Carvykti (ciltacabtagene autoleucel) is a personalized CAR T-cell therapy used to treat relapsed or refractory multiple myeloma (RRMM). It is used in adults whose multiple myeloma has returned or stopped responding to earlier treatments and may be used as early as the first relapse in certain patients.

Carvykti is a one-time infusion using a patient’s own genetically modified T cells to recognize and destroy multiple myeloma cells that express the BCMA protein.

For Carvykti treatment, T cells (a type of white blood cell) are collected from your blood and modified at the manufacturing site. A specialized receptor, called a chimeric antigen receptor (CAR), is added to the surface of the T cells. This enables it to recognize and attack multiple myeloma cells that carry the BCMA protein.

Once modified, the T cells are multiplied and infused back into your body as a personalized immunotherapy. After infusion, these CAR-T cells can seek out and kill BCMA-expressing multiple myeloma cells, helping improve disease control and clinical outcomes.

Carvykti is a BCMA-targeted CAR-T cell therapy.

Who Is Eligible for Carvykti Therapy?

Carvykti is FDA approved for the treatment of adults with relapsed or refractory multiple myeloma who meet all of the following criteria:

• Have multiple myeloma that has returned or stopped responding to treatment
• Have received at least one prior line of therapy
• Have been treated with:
  • A proteasome inhibitor, and
  • An immunomodulatory agent
• Have disease that is refractory to lenalidomide (no longer responds to lenalidomide treatment)

Carvykti may be used as early as the first relapse in appropriate patients when previous therapies have not been effective.

What is the Carvykti treatment process?

The Carvykti CAR T-cell therapy process is:

• T-cell collection: T cells, a type of white blood cell, are collected from your blood through a process called leukapheresis.
• Genetic modification: At a specialized manufacturing facility, a chimeric antigen receptor (CAR) is added to the surface of the T cells.
• Targeting BCMA: This CAR enables the T cells to recognize BCMA (B-cell maturation antigen), a protein found on multiple myeloma cells.
• Cell expansion: The modified CAR T cells are multiplied in the laboratory to create a sufficient number of cells for treatment.
• One-time infusion: The modified T cells are infused back into your body as a personalized immunotherapy.
• Cancer cell attack: After infusion, the CAR-T cells seek out and kill BCMA-expressing multiple myeloma cells, helping improve disease control and clinical outcomes.

How effective is Carvykti for RRMM?

New data from the Phase 3 CARTITUDE-4 study (NCT04181827) demonstrated that Carvykti was more effective than standard therapy.

• At 12 months, the estimated progression-free survival (PFS) rate was 75.9% with Carvykti compared to 49.5% with standard therapy. 
• In addition, 74.0% of patients treated with Carvykti achieved a complete response or better, while only 22.3% of patients on standard therapy reached that level of response. 
• An update to this study at a median follow-up of 33.6 months reported a statistically significant improvement in the overall survival rate with Carvykti compared to standard therapy.

These response rates were assessed by an Independent Review Committee (IRC) using the International Myeloma Working Group (IMWG) criteria.

Boxed Warnings

Carvykti has boxed warnings for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome (GBS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged and/or recurrent cytopenias, immune-effector cell-associated enterocolitis (IEC-EC), and secondary hematological malignancies. 

A boxed warning is the strongest safety-related warning issued by the FDA. 

• Cytokine Release Syndrome (CRS). This includes fatal or life-threatening reactions, that have occurred in patients following treatment with Carvykti. Do not administer this medicine to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). This may be fatal or life-threatening, and has occurred following treatment with Carvykti, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with Carvykti .  Supportive care and/or corticosteroids should be provided as needed.
• Parkinsonism and Guillain-Barré syndrome and their associated complications have occurred following Carvykti treatment resulting in fatal or life-threatening reactions.
• Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, have occurred in patients following treatment with this medicine. HLH/MAS can occur with CRS or neurologic toxicities.
• Prolonged or recurrent cytopenias (low blood cell counts) have occurred after treatment with Carvykti and may be associated with bleeding, infection, and the need for stem cell transplantation to restore blood cell production.
• Immune Effector Cell–associated enterocolitis (IEC-EC), including fatal or life-threatening reactions, has been reported following treatment with Carvykti.
• Secondary blood cancers, such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), have occurred after treatment with Carvykti. T-cell malignancies have also been reported following treatment of blood cancers with BCMA- and CD19-directed genetically modified autologous T-cell therapies, including Carvykti. 

