Patient Medication Information: uses, side effects, how to take - Carvykti

What is CARVYKTI used for:

CARVYKTI is used to treat patients with a type of cancer of the bone marrow called multiple myeloma. It is given when your cancer has not responded to or has come back after at least one treatment, and your cancer is not responding to your most recent therapy.

How CARVYKTI works:

CARVYKTI is a chimeric antigen receptor (CAR) T-cell therapy, a type of treatment that helps your immune system fight cancer. CARVYKTI is made from your own T cells (a type of white blood cells). These cells are taken from your blood and are modified to recognize and attack cancer cells. Specifically, the cells are modified to target a protein expressed on multiple myeloma cells. You may be given other therapies to treat your cancer while CARVYKTI is being made.

The ingredients in CARVYKTI are:

Medicinal ingredients: Ciltacabtagene autoleucel

Non-medicinal ingredients: Cryostor® CS5 (a substance used to preserve frozen cells), including dimethyl sulfoxide (DMSO). CARVYKTI may contain trace amounts of kanamycin.

Serious Warnings and Precautions

Fever and chills which may be symptoms of a serious side effect called cytokine release syndrome, which can be severe or fatal. Other symptoms include difficulty breathing, dizziness or feeling light-headed, feeling the need to throw up, headache, fast heartbeat, low blood pressure, feeling tired, vomiting, diarrhea, muscle pain and joint pain.
Neurologic toxicities include problems like confusion, difficulty with memory, difficulty speaking or slowed speech, difficulty understanding speech, loss of balance or coordination, confused about time or surroundings, being less alert or excessive sleepiness, passing out, fits (seizures), shaking, or weakness with loss of movement on one side of the body.
Hemophagocytic lymphohistiocytosis/ Macrophage activation syndrome, a strong and uncontrolled immune response, in which activated immune cells can build up in organs like liver, kidney, and spleen, and cause damage to these and other organs.

CARVYKTI comes in the following dosage forms:

CARVYKTI is a colourless to white (including shades of white, yellow, and pink) cell suspension for infusion, supplied in an infusion bag.

Do not use CARVYKTI if:

You are allergic to CARVYKTI or any of the other ingredients of this medicine (listed in “What are the ingredients in CARVYKTI”?). If you think you may be allergic, ask your doctor for advice.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you receive CARVYKTI. Talk about any health conditions or problems you may have, including if you:

have current or past problems with your nervous system - such as fits, stroke, new or worsening memory loss.
have any lung, heart or blood pressure (low or raised) problems.
have kidney problems.
have signs or symptoms of graft-versus-host disease. This happens when transplanted cells attack your body, causing symptoms such as rash, nausea, vomiting, diarrhea and bloody stools.
have had hepatitis B virus, hepatitis C virus or human immunodeficiency virus infection
have an infection. An infection will be treated before you receive CARVYKTI
have had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
notice the symptoms of your cancer getting worse. In myeloma this might include fever, feeling weak, bone pain, unexplained weight loss.
are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. This is because the effects of CARVYKTI in pregnant or breast-feeding women are not known and it may harm your unborn baby or breastfed child.
are a man and you plan to father a child after CARVYKTI treatment.

Other warnings you should know about:

Do not drive or use tools or machines until at least 8 weeks after having CARVYKTI, or if you feel tired, have balance and coordination problems, feel confused, weak or dizzy.
Do not donate blood, organs, tissues or cells for transplants after you have had CARVYKTI.
CARVYKTI contains substances that may cause allergic reactions. Your doctor will check you to look for any signs of a possible allergic reaction.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How you will receive CARVYKTI:

CARVYKTI will always be given to you by a healthcare professional at a qualified treatment centre.

Making CARVYKTI from your own blood cells

CARVYKTI is made from your own white blood cells. Your blood cells will be collected from you to prepare your medicine.
Your doctor will take some of your blood using a catheter (tube) placed in your vein.
Some of your white blood cells are separated from your blood - the rest of your blood is returned to your vein. This process is called ‘leukapheresis’. This process can take 3 to 6 hours and may need to be repeated.
Your white blood cells are sent to the manufacturing centre to make CARVYKTI.
While CARVYKTI is made, your healthcare provider may prescribe other medicines to continue to manage your multiple myeloma.

Medicines given before CARVYKTI treatment

A few days before - you will be given treatment called “lymphodepleting therapy” to prepare your body to receive CARVYKTI. This treatment reduces the number of white blood cells in your blood, so the modified white blood cells in CARVYKTI can grow in numbers when they are returned to your body.

30 to 60 minutes before - you may be given other medicines. These may include:

medicines called anti-histamines for an allergic reaction - such as diphenhydramine
medicines for fever - such as acetaminophen

Your doctor or nurse will check carefully that the CARVYKTI treatment is from your own modified white blood cells.

How you are given CARVYKTI

Your doctor or nurse will give you a one-time infusion of CARVYKTI into your vein. This is called an ‘intravenous infusion’ and takes about 30-60 minutes.

After you receive CARVYKTI

Plan to stay near the centre where you were treated for at least 4 weeks after you receive CARVYKTI.
- You will need to be monitored at the treatment centre daily for at least 14 days after you receive CARVYKTI. This is so your doctor can check if your treatment is working and treat you if you get any side effects. If you develop serious side effects, you may need to stay in the hospital until your side effects have been managed and it is safe for you to leave.
- If you miss any appointments, call your doctor or treatment centre as soon as possible to make a new appointment.

Usual dose:

CARVYKTI comes as a cell suspension in an infusion bag. The target dose is 0.5-1.0×10⁶CAR-positive viable T-cells per kg of body weight, with a maximum dose of 1×10⁸CAR-positive viable T-cells. CARVYKTI should be given to you as a one-time infusion.

