Drugs List

Therapeutic Indications

Uses

Leukaemia - acute lymphoblastic
Leukaemia - acute myeloid

Adults
Treatment of acute myeloid leukaemia (AML) in adults, for remission induction in untreated patients or for remission induction in relapsed or refractory patients.

Treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment.

Children
First line treatment of acute myeloid leukaemia (AML), in combination with cytarabine for remission induction.

Treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment.

Administration

For intravenous administration only.

Contraindications

Uncontrolled systemic infection
Breastfeeding
Pregnancy
Recent myocardial infarction
Serious cardiac arrhythmias
Severe cardiac disorder
Severe hepatic impairment
Severe myelosuppression
Severe renal impairment

Precautions and Warnings

Children under 18 years
Concurrent radiotherapy
History of anthracycline therapy
History of cardiotoxic drug therapy
History of mediastinal radiotherapy
History of pericardial irradiation
Within 7 months of discontinuing trastuzumab
Cardiovascular disorder
Dehydration
Gastrointestinal disorder
Hepatic impairment
Myelosuppression
Renal impairment

Administration of live vaccines is not recommended
Reduce dose in patients with glomerular filtration rate below 50ml/min
Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
Give pre-treatment counselling and consideration of oocyte cryopreservation
Give pre-treatment counselling and consideration of sperm cryopreservation
Maintain adequate hydration during therapy
Consult local policy on the safe use of anti-cancer drugs
Febrile neutropenia should be treated with broad spectrum IV antibiotics
If extravasation occurs follow local policy & seek expert help immediately
Staff: Not to be handled by pregnant staff
Treatment to be administered by or under supervision of specialist
Baseline & follow-up ECGs during & immediately after administration advised
Measurement of LV ejection fraction recommended before and during treatment
Monitor haematological parameters before and during treatment
Monitor hepatic function before treatment and regularly during treatment
Monitor renal function before treatment and regularly during treatment
Monitor patients for signs of tumour lysis syndrome
Monitor serum creatinine
Monitor serum phosphate levels
Monitor serum potassium and calcium
Monitor uric acid levels
Consider treatments to prevent hyperuricaemia
Delayed myocardial toxicity may occur
If mucositis/stomatitis occurs, delay next treatment until recovery
Risk of cardiomyopathy increases with high cumulative dosage
May colour urine red
Discontinue if cardiomyopathy occurs
Discontinue or review if symptoms of congestive heart failure occur
Not licensed for all indications in all age groups
Female: Ensure adequate contraception during treatment
Male: Contraception required during and for 3 months after treatment

Acute cardiotoxicity is usually a transient disturbance of cardiac function marked by ECG abnormalities (including severe arrhythmias) and does not usually predict subsequent development of delayed cardiomyopathy or require treatment discontinuation.

Delayed cardiotoxicity may manifest towards the end of therapy, within 2 to 3 months of finishing treatment or even years following the completion of treatment. This risk rises with increasing exposure to anthracyclines. Delayed cardiotoxicity is usually irreversible dose related cardiomyopathy, which may result in cardiac failure. Severe cardiac failure may occur precipitously without ECG changes. Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF). Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

Cardiotoxicity may occur at doses lower than the recommended cumulative limit of anthracyclines.

Infants and children appear to be more susceptible to anthracycline induced cardiac toxicity and long term periodic evaluation of cardiac function has to be performed.

Pregnancy and Lactation

Pregnancy

Idarubicin is contraindicated during pregnancy.

The manufacturer recommends that idarubicin is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Studies in rat have shown embryotoxicity and teratogenicity. Studies in rabbits only showed embryotoxicity. At the time of writing there is limited human data available. Idarubicin is less likely to cause cardiac abnormalities than other anthracyclines but the lipophilicity of idarubicin means that it will pass through the placenta more easily. Risks are unknown.

The effect of concurrent therapies must also be considered.

Lactation

Idarubicin is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking idarubicin. At the time of writing there are no published reports concerning the use of idarubicin while breastfeeding. The molecular weight of idarubicin is low enough that it should be expected to be present in the breast milk.

The effect of concurrent therapies must also be considered.

