Kymriah
Pronunciation: kim-RY-uh
Generic name: tisagenlecleucel
Other brand names of tisagenlecleucel include Kymriah (Ped ALL), Kymriah (DLBCL)
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics
What is Kymriah?
Kymriah is a personalized, prescription, immunotherapy treatment to treat certain blood cancers.
Approved Treatment Applications
Kymriah (tisagenlecleucel) is FDA-approved to treat:
- Relapsing or refractory acute lymphoblastic leukemia (ALL) in patients up to 25 years old
- Large B-cell lymphoma in adults
- Follicular lymphoma in adults.
Key Treatment Insights
- FDA approval: August 30, 2017
- Treatment type: personalized CAR-T cell therapy
- Unique characteristic: Individually made from a patient's white blood cells
- Administration: Single intravenous infusion
- Preparation: Short 4-day chemotherapy course.
How Kymriah Works
Innovative treatment process
1. Cell collection: Leukapheresis to extract T cells
2. Genetic modification: Cells engineered with a specific protein
3. Targeting mechanism: Modified T cells directed to attack cancer cells with CD19 antigen
4. Reinfusion: personalized cell treatment returned to the patient.
Clinical Effectiveness
Clinical trials report survival rates following Kymriah of:
- Follicular lymphoma: 87.7% survival at 24 months
- Aggressive B-cell non-Hodgkin’s lymphoma: 43.6% survival at 24 months
- Advanced B-cell acute lymphoblastic leukemia: 55% 5-year survival rate.
Potential side effects and warnings
Common side effects
The most common side effects of Kymriah are:
- Breathing difficulties
- Fever (100.4°F/38°C or higher)
- Chills and shaking
- Confusion
- Severe nausea or vomiting
- Muscle or joint pain
- Low blood pressure
- Dizziness
- Headache.
Serious side effects and warnings
Kymriah can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.
A serious side effect of Kymriah is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, body aches, vomiting, diarrhea, or feeling light-headed. Your caregivers will have medication available to quickly treat CRS if it occurs.
Kymriah can lower one or more types of blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this.
- Tell your healthcare provider right away if you get a fever, are feeling tired, weak, or short of breath, or have bruising or bleeding.
Having Kymriah in your blood may cause a false-positive HIV test result by some commercial tests.
Kymriah may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.
Life-threatening nerve problems can happen with Kymriah. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.
Hypersensitivity reactions may occur with this treatment. Get emergency medical help if you have signs of an allergic reaction such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.
Kymriah may cause other side effects that are severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following:
- difficulty breathing
- fever (100.4°F/38°C or higher)
- chills/shaking chills
- confusion
- severe nausea, vomiting, or diarrhea
- severe muscle or joint pain
- very low blood pressure
- dizziness/lightheadedness
- tremors, anxiety, agitation.
Tell all your healthcare providers that you have received Kymriah. Your healthcare providers may give you other medicines to treat your side effects.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking
To make sure Kymriah is safe for you, tell your doctor if you have ever had:
- hepatitis B or C;
- HIV (human immunodeficiency virus); or
- if you have received a vaccine in the past 2 weeks
- are pregnant or intending to become pregnant
- are breastfeeding.
Kymriah is only available through a restricted program called the Kymriah Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will order it through a qualified Kymriah Treatment Center.
Pregnancy
Females who can get pregnant may need pregnancy testing before receiving this medicine. You should also take birth control to prevent pregnancy during and shortly after treatment with Kymriah and chemotherapy.
If you receive Kymriah during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.
Breastfeeding
It may not be safe to breastfeed while using Kymriah. Ask your doctor about any risks.
How is Kymriah administered?
Since Kymriah is made from your own white blood cells, your healthcare provider has to take some of your blood.
- This is called “leukapheresis.”
- It takes 3 to 6 hours and may need to be repeated.
- A tube (intravenous catheter) will be placed in your vein to collect your blood.
