Référentiel des médicaments
Ciltacabtagene autoleucel
Ciltacabtagene autoleucel is a medicine in the class miscellaneous. It is used for multiple myeloma.
- Classe médicamenteuse: Miscellaneous
- Indications: multiple myeloma
Dernière mise à jour Sources: US FDA label
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L'essentiel
- Classe médicamenteuse
- Miscellaneous
- Code ATC
- L01XL05
- Interactions connues
- 68 (Majeure: 46 · Modérée: 21 · Mineure: 1)
- Noms commerciaux
- 1
- Pays et marchés
- 1
Indications
Mécanisme d'action
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.
Posologie adulte habituelle (résumé de la notice)
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
Grossesse et allaitement
- Grossesse
- 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.
- Allaitement
- 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.
Effets indésirables signalés
- Pyrexia
- Cytokine release syndrome
- Hypogammaglobulinemia
- Hypotension
- Musculoskeletal pain
- Fatigue
Mises en garde encadrées
- 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.
Précautions particulières
- 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
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
Principales interactions (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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Questions fréquentes
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.
Monographies complètes, posologies et vérificateur d'interactions dans l'application MediHelp
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