Details for: KYMRIAH
Company: NOVARTIS PHARMACEUTICALS CANADA INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02480514 | KYMRIAH | TISAGENLECLEUCEL | 600000000 CELLS | SUSPENSION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
KYMRIAH is used to treat:
What it does
The normal T-cells are taken from your blood and a new gene is put into the T-cells so that they can target
the cancer cells more effectively. When KYMRIAH is infused into your blood, the modified T-cells find and
kill the cancer cells.
If you have any questions about how KYMRIAH works or why this medicine has been prescribed for you,
ask your doctor.
When it should not be used
If you are allergic (hypersensitive) to tisagenlecleucel or any of the other ingredients of KYMRIAH. If you think you may be allergic, ask your doctor for advice.
What the medicinal ingredient is
tisagenlecleucel
What the non-medicinal ingredients are
Dextran, dextrose, dimethylsulfoxide (DMSO), human serum albumin, plasmaLyte A (multiple electrolytes for injection, Type 1, pH 7.4), and sodium chloride.
What dosage form it comes in
KYMRIAH is provided as a cell suspension in one or more infusion bags. KYMRIAH is administered as an intravenous infusion for one time only.
Warnings and precautions
The following serious side effects have been seen in people taking KYMRIAH:
- High fever and chills which may be symptoms of a serious condition called Cytokine Release Syndrome (CRS). Other symptoms of CRS are difficulty breathing, nausea, vomiting, diarrhea, muscle pain, joint pain, low blood pressure, or dizziness/light‑headedness.
- Neurological problems like altered or decreased consciousness, delirium, confusion, agitation, seizures, difficulty speaking and understanding speech, loss of balance
To help avoid side effects and ensure proper use, talk to your healthcare professional before receiving
KYMRIAH. Talk about any health conditions or problems you may have, including:
Monitoring before and after your treatment with KYMRIAH
Before receiving KYMRIAH
Before you are given KYMRIAH infusion, your doctor will:
Children
KYMRIAH has not been studied in children and adolescents below 18 years of age with diffuse large B-cell lymphoma and should not be administered in this age group for diffuse large B-cell lymphoma.
Older people (above 65 years of age)
Patients aged 65 years or older with diffuse large B-cell lymphoma can be administered KYMRIAH in the same way as younger adults.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- ’Live’ vaccines – in particular, do not receive ‘live’ vaccines:
- In the 6 weeks before being given a short course of chemotherapy (“lymphodepleting” chemotherapy) to prepare your body for the KYMRIAH cells
- During KYMRIAH treatment
- After treatment while the immune system is recovering.
Proper use of this medication
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask
your doctor for advice before taking KYMRIAH. This is because the effects of KYMRIAH in pregnant or
breast feeding women are not known, and it may harm your unborn baby or your newborn/infant.
Your doctor will check with you if you are pregnant.
If you become pregnant or think you may be pregnant after treatment with KYMRIAH, talk to your doctor
immediately.
Your doctor will discuss with you the potential risk(s) of receiving KYMRIAH during pregnancy or breastfeeding.
Contraception for women and men
Women of child-bearing potential should use effective birth control after being given Kymriah. Ask your
doctor about options of effective birth control.
Sexually active males receiving KYMRIAH should use a condom for intercourse.
Discuss pregnancy or fathering a child with your doctor if you have received KYMRIAH.
Driving and using machines
Do not drive, use machines, or take part in activities that need you to be alert. KYMRIAH can cause
problems such as altered or decreased consciousness, confusion and seizures (fits) in the 8 weeks
following infusion.
How you will receive KYMRIAH:
KYMRIAH will always be given to you by a qualified health care professional in a qualified treatment
center.
KYMRIAH contains human blood cells. Your doctor handling KYMRIAH will therefore take appropriate
precautions (wearing gloves and glasses for example) to avoid potential transmission of infectious
diseases.
Collection of blood to manufacture KYMRIAH
KYMRIAH is made from your own white blood cells.
Medicines given before KYMRIAH administration During the 30 to 60 minutes before being given KYMRIAH you may receive other medicines to help to reduce infusion reactions and/or fever. These may include acetaminophen and an H1 antihistamine such as diphenhydramine.
How you are given KYMRIAH
KYMRIAH is a one-time treatment.