Side Effects

Abdominal pain
Acute myeloid leukaemia
Alopecia
Anaemia
Anaphylaxis
Anorexia
Atrioventricular block
Bradycardia
Bundle branch block
Burning sensation
Cardiomyopathy
Cellulitis
Cerebral haemorrhage
Chills
Colitis
Congestive cardiac failure
Decreased ejection fraction
Dehydration
Diarrhoea
ECG changes
Enterocolitis
Erythema
Febrile neutropenia
Fever
Flushing
Gastric erosions
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Haemorrhage
Headache
Hyperkalaemia
Hyperphosphataemia
Hyperphosphaturia
Hyperpigmentation of skin
Hypersensitivity reactions
Hyperuricaemia
Hypocalcaemia
Hypoxia
Increases in hepatic enzymes
Infections
Itching
Leukopenia
Local reaction at injection site
Mucositis
Myelodysplastic syndrome
Myelosuppression
Myocardial infarction
Myocarditis
Nausea
Neutropenia
Neutropenic colitis
Oesophagitis
Pancytopenia
Pericarditis
Phlebitis
Pigmentation of nails
Radiation recall dermatitis
Rash
Red urine
Secondary leukaemia
Sepsis
Septic shock
Septicaemia
Serum bilirubin increased
Shock
Sinus tachycardia
Skin necrosis
Stomatitis
Tachyarrhythmia
Thrombocytopenia
Thromboembolism
Thrombophlebitis
Tumour lysis syndrome
Urticaria
Vomiting

Presentation

Injections of idarubicin.

Drugs List

Therapeutic Indications

Uses

Leukaemia - acute lymphoblastic
Leukaemia - acute myeloid

Adults
Treatment of acute myeloid leukaemia (AML) in adults, for remission induction in untreated patients or for remission induction in relapsed or refractory patients.

Treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment.

Children
First line treatment of acute myeloid leukaemia (AML), in combination with cytarabine for remission induction.

Treatment of relapsed acute lymphoblastic leukaemia (ALL) as second line treatment.

Dosage

Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.

Doses may vary significantly if this agent is used as monotherapy or different combinations.

When using this agent, specialist literature, national guidelines, cancer networks protocols and Trust chemotherapy protocols should be consulted.

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For intravenous administration only.

Contraindications

Uncontrolled systemic infection
Breastfeeding
Pregnancy
Recent myocardial infarction
Serious cardiac arrhythmias
Severe cardiac disorder
Severe hepatic impairment
Severe myelosuppression
Severe renal impairment

Precautions and Warnings

Children under 18 years
Concurrent radiotherapy
History of anthracycline therapy
History of cardiotoxic drug therapy
History of mediastinal radiotherapy
History of pericardial irradiation
Within 7 months of discontinuing trastuzumab
Cardiovascular disorder
Dehydration
Gastrointestinal disorder
Hepatic impairment
Myelosuppression
Renal impairment

Administration of live vaccines is not recommended
Reduce dose in patients with glomerular filtration rate below 50ml/min
Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
Give pre-treatment counselling and consideration of oocyte cryopreservation
Give pre-treatment counselling and consideration of sperm cryopreservation
Maintain adequate hydration during therapy
Consult local policy on the safe use of anti-cancer drugs
Febrile neutropenia should be treated with broad spectrum IV antibiotics
If extravasation occurs follow local policy & seek expert help immediately
Staff: Not to be handled by pregnant staff
Treatment to be administered by or under supervision of specialist
Baseline & follow-up ECGs during & immediately after administration advised
Measurement of LV ejection fraction recommended before and during treatment
Monitor haematological parameters before and during treatment
Monitor hepatic function before treatment and regularly during treatment
Monitor renal function before treatment and regularly during treatment
Monitor patients for signs of tumour lysis syndrome
Monitor serum creatinine
Monitor serum phosphate levels
Monitor serum potassium and calcium
Monitor uric acid levels
Consider treatments to prevent hyperuricaemia
Delayed myocardial toxicity may occur
If mucositis/stomatitis occurs, delay next treatment until recovery
Risk of cardiomyopathy increases with high cumulative dosage
May colour urine red
Discontinue if cardiomyopathy occurs
Discontinue or review if symptoms of congestive heart failure occur
Not licensed for all indications in all age groups
Female: Ensure adequate contraception during treatment
Male: Contraception required during and for 3 months after treatment

Acute cardiotoxicity is usually a transient disturbance of cardiac function marked by ECG abnormalities (including severe arrhythmias) and does not usually predict subsequent development of delayed cardiomyopathy or require treatment discontinuation.

