Lutholaz

Lutholaz

pegfilgrastim

Manufacturer:

Siam Bioscience

Distributor:

Zuellig Pharma

Marketer:

Apexcela
Concise Prescribing Info
Contents
Pegfilgrastim
Indications/Uses
Reduction in duration of neutropenia, incidence of febrile neutropenia & infection as manifested by febrile neutropenia in patients treated w/ cytotoxic for malignancy (except chronic myeloid leukemia & myelodysplastic syndromes).
Dosage/Direction for Use
SC Inj via thigh, abdomen or upper arm. Adult 6 mg dose (1 single pre-filled syringe) for each chemotherapy cycle, given at least 24 hr after cytotoxic chemotherapy.
Contraindications
Hypersensitivity to pegfilgrastim, filgrastim or proteins derived from E. coli.
Special Precautions
Discontinue at onset of pulmonary signs eg, cough, fever & dyspnoea in association w/ radiological signs of pulmonary infiltrates & deterioration in pulmonary function along w/ increased neutrophil count; if leukocyte counts exceed 50 x 109/L after expected nadir occurs. Permanently discontinue in patients w/ clinically significant hypersensitivity. Not to be used to increase dose of cytotoxic chemotherapy beyond established dose regimens. Not to be administered in patients w/ history of hypersensitivity to pegfilgrastim or filgrastim. Not to be restarted if patient has developed SJS. Closely monitor & standard symptomatic treatment including need for intensive care if capillary leak syndrome develops characterized by hypotension, hypoalbuminaemia, oedema & hemoconcentration. Evaluate patients w/ left upper abdominal &/or shoulder tip pain for enlarged spleen or splenic rupture. Increased risk of neutropenia, febrile neutropenia &/or infection if medication error eg, partial or missed dose occurs. Increased hematopoietic activity of bone marrow in response to growth factor therapy. Patients w/ de novo AML; myelodysplastic syndrome, chronic myelogenous leukemia & secondary AML; sickle cell trait or sickle cell disease. Glomerulonephritis; aortitis symptoms including fever, abdominal & back pain, malaise & increased inflammatory markers (eg, C-reactive protein & WBC count). Potential for immunogenicity. Carefully monitor spleen size. Regularly monitor platelet count & haematocrit. Perform WBC count at regular intervals during therapy. Fructose intolerance. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. AML patients <55 yr w/ cytogenetics.
Adverse Reactions
Headache; nausea; bone pain. Thrombocytopenia, leukocytosis; contact dermatitis; musculoskeletal pain (myalgia, arthralgia, pain in extremity, back & neck pain); inj site & non-cardiac chest pain, application site reaction.
Drug Interactions
Potentiated myelosuppression w/ 5-fluorouracil or other antimetabolites.
MIMS Class
Supportive Care Therapy / Haematopoietic Agents
ATC Classification
L03AA13 - pegfilgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
Presentation/Packing
Form
Lutholaz soln for inj 6 mg/0.6 mL
Packing/Price
1's
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