CARVYKTI® (ciltacabtagene autoleucel)

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/lightheadedness
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 breathing
- facial numbness, difficulty moving muscles of face and eyes

It is important that you tell your healthcare providers that you have received CARVYKTI^® and to show them your CARVYKTI^® Patient Wallet Card. Your healthcare providers may give you other medicines to treat your side effects.

Before you receive CARVYKTI^® tell your healthcare provider about all your medical conditions, including if you have:

Current or past neurologic problems (such as seizures, stroke, new or worsening memory loss)
Lung or breathing problems
Heart problems
Liver problems
Kidney problems
A recent or active infection
Low blood counts

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive CARVYKTI^®?

CARVYKTI^® is made from your own white blood cells, so your blood will be collected by a process called ‘leukapheresis’ (loo-kah-fur-ee-sis). The procedure can take 3 to 6 hours and may need to be repeated.
Your white blood cells are sent to a manufacturing center to make CARVYKTI^®. It takes about 4-5 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
While CARVYKTI^® is being made, you may get other medicines to treat the multiple myeloma. This is so that your multiple myeloma does not get worse.

Before you get CARVYKTI^®, your healthcare provider will give you chemotherapy for 3 days to prepare your body.

30 to 60 minutes before you are given CARVYKTI^®, you may be given other medicines. These may include:

medicines for an allergic reaction (antihistamines)
medicines for fever (such as acetaminophen)

When your CARVYKTI^® is ready, your healthcare provider will give CARVYKTI^® to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of CARVYKTI^® will be given in one infusion bag. The infusion usually takes approximately 30-60 minutes.

After getting CARVYKTI^®, you will be monitored at the certified healthcare facility where you received your treatment for at least 10 days after the infusion.

You should plan to stay close to the location where you received your treatment for at least 4 weeks. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur. You may be hospitalized if you develop serious side effects until your side effects are under control and it is safe for you to leave the hospital.

Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving CARVYKTI^®?

Do not drive, or operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get CARVYKTI^®. This is because the treatment can cause memory and coordination problems, sleepiness, confusion, dizziness, seizures, or other neurologic side effects as discussed by your healthcare provider.
You must not be given certain vaccines called live vaccines for some time before and after CARVYKTI^® treatment. Talk to your healthcare provider if you need to have any vaccinations.
Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of CARVYKTI^®?

The most common side effects of CARVYKTI^® include:

fever (100.4°F/38°C or higher), chills
dizziness or light-headedness
headache, muscle or joint pain, feeling very tired
altered mental state, confusion
infections
low levels of antibodies (immunoglobulins) in the blood
cough, being short of breath
diarrhea, nausea, decreased appetite, constipation
fast or irregular heartbeat
problems with blood clotting

In a study comparing CARVYKTI^® to standard therapy, there was a higher rate of death in the first 10 months in the CARVYKTI^® arm (14%) compared to the standard therapy arm (12%). The increased rate of deaths occurred before receiving CARVYKTI^® and after treatment with CARVYKTI^®. The reasons for death were progression of multiple myeloma and side effects of the treatment.

CARVYKTI^® can cause a very common side effect called cytokine release syndrome or CRS, which can be severe or fatal. Symptoms of CRS include fever, difficulty breathing, dizziness or lightheadedness, nausea, headache, fast heartbeat, low blood pressure, or fatigue. Tell your healthcare provider right away if you develop fever or any of these other symptoms after receiving CARVYKTI^®.

CARVYKTI^® can increase the risk of life-threatening infections including COVID-19 that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.

CARVYKTI^® can cause various neurologic side effects, some of which may be severe or fatal. Symptoms include but are not limited to confusion, disorientation, loss of consciousness, seizures, difficulty speaking, reading or writing, tremor, slower movements, changes in personality, depression, tingling and numbness of hands and feet, leg and arm weakness, and facial numbness.

CARVYKTI^® can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets [cells that help blood to clot]), which may make you feel weak or tired, or increase your risk of severe infection or bleeding that may lead to death. After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, chills, or any signs or symptoms of an infection, are feeling tired, or have bruising or bleeding.

CARVYKTI^® may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.

Having CARVYKTI^® in your blood may cause some commercial Human Immunodeficiency Virus (HIV) tests to incorrectly give you an HIV-positive result even though you may be HIV-negative.

These are not all the possible side effects of CARVYKTI^®. Call your healthcare provider if you have any side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI^®.

cp-258861v6

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