Delayed cardiotoxicity may manifest towards the end of therapy, within 2 to 3 months of finishing treatment or even years following the completion of treatment. This risk rises with increasing exposure to anthracyclines. Delayed cardiotoxicity is usually irreversible dose related cardiomyopathy, which may result in cardiac failure. Severe cardiac failure may occur precipitously without ECG changes. Delayed cardiomyopathy is manifested by reduced left ventricular ejection fraction (LVEF) and/or signs and symptoms of congestive heart failure (CHF). Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy and represents the cumulative dose-limiting toxicity of the drug.

Cardiotoxicity may occur at doses lower than the recommended cumulative limit of anthracyclines.

Infants and children appear to be more susceptible to anthracycline induced cardiac toxicity and long term periodic evaluation of cardiac function has to be performed.

Pregnancy and Lactation

Pregnancy

Idarubicin is contraindicated during pregnancy.

The manufacturer recommends that idarubicin is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Studies in rat have shown embryotoxicity and teratogenicity. Studies in rabbits only showed embryotoxicity. At the time of writing there is limited human data available. Idarubicin is less likely to cause cardiac abnormalities than other anthracyclines but the lipophilicity of idarubicin means that it will pass through the placenta more easily. Risks are unknown.

The effect of concurrent therapies must also be considered.

Lactation

Idarubicin is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking idarubicin. At the time of writing there are no published reports concerning the use of idarubicin while breastfeeding. The molecular weight of idarubicin is low enough that it should be expected to be present in the breast milk.

The effect of concurrent therapies must also be considered.

Side Effects

Abdominal pain
Acute myeloid leukaemia
Alopecia
Anaemia
Anaphylaxis
Anorexia
Atrioventricular block
Bradycardia
Bundle branch block
Burning sensation
Cardiomyopathy
Cellulitis
Cerebral haemorrhage
Chills
Colitis
Congestive cardiac failure
Decreased ejection fraction
Dehydration
Diarrhoea
ECG changes
Enterocolitis
Erythema
Febrile neutropenia
Fever
Flushing
Gastric erosions
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Haemorrhage
Headache
Hyperkalaemia
Hyperphosphataemia
Hyperphosphaturia
Hyperpigmentation of skin
Hypersensitivity reactions
Hyperuricaemia
Hypocalcaemia
Hypoxia
Increases in hepatic enzymes
Infections
Itching
Leukopenia
Local reaction at injection site
Mucositis
Myelodysplastic syndrome
Myelosuppression
Myocardial infarction
Myocarditis
Nausea
Neutropenia
Neutropenic colitis
Oesophagitis
Pancytopenia
Pericarditis
Phlebitis
Pigmentation of nails
Radiation recall dermatitis
Rash
Red urine
Secondary leukaemia
Sepsis
Septic shock
Septicaemia
Serum bilirubin increased
Shock
Sinus tachycardia
Skin necrosis
Stomatitis
Tachyarrhythmia
Thrombocytopenia
Thromboembolism
Thrombophlebitis
Tumour lysis syndrome
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: March 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

Summary of Product Characteristics: Idarubicin 5mg/5ml solution for injection. Accord Healthcare Ltd. Revised August 2017.

Summary of Product Characteristics: Idarubicin 10mg/10ml solution for injection. Accord Healthcare Ltd. Revised August 2017.

Summary of Product Characteristics: Idarubicin solution for injection 1 mg/ml. Teva UK Limited. Revised July 2014.

Summary of Product Characteristics: Zavedos 1mg/ml Solution for Injection. Pfizer Ltd. Revised April 2020.

Summary of Product Characteristics: Zavedos 5 mg powder solution for injection. Pfizer Ltd. Revised December 2014.

Summary of Product Characteristics: Zavedos 10 mg powder solution for injection. Pfizer Ltd. Revised December 2014.