Granocyte SC Injection 34 MIU/vial

Uses

Granocyte SC Injection 34 MIU/vial (rHuG-CSF) 13.4 million International Units (equivalent to 105 micrograms) per ml after reconstitution

Granocyte SC Injection 34 MIU/vial (rHuG-CSF) 33.6 million International Units (equivalent to 263 micrograms) per ml after reconstitution

The drug is used to reduce the risk of life-threatening infection in patients with neutropenia, particularly after cytotoxic chemotherapy. Granocyte SC Injection 34 MIU/vial is used for a treatment to reduce the duration of neutropenia and the severity of infections in patients with non-myeloid malignancy who have undergone autologous or allogeneic bone marrow transplantation, or treatment with established cytotoxic chemotherapy and in addition to reduce the incidence of infection associated with established cytotoxic chemotherapy. Granocyte SC Injection 34 MIU/vial is also used to mobilise peripheral blood progenitor cells (PBPCs) with Granocyte SC Injection 34 MIU/vial alone, or after myelosuppressive chemotherapy, in order to accelerate haematopoietic recovery by infusion of such cells, after myelosuppressive or myeloablative therapy. Granocyte SC Injection 34 MIU/vial is also used to accelerate the engraftment of these cells after their reinfusion.

Granocyte SC Injection 34 MIU/vial is also used to associated treatment for these conditions: Neutropenia, Mobilization of hematopoietic stem cells therapy

How Granocyte SC Injection 34 MIU/vial works

Granocyte SC Injection 34 MIU/vial is the glycosylated recombinant form of human granulocyte colony stimulating factor. Granocyte SC Injection 34 MIU/vial accelerates neutrophil recovery significantly after chemotherapy, with beneficial effects on clinical end-points such as incidence of laboratory-confirmed infection and length of hospital stay. Chemotherapy dose intensity has also been increased in patients receiving lenograstim, notably those with breast or small cell lung cancer, although improvements in tumour response and survival have not been demonstrated. Granocyte SC Injection 34 MIU/vial also assists neutrophil recovery in patients undergoing bone marrow transplantation, and stimulates the production of peripheral blood stem cells (PBSCs) for autologous transfusion after aggressive chemotherapy.

Dosage

Granocyte SC Injection 34 MIU/vial dosage

Intravenous-Neutropenia following bone marrow transplantation:

• Adult: 19.2 million IU/m2 or 150 mcg/m2 daily by IV infusion started the day after transplantation for a maximum of 28 consecutive days.
• Child: >2 yr: 19.2 million IU/m2 or 150 mcg/m2 daily by IV infusion started the day after transplantation for a maximum of 28 consecutive days.

Subcutaneous-

Mobilisation of peripheral blood progenitor cells for autologous peripheral blood stem cell transplantation:

• Adult: As monotherapy: 1.28 million IU/kg or 10 mcg/kg daily for 4-6 days (5-6 days in healthy donors). Following adjunctive myelosuppressive chemotherapy: 19.2 million IU/m2 or 150 mcg/m2daily, started the day after completion of chemotherapy for a maximum of 28 consecutive days.

Subcutaneous-

Chemotherapy-induced neutropenia:

• Adult: 19.2 million IU/m2 or 150 mcg/m2 daily, start the day after completion of chemotherapy for a maximum of 28 consecutive days.

Side Effects

Musculoskeletal pain, bone pain, splenic enlargement, nausea, fever, thrombocytopenia, anaemia, epistaxis, headache, diarrhoea, dysuria, osteoporosis, cutaneous vasculitis, anorexia, Sweet's syndrome, toxic epidermal necrolysis.

Toxicity

Species observed : Human (Man) Test type: TDLo ( Lowest Published Toxic Dose) Route of exposure: Subcutaneous Dose/Duration: 21428mg/kg/15 Toxic Effect: Skin and appendages: Dermatitis, allergic ( after systemic exposure )

Species observed : Rodent - Rat Test type: LD50 Route of exposure: Oral Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value

Species observed : Rodent - Rat Test type: LD50 Route of exposure: Subcutaneous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value

Species observed : Rodent - Rat Test type: LD50 Route of exposure: Intravenous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value

Species observed : Mammal - Dog Test type: LD50 Route of exposure: Intravenous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value

Species observed : Mammal - Dog Test type: LD50 Route of exposure: Subcutaneous Dose/Duration: >5mg/kg Toxic Effect: Details of toxic effects not reported other than lethal dose value

Precaution

Premalignant or malignant myeloid condition; sickle-cell disease; osteoporotic bone disease; signs of pulmonary infiltrates (withdraw treatment). Monitor CBC during therapy. Pregnancy and lactation.

Interaction

Increased risk of myelosuppression with myelosuppressive antineoplastic agents; increased pulmonary toxicity with bleomycin and cyclophosphamide.

Volume of Distribution

Apparent distribution volume (Vd area) is approximately 52 ± 5 mL/kg body weight.

Elimination Route

During repeated dosing (iv and sc routes), peak serum concentrations (at the end of iv infusion or after sc injection) are proportional to the injected dose. Repeated dosing with lenograstim by the two injection routes results in no evidence of drug accumulation.

Half Life

The pharmacokinetic profile of lenograstim is similar in healthy volunteers and cancer patients with elimination half-life (t½β) values of 2.3 - 3.3 hrs (volunteers); 2.8-7.5 hrs (cancer patients) following sc administration, and 0.8 - 2.1 hrs (volunteers); 1.1 - 4.0 hrs (cancer patients) following iv administration.

Clearance

Plasma clearance of lenograstim increased 3-fold (from 50 up to 150 mL/min) during repeated sc dosing.

Elimination Route

Granocyte SC Injection 34 MIU/vial is poorly excreted in urine as intact compound (less than 1% of the dose).

Pregnancy & Breastfeeding use

Pregnancy category is not classified.

Contraindication

Myeloid malignancies. Not to be used for 24 hr before or after cytotoxic chemotherapy.

Storage Condition

Should be stored in cool and dry place

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