Warnings and Precautions

• Prolonged and Recurrent Cytopenias: Cytopenia is low levels of red blood cells (anemia), white blood cells (leukopenia) or platelets (thrombocytopenia). Cytopenia may occur after Carvykti infusion. Prolonged neutropenia has been associated with increased risk of infection. Blood counts should be monitored before and after the infusion.
• Infections: Patients should be monitored for signs and symptoms of infection and receive appropriate treament if necessary.
• Hypogammaglobulinemia (low levels of immunoglobulins):  Your immunoglobulin levels will be monitored and immunoglobulin replacement therapy may be considered if required.
• Hypersensitivity Reactions: Hypersensitivity reactions have occurred. Monitor for hypersensitivity reactions during infusion. ( 5.8)
• Secondary Malignancies: Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including this medicine. Contact Janssen Biotech, Inc. at 1-800-526-7736, if this occurs.
• Immune-effector cell-associated enterocolitis (IEC-EC): 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. 

Differences in survival rates in the first 10 months were found in a study comparing Carvykti to standard therapy.

• 14% in the Carvykti arm died compared to 12% in the standard therapy arm.
• The increased death rate occurred before and after receiving Carvykti treatment.
• The reasons for death were progression of multiple myeloma and side effects of the treatment. 

However, the FDA has determined that the overall benefit of Carvykti continues to outweigh the potential risks. 

Carvykti side effects

Carvykti common side effects

Carvykti Common side effects may include:

• confusion, cough, trouble breathing, fast or irregular heartbeats, feeling light-headed or very tired;
• headache, dizziness;
• problems with speech;
• low blood cell counts;
• fever, chills, tiredness, or other signs of infection;
• decreased appetite, constipation, nausea, or diarrhea; or
• pain in your joints or muscles.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of Carvykti is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, severe vomiting or diarrhea, tremors, shaking, fast or irregular heartbeats, feeling light-headed, or feeling very tired. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also, call your doctor at once if you have:

• confusion, loss of consciousness, seizures, problems with speech, reading, or writing, depression
• personality changes, including a reduced ability to express emotions, being less talkative,
  disinterest in activities, and reduced facial expression
• tingling and numbness of hands and feet, leg and arm weakness, facial numbness; or
• low blood cell counts – fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath
• persistent or severe diarrhea, abdominal pain, and weight loss.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

Tell your doctor if you have ever had:

• neurologic problems (such as stroke, seizures, memory loss);
• breathing problems;
• heart problems;
• liver or kidney disease;
• diarrhea;
• recent or active infection; or
• low blood counts.

Pregnancy

Carvykti is not recommended for women who are pregnant or for women of childbearing potential not using contraception. Pregnant women should be advised that there may be risks to the fetus. Pregnancy after this therapy should be discussed with the treating physician.

Women will need pregnancy testing before receiving this medicine. You will also need to use birth control to prevent pregnancy during treatment with this medicine. Tell your doctor if you are pregnant or plan to become pregnant.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How should I receive Carvykti?

The Carvykti treatment process involves:

1. T-cell collection – A patient’s white blood cells (T cells) are collected via leukapheresis.
2. Genetic modification – The T cells are engineered to express a CAR that recognizes BCMA, a protein highly expressed on multiple myeloma cells.
3. Expansion and conditioning – The modified T cells are multiplied in a lab, while the patient undergoes lymphodepleting chemotherapy to prepare for infusion.
4. One-time infusion – The patient receives an intravenous (IV) infusion of Carvykti.
5. Post-treatment monitoring – Patients are closely monitored for cytokine release syndrome (CRS) and other potential side effects.

Dosing information

Recommended dose: 0.5-1.0×10⁶ CAR-positive viable T cells per kg, with a maximum dose of 1×10⁸ CAR-positive viable T cells per infusion.

Pre-medication required: Acetaminophen and an H1-antihistamine before infusion.

