Ciltacabtagene autoleucel (Carvykti®)

These are some of the most common or most serious side effects of this medication. Talk with your provider about the side effects you are having and how they can be managed.

Cytokine release syndrome (CRS) is an inflammatory reaction that affects your whole body. This medication can cause a quick and sudden release of cytokines (proteins) from your immune cells into your blood. Your body may become overwhelmed by this release of cytokines. This serious side effect can happen up to 4 weeks after the infusion.

Symptoms of CRS include

• Fever.
• Fatigue.
• Nausea or vomiting.
• Feeling dizzy or lightheaded.
• Headache.
• Trouble breathing or swallowing.
• Swelling of your face.
• Chest pain or racing heartbeat.
• Coughing or wheezing.

This can be a very serious side effect. Let your provider know right away so that treatment can be started if needed.

Your brain, spinal cord, and nerves make up your nervous system. This medication can cause brain (neurological) changes that can affect other parts of your body through your nervous system. These side effects are usually seen within the first 8 weeks after infusion. You may have: 

• Headaches.
• Numbness or tingling (neuropathy).
• Motor skill changes, like loss of control of your arms or legs.
• A hard time understanding when someone speaks to you or being unable to speak as you normally would (called aphasia).
• A change in your mental status, such as confusion, extreme tiredness (lethargy), memory loss, being unable to focus, sleep problems, and seeing or hearing things that aren’t really there (hallucinations), among others.
• A lack of blood flow and oxygen to your brain (called encephalopathy). 
• Seizures.

Contact your provider if you are having any neurological symptoms.

In rare cases, this medication can cause hemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS). These syndromes cause inflammation in your body. Symptoms can include:

• Persistent fevers. Call for a temperature over 100.4°F or 38°C or as directed by your provider.
• Rash.
• Enlarged lymph nodes, spleen, and/or liver.
•  Jaundice (yellowing of your skin or whites of your eyes).
• Hepatitis.
• Low blood counts.
• A change in your mental status.
• Trouble breathing.

Your provider will monitor you closely for these syndromes.

Hypogammaglobulinemia is low levels of immunoglobulin. This medication can cause low levels of immunoglobulin. Immunoglobulins are antibodies made by your immune system to help you fight infections. Your levels will be checked while on treatment and you may get immunoglobulin if needed. While your levels are low, you are at a higher risk of getting an infection. Talk with your provider before you get any vaccines and about ways you can decrease your chance of an infection.

Anemia is when your red blood cell count is lower than normal. Red blood cells carry oxygen to the tissues in your body. When your red cell count is low, you may feel tired or weak. Tell your providers if you have shortness of breath, trouble breathing, or pain in your chest. If your count gets too low, you may receive a blood transfusion.

This medication can cause serious infections, with or without a decrease in white blood cell counts.

White blood cells (WBC) help your body fight infection. While you are having cancer treatment, your WBC count can drop, putting you at a higher risk of an infection. Tell your provider right away if you have a fever (a temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips for preventing infection:

• Hand washing,  both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (those who have a cold, fever, or cough, or if someone you live with has these symptoms).
• When working outside, wear clothes that protect you, like long pants and gloves.
• Do not handle pet waste.
• Keep all cuts and scratches clean.
• Shower or bathe daily.
• Brush your teeth at least twice a day.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your providers before scheduling dental appointments or procedures.

Ask your providers before you or someone you live with has any vaccines. 

Platelets are blood cells that help your blood clot. Thrombocytopenia is when your platelet count is lower than normal, and you are at a higher risk of bleeding. Tell your providers if you have any bruising or bleeding, including nose bleeds, bleeding gums, or blood in your urine or stool. If your count gets too low, you may receive platelets from a donor. 

• Do not use a razor (an electric razor is fine).
• Do not do activities that can cause injury or bleeding.
• Talk to your provider before taking any non-steroidal, anti-inflammatory medications (NSAIDs) like Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib), and others. These can raise the risk of bleeding. 
• Use a soft-bristle toothbrush to brush your teeth. Ask your provider about flossing or using toothpicks. 

