Pegfilgrastim

Registered South African indications:

• Neutropaenia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Acute myeloid leukaemia
• Myelodysplastic syndrome
• Chronic myelogenous leukaemia
• Secondary acute myeloid leukaemia 
• De novo acute myeloid leukaemia patients aged < 55 years
• High dose chemotherapy
• Recent history of pulmonary infiltrates or pneumonia
• Patients with sickle cell trait or sickle cell disease
• Fructose intolerance

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

Reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy
- Except chronic myeloid leukaemia and myelodysplastic syndromes

Consult specialist for dosages and regimens

Not established for use in children below 18 years

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; not recommended

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Headache

Respiratory Disorders

• Acute respiratory distress syndrome
• Interstitial pneumonia
• Pulmonary oedema
• Pulmonary infiltrates
• Pulmonary fibrosis

Gastrointestinal Disorders

• Nausea

Hepatobiliary Disorders

• Increased lactate dehydrogenase 
• Increased alkaline phosphatase
• Increased alanine aminotransferase 
• Increased aspartate aminotransferase

Genitourinary Disorders

• Glomerulonephritis

Endocrine and Metabolic Disorders

• Elevations in uric acid

Musculoskeletal Disorders

• Bone pain
• Musculoskeletal pain

Skin and Subcutaneous Tissue Disorders

• Sweet's syndrome
• Cutaneous vasculitis
• Injection site reactions

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Leukocytosis
• Sickle cell crisis
• Splenomegaly
• Splenic rupture
• Capillary leak syndrome
• Hypersensitivity reactions
• Anaphylaxis

Others

• Non-cardiac chest pain

• Cytotoxic chemotherapy
• Antimetabolites
• Haematopoietic growth factors 
• Cytokines
• Lithium

• Full blood count and differential
• Urinalysis

Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow. Neutrophils produced in response to pegfilgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function. G-CSF has shown in vitro stimulating properties on human endothelial cells. G-CSF can promote growth of myeloid cells, including malignant cells in vitro, and similar effects may be seen on some non-myeloid cells in vitro.

Injection (per 0.6ml) 6mg

• Fulphila (Mylan)
• Neulastim (Amgen) originator
• Pegylastin (Accord Healthcare)