Filgrastim

History of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSF) such as filgrastim or pegfilgrastim. Patient with severe congenital neutropenia who develop leukaemia or evidence of leukaemic evolution.

Patient with pre-malignant or malignant myeloid condition, acute myeloid leukaemia; sickle-cell trait or disease, recent history of pneumonia or lung infiltrates, osteoporotic bone disease. Not indicated for use in chronic myeloid leukaemia or myelodysplastic syndrome. Safety and efficacy have not been established in radiation therapy recipients; avoid concomitant use. Not to be used in the period from 24 hours before to 24 hours after cytotoxic chemotherapy administration. Some available brands (e.g. filgrastim-sndz [Zarxio^®], filgrastim-aafi [Nivestym^®]) are approved by US FDA as biosimilars to the reference biological, filgrastim (Neupogen^®). Biosimilar agents are not interchangeable with filgrastim; instead, they are considered therapeutic alternatives (refer to local product-specific recommendations). Pregnancy and lactation. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Do not switch between different brands unless advised by your doctor. Monitoring Parameters Obtain CBC with differential and platelet count prior to and regularly during therapy. Additionally for severe chronic neutropenias (congenital, cyclic, idiopathic): Perform bone marrow morphology and karyotype before treatment; morphologic and cytogenic bone marrow exam annually. Monitor absolute neutrophil count (ANC) 3 times weekly for the 1st week then weekly thereafter (for neutropenia in advanced HIV infection); urinalysis; spleen size (e.g. ultrasound, clinical exam); bone density (in patients with osteoporosis undergoing >6 months continuous treatment). Assess for signs and symptoms of allergic reactions, capillary leak syndrome, aortitis, cutaneous vasculitis, myelodysplastic syndrome, acute myeloid leukaemia, ARDS, and splenic rupture.

Significant: Serious allergic reactions, including anaphylaxis; interstitial lung disease, alveolar haemorrhage (e.g. pulmonary infiltrates, haemoptysis), aortitis, moderate or severe cutaneous vasculitis, haematological effects (e.g. thrombocytopenia, leucocytosis, anaemia), myelodysplastic syndrome, acute myeloid leukaemia, splenomegaly, nephrotoxicity (e.g. haematuria, proteinuria, glomerulonephritis). Cardiac disorders: Chest pain. Gastrointestinal disorders: Diarrhoea, nausea, vomiting, constipation, oral pain. General disorders and administration site conditions: Fatigue, mucosal inflammation, pyrexia, asthenia, malaise, peripheral oedema. Hepatobiliary disorders: Hepatomegaly. Infections and infestations: Sepsis. Injury, poisoning and procedural complications: Transfusion reaction. Investigations: Increased blood alkaline phosphatase and blood lactate dehydrogenase, decreased Hb. Metabolism and nutrition disorders: Decreased appetite. Musculoskeletal and connective tissue disorders: Musculoskeletal pain, muscle spasms, ostealgia, back pain, osteoporosis. Nervous system disorders: Headache, dizziness, hypoaesthesia, paraesthesia. Psychiatric disorders: Insomnia. Renal and urinary disorders: Dysuria, UTI. Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, oropharyngeal pain, epistaxis, bronchitis, upper respiratory tract infection. Skin and subcutaneous tissue disorders: Alopecia, rash, erythema. Vascular disorders: Hypertension, hypotension.
Potentially Fatal: Severe sickle cell crisis, capillary leak syndrome, respiratory failure or acute respiratory distress syndrome (ARDS). Rarely, splenic rupture.

Due to the potential sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, filgrastim use is not recommended in the period 24 hours before to 24 hours after cytotoxic chemotherapy administration. Concurrent use with 5-fluorouracil may exacerbate the severity of neutropenia. Lithium may potentiate the myeloproliferative effects (e.g. promote neutrophil release) of filgrastim. May enhance the adverse effects of bleomycin, cyclophosphamide, and topotecan.

Haematopoietic Agents / Supportive Care Therapy

L03AA02 - filgrastim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.