Drugs List

Therapeutic Indications

Uses

Leukaemia - acute lymphoblastic

Combination treatment of acute lymphoblastic leukaemia (ALL).

Unlicensed Uses

Non-Hodgkin's lymphoma in children

Administration

For intravenous infusion given over a period of 0.5 to 2 hours.

Contraindications

History of significant haemorrhage
Breastfeeding
Coagulopathy
History of pancreatitis
History of thrombosis
Pancreatitis
Pregnancy
Serum bilirubin above 3 times upper limit of normal
Serum transaminases above 10 times upper limit of normal
Severe hepatic impairment

Precautions and Warnings

Dehydration
Hypertriglyceridaemia

Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient to avoid vincristine for 3 hours before dose
Maintain adequate hydration of patient prior / during treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Monitor coagulation values before and during treatment
Monitor hepatic function before treatment and regularly during treatment
Control any symptoms of hyperammonaemia that occur during treatment
Monitor blood or urinary glucose
Monitor cholesterol and triglyceride levels
Monitor patients for signs of tumour lysis syndrome
Monitor plasma concentrations of this drug
Monitor serum amylase and lipase regularly
Discontinue if pancreatitis occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue if severe hepatic changes occur
Female: Oral contraception may not be adequate during treatment
Male & female: Contraception required during & for 3 months after treatment

Colaspase (asparaginase) activity level should be monitored prior to each dose. Low colaspase (asparaginase) activity levels are often due to anti-asparaginase antibodies. Consider switching patient to a different asparaginase if low asparaginase activity levels are found.

Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

Pregnancy and Lactation

Pregnancy

Colaspase (asparaginase) is contraindicated in pregnancy.

The manufacturer suggests colaspase (asparaginase) should not be used in pregnancy unless the patient's condition requires treatment.
Embryotoxic and teratogenic effects have been shown with asparaginase preparations in animal studies.

The effect of concurrent therapies must also be considered.

Lactation

Colaspase (asparaginase) is contraindicated in breastfeeding.

The manufacturer suggests because of the potentially serious adverse effects on breastfed infant, colaspase (asparaginase) should be discontinued in breastfeeding.
It is not known whether this agent or its metabolites are excreted in human breast milk. However, due to the potential for serious toxicity in the breastfed infant it is recommended that breastfeeding is discontinued during treatment.

The effect of concurrent therapies must also be considered.

Side Effects

Abdominal pain
Agitation
Alterations in hepatic enzymes
Altered lipoproteins
Anaemia
Anaphylactic shock
Angioedema
Back pain
Bleeding
Blood urea increased
Bronchospasm
Cholestasis
Coma
Confusion
Decreased appetite
Decreased serum cholesterol
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Dizziness
Dyslipidaemia
Dyspnoea
Fatigue
Flushing
Gastro-intestinal symptoms
Haemorrhage
Hallucinations
Headache
Hepatic failure
Hepatic steatosis
Hepatocellular necrosis
Hyperammonaemia
Hyperglycaemia
Hypersensitivity reactions
Hyperuricaemia
Hypoalbuminaemia
Hypoglycaemia
Hypoparathyroidism
Hypotension
Hypothyroidism
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in plasma cholesterol
Increase in plasma triglyceride concentration
Infections
Intravascular coagulation (disseminated)
Jaundice
Joint pain
Ketoacidosis
Leukopenia
Myelosuppression
Nausea
Necrotising pancreatitis
Oedema
Pain
Pancreatitis
Parotitis
Pseudocysts
Rash
Reduction of fibrinogen
Reversible posterior leucoencephalopathy syndrome (RPLS)
Seizures
Serum bilirubin increased
Somnolence
Stroke
Thrombocytopenia
Thrombosis
Tremor
Unconsciousness
Urticaria
Vomiting
Weight loss

Presentation

Parenteral formulations of colaspase (E.coli derived asparaginase).

