Leuco-Plus

Leuco-Plus

filgrastim

Manufacturer:

Apexcela

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Filgrastim (recombinant methionyl, human granulocyte colony stimulating factor)
Indications/Uses
Patients w/ non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated w/ a significant incidence of severe neutropenia & fever. Reduction of time to neutrophil recovery & duration of fever, following induction or consolidation chemotherapy treatment of adults w/ AML. Reduction of duration of neutropenia & neutropenia-related clinical sequelae eg, febrile neutropenia, in patients w/ non-myeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. Mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis. Chronic administration to reduce the incidence & duration of sequelae of neutropenia in symptomatic patients w/ congenital, cyclic, or idiopathic neutropenia for adults & childn. Patients w/ neutropenic episodes associated w/ viral replication (HIV) or opportunistic infections in HIV/AIDS patients receiving antiretroviral treatment like prophylaxis & w/ neutropenia secondary to chemotherapy &/or RT for malignant disease associated w/ their base disease.
Dosage/Direction for Use
Patients receiving myelosuppressive chemotherapy Starting dose: 5 mcg/kg, single inj daily by SC bolus inj or rapid IV infusion (15-30 min). Dose may be increased in increments of 5 mcg/kg for each chemotherapy cycle. Cancer patients receiving bone marrow transplant 10 mcg/kg/day given as an IV infusion 4-24 hr. 1st dose should be administered at least 24 hr after cytotoxic chemotherapy & bone marrow infusion. Titrate against the neutrophil response: Absolute neutrophil count (ANC) >1,000/mm3 for 3 consecutive days reduce to 5 mcg/kg/day, & if ANC <1,000/mm3 at any time during the 5 mcg/kg/day administration, increase to 10 mcg/kg/day. Treatment should be administered for 14 days. Cancer patients undergoing mobilization procedure & collection of hematopoietic progenitor cells 10 mcg/kg/day by SC or IV given for at least 4 days before the 1st leukapheresis procedure & continued until the last leukapheresis. Patients w/ severe chronic neutropenia Median daily doses: 1.2 mcg/kg (idiopathic neutropenia), 2.1 mcg/kg (cyclic neutropenia), 6 mcg/kg (congenital neutropenia) & in rare instances, patients w/ congenital neutropenia >100 mcg/kg/day. Patients w/ acute myeloid leukemia receiving induction or consolidation chemotherapy 5 mcg/kg/day by SC. 1st dose should be administered at least 24 hr after cytotoxic chemotherapy. Prophylaxis & treatment of neutropenia in patients w/ HIV/AIDS Starting dose: 5 mcg/kg/day to achieve & maintain a normal number of neutrophils (ANC>2x 109/L).
Contraindications
Hypersensitivity to E.coli-derived proteins & filgrastim. Severe congenital neutropenia w/ abnormal cytogenetics.
Special Precautions
Avoid simultaneous use w/ chemotherapy & RT. Do not use in the period 24 hr before through 24 hr after the administration of cytotoxic chemotherapy. May act as growth factor for any tumor type. Increase risk of cardiac, pulmonary, neurological & dermatological toxicities at higher doses. Monitor hematocrit & platelet count. Determine bone density patients w/ osteoporosis for a period of >6 mth. Severe hepatic or renal dysfunction. Adult resp distress syndrome. Pregnancy & lactation.
Adverse Reactions
Mild to moderate medullary bone pain, dysuria & transient decrease in BP.
Drug Interactions
Lithium may potentiate the release of neutrophils.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Presentation/Packing
Form
Leuco-Plus soln for inj 300 mcg/mL
Packing/Price
1's
/thailand/image/info/leuco-plus soln for inj 300 mcg-ml/30 miu-ml?id=8e7069c4-cd3e-4f83-9cb0-a6a600eb35d0
/thailand/image/info/leuco-plus soln for inj 300 mcg-ml/300 µg?id=0394c54d-77a6-4e59-9470-acb600f6fed6
Form
Leuco-Plus soln for inj 480 mcg/mL
Packing/Price
1's
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