Your blood cells are then frozen and sent to the manufacturing site to make Kymriah.
- It takes about 3-4 weeks from the time your cells are received at the manufacturing site and shipped back to your healthcare provider, but the time may vary.
While waiting for Kymriah to be made, your healthcare provider may give you therapy to stabilize your cancer.
- In addition, before you get Kymriah, your healthcare provider may give you chemotherapy for a few days to prepare your body.
- When your body is ready, your healthcare provider will give you Kymriah through a tube (intravenous catheter) in your vein. This usually takes less than one hour.
- Your doctor may give you premedication with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes before infusion. Avoid using corticosteroids at any time except in the case of a life-threatening emergency.
- See How is Kymriah administered? for more information.
You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after getting Kymriah. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.
- Serious and sometimes fatal infections may develop after the injection. Call your doctor right away if you have a fever, chills, easy bruising, unusual bleeding, or other signs of infection.
Dosing information
B-cell lymphoma or follicular lymphoma
- Kymriah 0.6 to 6.0 x 108 CAR-positive viable T-cells intravenously.
B-cell precursor ALL
- Above 50kg: Kymriah 0.1 to 2.5 x 108 total CAR-positive viable T-cells intravenously.
- 50kg or less: Kymriah 0.2 to 5.0 x 106 CAR-positive viable T-cells per kg body weight intravenously
What happens if I miss a dose?
Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your premedications to prevent side effects of Kymriah.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid after receiving Kymriah?
Do not drive, operate machinery or partake in hazardous tasks for at least 8 weeks after receiving Kymriah.
Do not donate blood, an organ, or any tissues or cells from your own body.
Do not receive a "live" vaccine while using Kymriah, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
What other drugs will affect Kymriah?
Other drugs may interact with tisagenlecleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Manufacturer
Novartis Pharmaceuticals Corporation makes Kymriah. Other notable drugs from Novartis include:
- Clozaril (clozapine) for schizophrenia
- Diovan (valsartan) for high blood pressure
- Femara (letrozole) for breast cancer prevention
- Gleevec (imatinib mesylate) for various cancers
- Tegretol (carbamazepine) an anticonvulsant.
Kymriah Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kymriah.
Kymriah (tisagenlecleucel) - Novartis Pharmaceuticals Corporation
Formulation type | Strength |
---|---|
Bag | 0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS |
Popular FAQ
What is the cost of Kymriah?
Kymriah (tisagenlecleucel) is an expensive CAR-T cell cancer therapy costs over $612,000 for one treatment infusion, but most people do not pay this amount. In addition, the Centers for Medicare & Medicaid Services (CMS) states that CAR-T cell therapy would be covered for eligible people with Medicare. Continue reading
What's the difference between Kymriah and Yescarta?
Kymriah and Yescarta are two cell-based gene therapies. A few differences between the two medications include who and what they are FDA approved for, their dosage, and which companies make them. Continue reading
What is the survival rate of Kymriah?
Studies are ongoing to monitor the survival rate of patients who received Kymriah (tisagenlecleucel) as a cancer treatment. Currently, the available data shows the survival rate is 87.7% for patients with relapsed or refractory follicular lymphoma at 24 months after the Kymriah infusion, and 43.6% for patients with aggressive B-cell non-Hodgkin’s lymphoma. The 5-year survival rate for patients with advanced B-cell advanced B-cell acute lymphoblastic leukemia is 55%. Continue reading
How is Kymriah administered?
Kymriah is administered as a suspension through a tube (intravenous catheter) into your vein. This single-dose infusion usually takes less than one hour. Continue reading
What type of drug is Kymriah (tisagenlecleucel)?
Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy. In CAR-T cell therapy, a patient's cells are genetically modified to include a new protein that directs that specific white blood cell (known as T-cell) to target and kill leukemia cells. Continue reading
More about Kymriah (tisagenlecleucel)
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- FDA approval history
- Drug class: miscellaneous antineoplastics
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.