APPROVAL WITH CONDITIONS OF ATRIANCE™ for USE in the treatment of adults and children with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma - Fact Sheet

Date: 2007-10-23

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What is ATRIANCE™?

ATRIANCE™ is a sterile solution containing nelarabine 5 mg/mL for intravenous infusion.

Health Canada has approved ATRIANCE™ under the Notice of Compliance with Conditions (NOC/c) policy for use in adults and children who have a certain type of leukemia (T-cell acute lymphoblastic leukemia) or lymphoma (T-cell lymphoblastic lymphoma).  This approval is based on the unconfirmed surrogate endpoint of clinical response only.  This authorization reflects the promising nature of the clinical evidence which must be verified and/or extended with further studies.  Products approved under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.  

What is ATRIANCE^™ used for?

ATRIANCE™ is used for the treatment of adults and children with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

What are T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL)?

T-ALL and T-LBL are rare, extremely aggressive, and difficult to treat forms of  blood cancers involving T-cells.   T-cells are a type of cell in the blood that are a part of your immune system.

How does ATRIANCE™ work?

ATRIANCE™ damages cancer cells, causing their death

What are the advantages of ATRIANCE™ over other therapies?

Patients with relapsed or refractory T-ALL and T-LBL have limited treatment choices.  ATRIANCE™ provides a new option for patients with these diseases.

What do patients need to know about using ATRIANCE™?

ATRIANCE™ should be given under the supervision of a doctor experienced in the use of anti-cancer medicines.

Serious side effects with ATRIANCE™ include:

• persistent serious nervous system problems such as tingling or numbness (lack of sensation) in fingers, hands, toes, or feet;  difficulty with fine motor coordination tasks such as buttoning clothing;  unsteadiness while walking;  weakness arising from a low chair;  weakness in climbing stairs;  increased tripping while walking, extreme sleepiness, seizures (convulsions), or coma.
• sleepiness.  If you feel tired or weak, do not drive or use any tools or machinery.

Before receiving treatment with ATRIANCE™, patients should tell their doctor if they:

• have liver or kidney problems
• have had intrathecal chemotherapy or craniospinal irradiation.
• are pregnant or plan to become pregnant.  ATRIANCE™ may harm an unborn baby.
• are breast feeding.  It is not known whether ATRIANCE™ passes through breast milk.  Women should stop breast feeding if being treated with ATRIANCE™.
• or their close family/friends have recently been, or plan to be vaccinated with a live vaccine such as Polio, Varicella (chickenpox) or Typhoid.

Can ATRIANCE™ be taken with other drugs?

Patients should tell their healthcare professional about all the medicines they take, including prescription and non-prescription medicines, vitamins, and herbal supplements and recent vaccinations.

What are the common side effects and how serious are they?

Adults:

Very common side effects include:

• nervous system problems such as difficulty with sense of feeling in hands and/or feet, reduced sensitivity to light touch or pain, or abnormal sensation such as burning, prickling or sensations of something crawling on skin;
• infections (including pneumonia);
• blood problems including decreased blood counts, reduced resistance to infection, temporary anemia (which may make you feel tired or weak), bruising or bleeding; 
• feeling sleepy or drowsy, headache, dizziness, build up of fluid around the lungs, shortness of breath, difficult or laboured breathing, cough, nausea (feeling sick), or being sick/throwing up, diarrhea, constipation, muscle pain, swelling due to accumulation of fluid, high body temperature or fever, tiredness, feeling weak/loss of strength.

Common side effects include:

• loss of muscle coordination, convulsions, weight loss and loss of appetite, difficulty with memory/feeling disoriented, blurred vision, increases in blood levels of liver enzymes.

Children:

Very common side effects include:

• difficulty with sense of feeling in hands and/or feet;
• blood problems including decreased blood counts, reduced resistance to infection, temporary anemia (which may make you feel tired or weak), bruising or bleeding;
• abnormally low levels of potassium in the blood (which may make you feel weak), being sick/throwing up, headache, increases in blood levels of liver enzymes.

Common side effects include:

• infection (including pneumonia);
• convulsions, reduced sensitivity to light touch or pain, abnormal sensation such as burning, prickling or sensations of something crawling on skin;
• feeling drowsy or sleepy;
• abnormally low glucose in the blood (which may cause symptoms like feeling sick, sweating, weakness, faintness, confusion or hallucinations;  abnormally low levels of calcium in the blood which may cause symptoms like muscle cramps, abdominal cramps or spasms); abnormally low levels of magnesium in the blood;
• high body temperature/fever, feeling weak/loss of strength.

Who should not be treated with ATRIANCE™?

ATRIANCE™ should not be given to patients who are allergic to nelarabine, or to any of the other ingredients in ATRIANCE™.

How is ATRIANCE™ given?

ATRIANCE™ is given to patients by injecting it into a vein.  For adults, ATRIANCE™ is given over 2 hours on days 1, 3, and 5 every 21 days.  In children, ATRIANCE™ is given over 1 hour on days 1 to 5 every 21 days.

How is ATRIANCE™ available?

ATRIANCE™ is available as a sterile solution containing 5 mg of nelarabine per mL.

Where can I learn more about ATRIANCE™?

Additional information about ATRIANCE™ can be found at www.gsk.ca or by calling Medical Information at 1-800-387-7374.