Ciltacabtagene Autoleucel

Generic Name: Ciltacabtagene autoleucel

Dosage form: Suspension for intravenous infusion

Brand name: Carvykti

Medically reviewed by R Rash MD.  Updated on 23 Mar 2022.

What exactly is Ciltacabtagene Autoleucel?

Ciltacabtagene Autoleucel is a genetically engineered autologous T cell immunotherapy that is directed by BCMA. Ciltacabtagene Autoleucel is synthesized from the patient’s mononuclear cells in the peripheral blood, which is collected by a conventional leukapheresis process. The mononuclear cells are enriched for T cells and genetically modified ex vivo using a replication-incompetent lentiviral vector to express a chimeric antigen receptor (CAR) with an anti-BCMA targeting domain made up of two single-domain antibodies linked to a 4-1BB costimulatory domain and a CD3-zeta signaling domain.

Anti-BCMA CAR T cells that have been transduced are grown in cell culture, washed, formed into a suspension, and cryopreserved. Before being shipped as a frozen suspension in a patient-specific infusion bag, the product must pass a sterility test. The anti-BCMA CAR T cells are frozen and injected back into the patient, where they may recognize and eradicate BCMA-expressing target cells.

Ciltacabtagene Autoleucel may contain Natural Killer (NK) cells in addition to T cells. Dimethyl sulfoxide (DMS) is present in the formulation at a concentration of 5%. (DMSO).

Mechanisms of Action

Important information

Ciltacabtagene Autoleucel could cause adverse reactions that are serious or life-threatening and could cause death. Consult your physician or seek emergency assistance right immediately if you experience any of the following symptoms:

It is crucial to inform your healthcare provider that you’ve received Ciltacabtagene Autoleucel and also present them with your Ciltacabtagene Autoleucel Patient Card for Wallet. Your healthcare provider could give you additional medications to manage your symptoms.

Warnings and Precautions

Before you get Ciltacabtagene Autoleucel

Before receiving Ciltacabtagene Autoleucel, tell your doctor about your medical condition such as if you suffer from:

What other drugs can impact Ciltacabtagene Autoleucel?

Inform your doctor about every medication you are taking, including prescription and over-the-counter medicines as well as vitamins or herbal remedies.

Certain products sold by commercial Human Immunodeficiency Virus (HIV) tests could incorrectly show an HIV-positive test result when you’re receiving treatment using Ciltacabtagene Autoleucel.

How can I receive Ciltacabtagene Autoleucel?

Prior to receiving Ciltacabtagene Autoleucel the doctor who treats you will prescribe chemotherapy for 3 days in order to prepare your body for the procedure.

Thirty-six to sixty minutes prior to the time you receive Ciltacabtagene Autoleucel. You may receive additional medicines. They could include:

Once you are sure that your Ciltacabtagene Autoleucel is in good condition and your healthcare provider is satisfied, they will administer Ciltacabtagene Autoleucel to you via an infusion catheter (tube) that is inserted inside the vein (intravenous infusion). Your dose will be delivered via a single bag of infusion. Infusions typically last 30-60 minutes.

After receiving Ciltacabtagene Autoleucel, You will be monitored by the healthcare facility that is certified by the FDA in which you received the treatment for a minimum of 10 days following the infusion.

You must plan to stay near the place in which you received your treatment for a minimum of 4 weeks. Your doctor will be able to make sure that your treatment is working and will assist you to deal with any adverse reactions that might happen.

It is possible to be admitted to the hospital when you experience dangerous side effects. This will continue until your symptoms are controlled and safe to quit the hospital.

Your physician will be able to conduct blood tests in order to monitor your improvement. It is crucial to test your blood. If you don’t make an appointment, you should contact your healthcare professional as soon as you can to make a new appointment.

Dosing information

The usual adult dose for Multiple Myeloma

Recommended dose range is 0.5-1.0x106CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×108 CAR-positive viable T cells per single-dose infusion.

For autologous use only. For intravenous use only.

What should I be aware of following the initiation of Ciltacabtagene Autoleucel?

Ciltacabtagene Autoleucel side effects

The most frequent adverse effects are:

Ciltacabtagene Autoleucel can trigger a frequent side effect, a condition known as CRS, or cytokine release syndrome, and can be very serious or even fatal. The symptoms of CRS are the following: fever, breathing difficulties dizziness or lightheadedness headache, nausea, fast heartbeat or blood pressure that is low, or fatigue. Contact your healthcare professional immediately if you experience fever or experience any of these other symptoms following the administration of Ciltacabtagene Autoleucel.

