Spectrila - Asparaginase

What is Spectrila - Asparaginase used for?

Spectrila is a medicine for the treatment of acute lymphoblastic leukemia (ALL), a cancer of white blood cells called lymphoblasts. It contains the active ingredient asparaginase and is used in combination with other anticancer medicines.

How is Spectrila used - Asparaginase?

Spectrila is administered every 3 days by infusion (drip) into a vein, at a dose that depends on the patient's age and body surface.

Only healthcare professionals experienced in the treatment of tumors can prescribe and administer Spectrila. The healthcare professional should only administer the medicine in a hospital environment where resuscitation equipment is available. For more information, see the package leaflet.

Spectrila can only be obtained with a prescription and is available in a vial as a powder with which to create an infusion solution.

How does Spectrila - Asparaginase work?

The active ingredient of Spectrila, asparaginase, is an enzyme that acts by breaking down the amino acid asparagine and reducing its blood levels. Cancer cells need this amino acid to grow and multiply, so its reduction in blood causes them to die. Normal cells, on the other hand, can produce asparagine alone and are less affected by the action of the medicine.

What benefits of Spectrila - Asparaginase have been shown in studies?

In a study of 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 asparagine in the blood.

What are the risks associated with Spectrila - Asparaginase?

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), diarrhea, nausea, vomiting, abdominal pain, fatigue, swelling (caused by fluid accumulation), high blood sugar levels and low levels of albumin (a protein) in the blood, as well as other blood test abnormalities. For the full list of all side effects reported with Spectrila, see the package leaflet.

The most serious side effects of Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas) and liver problems.

Spectrila should not be used in patients who are allergic to asparaginase preparations or those with pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting disorders. It must not be used even in patients who have presented with pancreatitis, severe bleeding or blood clots following asparaginase treatment. For the full list of limitations, see the package leaflet.

Why has Spectrila - Asparaginase been approved?

Spectrila is effective in reducing the blood needed by cancer cells to survive. Although adult data are limited, the clinical experience with asparaginase use in adults is substantial and the benefits of Spectrila in adults can be expected to be similar.

Regarding the risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine's risk management plan.

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Spectrila's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Spectrila - Asparaginase?

A risk management plan has been developed to ensure that Spectrila is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, including the appropriate precautions to be followed by healthcare professionals and patients.