Ziextenzo

Ziextenzo

pegfilgrastim

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Pegfilgrastim
Indications/Uses
Reduction in the duration of neutropenia & incidence of febrile neutropenia in adult patients treated w/ cytotoxic chemotherapy for malignancy (w/ the exception of chronic myeloid leukaemia & myelodysplastic syndromes).
Dosage/Direction for Use
SC One 6-mg dose 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. Caution in patients w/ AML. 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. Take special care when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia. 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 in patients who developed SJS. Potential for immunogenicity. Transient +ve bone-imaging findings. Contains sorbitol. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Paed population. De novo AML patients <55 yr w/ cytogenetics t(15;17). Patients receiving high dose chemotherapy.
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 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
Ziextenzo soln for inj 6 mg/0.6 mL
Packing/Price
1's
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