Kymriah

Kymriah is a prescription medication used to treat a type of cancer in the white blood cells called acute lymphoblastic leukemia (ALL) and is also used to treat a certain type of non-Hodgkin lymphoma.  

Kymriah is a type of immunotherapy. The medication is prepared using the patient's own cells. It works by using the patient's immune system to kill the cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Kymriah include difficulty breathing, fever, chills, and confusion. Kymriah can also cause drowsiness and dizziness. Do not drive or operate heavy machinery for 8 weeks after you receive dose until you know how Kymriah affects you.

Kymriah is a prescription cancer treatment used to treat:

• patients up to 25 years old who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or refractory (did not go into remission after receiving other leukemia treatments).
• adult patients with non-Hodgkin lymphoma that has relapsed or is refractory after having at least two other kinds of treatment

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Kymriah. See the “Kymriah Precautions” section.

The most common side effects of Kymriah are:

• difficulty breathing
• fever (100.4°F/38°C or higher)
• chills (may be associated with shaking)
• confusion
• nausea, vomiting, diarrhea that is severe 
• severe muscle or joint pain
• very low blood pressure
• dizziness/lightheadedness
• headache

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

Kymriah can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.

Having Kymriah in your blood may cause a false-positive HIV test result by some commercial tests.

These are not all the possible side effects of Kymriah. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Kymriah including the following:

• cytokine release syndrome. This is a severe or life-threatening reaction, especially when you have an infection or inflammation. Your doctor will monitor you for these symptoms. Tell your doctor if you have a fever, shaking, cough, loss of appetite, diarrhea, difficulty breathing, confusion, vomiting, or dizziness after a treatment.
• neurotoxicity. This is severe or life-threatening damage to the nervous system. If you experience any of the following symptoms, call your doctor immediately: confusion; drowsiness; blurred vision; seeing things or hearing voices that do not exist (hallucinating); or pain, burning, numbness, tingling in the hands or feet; seizures; or coma (loss of consciousness for a period of time).
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity including chest pain, swelling of the face or mouth, difficulty breathing or swallowing, or rash.
• lowered blood count. This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.
• hypogammaglobulinemia. This is a reduced number of gamma globulins, a type of protein in the body. Gamma globulin levels will be monitored and may be replaced if your healthcare provider decides that is necessary.
• secondary cancers. This is new cancer as a result of treatment.

Kymriah can cause drowsiness and dizziness. Do not drive or operate heavy machinery for at least 8 weeks after receiving a dose of Kymriah.

Kymriah may cause a false positive result for HIV test that you can buy in the store.

Do not take Kymriah if you are allergic to Kymriah or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Kymriah, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Kymriah, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Kymriah or to any of its ingredients.
• have any immune system disorders.
• have an inflammatory disease like gout.
• have been diagnosed with a viral infection such as hepatitis B, hepatitis C, or HIV.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals or in pregnant women. Because of the risk of possible side effects for an unborn baby, it is not recommended to take Kymriah while pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Kymriah crosses into human milk. Because  of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kymriah.

Since Kymriah is made from your own white blood cells, your healthcare provider has to take some of your blood. This is called “leukapheresis.” It takes 3 to 6 hours and may need to be repeated. A tube (intravenous catheter) will be placed in your vein to collect your blood.

Your blood cells are frozen and sent to the manufacturing site to make Kymriah. It takes about 3-4 weeks to make Kymriah, but the time may vary.

Before you get Kymriah, your healthcare provider may give you acetaminophen (Tylenol) and a medication to treat allergies. 

When your body is ready, your healthcare provider will give you Kymriah through a tube (intravenous catheter) in your vein. This usually takes less than one hour.

You should plan to stay within 2 hours of the location where you received your treatment for at least 4 weeks after getting Kymriah. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur. 

The Kymriah dose you receive is based on your weight. Your healthcare provider will determine the right dose for you.

Kymriah dose is typically given 2-14 days after receiving chemotherapy.

Kymriah is provided as a single dose for infusion. This means it is included in an infusion bag that will be given as an infusion into the vein.

If Kymriah is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Keep all your appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Kymriah.

WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES

• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab.  
• Neurological toxicities, which may be severe or life-threatening, can occur following treatment with KYMRIAH, including concurrently with CRS. Monitor for neurological events after treatment with KYMRIAH. Provide supportive care as needed. 
• KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.