Ciltacabtagene Autoleucel increases the risk of developing life-threatening infections that could lead to death. Contact your healthcare professional immediately if you experience symptoms of chills, fever, or any indications or signs of infection.

Ciltacabtagene Autoleucel may cause a variety of neurologic effects, and some could be fatal or severe.
The symptoms include but aren’t included in confusion and disorientation, loss of awareness, seizure, trouble talking, reading, or writing as well as tremors, slow movement or changes in personality seizures as well as depression, tingling, and the feeling of numbness in feet and hands or arm weakness, as well as facial Numbness.

Ciltacabtagene Autoleucel may decrease one or more blood cells (red blood cells white blood cells or platelets (cells that assist in causing blood clots) This can cause you to feel tired or weak or increase the risk of bleeding or serious infection. Following treatment, your doctor will analyze your blood for this. Inform your healthcare provider immediately if you notice an illness that causes chills, fever, or any indications or signs of infection, are experiencing fatigue, or are suffering from bleeding or bruising.

Being a carrier of Ciltacabtagene Autoleucel present in your blood can result in some medical Human Immunodeficiency Virus (HIV) tests to falsely show an HIV positive result, even though you could be HIV-negative.

There are many possible adverse consequences. Consult your doctor for any adverse symptoms. You can report any side effects to the FDA via 800-FDA-1088.

Patients counseling information

Encourage the patient to study the FDA-approved labeling for patients (Medication Guidance). Be sure to inform patients about the possibility of failure in manufacturing (around 18% (17/97 in the study)(in the clinical study). If there is the manufacturing process fails and the second production of this medication could be tried. Additionally, when the patient is waiting for the drug, further anticancer treatments (other than lymphodepletion) could be required and can increase the chance of adverse reactions in the period prior to infusion which may hinder or stop administering Ciltacabtagene Autoleucel.

Instruct the patients to be observed on a daily basis for the first 10 consecutive days after the infusion in a REMS-certified healthcare facility. Also, advise patients to stay within the vicinity of a health facility for at least 4 weeks after the infusion.

Before infusion, inform your patients about the following dangers and urge them to seek medical attention in case of any of these warning signs and symptoms

Cytokine Release Syndrome (CRS)

Signs or symptoms of CRS, including fever, chills, fatigue, headache, tachycardia, hypotension, hypoxia, dizziness/lightheadedness, or organ toxicities

Neurologic Toxicities

Affects or signs that can be related to neurologic processes Some of them occur in the days, weeks or even months after the infusion, including

  • ICANS e.g. Aphasia or encephalopathy decreased levels of awareness, seizure dysgraphia, delirium
  • The signs of Parkinsonism include e.g. tremor micrographia or bradykinesia stiffness, shuffling gait tilted posture, masked facial features, apathy, flat affect sleepiness, lethargy
  • Guillain Barre Syndrome: e.g., motor weakness, polyradiculoneuritis
  • The peripheral neuropathy e.g. peripheral sensory or motor nerve problems
  • Cranial Nerve Palsies: e.g., facial paralysis, facial numbness

Recurrent and Protracted Cytopenias

The signs or symptoms that are related to bone marrow suppression such as thrombocytopenia, neutropenia, anemia, or febrile neutropenia last for many weeks or months. The symptoms or signs associated with bone marrow deficiency can be recurrent.

Infections

Aspects or signs that suggest the infection

Hypersensitivity Reactions

The signs or symptoms that are associated with hypersensitivity reactions include chest tightness, flushing the tachycardia, and breathing difficulties

Instruct patients on the necessity to:

  • Monitor blood counts prior to and following Ciltacabtagene Autoleucel infusion
  • Call Janssen Biotech, Inc. by calling 1-800-526-7736 in the event that they are diagnosed with secondary malignancy
  • Avoid driving or engaging in dangerous occupations or activities such as operating dangerous or heavy equipment for at least 8 weeks following treatment, as well in case of new symptoms of neurologic toxicities.
  • Inform their doctor about the treatment they received with Ciltacabtagene Autoleucel prior to receiving a live virus vaccination

Label

70 ml label

  • Ciltacabtagene autoleucel (CARVYKTI)
  • Suspension for Intravenous Infusion
  • Dose: One sterile bag for infusion.
  • Storage: Store and transport in a vapor phase of
    liquid nitrogen ≤ -120°C (-184°F). Thaw before using.
  • Rx only
Ciltacabtagene Autoleucel

30 ml Label

 

Ciltacabtagene Autoleucel

Additional details

Always consult your doctor to make sure the information presented on this page is applicable to your particular situation.

 

One Response

Leave a Reply