Riferimento farmaci
Ciltacabtagene autoleucel
Ciltacabtagene autoleucel is a medicine in the class miscellaneous. It is used for multiple myeloma.
- Classe del farmaco: Miscellaneous
- Indicato per: multiple myeloma
Ultimo aggiornamento Fonti: US FDA label
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- L01XL05
- Interazioni note
- 68 (Maggiore: 46 · Moderata: 21 · Minore: 1)
- Nomi commerciali
- 1
- Paesi e mercati
- 1
Per cosa si usa
Come agisce
BCMA-directed, genetically modified autologous T cell immunotherapy. The CAR has two BCMA-targeting single-domain antibodies, a 4-1BB co-stimulatory domain and a CD3-zeta signaling domain. On binding BCMA-expressing cells, the CAR promotes T cell activation, expansion and elimination of target cells.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
Relapsed or refractory multiple myeloma: single IV infusion of 0.5–1.0×10^6 CAR-positive viable T cells per kg body weight; maximum 1×10^8 CAR-positive viable T cells per single infusion
Gravidanza e allattamento
- Gravidanza
- Unsafe No data in pregnancy. CAR-T cells may cross the placenta and cause fetal B-cell depletion and low antibody levels. Not recommended in pregnancy or without contraception; confirm a negative pregnancy test before treatment.
- Allattamento
- Unknown No information on presence in milk or effects on the infant. Weigh breastfeeding benefits against the mother's need; follow the guidance for the lymphodepleting chemotherapy.
Effetti indesiderati segnalati
- Pyrexia
- Cytokine release syndrome
- Hypogammaglobulinemia
- Hypotension
- Musculoskeletal pain
- Fatigue
Avvertenze in evidenza
- Fatal or life-threatening CRS occurred; do not give to patients with active infection or inflammatory disorders; treat severe CRS with tocilizumab or tocilizumab and corticosteroids. Fatal or life-threatening ICANS, parkinsonism and Guillain-Barré syndrome occurred; monitor for neurologic events. HLH/MAS, prolonged and recurrent cytopenias, immune effector cell-associated enterocolitis, and secondary hematological malignancies (MDS, AML, T-cell malignancies) have occurred.
Chi deve prestare attenzione
- Increased early mortality in CARTITUDE-4: 14% of deaths in the CARVYKTI arm versus 12% in the control arm within 10 months
- Monitor at least daily for 7 days for CRS and neurologic toxicities; confirm that a minimum of two doses of tocilizumab are available before infusion
- Prolonged and recurrent cytopenias; monitor blood counts before and after infusion
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (68)
- Adalimumab + Ciltacabtagene autoleucel Major
- Anti-thymocyte + Ciltacabtagene autoleucel Major
- Azathioprine + Ciltacabtagene autoleucel Major
- Baricitinib + Ciltacabtagene autoleucel Major
- Basiliximab + Ciltacabtagene autoleucel Major
- Bendamustine + Ciltacabtagene autoleucel Major
- Capecitabine + Ciltacabtagene autoleucel Major
- Carboplatin + Ciltacabtagene autoleucel Major
- Certolizumab pegol + Ciltacabtagene autoleucel Major
- Chlorambucil + Ciltacabtagene autoleucel Major
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- IV preparation and dilution
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Domande frequenti
What is Ciltacabtagene autoleucel used for?
Ciltacabtagene autoleucel is a medicine in the class miscellaneous. It is used for Multiple myeloma.
What side effects have been reported with Ciltacabtagene autoleucel?
Pyrexia, Cytokine release syndrome, Hypogammaglobulinemia, Hypotension, Musculoskeletal pain, Fatigue. Serious warning: Fatal or life-threatening CRS occurred; do not give to patients with active infection or inflammatory disorders; treat severe CRS with tocilizumab or tocilizumab and corticosteroids.
Can Ciltacabtagene autoleucel be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. No data in pregnancy. CAR-T cells may cross the placenta and cause fetal B-cell depletion and low antibody levels. Not recommended in pregnancy or without contraception; confirm a negative pregnancy test before treatment. Breastfeeding: Unknown. No information on presence in milk or effects on the infant. Weigh breastfeeding benefits against the mother's need; follow the guidance for the lymphodepleting chemotherapy.
What does Ciltacabtagene autoleucel interact with?
MediHelp lists 68 known interactions for Ciltacabtagene autoleucel. Major: 46 · Moderate: 21 · Minor: 1. The most serious include Adalimumab, Anti-thymocyte, Azathioprine.
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