Neulastim

Neulastim

pegfilgrastim

Manufacturer:

Amgen

Distributor:

Zuellig
/
Agencia Lei Va Hong

Marketer:

KLN Pharma
Concise Prescribing Info
Contents
Pegfilgrastim
Indications/Uses
Reduction in duration of neutropenia & incidence of febrile neutropenia in adults treated w/ cytotoxic chemotherapy for malignancy (w/ the exception of chronic myeloid leukaemia & myelodysplastic syndromes).
Dosage/Direction for Use
SC One 6 mg dose (a single pre-filled syringe) for each chemotherapy cycle, given at least 24 hr after cytotoxic chemotherapy.
Contraindications
Hypersensitivity.
Special Precautions
Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment. Permanently discontinue in patients w/ clinically significant hypersensitivity. Do not use in patients w/ myelodysplastic syndrome, chronic myelogenous leukaemia, & secondary AML. Do not use to increase dose of cytotoxic chemotherapy beyond established dosage regimens. Reports of pulmonary adverse reactions, in particular interstitial pneumonia; glomerulonephritis; capillary leak syndrome; splenomegaly & splenic rupture; aortitis. Regular monitoring of platelet count & haematocrit is recommended. Associated w/ myelodysplastic syndrome & AML in breast & lung cancer patients in conjunction w/ chemotherapy &/or radiotherapy. Caution in patients w/ sickle cell trait or sickle cell disease. Perform WBC count at regular intervals during therapy. Discontinue immediately if leukocyte counts >50 x 109/L after expected nadir. Do not restart treatment if Stevens-Johnson syndrome develops. Potential for immunogenicity. Latex sensitivity. Transient positive bone-imaging findings. Contains sorbitol. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn. De novo AML patients <55 yr w/ cytogenetics t(15;17).
Adverse Reactions
Headache; nausea; bone pain. Thrombocytopenia, leukocytosis; musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain); inj site pain, non-cardiac chest pain.
Drug Interactions
Possible potentiated myelosuppression w/ 5-fluorouracil (5-FU) or other antimetabolites.
MIMS Class
Haematopoietic Agents / Supportive Care Therapy
ATC Classification
L03AA13 - pegfilgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Presentation/Packing
Form
Neulastim soln for inj 6 mg/0.6 mL
Packing/Price
1's
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