A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
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Brand Name :
carvykti
Synonyms :
ciltacabtagene autoleucel
Class :
Antineoplastic
Brand Name :
carvykti
Synonyms :
ciltacabtagene autoleucel
Class :
Antineoplastic
Dosage Forms & Strengths
Injection
1X108 CAR-viable positive T cells per single infusion
Administer within 2.5 hours
Injection
Treatment includes lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by ciltacabtagene autoleucel IV infusion
Lymphodepleting chemotherapy
Fludarabine: 30mg/m2 Intravenous every day for three days
Cyclophosphamide: 300mg/m2 Intravenous every day for 3 days
Ciltacabtagene autoleucel
After 2-4 days of Lymphodepleting chemotherapy, administer
0.5-1X106 CAR-positive viable T cells/kg intravenous
Do not exceed 1X108 CAR- T cells per single infusion
Dosage Forms & Strengths
Safety and efficacy not established
Refer adult dosing
may increase the toxic effect
may increase the toxic effect
may increase the toxic effect
may increase the toxic effect
may increase the toxic effect
may decrease the therapeutic effect
may decrease the therapeutic effect
may increase the toxic effect of immunosuppressants
may decrease the therapeutic effect
may increase the immunosuppressive effects
may increase the immunosuppressive effects
may increase the immunosuppressive effects
may increase the immunosuppressive effects
may increase the immunosuppressive effects
may increase the immunosuppressive effects
may decrease the therapeutic effect
may increase the toxic effect of immunosuppressants
may increase the immunosuppressive effects
may increase the toxic effect of immunosuppressants
It may enhance the immunosuppressive effects when combined with risankizumab
clofarabine and ciltacabtagene autoleucel increase the effect of each other by immunosuppression
By immunosuppressive effects, the effects of the other drug increases and results in risk of infection.
By immunosuppressive effects, the both the drugs action either decreases or results in risk of infection.
when melphalan is combined with ciltacabtagene autoleucel, the risk or severity of adverse effects can be increased
when both the drugs combine the effect of both drugs increases by immunosuppressive effects
when both the drugs are combined, the immunosuppressive effects of both the drugs increases and lead to an increased risk of infection
increases the risk of serious infection due to immunosuppression
interaction raises immunosuppressive effects and risk of infection
either of the drug in combination increases the effect of the other due to immunosuppression/risk of infection
increase immunosuppressive effects and risk of infection
increase immunosuppressive effects and risk of infection
either of the drug in combination increases the effect of the other due to immunosuppression/risk of infection
when both drugs are combined, there may be an increased risk of adverse effects
when both drugs are combined, there may be an increased risk of infection
when both drugs are combined, there may be an increased risk of adverse effects
may increase the immunosuppressive effects of each other
may enhance the immunosuppressive effects of each other
may diminish the activity of each other
may enhance the immunosuppressive effects of each other
may decrease the therapeutic effect
may increase the immunosuppressive effects
Frequency defined:
>10%
Any grade
CRS
Hypotension
Fatigue
Cough
Diarrhea
Encephalopathy
Upper respiratory tract infection
Headache
Viral infections
Dyspnea
Nasal congestion
Insomnia
Hypoxia
Pyrexia
Musculoskeletal pain
Chills
Nausea
Decreased appetite
Grade≥3
Neutropenia
Anemia
Increased AST
Pneumonia
Lymphopenia
Decreased white blood cells
Thrombocytopenia
1-10%
Any grade
Bacterial infections
Febrile neutropenia
Sepsis
Grade≥3
Hypotension
Fatigue
Cough
Diarrhea
Encephalopathy
Upper respiratory tract infection
Headache
Viral infections
Dyspnea
Constipation
Hypertension
Nasal congestion
Other adverse reactions
Thrombosis
Renal failure
Seizure
Rash
Delirium
Ataxia
Bradykinesia
Tremor
Peripheral neuropathy
Dysphagia
Chest pain
Pregnancy consideration: Insufficient data available
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Patient information leaflet
Generic Name: ciltacabtagene autoleucel
Pronounced: [ SIL-ta-KAB-ta-jeen-AW-toe-LOO-sel ]
Why do we use ciltacabtagene autoleucel?
It is used to treat multiple myeloma in adults
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