Patient Medication Information: uses, side effects, how to take - Atriance
Serious Warnings and Precautions
ATRIANCE should be given under the supervision of a doctor experienced in the use of anti-cancer drugs. ATRIANCE should only be given by injection into a vein. ATRIANCE may cause brain or nervous system disorders which can be fatal. You may be at increased risk of more serious side effects if you:
Serious side effects include:
Contact the doctor right away if any of the above occur. Your doctor will monitor you and may stop treatment if detect any of the symptoms. The above symptoms may not go away, even when ATRIANCE is stopped. |
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What is ATRIANCE used for?
ATRIANCE is used to treat adults and children who have a certain type of leukemia (T-cell acute lymphoblastic leukemia) or lymphoma (T-cell lymphoblastic lymphoma). ATRIANCE is only used when at least two other cancer treatments have already been used and the cancer:
- is not responding to the other cancer treatments or;
- has returned
How does ATRIANCE work?
ATRIANCE damages cancer cells, causing their death.
What are the ingredients in ATRIANCE?
Medicinal ingredients: nelarabine
Non-medicinal ingredients: sodium chloride, water for Injection. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH.
ATRIANCE comes in the following dosage forms:
Solution for injection, 5 mg/mL.
Do not use ATRIANCE if:
- You, or your child, are allergic to nelarabine or to any of the other ingredients in this drug. If you are not sure about this, talk to your healthcare professional before taking ATRIANCE.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ATRIANCE. Talk about any health conditions or problems you may have, including if you:
- or your child, have recently been, or plan to be vaccinated with a live vaccine such as Polio, Varicella (chickenpox) or Typhoid
- Have any past problems with muscles (pain, tenderness)
- Have low white blood cells
- Have low red blood cells
- Have had bleeding problems or blood clots
- Have kidney problems
Have liver problems. ATRIANCE can cause problems with your liver, which may develop into serious conditions such as hepatitis and liver failure. This may be fatal. Signs that your liver may not be working properly may include:
- Loss of appetite
- Feeling sick (nausea)
- Being sick (vomiting)
- Pain in your stomach (abdomen)
- Yellowing of your skin or the whites of your eyes (jaundice)
- Dark-colored urine
- Itching of your skin
Other warnings you should know about:
Increased levels of uric acid in the blood (hyperuricemia) You or your child may be given intravenous hydration to manage hyperuricemia. This treatment is provided if you or your child are at risk of developing tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment). Blood disorders
Treatment with Atriance can increase your risk of certain side effects, including:
a decrease in red blood cells which can be life-threatening (severe anemia). Signs that certain red cell counts are low may include:
- Severe lack of energy
- Pale skin
- Weakness
- Shortness of breath
a decrease in white blood cells (leukopenia and neutropenia). A decrease in white blood cells that may lead to infection which can be life-threatening, or to unexpected bruising or bleeding. Signs that certain white cell counts are low may include:
- Symptoms of infection (fever, chills, sore throat)
- Bruise or bleed easily
- Cold
Your doctor will monitor you periodically. Your doctor will conduct blood tests regularly during treatment to check for blood problems that have been associated with the use of ATRIANCE. Muscle or bone problems. ATRIANCE may cause muscle pain or weakness that does not go away after you stop taking the drug. Driving and using machines: Before you do tasks that require special attention, wait until you know how respond to ATRIANCE.
Pregnancy, Birth Control and Fertility for Men and Women, and Breastfeeding If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
- Do not use ATRIANCE if you are pregnant or plan to become pregnant. It may harm your unborn baby or put an unborn baby at serious risk.
- Tell your healthcare professional if you become pregnant while you or your male partner are being treated with ATRIANCE.
Men and women must use a highly effective method of birth control while taking ATRIANCE. Talk to your healthcare professional about birth control methods that may be right for you during this time
- Women: Prevent pregnancy while taking ATRIANCE.
- Men: Inform female sexual partners that you are taking ATRIANCE. Tell them the serious risk of harm to an unborn baby. Prevent pregnancy in your partner while taking ATRIANCE.
- It is not known whether taking ATRIANCE could affect how well your birth control pills will work. This could result in pregnancy
- ATRIANCE may affect your ability to become pregnant or to father a child
- ATRIANCE may pass through breast milk. Do not breast feed while taking ATRIANCE
- Male patients with partners who are pregnant, possibly pregnant, or who could become pregnant should use condoms during sexual intercourse while receiving ATRIANCE and for 3 months following completion of therapy
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ATRIANCE:
- cancer treatment that targets you, or your child’s, cerebrospinal fluid
- adenosine deaminase inhibitors, such as pentostatin
- It is not known whether taking ATRIANCE could affect how well your birth control pills will work. This could result in pregnancy.
How to take ATRIANCE:
- ATRIANCE will be given to you by a healthcare professional.
- The dose of ATRIANCE is based on your/your child's body surface area (which will be calculated by your doctor based on your height and weight).
- The healthcare professional will take the appropriate actions to prevent hyperuricemia before starting your/your child’s treatment
- ATRIANCE is administered intravenously (into a vein)
Usual dose:
Adults: The recommended dose is 1,500 mg/m²/day. ATRIANCE is administered over a period of 2 hours. Treatment will be on days 1, 3, and 5. This pattern of treatment is repeated every 21 days.
