Adult Dosing

Chemotherapy induced febrile neutropenia

• Recommended dose of tbo-filgrastim is 5 mcg/kg per day administered as a subcutaneous injection

• Administer the first dose of tbo-filgrastim no earlier than 24 hours following myelosuppressive chemotherapy
• Do not administer tbo-filgrastim within 24 hours prior to chemotherapy
• Monitor complete blood count (CBC) prior to chemotherapy and twice per week until recovery

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Mild renal impairment: No dose adjustments
• Moderate-severe renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Patient may develop splenic rupture on administration and may report upper abdominal or shoulder pain
• Patient may be evaluated for fever and lung infiltrates or respiratory distress after receiving therapy
• Serious allergic reactions may be seen in patients on tbo-filgrastim therapy
• Patient with sickle cell disease may experience severe and sometimes fatal crisis
• Tbo-filgrastim may exert tumor growth stimulatory effects on malignant cells including myeloid malignancies and myelodysplasia

Supplemental Patient Information

• Advise patients to inform about any signs of infection such as fever, redness or swelling
• Inform patients to avoid pregnancy while receiving tbo-filgrastim. If pregnancy occurs, advise patients of the possibility of fetal harm

Pregnancy Category:C

Breastfeeding: Unknown if excreted in human milk; nursing mothers should be cautioned before starting the therapy

• GI: Splenic Rupture
• RESP: Acute Respiratory Distress Syndrome
• DERM: Rash, pruritic rash, urticaria
• MUSC: Bone pain
• HYPERSENSITIVITY: Allergic reactions including angioneurotic edema, dermatitis allergic, drug hypersensitivity, hypersensitivity
• MISC: Tumor Growth Stimulatory Effects on Malignant Cells, Severe and sometimes fatal sickle cell crises

• Human granulocyte colony-stimulating factor (G-CSF); binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity

US Trade Name(s)

• Neutroval

US Availability

Neutroval

• INJ (prefilled syringe):300 mcg/0.5 mL
• INJ (prefilled syringe):480 mcg/0.8 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Hematopoietic Stem Cell Mobilizer