General dosing information:

• Administered intravenously at an authorized facility.
• Patients should stay within 2 hours of the treatment facility for at least 4 weeks post-infusion for monitoring.

What should I avoid after receiving this medicine?

• Do not drive, 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 other drugs will affect Carvykti?

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

Some commercial Human Immunodeficiency Virus (HIV) tests may incorrectly give you an HIV-positive result while you are receiving treatment with Carvykti.

Carvykti Package Insert

HCPs and patients often use the Carvykti Package Insert (PI) for more detailed information about this medicine. The Carvykti Package Insert contains more detailed information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the FDA label, or Carvykti Prescribing Information (PI).

Ingredients

Active ingredient: ciltacabtagene autoleucel

Inactive ingredients: DMSO

Manufacturer Information

Carvykti Manufacturer Janssen Biotech, Inc., Horsham, PA, USA.

Marketing Partner Legend Biotech, Somerset, NJ, USA.

Carvykti Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Carvykti.Carvykti (ciltacabtagene autoleucel) – Janssen Biotech, Inc.

Briumvi is used to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is given as an intravenous infusion every 6 months by a healthcare provider.

Clinical trials report that Briumvi is superior to teriflunomide at reducing relapses and significantly reducing brain lesions on magnetic resonance imaging (MRI).

• 49 % to 59 % fewer relapses were reported with Briumvi vs teriflunomide in 2 clinical trials.
• Both studies also reported near complete (97%) suppression of brain lesions (T1 Gd+ lesions) per MRI over 2 years.
• Zero relapses were reported in 86% to 87% of people taking Briumvi.

Briumvi (ublituximab-xiiy) gained FDA approval on December 28, 2022. There is no generic or biosimilar.

How does Briumvi work?

Briumvi’s mechanism of action involves targeting and destroying B cells (a type of immune cell) in the body. It does this by binding to a protein called CD20 on the B cells’ surface. By reducing B cells, Briumvi helps mitigate the immune system’s effect on the nervous system, which drives MS symptoms. 

Briumvi belongs to the drug class called CD20 monoclonal antibodies.

Briumvi side effects

The most common Briumvi side effects are:

• infusion reactions, which may include symptoms such as dizziness, nausea, light-headed, itchy, sweaty, headache, chest tightness, back pain, trouble breathing, or swelling in your face;
• cold sores around your mouth (herpes infections), skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• pain in your hands and feet;
• sleep problems (insomnia); or
• tiredness.

Serious side effects and warnings

Briumvi can cause the following serious side effects.

Infusion reactions. Infusion reactions are one of the most common side effects of Briumvi. Infusion reactions can be serious and may require you to be hospitalized. You will be monitored during your infusion and may be monitored after each infusion of Briumvi for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms:

• fever
• itchy skin
• wheezing
• chills
• dizziness
• nausea
• headache
• feeling faint
• abdominal pain
• flu-like symptoms
• swelling of the tongue or throat
• throat irritation
• fast heartbeat
• trouble breathing
• red face or skin
• hives.

These infusion reactions can happen over 24 hours after your infusion. You must call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion.

Infections. Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of Briumvi. Briumvi increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection, including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with Briumvi until your infection is gone.

Hepatitis B virus (HBV) reactivation: Before starting treatment with Briumvi, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had a hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Briumvi. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Briumvi.

Weakened immune system: Briumvi taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Progressive Multifocal Leukoencephalopathy (PML): PML may happen with Briumvi. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These symptoms may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory, which may lead to confusion, and personality changes.

Low immunoglobulins: Briumvi may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Briumvi may also cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Briumvi, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

It is not known if Briumvi is safe or effective in children.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before receiving this medicine

Do not receive Briumvi if you:

• have had a life-threatening allergic reaction to ublituximab, Briumvi, or any of the inactive ingredients in the infusion
• have an active hepatitis B virus (HBV) infection.

Before receiving, tell your healthcare provider about all your medical conditions, including if you:

• have or think you have an infection
• take or plan to take medicines that affect your immune system. These medicines may increase your risk of getting an infection
• have ever had hepatitis B or you are a carrier of the hepatitis B virus
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • Make sure all your vaccinations are up to date before starting Briumvi. You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Briumvi. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Briumvi and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Briumvi. If you would like to receive any non-live vaccines while you are being treated with Briumvi, talk to your healthcare provider.
  • If you have a baby and you received Briumvi during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Briumvi so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant
• are breastfeeding, or plan to breastfeed.

