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asparaginase

Spectrila · ATC code L01XX02

Key facts
Active substance
asparaginase
ATC code
L01XX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Spectrila 10,000 U powder for concentrate for solution for infusion
Marketing authorisation holder
Medac Gesellschaft fuer klinische Spezialpraeparate mbH
Information as of
2026-10-27

Key facts

Asparaginase (Spectrila) is an E. coli-derived enzyme used as a component of antineoplastic combination therapy for acute lymphoblastic leukaemia (ALL).

What it is used for

  • Acute lymphoblastic leukaemia (ALL) as part of combination chemotherapy in paediatric patients from birth to 18 years and in adults

Dosing

  • Adults and children older than 1 year: 5,000 U/m² body surface area intravenously every third day
  • Infants under 6 months: 6,700 U/m²; 6–12 months: 7,500 U/m² (limited data)
  • Intravenous infusion only, over 0.5 to 2 hours; never as a bolus
  • No dose adjustment in renal impairment or mild to moderate hepatic impairment
  • Treatment may be monitored by trough asparaginase activity three days after administration
  • Given only by staff experienced with antineoplastics, in hospital with resuscitation equipment

Contraindications

  • Hypersensitivity to the active substance or any native (non-pegylated) E. coli asparaginase
  • Pancreatitis, or history of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase
  • Severe hepatic impairment
  • Pre-existing known coagulopathy (e.g. haemophilia)

Important warnings

  • Life-threatening situations may arise: acute pancreatitis, hepatotoxicity, anaphylaxis, coagulation disorders including thrombosis, hyperglycaemia
  • Bilirubin, transaminases and coagulation parameters should be determined before starting
  • Close monitoring of liver tests, glucose, coagulation, amylase, lipase, triglycerides and cholesterol after administration
  • Batch number should be recorded for traceability

Side effects

  • Very common: hypersensitivity reactions, hyperglycaemia, hypoalbuminaemia, nausea, vomiting, diarrhoea, abdominal pain, oedema, fatigue, laboratory changes
  • Common and serious: thromboembolic events, acute pancreatitis
  • Rare: anaphylactic shock, severe hepatotoxicity including hepatic failure

Interactions

  • Increased toxicity of hepatotoxic or hepatically metabolised medicines; monitor liver parameters
  • Myelosuppressive agents: myelosuppression and infections can occur
  • Oral contraceptives are not considered sufficiently safe during treatment

Pregnancy and breastfeeding

  • Women of childbearing potential: effective non-oral contraception during and for 7 months after treatment; men for 4 months after treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • SpectrilaMedac Gesellschaft fuer klinische Spezialpraeparate mbH · EMEA/H/C/002661

Source: European Medicines Agency (EMA), product information

Turkey

  • Leunase EnjektablONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Spectrila
Liechtenstein
Spectrila
Norway
Spectrila

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Spectrila – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/spectrila-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.