After you are given KYMRIAH
Plan to stay within proximity (2 hours’ travel) from the hospital where you were treated for at least 4 weeks after you have been given Kymriah. Your doctor will recommend that you return to the hospital 2 to 3 times a week for at least the first week and will consider whether you need to stay at the hospital as an in-patient after infusion. This is so your doctor can check if your treatment is working and help you if you have any side effects.
Side effects and what to do about them
Listed below are the most common (but not all) possible side effects you may feel when taking KYMRIAH.
If you experience any side effects, including those not listed here, contact your healthcare professional.
Very common:
Common:
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | |
---|---|---|---|
VERY COMMON | |||
Fever, chills, shivering, nausea, vomiting, tiredness, dizziness, pain where the infusion needle is inserted, blisters, itching, and/or shortness of breath or wheezing during or shortly after infusion (possible infusion reaction) | ✔ | ||
Feeling warm, fever, chills or shivering, coughing (possible symptoms of an infection) | ✔ | ||
Bleeding or bruising more easily (possible symptoms of low levels of cells in the blood known as platelets) | ✔ | ||
Frequent infections, weakness, fatigue, fever, chills and/or shivering, sore throat, mouth ulcers , rash, swelling, yellow or pale skin, yellow eyes, uncontrolled internal or external bleeding, blood in the urine, breathlessness, abnormal body movement, irritability (possible symptoms of blood disorders) | ✔ | ||
Extreme tiredness, weakness and shortness of breath (may be symptoms of a lack of red blood cells) | ✔ | ||
High fever, chills, muscle pain, joint pain, nausea, vomiting, diarrhea, excessive sweating, rash, loss of appetite, fatigue, headache, dizziness/light‑headedness, shortness of breath, heavy breathing, rapid breathing, blue discoloration of lips or extremities (possible symptoms of CRS) | ✔ | ||
Side effects affecting the respiratory organs, like, coughing, rapid breathing, painful breathing, shortness of breath or labored breathing, breathlessness (possible symptom of pulmonary edema, a build-up of fluid in the alveoli (air spaces) in the lungs, which keeps oxygen from getting into the blood) | ✔ | ||
Personality changes, headache, confusion, paralysis of part or all of the body, stiff neck, abnormal speech and eye movement (possible symptoms of encephalopathy or metabolic encephalopathy) | ✔ | ||
Dizziness, light-headedness (possible symptoms of hypotension) | ✔ | ||
Viral or bacterial or fungal infections | ✔ | ||
Swollen ankles (possible symptoms of low levels of albumin in the blood) | ✔ | ||
State of severe confusion (delirium) | ✔ | ||
Blue discoloration of lips or extremities (hypoxia) | ✔ | ||
Severely decreased urine output (possible symptoms of acute kidney injury) | ✔ | ||
COMMON | |||
Tiredness, confusion, muscle twitching, convulsions (possible symptoms of low level of sodium in blood) | ✔ | ||
Side effects affecting the nervous system, including involuntary shaking of the body (tremor), tingling or numbness (paresthesia), impaired memory or thinking (cognitive disorders), sensation of numbness or tingling in finger and toes (peripheral neuropathy), uncontrollable movements or actions of the body including tremors, jerks, twitches, spasms, contractions, or gait problems (motor dysfunction, ataxia), difficulty in speaking or understanding speech (speech disorders) | ✔ | ||
Fever, malaise, yellow color of your skin and eyes (possible symptoms of hemophagocytic lymphohistiocytosis) | ✔ | ||
Producing less urine than normal and/or muscle spasms (possible symptoms of tumor lysis syndrome) | ✔ | ||
Weakness or paralysis of limbs or face, difficulty speaking (possible symptoms of a stroke) | ✔ | ||
Convulsions, fits (seizures) | ✔ | ||
Severe nerve pain (neuralgia) | ✔ | ||
Fast and/or irregular heartbeat, breathlessness, difficulty breathing when lying down, swelling of the feet or legs, stopped heartbeat (possible symptoms of heart failure, worsening of heart failure or cardiac arrest) | ✔ | ||
Swelling and edema (possible symptoms of capillary leak syndrome in context of CRS) | ✔ | ||
High fever, chills, difficulty to breath, yellow skin and eyes, bloody stools, severely decreased urine output (possible symptoms of multiple organ dysfunction syndrome) | ✔ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
If you want more information about KYMRIAH:
- 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 http://hc-sc.gc.ca/indexeng.php; the manufacturer’s website http://www.novartis.ca, or by calling 1-800-363-8883.
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd., Dorval, Quebec
H9S 1A9
Last Revised:
KYMRIAH is a registered trademark