Pregnancy

Briumvi may harm your unborn baby. You should use birth control (contraception) during treatment with Briumvi and for at least 6 months after your last infusion of Briumvi. Talk with your healthcare provider about what birth control method is right for you during this time. You may need to have a negative pregnancy test before each infusion of Briumvi.

Pregnancy Registry. There is a pregnancy registry for women who take Briumvi during pregnancy. If you become pregnant while receiving Briumvi or within 6 months following the last dose of Briumvi, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Briumvi Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can enroll you in this registry by calling 1-877-411-4546 or visiting www.briumvipregnancyregistry.com.

Breastfeeding

It is not known if Briumvi passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Briumvi.  

How will I receive Briumvi?

Briumvi is given through a needle placed in your vein (intravenous infusion) in your arm.

• Your healthcare provider may do a pregnancy test before each infusion of Briumvi.
• Before treatment with Briumvi, you will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe.
• You may also receive other medicines to help reduce the risk of an infusion reaction.

Your first dose of Briumvi will last about 4 hours.

• Your second dose of Briumvi will be given 2 weeks after your first dose. This infusion will last about 1 hour.
• Your next doses of Briumvi will be given as 1 infusion every 24 weeks. These infusions will last about 1 hour.  

Dosing information

Dose of Briumvi for Multiple Sclerosis (Adults):

• First Infusion: 150 mg IV over at least 4 hours.
• Second Infusion (2 weeks after the first infusion): 450 mg IV over at least 1 hour.
• Subsequent Infusions (24 weeks after the first infusion and every 24 weeks thereafter): 450 mg IV every 24 weeks over at least 1 hour.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Briumvi injection.

What should I avoid while receiving Briumvi?

Avoid receiving a “live” vaccine while you are being treated with Briumvi, and for at least 4 weeks before your treatment. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid receiving a “non-live” vaccine for at least 2 weeks before your treatment with Briumvi.

What other drugs will affect Briumvi?

Tell your doctor about all your other medicines, especially:

• Drugs that weaken the immune system, such as cancer medications, steroids, and medicines to prevent organ transplant rejection.

Breyanzi is used to treat 5 types of non-Hodgkin lymphoma, including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), with relapsed or refractory (R/R) marginal zone lymphoma (MZL) in specific patients.

Breyanzi is a one-time infusion of CAR T cell therapy that may help you have complete and lasting remission. 

Breyanzi is a cancer treatment created using immune cells, called T cells, collected from the patient’s own blood. The T cells are modified to become CAR T cells and are then infused back into the patient’s body. The CART T cells can attach to the cancer cells and kill them, helping clear the cancer from the body.  Before your infusion, you will have chemotherapy to prepare your body for your treatment. 

Breyanzi FDA approval was first received on February 5, 2021, for the company Bristol Myers Squibb (BMS).  It contains lisocabtagene maraleuce. The most recent approval was for relapsed or refractory marginal zone lymphoma (MZL) on December 4, 2025.

What is Breyanzi used for?

Breyanzi is FDA-approved to treat five types of non-Hodgkin lymphoma: large B-cell lymphoma, relapsed or refractory chronic CLL/SLL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL)  in specific patients.

Large B-cell lymphoma

Breyanzi is used to treat large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in adults. You can only be treated with Breyanzi if:

• your first treatment has not worked, or your cancer returned within a year of your first treatment, OR
• your first treatment has not worked, or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age, OR
• two or more kinds of treatment have not worked or stopped working.

It is not indicated for the treatment of primary central nervous system lymphoma.

Relapsed or refractory chronic CLL/SLL

Breyanzi is used to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have:

• received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. 
• This is an accelerated FDA approval.

Relapsed or refractory follicular lymphoma (FL) 

Breyanzi is used to treat relapsed or refractory follicular lymphoma (FL) in adults who have:

• received 2 or more prior lines of systemic therapy. 
• This is an accelerated FDA approval.

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

It is approved for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Relapsed or refractory (R/R) marginal zone lymphoma (MZL)

Breyanzi is approved for adult patients who have received at least two prior lines of systemic therapy.

