Ciltacabtagene autoleucel

Generic name: Ciltacabtagene Autoleucel
Brand names: Carvykti
Dosage form: intravenous suspension (-)
Drug class: Miscellaneous antineoplastics

Usage of Ciltacabtagene autoleucel

Ciltacabtagene autoleucel is an immunotherapy medicine used to treat multiple myeloma in adults. ciltacabtagene autoleucel is given after at least four other treatments have failed.

Ciltacabtagene autoleucel is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Ciltacabtagene autoleucel may also be used for purposes not listed in this medication guide.

Ciltacabtagene autoleucel side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of ciltacabtagene autoleucel is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also call your doctor at once if you have:

confusion, loss of consciousness, seizures, problems with speech, reading or writing, depression;

tingling and numbness of hands and feet , leg and arm weakness, facial numbness; or

low blood cell counts--fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of ciltacabtagene autoleucel may include:

confusion, cough, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired;

headache, dizziness;

problems with speech;

low blood cell counts;

fever, chills, tiredness, or other signs of infection;

decreased appetite, constipation, nausea or diarrhea; or

pain in your joints or muscles.

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 FDA at 1-800-FDA-1088.

Before taking Ciltacabtagene autoleucel

Tell your doctor if you have ever had:

neurologic problems (such as stroke, seizures, memory loss);

breathing problems;

heart problems;

liver or kidney disease;

recent or active infection; or

low blood counts.

Women will need pregnancy testing before receiving this medicine. You also will need to use birth control to prevent pregnancy during treatment with ciltacabtagene autoleucel. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Relate drugs

How to use Ciltacabtagene autoleucel

Usual Adult Dose for Multiple Myeloma:

Provided as one bag with a single dose for IV infusion:Recommended dose range: 0.5 to 1.0 × 10(6) CAR-positive viable T cells per kg of body weightMaximum dose of 1×10(8) CAR-positive viable T cells per single infusionTreatment duration: The single IV infusion should be administered within 2.5 hoursComments:-This drug is for autologous use only. The patient identity must match the identifiers on the drug cassette and infusion bag. Do not use if the information on the patient-specific labels does not match. Use: For the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD 38 monoclonal antibody.

Warnings

A serious side effect of ciltacabtagene autoleucel is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

What other drugs will affect Ciltacabtagene autoleucel

Other drugs may affect ciltacabtagene autoleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Disclaimer

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