What is Ciltacabtagene autoleucel?
Ciltacabtagene Autoleucel is used as an immunotherapy to treat multiple myeloma in adults. Ciltacabtagene is administered after at least four other treatments fail. Ciltacabtagene autoleucel can be obtained under a special programme. You must register for the programme, and you must understand the risks and advantages of the medicine. Ciltacabtagene Autoleucel can be used in other ways not mentioned in this guide.
Side effects of Ciltacabtagene autoleucel
If you experience any of the following signs and symptoms of an allergic reaction: hives, difficulty breathing and/or swelling in your lips, face, tongue or throat. Seek medical help immediately. Cytokine Release Syndrome (CRS) is a serious side effect caused by ciltacabtagene. If you experience any of the following symptoms, tell your carers immediately: high fever, chills or difficulty breathing, severe nausea and diarrhoea; tremors or shaking; fast or irregular heartbeats; feeling light-headed or very tired. Your carers have medications available to treat CRS quickly if it occurs.
Call your doctor immediately if you:
- Depression, confusion, loss of consciousness, or seizures.
- If you experience tingling or numbness in your hands, feet, legs, arms, or face, then this is a sign of a neurological disorder.
- Low blood cell counts can cause fever, chills, and fatigue, as well as flu-like symptoms. Other symptoms include mouth sores or skin sores. They may also be accompanied by easy bruising and unusual bleeding.
Some of the common side effects associated with ciltacabtagene autoleucel include:
- Feeling light-headed, having trouble breathing, or feeling confused
- Headache, dizziness;
- Speech problems;
- Low blood cell count
- If you have any of the following symptoms, it is likely that you are infected with:
- Constipation or nausea;
- You may experience pain in your muscles or joints.
There may be other side effects. Call your physician immediately if experiencing side effects; alternatively, the FDA can be reached at 1-800-FDA-1088 in order to report these.
Similar/related drugs
Blenrep, Tecvayli, Xpovio, Kyprolis, Elrexfio, Talvey, and Revlimid
Warnings
Cytokine-release syndrome is a serious side effect that can cause fever, chills, and difficulty breathing. If this occurs, your carers have medications available to treat it quickly.
Before you take this drug
Inform your physician of any of the following issues:
- Neurologic disorders (such as strokes, seizures, and loss of memory)
- Breathing problems
- Heart problems
- Liver or kidney disease
- Recent or active infection
- Low blood counts
Before receiving this medication, women will be required to undergo a pregnancy test. You will also need to use contraception during the treatment of ciltacabtagene. Inform your physician immediately if you are expecting or planning on becoming pregnant. Breastfeeding may not be possible while on this medication; therefore if any risks or side-effects arise please seek the advice of your healthcare provider immediately.
How to take Ciltacabtagene autoleucel?
Ciltacabtagene autoleucel can only be obtained at a hospital or clinic that is authorised and administered by healthcare professionals who are specially trained. Ciltacabtagene autoleucel must be administered through a process known as leukapheresis (LOO-kuh-fuh-REE-sis). Leukapheresis is the process of collecting some of your own blood through a catheter that's placed in a vein. The catheter is attached to a machine that separates the white blood cells and other blood components. The cells will then be sent to a lab, where they will be made into ciltacabtagene autoleucel. This process can take up to five weeks. You will receive a pre-treatment of chemotherapy about 3 days prior to receiving ciltacabtagene.
Before you are prescribed ciltacabtagene autoleucel, you will receive other medications that help to prevent side effects and allergic reactions. Your care provider will administer the medicine through an IV once your body is ready. After receiving ciltacabtagene autoleucel, you will be closely monitored to ensure you don't have any serious side effects or allergic reactions. To ensure that ciltacabtagene autoleucel is not causing any harmful effects, you will need to have frequent blood tests. You may be at greater risk of developing cancer if you use ciltacabtagene. You should ask your doctor about the risk. You may have to continue having cancer screening tests throughout your lifetime. Ciltacabtagene can cause false positives on laboratory tests for HIV (human immunodeficiency). Inform any doctor that treats you of your use of ciltacabtagene. Plan to stay close to the hospital or clinic that you visited where you received your ciltacabtagene autoleucel for at least four weeks. You should not be so far from the hospital that it will take you more than two hours to get back.
Details on dosage
Adult dose for multiple myeloma:
One bag containing a single IV dose:
Recommended dose range: 0.5-0.10(6) CAR-positive T cells per kilogramme of bodyweight
The maximum dose of CAR-positive T cells that can be infused in a single infusion is 1x10(8).
Treatment Duration: A single IV infusion is administered within 2.5 hours.
Comments:
This drug is only for autologous use. The patient's identity must match that of the infusion bag and drug cassette. If the patient-specific label information does not match, do not use it.
Use: To treat adult patients with relapsed or refractory myeloma after at least four prior therapies, including an immunomodulator, a proteasome inhibitor, and a monoclonal anti-CD 38 antibody.
What happens if I miss the dose?
If you miss a chemotherapy treatment or miss a dose to prevent ciltacabtagene side effects, call your doctor.
What happens if I overdose?
In a medical setting, an overdose is treated immediately.
What should be avoided?
Ciltacabtagene Autoleucel may cause confusion, memory problems, seizures, or drowsiness. Do not drive or operate machinery for 8 weeks following treatment with ciltacabtagene. Ask your doctor if you should receive a live vaccine. Live vaccines are available for measles (MMR), rubella, mumps (MMR), yellow fever (typhoid), varicella (chickenpox), or shingles (shingles). Don't donate any organs, tissues, or cells.
Interaction with other drug
Other medications, such as prescription and over-the-counter medicines, vitamins, and herbal products, may also affect ciltacabtagene. Inform your doctor of all the other medications you take.