Breyanzi side effects

Common Breyanzi side effects

Common Breyanzi side effects may include:

• headache, dizziness;
• confusion, problems with speech or thinking;
• fever, chills, shaking;
• nausea, vomiting, stomach pain;
• diarrhea, constipation;
• fast or irregular heartbeats;
• cough, trouble breathing;
• swelling; or
• pain in your bones, joint, or muscles.

Serious Bryanzi side effects

Get emergency medical help if you have signs of an allergic reaction, hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to treat CRS if it occurs.

Breyanzi may cause other serious side effects. Call your doctor at once if you have:

• problems with speech;
• confusion, trouble concentrating, memory problems;
• decreased consciousness;
• tremors, or a seizure; or
• signs of infection – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Breyanzi may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication. This medication may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online .

How will I receive Breyanzi?

Breyanzi is a one-time cancer treatment made from your own white blood cells. The process takes several weeks and involves collecting, modifying, and then infusing those cells back into your body, with close monitoring for side effects.

Breyanzi is a liquid medicine given intravenously (into a vein) by a doctor or nurse. It is usually given as two infusions over about 30 minutes total as a one-time dose.

Breyanzi treatment process

Step 1: T Cell collection

• T cells, which are a type of white blood cell, are collected using a procedure called leukapheresis (a process that removes white blood cells from the body).

Step 2: T Cell activation

• The collected T cells are sent away and modified so they can better recognize and attack cancer cells.
• This modification process takes about 3–4 weeks.

Step 3: Preparation for infusion

• You will receive chemotherapy medicines a few days before Breyanzi to prepare your body; this is called lymphodepleting chemotherapy.

Step 4: Breyanzi infusion

• The modified cells are then infused back into your body as Breyanzi. Because the treatment is made from your own cells, it must only be given to you.

Step 5: Follow-up

• Your healthcare provider will check if the treatment is working and monitor for side effects.
  You should plan to stay near the treatment center for at least 4 weeks after receiving Breyanzi.

It is very important not to miss your cell collection or treatment appointment

Before taking this medicine

Tell your doctor if you have ever had:

• hepatitis B or C; or
• if you have received a vaccine within the past 6 weeks.

Using Breyanzi may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

You may need to have a negative pregnancy test before starting this treatment.

Warnings

Breyanzi has a boxed warning for cytokine release syndrome(CRS), neurologic toxicity, and secondary hematological malignancies.

Cytokine release syndrome (CRS): This is a common but serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to treat this condition if it occurs.

Breyanzi may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with this medicine. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including this therapy.

What should I avoid after receiving Breyanzi?

 Avoid driving or operating machinery for at least 2 weeks after receiving this treatment. This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures.

Do not donate blood, organs, tissues, or cells for transplantation.

Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your Breyanzi treatment, and until your doctor tells you your immune system has recovered

What other drugs will affect Breyanzi?

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. You should keep a written list of all the prescription and nonprescription (over-the-counter) medicines you take, along with any products such as vitamins, minerals, or other dietary supplements. Remember to bring this list with you each time you see a doctor or are hospitalized. This information is important to have on hand for emergencies.

Blincyto (blinatumomab) is an injectable immunotherapy treatment that may be used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children aged 1 month and older. It is a biologic treatment that is usually given after other cancer treatments have been tried without success.

Blincyto’s mechanism of action is to connect the protein CD3 found on the surface of T cells (a type of white blood cell that is an essential part of our immune system) to another protein, CD19 found on cancerous and non-cancerous B-cells. This activates the T-cell and Blincyto works by causing the destruction (lysis) of CD19 cells. Blincyto is a bispecific CD19-directed CD3 T-cell engager. In one study, 81% of patients with B-cell precursor ALL with minimal residual disease receiving Blincyto had no detectable cancer after 4 weeks.

Blincyto was FDA-approved on December 3, 2014. There is no generic Blincyto available.

What is Blincyto used for?

Blincyto is used to treat adults and children 1 month and older with:

• B-cell precursor ALL in remission when only a small number of cancer cells remain in the body (minimal residual disease [MRD])
• B-cell precursor ALL that has come back or did not respond to previous treatments
• Philadelphia-chromosome negative B-cell precursor ALL in the consolidation phase of chemotherapy treatment with multiple phases.

