Patient Medication Information: uses, side effects, how to take - Trisenox (Teva Canada, 12 mg)
Serious Warnings and Precautions
TRISENOX may cause:
For more information on these and other serious side effects, see the Serious side effects and what to do about them table, below. You will receive TRISENOX under the care of a healthcare professional who has experience in treating people who have leukemia (cancer of the white blood cells). |
What is TRISENOX used for?
TRISENOX is used to treat people with acute promyelocytic leukemia (APL) who no longer benefit from, or whose disease has returned after treatment with certain group of anticancer medicines (retinoids and anthracyclines). APL is a type of blood cancer.
How does TRISENOX work?
The active ingredient in TRISENOX, arsenic trioxide belongs to a class of medicines called anti-neoplastics. The way it works in this disease is not completely understood. It is thought to work by slowing the growth of leukemia cells.
What are the ingredients in TRISENOX?
Medicinal ingredient: Arsenic trioxide.
Non-medicinal ingredients: Hydrochloric acid, sodium hydroxide and water for injection.
TRISENOX comes in the following dosage forms:
Solution:
- 12 mg/6 mL (2 mg/mL) stoppered vial
Do not receive TRISENOX if:
- you are allergic or hypersensitive to arsenic or any of the nonmedicinal ingredients in TRISENOX (See What are the ingredients in TRISENOX?).
- you are pregnant or breastfeeding.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive TRISENOX. Talk about any health conditions or problems you may have, including if you:
- have kidney problems
- have liver problems
have or had any heart problems including irregular heartbeat. TRISENOX may cause a deadly type of heartbeat problems (QT prolongation, torsades de pointes). The chance of having heartbeat problems may be raised if you:
have a heart disease. These includes
- heart failure
- QT/QTc prolongation or a family history of QT/QTc prolongation
- a family history of sudden cardiac death at less than 50 years of age
- are taking other medicines which are known to cause serious problems in heart rhythm.
- have low levels of potassium, calcium or magnesium in your blood
- have diabetes
Other warnings you should know about:
Pregnancy, Breastfeeding and Fertility:
If you are a woman:
Pregnancy:
- Do NOT receive TRISENOX during pregnancy. TRISENOX may cause miscarriage and harm your unborn baby if received during pregnancy.
If you are of an age where you could become pregnant:
- your healthcare professional will have you take a pregnancy test before starting TRISENOX.
- you must use an effective birth control during treatment with TRISENOX and f or at least 6 months after the last dose.
- ask your healthcare professional about options of effective birth control.
- If you become pregnant while receiving TRISENOX tell your healthcare professional right away. You and your healthcare professional will decide what is best for you and your baby.
Breastfeeding:
- Arsenic can pass into your breastmilk and may harm your baby.
- Do NOT breast-feed while on TRISENOX and for 3 months after your last dose.
If you are a man:
- arsenic may be present in your semen.
- if your sex partner is pregnant or may become pregnant, use a condom during your treatment with TRISENOX and for 3 months after receiving your last dose.
Other cancers
TRISENOX may increase your risk of getting other cancers
Driving and using machines
It is not known If TRISENOX may affect you being able to drive or use any tools or machines. However, use caution until you know how TRISENOX affects you.
Lab and blood tests: Your healthcare professional will do lab tests before you receive TRISENOX and/or during treatment to monitor your progress or check for side effects. These tests may check:
- the level of blood cells in your body.
- that your heart, liver, kidneys or lungs are working properly.
- your blood sugar level.
- your blood's ability to clot, and how long it takes to clot.
- the level of calcium, potassium, magnesium and other essential minerals (electrolytes) —like sodium in your blood.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not receive TRISENOX with any medicine that may:
See the list of medicines below. There are many other medicines that may cause heart or electrolytes problems. Ask your healthcare professional. |
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The following may interact with TRISENOX, but are not limited to:
medicines that may have an unwanted effect on how well your heart works (QT prolongation). These may include.
