Pronunciation:

eye-de-KAB-ta-jeen vik-LOO-sel

Brand Names:

• Abecma

Dosage Forms:

• Suspension

Warnings:

Warning: Cytokine Release Syndrome, Neurologic Toxicities, HLH/MAS, and Prolonged CytopeniaCytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with idecabtagene vicleucel. Do not administer idecabtagene vicleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with idecabtagene vicleucel, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with idecabtagene vicleucel. Provide supportive care and/or corticosteroids as needed.Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with idecabtagene vicleucel. HLH/MAS can occur with CRS or neurologic toxicities.Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with idecabtagene vicleucel.Idecabtagene vicleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS .

Classifications:

Therapeutic—

Antineoplastic Agent

Chemical—

CAR T-Cell Agent

Uses of This Medicine:

Idecabtagene vicleucel injection is used treat multiple myeloma (bone marrow cancer) in patients whose cancer has come back and who have received at least 4 previous treatments (eg, an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent) that did not work well.

Idecabtagene vicleucel injection is an antineoplastic (cancer) medicine that is made from your own white blood cells, which have been modified to recognize and attack your cancer cells. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of receiving it.

This medicine is available only under a restricted distribution program called Abecma® REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of idecabtagene vicleucel injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of idecabtagene vicleucel injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart problems or
• Heart rhythm problems (eg, tachycardia) or
• Hypotension (low blood pressure) or
• Infections (including hepatitis B), active or history of or
• Kidney disease or
• Seizures, history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer center. It is given through a needle placed into one of your veins using a pump. This medicine must be given slowly, so your IV tube will need to stay in place for at least 30 minutes. It is given 2 days after completing treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

You may also receive other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.

Your doctor will check you for unwanted effects at least daily for 7 days. Your doctor will also want you to stay close to the hospital or center for at least 4 weeks after your infusion.

It is very important that you understand the requirements of the Abecma® REMS program, and become familiar with the Abecma® Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.

This medicine may cause cytokine release syndrome (CRS), which may be life-threatening and requires immediate attention. Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause a severe inflammatory condition that could be life-threatening, including hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), which is caused by an overactive immune system. Check with your doctor right away if you have a fever, cough that does not go away, right upper abdominal or stomach pain and fullness, rash, redness in one part of your body, swollen, painful, or tender lymph glands in the neck, armpit, or groin, mental status changes, shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination, seizures, or warm feeling or swelling of your skin.

Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine. These may be symptoms of serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

While you are being treated with idecabtagene vicleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

back pain

black, tarry stools

being forgetful

bloating or swelling of the face, arms, hands, lower legs, or feet

body aches and pain

bone pain

bleeding gums

blood in the urine or stools

blue lips, fingernails, or skin

blurred vision

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

burning, numbness, pain, or tingling in all the fingers except the smallest finger

changes in patterns and rhythms of speech

chest discomfort, pain, or tightness

chills

cold flu-like symptoms

cold sweats

coma

confusion

confusion as to time, place, or person

cough or hoarseness

decreased frequency or amount of urine

depression

difficulty in breathing

difficulty in moving

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drooping upper eyelids

drowsiness

dryness or soreness of the throat

ear congestion

fast, pounding, or irregular heartbeat or pulse

fever

hallucinations

headache

holding false beliefs that cannot be changed by fact

hostility

increased blood pressure

increased thirst

infection from breathing foreign substance into the lungs

irregular, fast ,or slow, or shallow breathing

irritability

joint pain

loss of appetite

loss of memory

loss of strength or energy

loss of voice

lower back or side pain

mood or mental changes

muscle aches, cramps, pains, stiffness, spasms, or twitching

nausea

nerve pain

nervousness

pain in the lower back, bottom, hips, or upper leg

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

problems with memory

problems with speech

rapid weight gain

seizures

sleepiness

slow or fast heartbeat

slurred speech

sneezing

stiff neck

stuffy or runny nose

stupor

swollen joints

tender, swollen glands in the neck

tingling of the hands or feet

trembling and shaking of hands

trouble in swallowing

ulcers, sores, or white spots in the mouth

unsteadiness or awkwardness

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

unusual excitement, nervousness, or restlessness

unusual weight gain or loss

voice changes

vomiting

weakness in the arms, hands, legs, or feet

Less common

Coughing that sometimes produces a pink frothy sputum

diarrhea

fainting

increased sweating

partial or slight paralysis

shakiness and unsteady walk

stomach pain

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins

unsteadiness, trembling, or other problems with muscle control or coordination

vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blemishes on the skin

blistering, crusting, irritation, itching, or reddening of the skin

constipation

cracked, dry, scaly skin

fear

feeling of constant movement of self or surroundings

pain in the mouth

pimples

sensation of spinning

skin rash or blisters

toothache

trouble sleeping

unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.