It is not known if Blincyto is safe and effective in children under 1 month of age.

Blincyto side effects

The most common side effects of Blincyto include:

• fever
• infusion-related reactions (see below)
• headache
• infections
• muscle, joint, and bone pain
• low white or red blood cell counts (neutropenia or anemia)
• low platelet count (thrombocytopenia)
• diarrhea.

Some side effects may occur during the Blincyto injection. Tell your healthcare provider right away if you feel dizzy, nauseated, light-headed, chilled or feverish, or if you have a headache, skin rash, trouble breathing, or swelling in your face.

Serious side effects and warnings

Get emergency medical help if you have signs of an allergic reaction to Blincyto such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Blincyto may cause serious side effects, including:

Cytokine release syndrome (CRS) and infusion reactions. CRS can occur when your immune system responds to immunotherapy medications such as Blincyto more aggressively than it should and symptoms may be similar to infusion reactions. Tell your healthcare provider right away if you develop a fever, chills, wheezing or difficulty breathing, dizziness, headache, low blood pressure, nausea or vomiting, body aches, diarrhea, facial swelling, a skin rash, or feel tired or light-headed.

Neurologic problems. Blincyto may affect your nerves and can cause some serious neurological disorders including a potentially life-threatening neurotoxicity called immune effector cell-associated neurotoxicity syndrome (ICANS). Tell your healthcare provider right away if you experience:

• seizures
• difficulty in speaking or slurred speech
• loss of consciousness
• trouble sleeping
• confusion and disorientation
• loss of balance
• headache
• difficulty with facial movements, hearing, vision, or swallowing
• tremors.

People with Down Syndrome over the age of 10 years may have a higher risk of seizures with Blincyto.

Life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop any signs or symptoms of an infection.

Tumor Lysis Syndrome (TLS) is caused by the fast breakdown of cancer cells. It can be life-threatening
and may lead to death. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with Blincyto, including:

• nausea and vomiting
• confusion
• shortness of breath
• irregular heartbeat
• dark or cloudy urine
• reduced amount of urine
• unusual tiredness
• muscle cramps.

Low white blood cell counts (neutropenia) are common with Blincyto treatment and may sometimes be life-threatening. They can increase your risk of infection. Your healthcare provider will do blood tests to check your white blood cell counts during treatment. Tell your healthcare provider right away if you get a fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands or feet, or feel light-headed or short of breath.

Abnormal liver blood tests. Your healthcare provider will do blood tests to check your liver before you start Blincyto and during treatment.

Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with Blincyto and
corticosteroids. It may be severe and lead to death. Tell your healthcare provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting.

People receiving Blincyto are at risk of seizures or losing consciousness and should not drive or engage in hazardous activities.

Blincyto may harm an unborn baby and should not be taken by females who are pregnant.

Before taking this medicine

You should not use Blincyto if you are allergic to blinatumomab, Blincyto, or any inactive ingredients in the injection.

To make sure Blincyto is safe for you, tell your doctor if you have:

• nerve problems or a neurologic disorder, such as seizures, confusion, trouble speaking, or problems with balance
• Down syndrome
• a history of chemotherapy or radiation treatment to your brain
• an infection
• have recently received a vaccine or if you are scheduled for a booster dose
• are pregnant or plan to become pregnant
• are breastfeeding.

Pregnancy

Blincyto may harm an unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Blincyto. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with Blincyto, and for 48 hours after their last dose. Do not use Blincyto if you are pregnant. If you inadvertently become pregnant while receiving Blincyto, tell your healthcare provider right away.

Breastfeeding

It is not known if Blincyto passes into your breast milk. You should not breastfeed while using this medicine and for at least 48 hours after your last dose.

How is Blincyto administered?

Blincyto will be given to you by a continuous intravenous (IV) infusion into your vein using a small portable infusion pump. This means you can still carry out daily activities as normal, although you should be careful not to drive or engage in hazardous tasks while receiving the infusion.