antiarrhythmic medicines (used to treat irregular heart rhythm) such as:
- quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dronedarone, flecainide, propafenone
medicines used to treat mood swings and other type of mental problems including schizophrenia, and depression. These include:
- a class of medicine called antipsychotics such as: chlorpromazine, pimozide, haloperidol, droperidol, ziprasidone
- a class of medicine called antidepressants such as: fluoxetine, citalopram, venlafaxine, amitriptyline, imipramine, maprotiline
- opioid medicines (used to treat addiction or relieve severe pain) such as: methadone
- antibiotics medicines (used to treat bacterial infections) such as: erythromycin, clarithromycin, telithromycin, moxifloxacin, levofloxacin, ciprofloxacin)
- tacrolimus - used to prevent transplanted organ rejection
- antimalarials medicines (used to treat malaria) such as: quinine, chloroquine
- antifungal medicines (used to treat fungal infection) such as: ketoconazole, fluconazole, voriconazole
- domperidone - used to treat gastrointestinal disorders
- medicines used to treat asthma such as salbutamol
- medicines used to relieve nausea and vomiting such as: dolasetron, ondansetron
- medicines in a class called tyrosine kinase inhibitors (used to treat cancer), vandetanib, sunitinib, nilotinib, lapatinib
- medicines in a class called histone deacetylase inhibitors (used to treat a type of skin cancer) such as vorinostat
any medicines that cause imbalance in essential minerals (electrolytes) in your body:
- diuretics (water pills)
- medicines used to relieve and prevent constipation (laxatives and enemas)
- amphotericin B
- high dose corticosteroids
- previous use of anthracyclines medicines (used to treat cancer)
How you will receive TRISENOX:
You will receive TRISENOX :
- in a healthcare setting under the care of a healthcare professional who has experience in treating people who have leukemia.
- as an infusion (drip) into your vein over 1 to 2 hours. However, the injection time may be longer if you have side effects during the infusion.
Usual dose:
- TRISENOX is usually given once a day for a specific period of time.
- Your healthcare professional will work out the right dose of TRISENOX for you.
- Use TRISENOX as ordered by your healthcare professional. Follow all instructions closely.
Overdose:
Stop recevingTRISENOX and contact with your healthcare professional right away if you notice any sign of having too much arsenic (overdose) in your body:
- convulsions (seizures)
- muscle weakness
- trouble thinking as clearly or quickly as you normally do (confusion)
| If you think you, or a person you are caring for, have received too much TRISENOX, contact a healthcare professional right away, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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What are possible side effects from using TRISENOX?
These are not all the possible side effects you may have when taking TRISENOX. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- eye irritation, blurred vision
- nausea, diarrhea, vomiting, stomach pain, constipation, indigestion (feeling full or bloated), bleeding in the mouth
- feeling weak or tired
- pain, redness or swelling where the shot was given
- decreased appetite
- pain (joint pain, muscle pain, bone pain, back pain, neck pain, pain in arm or leg)
- headache
- dizziness
- pins and needles feeling, reduced sense of touch, trembling
- touble sleeping, feeling anxious
- skin irritation, itchiness, bruises, dry skin, redness
- sweating a lot
- flushing, pale skin
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 | |||
| Differentiation Syndrome: fever, cough, difficulty in breathing, swelling in the arms or legs, sudden weight gain (of more than 5 kg), chest pain, signs of kidney problems like unable to pass urine, change in amount of urine passed; or signs of low blood pressure like dizziness or passing out; signs of liver problems like dark urine or yellow skin or eyes | √ | ||
Heart problems, including :
| √ | ||
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 | ||
| |||
| Atrial fibrillation (abnormal heart rhythm which is rapid and irregular): chest discomfort with unpleasant awareness of your heartbeat, faintness, shortness of breath, weakness | √ | ||
| Depression (sad mood that won’t go away): 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) and thoughts of death or suicide. If you have a history of depression, your depression may become worse | √ | ||
Blood pressure problems
| √ | ||
| Electrolyte Imbalance: weakness, drowsiness, muscle | √ | ||
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 | ||
| pain or cramps, irregular heartbeat | |||
| Infections (including of the mouth, sinuses, lungs, blood): fever, chills, sweating, very bad sore throat, mouth sores, ear or sinus pain, chest pain when you breath or cough, cough which may produce phlegm, nausea, vomiting or diarrhea, shortness of breath, pain with passing urine | √ | ||
| Hyperglycemia (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue | √ | ||
| COMMON | |||
| Haemorrhage (bleeding): signs include throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop. | √ | ||
| VERY RARE | |||
| Tumour lysis syndrome (the sudden, rapid death of cancer cells due to the treatment): nausea, shortness of breath, irregular heartbeat, heart rhythm disturbances, less passing less urine, clouding of urine, muscle spasms or twitching, tiredness and/or joint pain, severe muscle weakness, and seizures. | √ | ||
| UNKNOWN | |||
| Serious brain problems (encephalopathy): problems with balance and movement, such as difficulty walking, confusion, memory problems or drowsiness, eye problems, such | √ | ||
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 | |
| as double or blurred vision or eye movements that you cannot control | ||
| Allergic reactions: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat, low blood pressure, confusion, reduced alertness, cold, moist skin, fast breathing, fast heartbeat | ||
| √ | ||
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:
TRISENOX will be stored by your healthcare professional. It should be kept:
- at room temperature (15 to 30ºC).
- protected from freezing.
- out of reach and sight of children.
TRISENOX should be discarded:
- after expiry date stated on the vial label.
- If the solution contains foreign particulate or is discoloured.
If you want more information about TRISENOX:
- 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.tevacanada.com, or by calling 1-833-662-5644.