A secondary cancer happens as a result of cancer treatment for another cancer. This is rare, but you should know your risk. Secondary cancers can be related to chemotherapy and other anti-cancer medications. Often, a secondary cancer is a blood cancer. This can happen years after treatment and is often related to repeated treatments or high doses. Your provider will watch your labs closely. They may suggest you have a blood test called a complete blood count with differential. This is often done each year if you had high risk therapies.

Fatigue can cause exhaustion, feeling worn out and that your body is "heavy" and hard to move, or being unable to focus. It is common when you have cancer, and it is not the same as feeling tired. You may need to adjust your schedule to manage fatigue. Plan times to rest during the day and save your energy for more important activities. Exercise can help lessen fatigue. Talk to your providers about ways to deal with this side effect.

You may have joint or muscle pain/aches and headaches while taking this medication. Your provider can recommend medications and other ways to help relieve your pain.

Nutrition is an important part of your care. Cancer treatment can affect your appetite and make it hard to eat. Ask your provider about nutrition counseling services. Some tips you can follow are:

• Try to eat five or six small meals or snacks during the day, instead of 3 larger meals.
• Nutritional supplements may help if you are not eating enough.
• You may have a metallic taste or find that food has no taste. You may dislike foods or beverages that you liked before cancer treatment. These symptoms can last for months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products, and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce, or dressing.
• Use seasonings like basil, oregano, or rosemary to add flavor.

Diarrhea is when you pass three or more stools in a day. Your providers can suggest medications to relieve diarrhea. Do not take any medications to manage your diarrhea without talking to your provider first, as your stool may need to be tested. To manage it, try eating foods that are low in fiber and bland, like white rice and boiled or baked chicken. Try not to eat raw fruits, vegetables, whole grain breads, cereals, and seeds. Soluble fiber is a type of fiber found in some foods that helps absorb (soak up) fluid. Foods high in soluble fiber are applesauce, bananas (ripe), canned fruit, oranges, boiled potatoes, white rice, foods made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Stay hydrated by drinking 8 to 10 glasses of non-alcoholic, non-caffeinated fluid each day.

Constipation is when you have less bowel movements than usual or are having trouble passing stool. To relieve constipation, you can include fiber in your diet (fruits like prunes, apples, peaches, and pear nectars/juices), drink 8 to 10 glasses of non-alcoholic fluids a day, and stay active. Taking a stool softener once or twice a day can prevent constipation. If you do not have a bowel movement for 2 to 3 days, call your provider. 

Tachycardia is when your heart rate, or how fast your heart beats, is higher than normal. When your heart rate reaches 100 beats per minute (BPM) at rest, you are tachycardic. Call your provider if you: 

• Feel like your heart is racing. 
• Feel your heart pounding or skipping beats.
• Are short of breath,
• Feel dizzy or faint.

Your provider will monitor your heart rate during and after treatment.

Talk to your providers if you have nausea and/or vomiting. They can prescribe medications to help you. Making changes to your diet can also help. Avoid things that make your symptoms worse, like heavy or greasy/fatty foods and spicy or acidic foods, like tomatoes, lemons, and oranges. Try saltines or ginger ale to help your symptoms.  

Call your providers if you cannot keep fluids down for more than 12 hours or if you feel lightheaded or dizzy.

This medication can cause low blood pressure (hypotension). You may have your blood pressure checked while having treatment. Let your provider know if you have any headaches, vision changes, dizziness, or take blood pressure medication.

There is a higher risk of health problems for your baby if you are pregnant, become pregnant, or get someone pregnant while on this medication. To lower the risk of birth defects, you should use birth control (contraception) to avoid pregnancy. Talk with your provider about what kind of birth control is safest for you and your partner.

Some people may have an allergic reaction to this medication. Signs of an allergic reaction are:

• Shortness of breath or trouble breathing.
• Chest pain.
• Rash.
• Itching.
• Flushing (reddening of the skin, often on the face, neck, or chest).
• A drop in blood pressure (you may feel lightheaded, dizzy, or weak).

If you have any of these signs while you are getting an infusion, tell your provider right away. The infusion will be slowed down or stopped. Depending on your reaction, you may still be able to get the medication if you are given medicine to prevent a reaction or if the medication is given at a slower rate.