What is Oncaspar - Pegaspargasi and what is it used for?
Oncaspar is used in adults and children to treat acute lymphoblastic leukemia (ALL), a cancer that originates in a particular type of white blood cell (lymphoblasts), in combination with other anticancer medicines. Contains the active ingredient pegaspargase.
How is Oncaspar used - Pegaspargasi?
Oncaspar is usually given every 14 days by injection into a muscle or by infusion (drip into a vein), at a dose that varies according to age and body surface area.
The prescription and administration of the drug should only be carried out by healthcare professionals with experience in the use of anticancer drugs. The healthcare worker must administer the drug in a hospital setting with the availability of means for resuscitation.
For more information, see the package leaflet. Oncaspar can only be obtained with a prescription and is available in a bottle as a solution for injection or infusion.
How does Oncaspar - Pegaspargasi work?
The active substance (pegaspargase) contains the enzyme asparaginase, which works by breaking down the amino acid asparagine and reducing its levels in the blood. Cancer cells need this amino acid to grow and multiply, so its reduction in the blood causes the cells to die. Unlike cancer cells, normal cells can produce asparagine themselves and are less affected by the action of the medicine.
The asparaginase enzyme contained in this medicine is combined with a chemical that slows its elimination from the body and can reduce the risk of allergic reactions.
What benefits of Oncaspar - Pegaspargase have been shown in studies?
In a study of 118 newly diagnosed children with ALL, 75% of subjects treated with Oncaspar (in combination with other medicines) achieved remission and had no relapse or new cancer after 7 years. This data compares with the 66% obtained from subjects treated with another asparaginase.
In another study involving 76 children who had cancer recurrence after previous treatment, approximately 40% of patients treated with Oncaspar (some of whom were allergic to other asparaginase-based therapies) achieved remission, compared with 47. % of patients treated with an asparaginase-based comparator.
What are the risks associated with Oncaspar - Pegaspargasi?
The most common side effects with Oncaspar (which may affect more than 1 in 10 people) are allergic reactions (including severe), rash, hives, hyperglycaemia, pancreatitis (inflammation of the pancreas), diarrhea and abdominal pain. For the full list of side effects reported with Oncaspar, see the package leaflet.
Oncaspar must not be used in patients with severe liver disease, in patients with a previous history of pancreatitis or in those who have experienced severe bleeding or blood clots following asparaginase treatment. For the full list of restrictions, see the package leaflet.
Why has Oncaspar - Pegaspargasi been approved?
Studies have shown that Oncaspar is effective in ALL patients, including patients allergic to other asparaginase-containing medicines. Oncaspar also has the advantage of requiring fewer injections, as the medicine stays longer in the body than other asparaginases. However, data for adult patients is limited and the pharmaceutical company that markets the medicine has been requested. to provide further data regarding the benefits in this patient population.
Regarding the risks, the side effects of Oncaspar are similar to those caused by other asparaginase medicines and are manageable.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Oncaspar'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 Oncaspar - Pegaspargasi?
A risk management plan has been developed to ensure that Oncaspar is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Oncaspar, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the pharmaceutical company that markets Oncaspar will complete two additional clinical studies on the safety and efficacy of Oncaspar, which will help to better understand the benefits and risks of the medicine in question in adults and in newly diagnosed patients.
Further information can be found in the summary of the risk management plan.
More information about Oncaspar - Pegaspargasi
For more information about Oncaspar therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Oncaspar - Pegaspargasi published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
