Idecabtagene vicleucel

What is Idecabtagene vicleucel?

• Idecabtagene vicleucel (Abecma) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy used to treat multiple myeloma.

What are the uses of this medicine?

• Idecabtagene vicleucel (Abecma) is for the treatment of multiple myeloma in patients who have received at least four kinds of treatment regimens that have not worked or have stopped working. Abecma is a medicine made from your own white blood cells; the cells are genetically modified to recognize and attack your multiple myeloma cells.

Multiple myeloma:

• Multiple myeloma that has relapsed (come back) or is refractory (does not respond to treatment).
• It is used in adults who have received at least four previous treatments that included an immunomodulating agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

How does this medicine work?

• (uh-BEK-muh) A drug used to treat adults with multiple myeloma that relapsed (came back) or did not get better after treatment with at least four other anticancer therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulating agent. It is also being studied in the treatment of other types of cancer.
• Abecma is made using a patient’s T cells (a type of immune system cell).
• A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory.
• These changed T cells called CAR T cells are grown in large numbers in the laboratory and given to the patient by infusion.
• Upon administration, idecabtagene vicleucel specifically recognizes and kills BCMA-expressing tumor cells.
• BCMA, a tumor-specific antigen and a receptor for both a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF), is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and plays a key role in plasma survival; it is found on the surfaces of plasma cells and overexpressed on malignant plasma cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• HIV and the lentivirus used to make Abecma have limited, short spans of identical genetic material (RNA).
• Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received Abecma.

Is this medicine FDA approved?

• Idecabtagene vicleucel was approved for medical use in the United States in March 2021.

How should this medicine be used?

• Confirm the patient's identity prior to infusion.
• Premedicate with acetaminophen and an H1-antihistamine.
• Avoid prophylactic use of dexamethasone or other systemic corticosteroids.
• Confirm availability of tocilizumab prior to infusion.
• Dosing of Abecma is based on the number of chimeric antigen receptor (CAR)-positive T cells.

Recommended dosage:

• Abecma is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags.
• The recommended dose range is 300 to 460 × 106 CAR-positive T cells.

Administration:

• Abecma is made from your own white blood cells, so your blood will be collected by a process called "leukapheresis" (LOO-kuh-feh-REE-sis).
• Your blood cells will be sent to a manufacturing center to make your Abecma.
• When your Abecma is ready, your healthcare provider will give Abecma to you through a catheter (tube) placed into your vein (intravenous infusion). Your dose of Abecma may be given in one or more infusion bags. The infusion usually takes up to 30 minutes for each infusion bag.
• You will be monitored at the certified healthcare facility where you received your treatment daily for at least 7 days after the infusion.
• You should plan to stay within 2 hours of this location for at least 4 weeks after getting Abecma.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As suspension for intravenous infusion
• A single dose of Abecma contains a cell suspension of 300 to 460 × 106 CAR-positive T cells in one or more infusion bags.

This medicine is available in fallowing brand namesː

• Abecma

What side effects can this medication cause?

The most common side effects of this medicine include:

• fatigue
• fever (100.4°F/38°C or higher)
• chills/shivering
• severe nausea or diarrhea
• decreased appetite
• headache
• dizziness/lightheadedness
• confusion
• difficulty speaking or slurred speech
• cough
• difficulty breathing
• fast or irregular heartbeat

• Abecma can cause a very common side effect called cytokine release syndrome.
• Abecma can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets), which may make you feel weak or tired or increase your risk of severe infection or bleeding.

What special precautions should I follow?

• Abecma can cause a very common side effect called cytokine release syndrome. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
• Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with Abecma, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity occur at any time.
• Allergic reactions may occur with the infusion of Abecma. Monitor for hypersensitivity reactions during infusion.
• Abecma should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after Abecma infusion. Monitor patients for signs and symptoms of infection; treat appropriately.
• Patients may exhibit prolonged cytopenias following lymphodepleting chemotherapy and Abecma infusion. Monitor blood counts prior to and after Abecma infusion.
• Plasma cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Abecma. Monitor and consider immunoglobulin replacement therapy.
• Patients treated with Abecma may develop secondary malignancies. In the event that a secondary malignancy occurs after treatment with Abecma, contact Bristol-Myers Squibb at 1-888-805-4555.
• Due to the potential for neurologic events, including altered mental status or seizures, patients receiving Abecma are at risk for altered or decreased consciousness or coordination in the 8 weeks following Abecma infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data with Abecma use in pregnant women.
• It is not known if Abecma has the potential to be transferred to the fetus.

Can this medicine be used in children?

• The safety and efficacy of Abecma in patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• IDECABTAGENE VICLEUCEL

Inactive ingredients:

• DIMETHYL SULFOXIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Celgene Corporation, a Bristol-Myers Squibb Company
• 556 Morris Avenue
• Summit, NJ

Marketed by:

• Celgene Corporation, a Bristol-Myers Squibb Company (Summit, NJ 07901), and bluebird bio, Inc.

What should I know about storage and disposal of this medication?

• Store Abecma frozen in the vapor phase of liquid nitrogen (less than or equal to minus 130°C).
• Thaw Abecma prior to infusion.

• Dailymed label info on Idecabtagene vicleucel
• FDA Idecabtagene vicleucel

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