Pronunciation:

sil-ta-KAB-ta-jeen aw-toe-LOO-sel

Brand Names:

• Carvykti

Dosage Forms:

• Suspension

Warnings:

Warning: Cytokine Release Syndrome, Neurological Toxicities, HLH/MAS, Prolonged and Recurrent Cytopenia, and Secondary Hematological MalignanciesCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ciltacabtagene autoleucel. Do not administer ciltacabtagene autoleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with ciltacabtagene autoleucel, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ciltacabtagene autoleucel. Provide supportive care and/or corticosteroids as needed.Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with ciltacabtagene autoleuce.Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with ciltacabtagene autoleucel. HLH/MAS can occur with CRS or neurologic toxicities.Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with ciltacabtagene autoleucel.Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with ciltacabtagene autoleucel.Ciltacabtagene autoleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ciltacabtagene autoleucel REMS Program .

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

CAR T-Cell Agent

Uses of This Medicine:

Ciltacabtagene autoleucel injection is used to treat multiple myeloma (bone marrow cancer) in patients whose cancer has come back and who have received at least 4 previous treatments (eg, an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent) that did not work well.

Ciltacabtagene autoleucel injection is an antineoplastic (cancer) medicine that is made from your own white blood cells, which have been modified to recognize and attack your cancer cells. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of receiving it.

This medicine is available only under a restricted distribution program called Carvykti™ REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ciltacabtagene autoleucel injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ciltacabtagene autoleucel injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems or
• Heart rhythm problems (eg, tachycardia) or
• Hypotension (low blood pressure) or
• Infections (including hepatitis B), active or history of or
• Lung or breathing problems or
• Kidney disease or
• Seizures, history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer center. It is given through an IV catheter that is placed into one of your veins using a pump. This medicine must be given slowly, so your IV will need to stay in place for at least 30 to 60 minutes. It is given 2 to 4 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

You may also receive other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.

Your doctor will check you for unwanted effects at least daily for 10 days. Your doctor will also want you to stay close to the hospital or center for at least 4 weeks after your infusion.

It is very important that you understand the requirements of the Carvykti™ REMS program, and become familiar with the Carvykti™ Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.

This medicine may cause cytokine release syndrome (CRS), which may be life-threatening and requires immediate attention. Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

This medicine may cause serious nerve problems, which may be life-threatening and require immediate attention, including immune effector cell-associated neurotoxicity syndrome (ICANS), parkinsonism, Guillain-Barré syndrome, myelitis, peripheral neuropathy, and cranial nerve palsies. Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, agitation, back pain, blurred vision, changes in personality, coma, confusion, disorientation, difficulty with speaking, dizziness, drowsiness, facial numbness, fever, headache, irritability, mood or mental changes, slower movements, slurred speech, stiff neck, sudden numbness and weakness in the arms and legs, tremor, unusual tiredness or weakness, or vomiting.

This medicine may cause a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), which is caused by an overactive immune system. Check with your doctor right away if you have a fever, cough that does not go away, right upper abdominal or stomach pain and fullness, rash, redness in one part of your body, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, seizures, or warm feeling or swelling of your skin.

Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine. These may be symptoms of serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risk for hypogammaglobulinemia (immune system problem). Talk to your doctor if you have questions about these risks.

This medicine may increase your risk of getting blood cancers (eg, myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)). Tell your doctor if you have bone pain, blood in the urine or stools, fever or chills, cough, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

While you are being treated with ciltacabtagene autoleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

back pain

black, tarry stools

bladder pain

bleeding gums

blood in the eye

bloody or cloudy urine

blurred vision

body aches or pain

bone pain

bruising

chest pain or tightness

chills

confusion

confusion as to time, place, or person

cough or hoarseness

coughing up blood

decreased vision or other changes in vision

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

ear congestion

eye pain

fainting

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

hallucinations

headache

holding false beliefs that cannot be changed by fact

increased menstrual flow or vaginal bleeding

irritability

large, flat, blue or purplish patches in the skin

lightheadedness

loss of voice

lower back or side pain

mood or mental changes

muscle pain, spams, twitching, or jerking

nervousness

nosebleeds

painful or difficult urination

pale skin

paralysis

pounding in the ears

problems with speech or speaking

prolonged bleeding from cuts

red or dark brown urine

redness in whites of the eyes

rhythmic movement of the muscles

seizures

shakiness and unsteady walk

sneezing

sore throat

stiffness

stuffy or runny nose

sweating

swelling

swollen glands

trembling and shaking of the hands

trouble breathing

trouble sleeping

ulcers, sores, or white spots in the mouth

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

vomiting

Less common

Discouragement

feeling sad or empty

generalized slowing of mental and physical activity

incremental or ratchet-like movement of the muscle

lack of appetite

loss of balance control

loss of interest or pleasure

muscle discomfort

partial or slight paralysis

rigid or stiff muscles

seizures

shuffling walk

slowed movements

slurred speech

stiffness of the arms and legs

tic-like (jerky) movements of the head, face, mouth, and neck

trouble concentrating

trouble sleeping

uncontrolled eye movements

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

diarrhea

rash

Less common

Abnormal posture

double vision

fall

seeing double

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.