Lisocabtagene maraleucel (Intravenous route)

Pronunciation:

lis-oh-KAB-ta-jeen mar-a-LOO-sel

Brand Names:

  • Breyanzi

Dosage Forms:

  • Suspension

Warnings:

Intravenous route(Suspension)

Warning: Cytokine Release Syndrome and Neurologic ToxicitiesCytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving lisocabtagene maraleucel. Do not administer lisocabtagene maraleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving lisocabtagene maraleucel, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurological events after treatment with lisocabtagene maraleucel. Provide supportive care and/or corticosteroids as needed.Lisocabtagene maraleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi(R) REMS .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Lisocabtagene maraleucel injection is used to treat large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B that has come back (relapsed) or did not respond to the treatment (refractory) in patients who have received at least 2 previous treatments that did not work well.

Lisocabtagene maraleucel 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 Breyanzi® 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 lisocabtagene maraleucel 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 lisocabtagene maraleucel 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, arrhythmia, 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 medical facility. It is given through a needle placed into one of your veins using a pump. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes. It is given 2 to 7 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 Breyanzi® REMS program, and become familiar with the Breyanzi® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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 serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention. 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.

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 lisocabtagene maraleucel 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
bleeding gums
bloody urine
blurred vision
body aches or pain
burning, numbness, tingling, or painful sensations
chest pain
chills
coma
confusion
cough
coughing up blood
decrease frequency or amount of urine
diarrhea
difficulty swallowing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
ear congestion
fast, pounding, or irregular heartbeat or pulse
fever
hallucinations
headache
hives, itching
holding false beliefs that cannot be changed by fact
increased menstrual flow or vaginal bleeding
increased thirst
irritability
loss of appetite
loss of voice
lower back or side pain
mood or mental changes
muscle or bone pain
muscle spasm, tenderness, twitching, jerking, wasting, or weakness
nausea
nosebleeds
painful or difficult urination
paralysis
pounding in the ears
problems with speech or speaking
prolonged bleeding from cuts
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red or black, tarry stools
red or dark brown urine
runny or stuffy nose
seizures
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
skin rash
slow or fast heartbeat
sneezing
sore throat
stiff neck
stomach pain
sweating
trembling and shaking of the hands or feet
trouble breathing
ulcers, sores, or white spots in the mouth
unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
vomiting
weight gain

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
Constipation
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site
trouble sleeping

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.


Last Updated: 6/2/2022

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.