• One induction treatment cycle is usually 4 weeks (28 days) of continuous infusion followed by 2 weeks (14 days) break without infusion.
• For the first 3 to 9 days of the first cycle and the first 2 days of the second cycle, you will usually receive this in a hospital under the care of your healthcare provider.
• For the rest of the cycle, your healthcare provider will decide if you receive your treatment at home or through an outpatient clinic or infusion center.
• Your healthcare provider will decide the number of treatment cycles of Blincyto but a treatment course for MRD is usually 1 cycle of Blincyto for induction followed by up to 3 additional cycles for consolidation (continued therapy). This usually consists of one IV infusion for 4 weeks (28 days), followed by an 8-week (56 days) break during which you will not receive Blincyto. This is 1 consolidation treatment cycle (84 days).
• Your healthcare provider may change your dose of Blincyto, delay, or completely stop treatment if you have certain side effects, and do blood tests during treatment to check you for side effects.

Before receiving Blincyto, you will be given a corticosteroid medicine to help reduce infusion reactions.

Before and during treatment, you may be given chemotherapy as an injection into the space that
surrounds the spinal cord and the brain (intrathecal injection) to help prevent central nervous system relapse of ALL.

• It is very important to keep the area around the IV catheter clean to reduce the risk of getting an infection. Your healthcare provider will show you how to care for your catheter site.

Receiving Blincyto at home

If your healthcare provider has decided you can receive Blincyto at home, your infusion bag will be changed at an outpatient center or by your home healthcare provider.

• Blincyto is available in 24-hour, 48-hour, and 7-day infusion bags. Your bag will need to be changed every day, every 2 days, or once a week based on what your doctor decides is best for you.
• Call your doctor if you experience any problems or side effects.
• Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your infusion pump settings may cause a dose that is too high or too low to be given.
• Call your healthcare provider or nurse right away if you have any problems with your pump or your pump alarm sounds.
• Keep Blincyto out of reach of children or pets in the household.

What happens if I miss a dose?

Call your healthcare provider if you do not receive your IV bags on time or if your home healthcare provider does not change the infusion bag in time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include fever, tremors, and headache.

What should I avoid while using Blincyto?

Do not receive a “live” vaccine while using Blincyto, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Ask your doctor how soon it is safe for you to receive a vaccine after you stop using this medicine.

Avoid driving or hazardous activity until you know how Blincyto will affect you. Blincyto increases your risk of seizures, losing consciousness, and a serious nerve toxicity syndrome called ICANS (see above).

What other drugs will affect Blincyto?

Other drugs may interact with blinatumomab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

No formal drug interaction studies have been conducted with Blincyto. The highest drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle. People receiving medications with a narrow therapeutic index metabolized by the cytochrome p450 system, such as warfarin or cyclosporin should be monitored for increases in side effects and the dosage of the interacting drug adjusted if needed.

No formal drug interaction studies have been conducted with Blincyto, but starting Blincyto treatment causes the short-lived release of cytokines that may suppress CYP450 enzymes and affect medications with a narrow therapeutic index, such as warfarin.

Storage

Intravenous (IV) bags containing Blincyto for infusion will arrive in a special package.

• Do not open the package.
• Do not freeze the package.

The package containing Blincyto will be opened by your healthcare provider and stored in the refrigerator at 36°F to 46°F (2°C to 8°C).

The prepared preservative-free Blincyto infusion bag lasts for 48 hours at room temperature 73°F to 81°F (23°C to 27°C) or 8 days when refrigerated at 36°F to 46°F (2°C to 8°C).

The prepared preservative-containing Blincyto infusion bag lasts for 7 days at room temperature 73°F to 81°F (23°C to 27°C) or 14 days when refrigerated at 36°F to 46°F (2°C to 8°C).

Do not throw away (dispose of) any Blincyto in your household trash. Talk with your healthcare provider about the disposal of Blincyto and used supplies.

Keep out of reach of children.

Blincyto infusion ingredients

Active ingredient: blinatumomab.
Inactive ingredients: citric acid monohydrate, lysine hydrochloride, polysorbate 80, trehalose dihydrate, sodium hydroxide, and preservative-free sterile water for injection.
Inactive ingredients of IV solution stabilizer: citric acid monohydrate, lysine hydrochloride, polysorbate 80, sodium hydroxide, and water for injection.

