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Information about Spectrila▼

What is it and what is it used for?

Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines.

How Spectrila works
The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine. The cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die. Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.

How Spectrila is used
Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient’s age and body surface area.

Only healthcare professionals experienced in cancer treatments should prescribe and give Spectrila. The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available. For further information, see the package leaflet.

Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.

What are the benefits?

Spectrila is effective at reducing blood levels of asparagine that the cancer cells need to survive. Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.

As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine’s risk minimisation plan.

The The European Medicines Agency concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.

What are main side effects?

The most common side effects with Spectrila (which may affect more than 1 in 10 people) are:
  • allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing)
  • diarrhoea
  • nausea
  • vomiting
  • abdominal pain
  • tiredness
  • swelling (caused by fluid build-up)
  • high blood sugar
  • low blood levels of albumin (a protein) and other abnormalities in blood tests
The most serious side effects with Spectrila include:
  • severe allergic reactions
  • blood clots
  • pancreatitis (inflammation of the pancreas)
  • liver problems
For the full list of side effects reported with Spectrila, see the package leaflet.

Who should avoid taking it?

Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have:
  • pancreatitis (inflammation of the pancreas)
  • severe liver disease
  • blood clotting problems.

It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment.

For the full list of restrictions, see the package leaflet.

What studies have been done?

In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.

Can patients be prescribed this medicine?

The SMC have approved asparaginase (Spectrila) for use within NHS Scotland 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.

The National Institute for Health and Care Excellence (NICE) will assess Spectrila for use by NHS England and NHS Wales when the manufacturer submits their application.

Sources

Spectrila was first approved for use in the EU in 2016. It is manufactured by medac GmbH.

European Medicines Agency website page for Spectrila (accessed 11/04/18)
NICE website
SMC website

Links available in External Resources

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


For the full list of side effects and restrictions, see the package leaflet (link to package leaflet available in External Resources).