Ciltacabtagene Autoleucel(Carvykti) FDA Package Insert

Ciltacabtagene Autoleucel(Carvykti) FDA Package Insert

1、Indications and Usage

Carvykti (Ciltacabtagene Autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy 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-CD38 monoclonal antibody.

2、Dosage and Administration

1. For autologous use only. For intravenous use only.

2. Use a lymphodepleting regimen of cyclophosphamide and fludarabine before infusing Carvykti.

3. Do not use a leukocyte-depleting filter.

4. Premedicate with acetaminophen and an H1 antihistamine.

5. Avoid prophylactic use of systemic corticosteroids.

6. Confirm the availability of tocilizumab prior to infusion.

7. The dosage of Carvykti is based on the number of CAR-positive viable T cells.

8. The recommended dose range of Carvykti is 0.5 – 1.0 × 106 CAR-positive viable T cells per kg of body weight, with a maximum dose of 1 × 108 CAR-positive viable T cells per single infusion.

3、Dosage Forms and Strengths

1. Carvykti is a cell suspension for intravenous infusion.

2. One dose of Carvykti contains a cell suspension of 0.5 – 1.0 × 106 CAR-positive viable T cells per kg of body weight in one infusion bag.

4、Contraindications

None

5、Warnings and Precautions

1. Prolonged and Recurrent Cytopenia: Patients may exhibit ≥Grade 3 cytopenia following Carvykti infusion. Cytopenia may recur after initial recovery. Monitor blood counts prior to and after Carvykti infusion. Prolonged neutropenia has been associated with increased risk of infection.

2. Infections: Monitor patients for signs and symptoms of infection and treat appropriately.

3. Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy.

4. Allergic Reactions: Allergic reactions have occurred. Monitor for allergic reactions during infusion.

5. Secondary Malignancies: Secondary hematologic malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred.

6. Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks after receiving Carvykti and in the event of new onset of neurologic toxicities.

6、Adverse Reactions

The most common non-laboratory adverse reactions (incidence ≥20%) with Carvykti include fever, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infection of unspecified pathogen, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infection, coagulopathy, constipation, and vomiting. The most common laboratory abnormalities (incidence ≥50%) include thrombocytopenia, neutropenia, anemia, elevated transaminases, and hypoalbuminemia. For more quality information, please contact Yaodei, where we will do our best to help you understand more about high-quality overseas drugs.

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