Due to the addition of bacteriostatic saline, 7-day bags of Blincyto solution for infusion with a preservative contain benzyl alcohol and are not recommended for use in patients weighing less than 22 kg.

Available as Blincyto 35 mcg in a single-dose vial for reconstitution.

Who makes Blincyto?

Amgen Inc. makes Blincyto 35 mcg single-dose vials for reconstitution.

Blincyto Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Blincyto.Blincyto (blinatumomab) – Amgen Inc.

Bavencio is used to treat a type of skin cancer called Merkel cell carcinoma in adults and children at least 12 years old, when the cancer has spread to other parts of the body (metastatic).

What is Bavencio?

Bavencio is also used to treat a certain type of cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. Bavencio is given for this condition after platinum cancer medicines did not work or have stopped working.

Bavencio is also used alone or in combination with another medicine called axitinib to treat advanced kidney cancer that has spread or cannot be removed with surgery.

Warnings

Bavencio works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have symptoms such as: fever, cough, flu symptoms, muscle pain or weakness, vision changes, chest pain, trouble breathing, severe stomach pain or diarrhea, skin rash, swelling in your ankles, increased or decreased urination, blood in your urine or stools, weight changes, hair loss, unusual bleeding, dark urine, or jaundice (yellowing of your skin or eyes).

Before taking this medicine

To make sure Bavencio is safe for you, tell your doctor if you have ever had:

• a condition that affects your nervous system such as myasthenia gravis or Guillain-Barré syndrome;
• an immune system disorder such as ulcerative colitis or Crohn’s disease;
• lung problems or a breathing disorder;
• liver or kidney disease;
• heart problems or high blood pressure;
• high cholesterol;
• diabetes;
• an organ transplant; or
• if you have received or will receive a transplant of stem cells from a donor.

You should not use avelumab if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.

You should not breastfeed while using this medicine and for at least 1 month after your last dose.

How is Bavencio given?

Bavencio is given as an infusion into a vein, usually once every 2 weeks. A healthcare provider will give you this injection.

Bavencio must be given slowly and the IV infusion can take at least 60 minutes to complete.

You may be given other medication to prevent certain side effects that may occur during the infusion.

You may need frequent medical tests to check your heart or liver function, and to help your doctor determine how long to treat you with Bavencio.

Dosing information

Usual Adult Dose for Merkel Cell Carcinoma:

800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Usual Adult Dose for Urothelial Carcinoma:

800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Uses:
-For maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy
-Previously treated urothelial carcinoma: For treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy OR have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Renal Cell Carcinoma:

800 mg IV over 60 minutes every 2 weeks in combination with axitinib 5 mg orally 2 times a day (12 hours apart) with or without food
Duration of therapy: Until disease progression or unacceptable toxicity

Use: In combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

Usual Pediatric Dose for Merkel Cell Carcinoma:

12 years and older:
800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For metastatic Merkel cell carcinoma (MCC) in pediatric patients 12 years and older

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What to avoid

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Bavencio side effects

Get emergency medical help if you have signs of an allergic reaction to Bavencio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, itchy, feverish, chilled, or have stomach or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have:

• sudden chest pain or discomfort;
• severe stomach pain, diarrhea, bloody or tarry stools;
• blistering or peeling skin rash;
• pounding heartbeats or fluttering in your chest;
• flu-like symptoms;
• pain or burning when you urinate;
• joint pain, weakness;
• vision changes;
• liver problems – loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• heart problems – chest pain or pressure, pain spreading to your jaw or shoulder, sweating;
• kidney problems – little or no urination, red or pink urine, swelling in your feet or ankles; or
• signs of a hormonal disorder – feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, sweating, feeling cold, weight gain, or weight loss.

Common Bavencio side effects may include:

• hoarse voice;
• cough, shortness of breath;
• trouble speaking;
• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;
• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• severe headache, blurred vision, pounding in your neck or ears;
• painful urination;
• stomach pain, nausea, diarrhea, loss of appetite;
• feeling tired;
• chills, fever;
• muscle pain, back pain, bone pain;
• rash;
• swelling in your hands or feet;
• redness or swelling where the injection was given;
• liver problems; or
• symptoms of underactive thyroid – tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures.