Aldesleukin powder for solution for injection 18 million iu/ml
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections or infusions of aldesleukin.
Drugs List
Therapeutic Indications
Uses
Metastatic renal cell carcinoma
Treatment of metastatic renal cell carcinoma.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
Continuous intravenous infusion
Induction cycle
18 million i.u. (units) per square metre per day as a continuous IV infusion for 5 days followed by a 2 to 6 day rest period. After the rest period a further 5 days continuous infusion is given which is followed by another rest period of 3 weeks. A second induction cycle is given after the 3 week break after the first cycle.
Maintenance cycle
18 million units per square metre as a continuous infusion for 5 days may be given up to 4 times with rest periods of 4 weeks between cycles to patients who respond or have disease stabilisation.
Subcutaneous injection
18 million units every day for 5 days, followed by 2 days rest. For the following 3 weeks, administer 18 million units on days 1 and 2 of each week followed by 9 million units on days 3 to 5. On days 6 and 7 no treatment is administered. After 1 week rest period, repeat this 4-week cycle. Maintenance cycles may be given to patients who respond or have disease stabilisation.
Administration
Aldesleukin is administered by subcutaneous injection or continuous intravenous infusion.
Contraindications
Acute infection
Autoimmune disease
Children under 18 years
Haematocrit less than 30%
Leucocyte count below 4 x 10 to the power of 9 / L
Major organ dysfunction
Organ transplant recipients
Performance status of ECOG greater than or equal to 2
Platelet count below 100 x 10 to the power of 9/ L
pO2 below 60mmHg during rest
Raised serum creatinine
Breastfeeding
Central nervous system metastasis
Elevated serum bilirubin
History of severe cardiac disorder
Pregnancy
Seizures
Precautions and Warnings
History of autoimmune disorder
Patients over 65 years
Performance status of ECOG 1 or greater
Period of less than 24 months between diagnosis and treatment date
Crohn's disease
Diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Evaluate and treat CNS metastases prior to therapy
Treat bacterial infections prior to therapy
Consult local policy on the safe use of anti-cancer drugs
Repeated local injection may result in necrosis at injection site
Staff: Not to be handled by pregnant staff
Treatment to be administered by or under supervision of specialist
Monitor blood pressure pre-treatment and periodically thereafter
Monitor haematological parameters before and during treatment
Monitor renal and hepatic function before and during treatment
Monitor serum electrolytes before and during treatment
Perform chest X-ray prior to and periodically during treatment
Perform ECG before treatment
Monitor blood gases regularly
Monitor blood glucose
Monitor fluid balance
Monitor respiratory function
Monitor thyroid function regularly
Monitor urine output
Consider the use of anti-emetics before and during therapy
Discontinue if patient develops severe lethargy or somnolence
Discontinue if patients show signs of SIRS/capillary leak syndrome
Interrupt treatment if measures to resolve hypotension fail
Male & female: Ensure adequate contraception during treatment
Aldesleukin may exacerbate effusions from serosal surfaces. Considerations should be given to treating these prior to initiation of therapy, particularly when effusions are located in anatomic sites where worsening may lead to impairment of major organ function.
If intravenous fluids are administered, care must be taken to weigh potential benefits of the expansion of intravascular volume against the risk of pulmonary oedema secondary to capillary leakage.
Pregnancy and Lactation
Pregnancy
Aldesleukin is contraindicated during pregnancy.
The manufacturer does not recommend using aldesleukin during pregnancy, unless the potential benefit justifies the potential risk to the foetus. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Aldesleukin is contraindicated during breastfeeding.
Use of aldesleukin when breastfeeding is contraindicated by the manufacturer. The presence of aldesleukin in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abnormal liver function tests
Acidosis
Adult respiratory distress syndrome
Agitation
Agranulocytosis
Anaemia
Anorexia
Anxiety
Aplastic anaemia
Arrhythmias
Ascites
Blood glucose disturbances
Blood pressure changes
Capillary leak syndrome
Cardiac failure
Cardiac tamponade
Cardiomyopathy
Cerebrovascular haemorrhage
Chest pain
Coagulation disorders
Coma
Confusion
Convulsions
Cough
Cyanosis
Dehydration
Depression
Dizziness
Dysphagia
Dyspnoea
ECG changes
Electrolyte disturbances
Eosinophilia
Epistaxis
Eye disorder
Febrile neutropenia
Fever
Gastritis
Gastro-intestinal perforation
Gastro-intestinal symptoms
Haematuria
Haemolytic anaemia
Haemoptysis
Haemorrhage
Hallucinations
Headache
Hepatic failure
Hypersensitivity reactions including anaphylaxis
Hyponatraemia
Hypophosphataemia
Hypothermia
Hypoxia
Increased susceptibility to infection
Influenza-like syndrome
Injection site reactions
Insomnia
Intestinal obstruction
Intravascular coagulation (disseminated)
Irritability
Lethargy
Leucopenia
Leukoencephalopathy
Malaise
Musculoskeletal disturbances
Myasthenia
Myocardial infarction
Myocardial ischaemia
Myocarditis
Necrosis (injection site)
Neuropathy
Neutropenia
Oedema
Optic nerve damage
Pain
Palpitations
Pancreatitis
Paraesthesia
Paralysis
Pericardial effusion
Pleural effusion
Pulmonary embolism
Pulmonary oedema
Quincke's oedema
Renal failure
Renal impairment
Skin disorder
Somnolence
Speech disturbances
Stevens-Johnson syndrome
Stomatitis
Syncope
Tachycardia
Taste loss
Thrombocytopenia
Thrombophlebitis
Thrombosis
Thyroid abnormalities
Urinary abnormalities
Vesiculo-bullous reactions
Weight changes
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: June 2019
Reference Sources
Summary of Product Characteristics: Proleukin powder for solution for injection. Novartis Pharmaceuticals. Revised May 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.