Drug

ATRIANCE®

nelarabine

Atriance Overview

This is a summary of the European public assessment report (EPAR) for Atriance. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Atriance.

 

Atriance is given by intravenous infusion (a drip into a vein) under the supervision of a doctor who has experience in the use of these types of medicine. The dose and frequency of infusion depend on the patient’s age and body surface area. In adults and adolescents aged over 16 years, the recommended starting dose is 1,500 mg per square metre, given over two hours on days one, three and five, repeated every 21 days. Younger patients receive a lower dose (650 mg per square metre) given over one hour on five consecutive days, repeated every 21 days. This schedule can also be used in patients aged 16 to 21 years. Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.

Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).

The active substance in Atriance, nelabarine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells. It belongs to the group of anticancer medicines called ‘antimetabolites’.

Nelarabine is converted within cells into an analogue of guanine, one of the fundamental chemicals that make up DNA. In the body, this analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases. This stops the production of DNA and thus slows down the growth and multiplication of cells. As the guanine analogue accumulates in T-cells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.

Atriance was shown to be effective in a proportion of the patients in both studies. In the first study, among the 39 children and young adults who had failed two or more previous treatments, five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts. In the second study, among the 28 adults and adolescents who had failed two or more previous treatments, five (18%) had a complete response to treatment. In both studies, more patients had a partial response to Atriance treatment, with blood counts returning towards normal levels.

The company that markets Keytruda will provide information packs for doctors who are expected to prescribe Keytruda on how the medicine should be used and how to manage side effects, particularly side effects on the immune system. Information on the risks of being given donor stem cell transplants after Keytruda treatment will also be included. The company will provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience side effects.

In addition, the company will provide the final results of studies with Keytruda to confirm the long-term benefits of the medicine. Moreover, the company will carry out analyses to better understand which patients are likely to benefit most from treatment with Keytruda.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Keytruda have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Keytruda are continuously monitored. Side effects reported with Keytruda are carefully evaluated and any necessary action taken to protect patients.

The European Commission granted a marketing authorisation valid throughout the European Union for Atriance on 22 August 2007.

For more information about treatment with Atriance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What are the risks associated with Atriance?

The most common side effects with Atriance in adults (seen in more than 1 patient in 10) are infection, febrile neutropenia (low white-blood-cell counts with fever), neutropenia (low white-blood-cell counts), thrombocytopenia (low platelet counts), anaemia (low red-blood-cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoesthesia (a reduced sense of touch), paresthesia (abnormal sensations), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, fatigue (tiredness) and asthenia (weakness). Most of these side effects were also seen very commonly in children. Severe side effects affecting the brain and nervous system have been reported in patients taking Atriance, including somnolence, convulsions, and peripheral neuropathy causing numbness, unusual sensations, weakness and even paralysis. Patients should be monitored closely for these side effects and treatment stopped if necessary.

Atriance must not be used in people who are hypersensitive (allergic) to nelarabine or any of the other ingredients.

Owner of copyright and other intellectual property rights to European Medicines Agency

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