CARVYKTI- ciltacabtagene autoleucel injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CILTACABTAGENE AUTOLEUCEL (UNII: 0L1F17908Q) (CILTACABTAGENE AUTOLEUCEL - UNII:0L1F17908Q)

Available from:

Janssen Biotech, Inc

Administration route:

INTRAVENOUS

Therapeutic indications:

CARVYKTI (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. None. Risk Summary There are no available data on the use of CARVYKTI in pregnant women. No reproductive and developmental toxicity studies in animals have been conducted with CARVYKTI to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known whether CARVYKTI has the potential to be transferred to the fetus and cause fetal toxicity. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia. Therefore, CARVYKTI is not recommended for women who are pregnant, or for women of childbearing potential not using contraception. Pregnant women should be advised that there may be risks to the fetus. Pregnancy after CARVYKTI therapy should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Risk Summary There is no information regarding the presence of CARVYKTI in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CARVYKTI and any potential adverse effects on the breastfed infant from CARVYKTI or from the underlying maternal condition. Pregnancy Testing Pregnancy status for females of child-bearing age should be verified prior to starting treatment with CARVYKTI. Contraception There are insufficient data to provide a recommendation concerning duration of contraception following treatment with CARVYKTI. In clinical trials, female patients of childbearing potential were advised to practice a highly effective method of contraception and male patients with partners of childbearing potential or whose partners were pregnant were instructed to use a barrier method of contraception, until one year after the patient has received CARVYKTI infusion. See the prescribing information for lymphodepleting chemotherapy for information on the need for contraception in patients who receive the lymphodepleting chemotherapy. Infertility There are no data on the effect of CARVYKTI on fertility. Safety and effectiveness of CARVYKTI in pediatric patients have not been established. Of the 97 patients in CARTITUDE-1 that received CARVYKTI, 28% were 65 to 75 years of age, and 8% were 75 years of age or older. CARTITUDE-1 did not include sufficient numbers of patients aged 65 and older to determine whether the effectiveness differs compared with that of younger patients. In 62 patients less than 65 years of age, all grade and Grade 3 and higher neurologic toxicities occurred in 19% (12/62) and 6% (4/62), respectively. Of the 35 patients ≥65 years of age, all grade and Grade 3 and higher neurologic toxicities occurred in 37% (13/35) and 20% (7/35), respectively. Of the 188 patients in CARTITUDE-4 that received CARVYKTI, 38% were 65 to 75 years of age, and 2% were 75 years of age or older. In 112 patients less than 65 years of age, all grade and Grade 3 and higher neurologic toxicities occurred in 16% (18/112) and 3% (3/112) respectively. Of the 76 patients ≥65 years of age, all grade and Grade 3 and higher neurologic toxicities occurred in 34% (26/76) and 7% (5/76) respectively.

Product summary:

CARVYKTI ® is supplied in one infusion bag containing a frozen suspension of genetically modified autologous T cells in 5% DMSO, either as a: Each CARVYKTI infusion bag is individually packed in an aluminum cryo-cassette. Match the identity of the patient with the patient identifiers on the cassette and infusion bag upon receipt. Store and transport below -120°C, e.g., in a container for cryogenic storage in the vapor phase of liquid nitrogen. Store CARVYKTI in the original packaging containing the cassette protecting the infusion bag. Thaw CARVYKTI prior to infusion [see Dosage and Administration (2)] .

Authorization status:

Biologic Licensing Application

Patient Information leaflet

CARVYKTI- CILTACABTAGENE AUTOLEUCEL INJECTION, SUSPENSION
Janssen Biotech, Inc
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MEDICATION GUIDE
CARVYKTI ®(CAR-VICK-TEE)
(CILTACABTAGENE AUTOLEUCEL)
Manufactured/Marketed by: Janssen Biotech, Inc., Horsham, PA 19044,
USA. U.S. License Number 1864
Marketed by: Legend Biotech, Somerset, NJ 08873, USA. For patent
information: www.janssenpatents.com.
For more information, call 1-800-526-7736 or go to www.CARVYKTI.com.
© Johnson & Johnson and its affiliates 2022–2024
This Medication guide has been approved by the U.S. Food and Drug
Administration.
Read this Medication Guide before you start your CARVYKTI treatment.
The more you know about your
treatment, the more active you can be in your care. Talk with your
healthcare provider if you have questions
about your health condition or treatment. Reading this Medication
Guide does not take the place of talking
with your healthcare provider about your treatment.
What is the most important information I should know about CARVYKTI?
CARVYKTI may cause side effects that are severe or life-threatening
and can lead to death. Call your
healthcare provider or get emergency help right away if you get any of
the following:
•
fever (100.4°F/38°C or higher)
•
chills or shaking chills
•
fast or irregular heartbeat
•
difficulty breathing
•
very low blood pressure
•
dizziness/light headedness
•
effects on your nervous system, some of which can occur days or weeks
after you receive the
infusion, and may initially be subtle such as:
•
feeling confused, less alert, or disoriented, having difficulty
speaking or slurred speech,
having difficulty reading, writing, and understanding words, memory
loss
•
loss of coordination affecting movement and balance, slower movements,
changes in
handwriting
•
personality changes including a reduced ability to express emotions,
being less talkative,
disinterest in activities, and reduced facial expression
•
tingling, numbness, and pain of hands and feet, difficulty walking,
leg and/or arm weakness,
and difficulty breath

Summary of Product characteristics

CARVYKTI- CILTACABTAGENE AUTOLEUCEL INJECTION, SUSPENSION
JANSSEN BIOTECH, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CARVYKTI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CARVYKTI.
CARVYKTI
(CILTACABTAGENE AUTOLEUCEL) SUSPENSION FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2022
WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS,
PROLONGED AND RECURRENT CYTOPENIA, AND SECONDARY HEMATOLOGICAL
MALIGNANCIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CYTOKINE RELEASE SYNDROME (CRS), INCLUDING FATAL OR LIFE-THREATENING
REACTIONS,
OCCURRED IN PATIENTS FOLLOWING TREATMENT WITH CARVYKTI. DO NOT
ADMINISTER
CARVYKTI TO PATIENTS WITH ACTIVE INFECTION OR INFLAMMATORY DISORDERS.
TREAT SEVERE
OR LIFE-THREATENING CRS WITH TOCILIZUMAB OR TOCILIZUMAB AND
CORTICOSTEROIDS. ( 2.2,
2.3, 5.2)
IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), WHICH
MAY BE
FATAL OR LIFE-THREATENING, OCCURRED FOLLOWING TREATMENT WITH CARVYKTI,
INCLUDING
BEFORE CRS ONSET, CONCURRENTLY WITH CRS, AFTER CRS RESOLUTION, OR IN
THE ABSENCE OF
CRS. MONITOR FOR NEUROLOGIC EVENTS AFTER TREATMENT WITH CARVYKTI.
PROVIDE
SUPPORTIVE CARE AND/OR CORTICOSTEROIDS AS NEEDED. ( 2.2, 2.3, 5.3)
PARKINSONISM AND GUILLAIN-BARRÉ SYNDROME AND THEIR ASSOCIATED
COMPLICATIONS
RESULTING IN FATAL OR LIFE-THREATENING REACTIONS HAVE OCCURRED
FOLLOWING TREATMENT
WITH CARVYKTI. ( 5.3)
HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS/MACROPHAGE ACTIVATION SYNDROME
(HLH/MAS),
INCLUDING FATAL AND LIFE-THREATENING REACTIONS, OCCURRED IN PATIENTS
FOLLOWING
TREATMENT WITH CARVYKTI. HLH/MAS CAN OCCUR WITH CRS OR NEUROLOGIC
TOXICITIES. (
5.4)
PROLONGED AND/OR RECURRENT CYTOPENIAS WITH BLEEDING AND INFECTION AND
REQUIREMENT
FOR STEM CELL TRANSPLANTATION FOR HEMATOPOIETIC RECOVERY OCCURRED
FOLLOWING
TREATMENT WITH CARVYKTI. ( 5.6)
SECONDARY HEMATOLOGICAL MALIGNANCIES, INCLUDING MYELODYSPLASTIC
SYNDROME AND
ACUTE MYELOID LEUKEMIA, HAVE OCCURRED FOLLOWING TREATMENT WITH