Mylan Healthcare


Antah Pharma
Concise Prescribing Info
Reduction in duration & incidence of neutropenia & incidence of infection as manifested by febrile neutropenia in adults treated w/ cytotoxic chemotherapy for malignancy.
Dosage/Direction for Use
6 mg SC inj for each chemotherapy cycle at least 24 hr after cytotoxic chemotherapy.
Special Precautions
Discontinue use in patients w/ clinically significant hypersensitivity; history of hypersensitivity to pegfilgrastim or filgrastim. SJS. Not to be used in myelodysplastic syndrome, chronic myelogenous leukaemia, secondary acute myeloid leukaemia (AML). Long-term effects in AML & De novo AML patients <55 yr; history of pulmonary infiltrates or pneumonia; glomerulonephritis; sickle cell trait or disease; aortitis. Monitor for pulmonary signs of acute resp distress syndrome; urinalysis. Closely monitor patients who develop capillary leak syndrome. Regularly monitor platelet count, hematocrit & perform WBC count. Mobilisation of blood progenitor cells in patients or healthy donors. Transient +ve bone-imaging findings. Immunogenicity. High-dose & long-term use. Hereditary fructose intolerance. Combination w/ chemotherapeutic agents causing severe thrombocytopenia. Not recommended in women of childbearing potential not using contraception & during pregnancy. Lactation. Childn. Elderly >65 yr.
Adverse Reactions
Headache; nausea; bone pain. Thrombocytopenia, leukocytosis; musculoskeletal pain eg, myalgia, arthralgia, pain in extremity, back & neck pain; inj site & non-cardiac chest pain.
Drug Interactions
Potentiated myelosuppression w/ 5-fluorouracil & other antimetabolites. Chemotherapy associated w/ delayed myelosuppression eg, nitrosoureas.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
L03AA13 - pegfilgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Fulphila soln for inj 6 mg/0.6 mL
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