CARVYKTI® (ciltacabtagene autoleucel) is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. It is used when at least one other treatment has not worked or has stopped working. CARVYKTI® is a medicine made from your own white blood cells, which have been changed (genetically modified) to recognize and attack your multiple myeloma cells.
It's important to be aware of the potential side effects associated with CARVYKTI (ciltacabtagene autoleucel). Treatment with CARVYKTI includes a period of close, daily monitoring for the first 7 days after infusion as well as check-ins with your doctor.
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 experience any of the following:
Fever (100.4°F or 38°C or higher)
Chills or shaking chills
Fast or irregular heartbeat
Difficulty breathing
Very low blood pressure
Dizziness or lightheadedness
Persistent or severe diarrhea, abdominal pain, and weight loss
Effects on the Nervous System
Call your healthcare providers or get emergency help right away if you experience effects on your nervous system, some of which can occur days or weeks after you receive your infusion and may initially be subtle, such as:
Feeling confused, less alert, or disoriented
Difficulty speaking or slurred speech
Difficulty reading, writing, and understanding words
Memory loss
Loss of coordination affecting movement and balance
Slower movements
Changes in handwriting
Personality changes, including reduced ability to express emotions, being less talkative, disinterested in activities, and reduced facial expression
Tingling, numbness, and pain in hands and feet
Difficulty walking, leg and/or arm weakness
Difficulty breathing
Facial numbness, difficulty moving face and eye muscles
CARVYKTI Patient Wallet Card
For you to keep with you at all times, so any doctors treating you know that you have received CARVYKTI.
Cytokine Release Syndrome
CARVYKTI can cause a side effect called cytokine release syndrome, or CRS. It occurs when your immune system becomes overly active, which can be caused by CARVYKTI and its effect on the cancer cells. CRS can be severe or even fatal.
While CRS occurred in 84% of people in studies, it's important to remember that everyone's experience is different.
It typically started around 7 days after treatment, but for some people it started as early as 1 day or as late as 23 days.
It usually lasted about 4 days, but for some people it lasted anywhere from 1 to 97 days.
Signs and symptoms of CRS may include:
- Fever
- Difficulty breathing
- Dizziness or
lightheadedness - Nausea
- Headache
- Fast heartbeat
- Low blood pressure
- Fatigue
This is why it’s important to share any changes in how you’re feeling with your doctor, regardless of how small they may seem. The members of your healthcare team are experts trained to manage CRS and they’re ready to support you.
Neurologic
toxicity
Neurologic toxicity
CARVYKTI can cause neurologic side effects. Some of these side effects can be severe or even fatal.
- In clinical studies, 24% of people treated with CARVYKTI experienced neurologic side effects, and about one-third of those were considered serious or severe
Some neurologic side effects can be signs of a serious immune reaction known as ICANS (immune effector cell-associated neurotoxicity syndrome).
- 13% of people treated with CARVYKTI in clinical studies experienced ICANS
- ICANS cases ranged from mild to severe
People treated with CARVYKTI developed ICANS about 8 days after treatment (some developed ICANS in as little as 1 day to 28 days after).
On average, ICANS lasted about 6 days (people had ICANS for as little as 1 day or up to 1229 days).
Other forms of neurologic toxicity aside from ICANS may include:
- Parkinsonism
- Guillain-Barré syndrome (GBS)
- Immune-mediated myelitis
- Peripheral neuropathy
- Cranial nerve palsies
Some people treated with CARVYKTI in clinical studies have experienced these other forms of neurologic toxicity. In a separate, ongoing clinical study of CARVYKTI, one person died after developing GBS. Your doctor will monitor for GBS and provide care as needed.
Signs or symptoms associated with neurologic toxicity, some of which may occur days or weeks following the infusion, may include:
- 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
- Facial numbness
Common Side Effects
The most common side effects of CARVYKTI include:
Fever (100.4°F/38°C or higher), chills
Dizziness or lightheadedness
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
OTHER POSSIBLE SIDE EFFECTS
In a study comparing CARVYKTI with standard therapy, there was a higher rate of death in the first 10 months of people using CARVYKTI (14%) compared with people using standard therapy (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 increase the risk of life-threatening infections, including COVID-19, that may lead to death.
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 doctors will test your blood to check for this. Tell your doctors 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 can cause serious gastrointestinal side effects, including severe or persistent diarrhea or ruptured bowel, which can be life-threatening and may lead to death. Tell your healthcare provider right away if you develop diarrhea, abdominal pain, weight loss, fever, chills, or any signs or symptoms of an infection.
CARVYKTI may increase your risk of getting cancers including certain types of blood cancers. Your doctor 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. Tell your doctors immediately if you experience any side effects.
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