Possible side effects from using CARVYKTI:

These are not all the possible side effects you may have when taking CARVYKTI. If you experience any side effects not listed here, tell your healthcare professional.

Very common (may affect more than 1 in 10 people):

low number of platelets’ (cells that help blood to clot), and red blood cells
low number white blood cell (neutrophils) which can occur with a fever
pain, including muscle and joint pain
feeling very tired, difficulty sleeping
infected nose, sinuses or throat (a cold)
nausea, decreased appetite, constipation, vomiting, diarrhea
headache
swelling caused by fluid buildup in the body
high level of bilirubin in the blood
laboratory test results showing increased levels of liver enzymes (abnormal liver function test) or a higher level of a protein (C-reactive protein) in blood that may indicate inflammation
laboratory test results showing low levels of antibodies, called immunoglobulins (hypogammaglobulinemia) that are important in fighting infections

Common (may affect up to 1 in 10 people):

low level of ‘fibrinogen’, a type of protein in the blood, making it more difficult to form clots
stomach pain
increased levels of a protein called ‘ferritin’ in the blood
muscle tremor
tightness, muscular weakness
weak muscles that cause partial paralysis
severe confusion
fungal infections
blood clots
sleep problems

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Get immediate medical help
Frequency/Side Effect/Symptom	Talk to your healthcare professional	Get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
Only if severe	In all cases
Only if severe	In all cases
VERY COMMON (may affect more than 1 in 10 people)
Fever, chills, reduced blood pressure which may cause symptoms such as dizziness and lightheadedness, fluid in the lungs (all symptoms of a condition called cytokine release syndrome which may be severe and can be fatal)		✓	✓
Any signs of an infection, which may include fever, chills or shivering, rapid pulse, or depending on the location of infection, you may also experience sore throat, cough, shortness of breath or rapid breathing, chest pain, or pain with urination or blood in urine (increased risk of		✓	✓
life-threatening infections that may lead to death)
Feeling tired, muscle weakness or cramps or an irregular heartbeat which may be a sign of low levels in the blood of calcium, potassium, sodium, magnesium, phosphate or albumin		✓
Abnormal heartbeat		✓
Problems being able to produce or control movement including muscle spasms, muscle tightness, muscular weakness, writing difficulty, changes in handwriting		✓
Difficulty reading, writing, understanding words, slow speech, depressed level of consciousness, feeling confused (symptoms of a condition called Immune Effector Cell-Associated Neurotoxicity Syndrome or may be signs and symptoms of parkinsonism)		✓	✓
Spontaneous or prolonged and excessive bleeding (coagulopathy)		✓	✓
Shortness of breath, confusion or drowsiness which may be a sign of low oxygen level in the blood (hypoxia)		✓
Nerve damage that may cause tingling, numbness, pain or loss of pain sensation		✓
COMMON (may affect up to 1 in 10 people)
Bleeding, which can be severe, called a ‘hemorrhage’		✓	✓
Decreased or lack of urination, feeling sick to the stomach, swelling of the ankles, legs or feet, feeling tired, confusion, seizures or coma (kidney failure)		✓	✓
Facial numbness, difficulty moving muscles of face and eyes (signs and symptoms of cranial nerve palsies)		✓	✓
Tingling, numbness, and pain of hands and feet, difficulty walking, leg and/or arm weakness, difficulty		✓	✓
breathing (signs and symptoms of Guillain-Barré syndrome)
Cancer of the blood (hematologic malignancy): Symptoms of new cancer including new lymphoma or leukemia from a type of white blood cells called T -cells. Symptoms may include any new swelling of glands (lymph nodes) or changes in skin (such as new rashes, bruising or lumps), fever, feeling weak, bleeding gums, night sweats, sudden weight loss.		✓	✓
Serious gastrointestinal side effects, including severe or persistent diarrhea or rupture of the wall of the digestive system (often presenting as sudden start of severe abdominal pain, followed by fever and chills), which can be life-threatening and may lead to death.		✓	✓
UNCOMMON (may affect up to 1 in 100 people)
Serious immune reaction with activated immune cells building up in organs like liver, kidney, spleen, causing damage to these organs, and could be life-threatening (hemophagocytic lymphohistiocytosis). Symptoms may include fever, decrease in blood cell levels, difficulty breathing, low blood pressure and an increased risk of bleeding.		✓	✓
Quick breakdown and death of large number of cancer cells leading to release of their contents causing a change in certain chemicals in the blood (tumour lysis syndrome). Symptoms may include feeling sick to the stomach, vomiting, diarrhea, muscle tightness or spasms, weakness, numbness or tingling, feeling tired, decreased urination, irregular		✓	✓
heart rate, feeling confused, hallucinating and seizures.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

If you want more information about CARVYKTI:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: Drug Product Database: Access the database; the manufacturer’s website innovativemedicine.jnj.com/canada, or by calling 1-800-567-3331 or 1-800-387-8781.

CARVYKTI is co-developed with Legend Biotech.

Date of Authorization: 2026-10-09

All trademarks used under license.

Rx or OTC	Prescription (Rx)?
DIN	02535270
Schedule(s)	SCHEDULE D; PRESCRIPTION
Active ingredient(s)	Ciltacabtagene autoleucel 100000000 CELLS
Dosage form(s)	Suspension
Route(s) of administration	Intravenous
Drug class (WHO ATC)	L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01X Other antineoplastic agents L01XL05 Ciltacabtagene autoleucel
Company	JANSSEN INC
Current status	Approved
Current status date	February 9, 2023

Carvykti: Uses, Side Effects and Dosage