Drugs List

Therapeutic Indications

Uses

Leukaemia - acute lymphoblastic

Combination treatment of acute lymphoblastic leukaemia (ALL).

Unlicensed Uses

Non-Hodgkin's lymphoma in children

Dosage

Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

Adults

Children

Administration

For intravenous infusion given over a period of 0.5 to 2 hours.

Contraindications

History of significant haemorrhage
Breastfeeding
Coagulopathy
History of pancreatitis
History of thrombosis
Pancreatitis
Pregnancy
Serum bilirubin above 3 times upper limit of normal
Serum transaminases above 10 times upper limit of normal
Severe hepatic impairment

Precautions and Warnings

Dehydration
Hypertriglyceridaemia

Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Advise patient to avoid vincristine for 3 hours before dose
Maintain adequate hydration of patient prior / during treatment
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Monitor coagulation values before and during treatment
Monitor hepatic function before treatment and regularly during treatment
Control any symptoms of hyperammonaemia that occur during treatment
Monitor blood or urinary glucose
Monitor cholesterol and triglyceride levels
Monitor patients for signs of tumour lysis syndrome
Monitor plasma concentrations of this drug
Monitor serum amylase and lipase regularly
Discontinue if pancreatitis occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue if severe hepatic changes occur
Female: Oral contraception may not be adequate during treatment
Male & female: Contraception required during & for 3 months after treatment

Colaspase (asparaginase) activity level should be monitored prior to each dose. Low colaspase (asparaginase) activity levels are often due to anti-asparaginase antibodies. Consider switching patient to a different asparaginase if low asparaginase activity levels are found.

Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

Pregnancy and Lactation

Pregnancy

Colaspase (asparaginase) is contraindicated in pregnancy.

The manufacturer suggests colaspase (asparaginase) should not be used in pregnancy unless the patient's condition requires treatment.
Embryotoxic and teratogenic effects have been shown with asparaginase preparations in animal studies.

The effect of concurrent therapies must also be considered.

Lactation

Colaspase (asparaginase) is contraindicated in breastfeeding.

The manufacturer suggests because of the potentially serious adverse effects on breastfed infant, colaspase (asparaginase) should be discontinued in breastfeeding.
It is not known whether this agent or its metabolites are excreted in human breast milk. However, due to the potential for serious toxicity in the breastfed infant it is recommended that breastfeeding is discontinued during treatment.

The effect of concurrent therapies must also be considered.

Side Effects

Abdominal pain
Agitation
Alterations in hepatic enzymes
Altered lipoproteins
Anaemia
Anaphylactic shock
Angioedema
Back pain
Bleeding
Blood urea increased
Bronchospasm
Cholestasis
Coma
Confusion
Decreased appetite
Decreased serum cholesterol
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Dizziness
Dyslipidaemia
Dyspnoea
Fatigue
Flushing
Gastro-intestinal symptoms
Haemorrhage
Hallucinations
Headache
Hepatic failure
Hepatic steatosis
Hepatocellular necrosis
Hyperammonaemia
Hyperglycaemia
Hypersensitivity reactions
Hyperuricaemia
Hypoalbuminaemia
Hypoglycaemia
Hypoparathyroidism
Hypotension
Hypothyroidism
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increase in plasma cholesterol
Increase in plasma triglyceride concentration
Infections
Intravascular coagulation (disseminated)
Jaundice
Joint pain
Ketoacidosis
Leukopenia
Myelosuppression
Nausea
Necrotising pancreatitis
Oedema
Pain
Pancreatitis
Parotitis
Pseudocysts
Rash
Reduction of fibrinogen
Reversible posterior leucoencephalopathy syndrome (RPLS)
Seizures
Serum bilirubin increased
Somnolence
Stroke
Thrombocytopenia
Thrombosis
Tremor
Unconsciousness
Urticaria
Vomiting
Weight loss

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: August 2019

Reference Sources

Summary of Product Characteristics. Spectrila 10,000 units powder for concentrate for solution for infusion. Medac GmbH. Revised March 2019.