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Axicabtagene Ciloleucel Injection

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WARNING

Cytokine release syndrome is a potentially fatal reaction to axicabtagene ciloleucel injection (CRS). For at least 4 weeks following your infusion, a doctor or nurse will keep a close eye on you. If you currently have or suspect that you may have an infection of any kind, tell your doctor. In order to lessen the chance of adverse responses to axicabtagene ciloleucel, you will get medicine 60 minutes before to your infusion. A fever, chills, fast or irregular heartbeat, shaking, diarrhoea, exhaustion, weakness, difficulty breathing, shortness of breath, confusion, nausea, vomiting, dizziness, or lightheadedness are just a few of the symptoms that you should mention to your doctor right away if you experience them during or after your infusion.

An adverse reaction to axicabtagene ciloleucel injection could be severe or even fatal. Following axicabtagene ciloleucel therapy, these side effects are possible. If you have seizures, a stroke, or memory loss, let your doctor know. Inform your doctor right away if you experience any of the following symptoms: headache, dizziness, trouble falling or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, trouble understanding or speaking.

Due to the dangers of CRS and neurological toxicities, axicabtagene ciloleucel injection is only accessible through a unique, restricted distribution programme. Only medical professionals and healthcare facilities that take part in the programme may provide you drugs. If you have any inquiries regarding this programme, speak with your doctor.

When you start axicabtagene ciloleucel therapy, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Why is this medication prescribed?

Axicabtagene ciloleucel injection is used to treat a specific type of non-lymphoma Hodgkin’s (cancer that starts in white blood cells that normally fight infection) in patients who have already received treatment with at least two other chemotherapy drugs and the cancer has returned or is unresponsive to other treatments. The drug axicabtagene ciloleucel injection belongs to a group of treatments known as autologous cellular immunotherapy, which is a treatment made from the patient’s own blood cells. It functions by activating the body’s immune system, a collection of cells, tissues, and organs that defends the body against attacks from bacteria, viruses, cancer cells, and other pathogens.

How should this medicine be used?

An intravenous (IV) injection of axicabtagene ciloleucel injection is administered by a doctor or nurse at a clinic or infusion facility. The medication is available as a suspension (liquid). The normal dosage is administered all at once over a period of up to 30 minutes. Your doctor or nurse will administer additional chemotherapy drugs to your body prior to giving you your axicabtagene ciloleucel dose in order to get your body ready for it.

A cell collection facility will use a process known as leukapheresis to collect a sample of your white blood cells prior to administering your dosage of axicabtagene ciloleucel injection (a process that removes white blood cells from the body). This drug must only be administered to you because it is created from your own cells. Being on time is crucial in order to avoid missing your scheduled cell collection appointment(s) or your treatment dose. Plan to remain close to the location of your axicabtagene ciloleucel therapy for at least 4 weeks following your dose. Your healthcare practitioner will check to see if your medication is having the desired effect and keep an eye out for any potential adverse effects. Discuss with your doctor how to be ready for leukapheresis as well as what to expect both during and after the treatment.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving axicabtagene ciloleucel injection,

  • If you have an allergy to axicabtagene ciloleucel, gentamicin, any other drugs, dimethyl sulfoxide (DMSO), or any other components of axicabtagene ciloleucel injection, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: medicines such methylprednisolone (Medrol), prednisolone, and prednisone, as well as dexamethasone (Rayos). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you currently have or ever had lung, renal, heart, or liver disease.
  • If you are breastfeeding a child or intend to become pregnant, let your doctor know. A pregnancy test is required before you begin axicabtagene ciloleucel therapy. Call your doctor right away if you get pregnant while having axicabtagene ciloleucel injection.
  • You should be aware that axicabtagene ciloleucel injection may cause you to feel sleepy, confused, weak, dizzy, experience seizures, and have trouble with your coordination. After receiving your axicabtagene ciloleucel dose, wait at least 8 weeks before operating machinery or operating a vehicle.
  • After receiving your axicabtagene ciloleucel injection, refrain from giving blood, organs, tissues, or cells for transplantation.
  • Find out from your doctor if you require any vaccines. For at least 6 weeks prior to beginning chemotherapy, throughout your axicabtagene ciloleucel treatment, and until your doctor notifies you that your immune system has healed, refrain from getting any vaccinations without first consulting a medical professional.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

You must contact your doctor and the collection centre right once if you fail to keep the appointment to collect your cells. You must contact your doctor straight away if you are running late for your axicabtagene ciloleucel dosage appointment.

What side effects can this medication cause?

Side effects from axicabtagene ciloleucel are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Abdominal pain
  • Back ache
  • Muscle or joint pain
  • Mouth ache
  • Reduced appetite
  • Loss of weight

Some adverse effects can be very harmful. Call your doctor right away if you have any of these signs or any of those in the IMPORTANT WARNING section:

  • Urethral blood
  • More readily bleeding than usual
  • Fever, chills, sore throat, or other symptoms of infection
  • Decreased frequency or volume of urine
  • Light skin
  • Fatigue
  • Swelling of the lower legs, hands, feet, ankles, lips, tongue, throat, arms, or other body parts
  • Having trouble swallowing
  • Rash
  • Hives
  • Itching

Your chance of developing some malignancies may increase if you receive an injection of axicabtagene ciloleucel. You should discuss the dangers of using this drug with your doctor.

Other adverse effects of axicabtagene ciloleucel are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What other information should I know?

Respect all scheduled times with your doctor, the cell collection facility, and the lab. To monitor your body’s reaction to the axicabtagene ciloleucel injection, your doctor may request specific lab tests before to, during, and after your therapy.

Inform the lab staff and your doctor that you are receiving an injection of axicabtagene ciloleucel prior to any laboratory test. The outcomes of some laboratory tests could be impacted by this medicine.

Ask your pharmacist any inquiries you may have regarding the injection of axicabtagene ciloleucel.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Yescarta®
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