Idarubicin Hydrochloride

Registered South African indications:

• Acute non-lymphocytic leukaemia
• Acute myeloblastic leukaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other anthracyclines or anthracenediones
• Pregnancy
• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• Uncontrolled infections
• Severe cardiomyopathy
• Recent myocardial infarction
• Severe arrhythmias
• Persistent myelosuppression
• Previous treatment with maximum cumulative doses of idarubicin and/or other anthracyclines and anthracenediones 

Cautions

• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Risk factors for increased cardiotoxicity
• Cardiovascular disease
• High cumulative doses
• Infants and children
• Immunocompromised patients
• Risk factors for increased risk of bleeding and perforation
• Men desiring fertility
• Galactose intolerance
• Lapp lactose deficiency
• Glucose-galactose malabsorption 

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

Used for the treatment of

Acute non-lymphocytic leukaemia
Acute myeloblastic leukaemia

Consult specialist for dosages and regimens

Not approved for use in South Africa for children

Pregnancy

• FDA Pregnancy Category D

Breastfeeding

• Contraindicated

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended 
• Severe: Contraindicated

Hepatic Impairment

• Mild to moderate: Caution; no dose adjustment recommended 
• Severe: Contraindicated

Elderly            

• No dose adjustment recommended

Central Nervous System Disorders

• Cerebral haemorrhages
• Headache

Cardiovascular Disorders

• Bradycardia
• Sinus tachycardia
• Tachyarrhythmia
• Asymptomatic reduction of left ventricular ejection fraction
• Congestive cardiac failure
• Cardiomyopathies 
• ECG abnormalities
• Myocardial infarction
• Pericarditis
• Myocarditis
• Atrioventricular 
• Bundle branch block
• Local phlebitis
• Thrombophlebitis
• Haemorrhages
• Shock
• Thromboembolism
• Flush
• Cardiotoxicity

Gastrointestinal Disorders

• Nausea and vomiting
• Mucositis
• Stomatitis
• Diarrhoea
• Abdominal pain 
• Burning sensation
• Gastrointestinal tract bleeding
• Oesophagitis
• Colitis 
• Gastric erosions
• Stomatitis 
• Ulceration of mucosa
• Dehydration 
• Perforation of colon

Hepatobiliary Disorders

• Elevation of the hepatic enzymes 
• Increased bilirubin

Genitourinary Disorders

• Red coloration of the urine

Endocrine and Metabolic Disorders

• Anorexia
• Dehydration
• Hyperuricaemia
• Tumour lysis syndrome
• Hyperuricaemia

Skin and Subcutaneous Tissue Disorders

• Alopecia
• Rash
• Itch
• Hypersensitivity of irradiated skin 
• Skin and nail hyperpigmentation
• Urticaria
• Cellulitis
• Tissue necrosis
• Acral erythema
• Local reaction
• Phlebitis
• Thrombophlebitis 
• Severe cellulites
• Tissue necrosis

Immune, Blood and Lymphatic System Disorders

• Secondary leukaemia 
• Anaemia
• Severe leukopenia 
• Neutropenia
• Thrombocytopenia
• Pancytopenia
• Anaphylaxis
• Fever
• Pronounced myelosuppression

• Combination chemotherapy regimens
• Cardiotoxic agents
• Cardioactive compounds
• Radiotherapy 
• Live attenuated vaccines 
• Oral anticoagulants
• Anticancer chemotherapy
• Cyclosporin A

• Full blood count with differential
• Left ventricular ejection fraction
• Electrolytes
• Renal function
• Hepatic function
• Uric acid

Idarubicin is a DNA intercalating anthracycline which interacts with topoisomerase II and has an inhibitory effect on nucleic acid synthesis. Idarubicin has a high potency and is an effective agent against murine leukaemia and lymphomas both by intravenous and oral route. The modification in position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake.

Capsule 5mg

• Zavedos (Pfizer) originator

Injection (per vial) 5mg

• Zavedos (Pfizer) originator

Injection (per vial) 10mg

• Zavedos (Pfizer) originator