Ixabepilone

Registered South African indications:

• Breast cancer

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to polyoxyethylated castor oil 
• Pregnancy
• Neutrophil count <1 500/mm³ or platelet count <100 000/mm³
• Coadministration therapy with ixabepilone and capecitabine in patients with AST or ALT >2.5 times upper limit of normal or bilirubin >1 times upper limit of normal

Cautions

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Pre-existing neuropathy
• History of cardiovascular disease
• Diabetes mellitus
• May impair ability to drive and operate machinery

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

Used for the treatment of

Locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy (additional agent required)

Consult specialist for dosages and regimens

Not established for use in children

Pregnancy

• FDA Pregnancy Category D

Breastfeeding

• Caution; not recommended

Renal Impairment

• Caution: no dose adjustment recommended

Hepatic Impairment

• Caution; dose adjustment recommended

Elderly            

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Peripheral sensory neuropathy
• Fatigue
• Headache
• Peripheral neuropathy
• Pain
• Dizziness
• Insomnia

Cardiovascular Disorders

• Oedema 
• Chest pain

Respiratory Disorders

• Dyspnoea
• Upper respiratory tract infection
• Cough

Gastrointestinal Disorders

• Nausea and vomiting
• Stomatitis
• Mucositis
• Diarrhoea 
• Abdominal pain
• Constipation
• Dysgeusia 
• Gastroesophageal reflux

Endocrine and Metabolic Disorders

• Anorexia
• Hot flush
• Weight loss
• Dehydration

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Musculoskeletal pain
• Weakness

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Nail disorder 
• Palmar-plantar erythrodysaesthesia syndrome
• Skin rash
• Pruritis
• Desquamation
• Hyperpigmentation

Immune, Blood and Lymphatic System Disorders

• Leukopenia 
• Anaemia
• Febrile neutropaenia
• Thrombocytopaenia
• Neutropenia 
• Hypersensitivity
• Infection
• Fever

Sensory Disorders

• Increased lacrimation

• Bacillus calmette guérin vaccine
• Conivaptan
• CYP3A4 inducers
• CYP3A4 inhibitors
• Dabrafenib
• Deferiprone
• Dexamethasone 
• Dipyrone
• Enzalutamide
• Fusidic acid
• Idelalisib
• Lenograstim
• Lipegfilgrastim
• Mifepristone
• Mitotane
• Palifermin
• Pitolisant
• St John's wort
• Stiripentol

• Full blood count with differential
• Hepatic function

Ixabepilone is a semi-synthetic analogue of epothilone B that stabilises microtubule dynamics, resulting in blockade of cancer cells during the mitotic stage of the cell division cycle which leads to apoptosis and cell death. Natural epothilones and their analogues have a tubulin-binding mode distinct from that of other microtubule-stabilising agents.

Injection (per vial) 15mg

• Ixempra (Bristol Myers Squibb) originator

Injection (per vial) 45mg

• Ixempra (Bristol Myers Squibb) originator