Children: The recommended dose for children 15 years and younger is 650 mg/m²/day. ATRIANCE is administered over a period of 1 hour. Treatment will be on days 1 to 5. This pattern of treatment is repeated every 21 days.
Overdose:
| If you think you, or a person you are caring for, have taken too much ATRIANCE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you or your child miss a scheduled dose of ATRIANCE, contact your/your child’s doctor. Your/your child’s doctor will advise you on what to do about the next dose.
What are possible side effects from using ATRIANCE?
These are not all the possible side effects you may have when taking ATRIANCE. If you experience any side effects not listed here, tell your healthcare professional.
Adults:
- abdominal expansion;
- dehydration;
- feeling sleepy or drowsy, dizziness, 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;
- loss of muscle coordination, weight loss and loss of appetite, difficulty with memory/feeling disoriented, difficulty sleeping, blurred vision;
- mouth sores, redness and swelling of the lining of the mouth;
- nose bleeds;
- pain in the joints, back or extremities;
- stomach pain;
- taste disturbance or loss of taste;
- tiny red spots on skin;
- tremors;
- unusual walking pattern.
Children:
- 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; increase in creatinine (a substance produced by the kidneys) in the blood;
- feeling drowsy or sleepy;
- high body temperature/fever, feeling weak/loss of strength;
- loss of muscle coordination or balance;
- tremors.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Brain or nervous system disorders including headache, sleepiness, tingling or numbness in fingers, hands, toes or feet, reduced sensitivity to light touch or pain, balance problems, speech problems, collapse or periods of unconsciousness or lack of awareness, or seizures/convulsions. | ✓ | ||
| Low white blood cells which may give you a greater chance of infection (including but not limited to sepsis, bacteremia, fungal | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| infection), which may be life threatening. Symptoms of infection may include: fever; serious deterioration of general condition; fever with local symptoms such as sore throat/mouth or urinary problems. | |||
| Hypokalemia (low level of potassium in the blood) (children only): muscle weakness, muscle spasms, cramping, constipation, feeling of skipped heart beats or palpitations, fatigue, tingling or numbness | ✓ | ||
| Fluid around the lungs (adults only): chest pain, difficult or painful breathing, cough | ✓ | ||
| Pneumonia (infection in the lungs): chest pain when you breath or cough, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking, chills, nausea, vomiting or diarrhea, shortness of breath, build up of fluid around the lungs | ✓ | ||
| Low platelets which may give you a greater chance for bleeding. Symptoms may include easy bruising or unusual bleeding while brushing teeth or from other sources. | ✓ | ||
| Low red blood cells: fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | ✓ | ||
| Tachycardia (abnormally fast heartbeat) (adults only): dizziness, light headedness, shortness of breath, racing heart | ✓ | ||
| COMMON | |||
| Stroke: Speech difficulty, weak on one side of the body, dizziness, poor balance | ✓ | ||
| Abnormally low blood sugars (children only): feeling sick, sweating, weakness, faintness, confusion or hallucinations. | ✓ | ||
| Abnormally low levels of calcium in the blood (children only): muscle cramps, abdominal cramps or spasms. | ✓ | ||
| Low levels of magnesium in the blood (children only): abnormal eye movements, fatigue, muscle spasms or cramps, muscle weakness, numbness. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Increase in creatinine (a substance produced by the kidneys) in the blood: a sign of kidney problems, which might lead less frequent urination. | ✓ | ||
| Tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment) (adults only): nausea, shortness of breath, irregular heartbeat, heart rhythm disturbances, lack of urination, clouding of urine, muscle spasms or twitching, tiredness and/or joint pain, severe muscle weakness, and seizures. | ✓ | ||
| Hypotension (low blood pressure) (adults only): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | ✓ | ||
| Depression (sad mood that won’t go away) (adults only): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) | ✓ | ||
| Increased levels of liver enzymes (AST) in the blood: dark urine, fatigue, loss of appetite, yellowing of the skin or eyes | ✓ | ||
| Hyperglycemia: (high blood sugar) (adults only): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue | ✓ | ||
| Chest Pain (adults only) | ✓ | ||
| UNCOMMON | |||
| Blindness | ✓ | ||
| Hallucinations: See or hear things that are not there | ✓ | ||
| Sudden or very bad headache | ✓ | ||
| UNKNOWN | |||
| Spinal cord disorders (block of blood supply to, or inflammation of, the spinal cord): leg | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| weakness, numbness, paralysis of arms and legs, inability to control bowel movements and urine release. | |||
| Leukoencephalopathy (a rare brain infection): clumsiness of limbs, disturbance of vision, changes in thinking, memory and orientation, confusion, personality changes. | ✓ | ||
| Rhabdomyolysis (abnormal breakdown of muscle tissue): abnormal urine colour, muscle aching, weakness of affected muscles. | ✓ | ||
| Sudden liver failure: yellowing of skin and eyes, stomach pain, nausea and/or vomiting. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store between 15° to 25°C.
Keep out of reach and sight of children.
If you want more information about ATRIANCE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.nsandoz.ca, or by calling 1-800-361-3062.
Last Revised: NOV 30, 2022
ATRIANCE is a registered trademark.