Asparaginase

Colaspase

Therapeutic Indications

Asparaginase is indicated for:

Acute lymphoblastic leukaemia (ALL)

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old) Adults (18 years old or older)

Asparaginase is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 5000 U/m² every third day

Acute lymphoblastic leukaemia (ALL)

Irrespective of gender only Infants (40 days - 1 year old)

Asparaginase is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Intravenous - 6700-7500 U/m² every third day

Contraindications

Active ingredient Asparaginase is contraindicated in the following cases:

Severe hepatic impairment

No gender/age discrimination

Severe hepatic impairment (bilirubin >3 times upper limit of normal [ULN]; transaminases >10 times ULN).

Coagulopathy

No gender/age discrimination

Due to the inhibition of protein synthesis (decreased synthesis of factors II, V, VII, VIII, and IX, proteins C and S, antithrombin III [AT III]) caused by asparaginase, coagulation disorders can occur which can manifest either as thrombosis, disseminated intravascular coagulation (DIC), or bleeding. The risk of thrombosis seems to be higher than the risk of bleeding. Symptomatic thromboses related to the use of central venous catheters have been described, too.

Approximately half of the thrombotic events is localised in cerebral vessels. Sinus vein thrombosis can occur. Ischaemic strokes are rare. Acquired or genetically decreased physiologic coagulation inhibitors (protein C, protein S, antithrombin) are also described in relation to vascular complications. Frequent evaluation of coagulation parameters is important before and during asparaginase treatment. Expert advice should be sought in cases where AT III is decreased.

Pancreatitis

No gender/age discrimination

Treatment with asparaginase should be discontinued in patients developing acute pancreatitis. Acute pancreatitis has developed in less than 10% of patients. In rare cases, haemorrhagic or necrotising pancreatitis occurs. There have been isolated reports of fatal outcomes. Clinical symptoms include abdominal pain, nausea, vomiting and anorexia. Serum amylase and lipase are usually elevated, although in some patients they can be normal due to impaired protein synthesis. Patients with severe hypertriglyceridaemia are at increased risk of developing acute pancreatitis. These patients should no longer be treated with any asparaginase preparation.