TECARTUS (pronounced tek-ahr-tuhs)
|Read this Medication Guide before you start your TECARTUS treatment. The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment.
|What is the most important information I should know about TECARTUS?
TECARTUS may cause side effects that are life-threatening and can lead to death. Call or see your healthcare provider or get emergency help right away if you get any of the following:
It is important to tell your healthcare provider that you received TECARTUS and to show them your TECARTUS Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
- Fever (100.4°F/38°C or higher)
- Difficulty breathing
- Chills or shaking chills
- Dizziness or lightheadedness
- Severe nausea, vomiting, or diarrhea
- Fast or irregular heartbeat
- Severe fatigue or weakness
|What is TECARTUS?
TECARTUS is a treatment for adults with mantle cell lymphoma or acute lymphoblastic leukemia. It is used following disease progression while on or after other treatment. TECARTUS is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.
|Before getting TECARTUS, tell your healthcare provider about all your medical problems, including if you have or have had:
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Neurologic problems (such as seizures, stroke, or memory loss)
- Lung or breathing problems
- Heart problems
- Liver problems
- Kidney problems
- A recent or active infection
|How will I receive TECARTUS?
What should I avoid after receiving TECARTUS?
- Since TECARTUS is made from your own white blood cells, your blood will be collected by a process called "leukapheresis" (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
- Your blood cells will be sent to a manufacturing center to make your TECARTUS.
- Before you get TECARTUS, you will get three days of chemotherapy to prepare your body.
- When your TECARTUS is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
- You will be monitored where you received your treatment daily for at least seven days for patients with MCL and at least 14 days for patients with ALL after the infusion.
- You should plan to stay close to the location where you received your treatment for at least four weeks after getting TECARTUS. Your healthcare provider will help you with any side effects that may occur.
- You may be hospitalized for side effects. Your healthcare provider will discharge you if your side effects are under control and it is safe for you to leave the hospital.
- Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.
- Do not drive, operate heavy machinery, or do other dangerous things for eight weeks after you get TECARTUS because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
- Do not donate blood, organs, tissues, or cells for transplantation.
|What are the possible or reasonably likely side effects of TECARTUS?
The most common side effects of TECARTUS include:
These are not all the possible side effects of TECARTUS. Call your healthcare provider about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
- Fever (100.4°F/38°C or higher)
- Low white blood cells (can occur with a fever)
- Low red blood cells
- Low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
- Fast heartbeat
- Difficulty speaking or slurred speech
|General information about the safe and effective use of TECARTUS
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about TECARTUS, talk with your healthcare provider. You can ask your healthcare provider for information about TECARTUS that is written for health professionals. You can get additional information by contacting Kite at 1-844-454-KITE (5483) or at www.Tecartus.com.
|What are the ingredients in TECARTUS?
Active ingredients: brexucabtagene autoleucel.
Inactive ingredients: albumin (human); DMSO.