continued until after the expected nadir and until the neutrophil count has recovered. Bone density monitoring is advised for patients with osteoporotic disease receiving lenograstim for longer than 6 months.

Use of lenograstim in severe renal or hepatic impairments is not recommended.

Pregnancy & lactation: Risk to human foetus unknown. Some abortifacient effect in rabbits has been seen. Not recommended in nursing women. Dosage: Granocyte 34 (33.6 million units/vial) is used in patients with body surface area up to 1.8 m2.

Bone-marrow transplantation: adult & child over 2 years- the recommended dose is 19.2 million units (150mcg)/m2/day, start treatment 24 hours after transplantation by i.v infusion in 30minutes, diluted in isotonic saline solution; the treatment should be continued until neutrophil count stable in acceptable range (max. 28 days).

Cytotoxic chemotherapy induced neutropenia: adult & child over 2 years- by s.c injection,

19.2 million units (150mcg)/m2/day, start treat¬ment 24 hrs. after completion of chemotherapy;

treatment should continue until neutro-phil count stable in acceptable range (max. 28 days). PBPCs mobilisation: when lenograstim is used alone, by s.c injection, 1.28 million units (10mcg)/kg/day for 4-6 days (5-6 days in healthy donors); used following adjunctive myelosuppressive chemotherapy (to improve yield), by s.c injection, 19.2 million units (150mcg)/m2/ day, start treatment 24 hours after completion of chemotherapy & continue treatment until neutrophil count stable in acceptable range.

Leukapheresis should be performed between day 5 and 7. In both cases, one leukapheresis is often sufficient to obtain the acceptable min¬imum yield (? 2.0 x 106 CD34+ cells per kg). Elderly: As per adult dose. Children: As per adult dose, safety demonas-trated in children older than 2 years in bone marrow transplan¬tation.

Administration: Granocyte is for s.c or i.v administration following reconstitution with water for injection.

After reconstitution, Granocyte should be stored at 2 to 8°C & used within 24 hours. For i.v infusion, Granocyte should be diluted in

0. 9% NaCl solution.

Granocyte 34 (33.6 million units/vial) should not be diluted below 1 vial into 100ml. Granocyte vials are for single dose use only. Drug interaction: Treatment not recommended from one day before until one day after chemotherapy. Interactions with other hemopoiet¬ic growth factors and cytokines not established. 34 million units vial: 7355.33 MRP