Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ebvallo

Document Subject

Generated Narrative: MedicinalProductDefinition mpdc231a8d527554079b48b6c9ff637f0d

identifier: http://ema.europa.eu/identifier/EU/1/22/1700/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ebvallo 2.8 × 107 – 7.3 × 107 cells/mL dispersion for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-dc231a8d527554079b48b6c9ff637f0d

identifier: http://ema.europa.eu/identifier/EU/1/22/1700/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ebvallo

Attesters

What is in this leaflet

1. What Ebvallo is and what it is used for
2. What you need to know before you are given Ebvallo
3. How Ebvallo is given
4. Possible side effects
5. How to store Ebvallo
6. Contents of the pack and other information

Ebvallo contains the active substance tabelecleucel.

Tabelecleucel is an allogeneic T-cell immunotherapeutic. It is called an allogeneic immunotherapeutic because the blood cells used to make this medicine come from human donors who are not related to the patient who is being treated. Ebvallo is made in a laboratory from T cells (a type of white blood cell) from a healthy donor who is immune to the Epstein-Barr virus. These cells have been individually selected to match with the patient receiving Ebvallo. Ebvallo is given as an injection into a vein.

Ebvallo is used to treat a rare kind of cancer called Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) for adults and children 2 years of age and older. Some people experience this condition months or years after they have had a transplant. Patients will have received treatment with other medicines for this condition, such as monoclonal antibodies or chemotherapy, before they are given Ebvallo.

You must not be given Ebvallo

• if you are allergic to tabelecleucel or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

Warnings and precautions
Talk to your doctor or nurse before you are given Ebvallo if:

• you have had a solid organ transplant or bone marrow transplant, so your doctor can monitor you for signs and symptoms of transplant rejection.

• you are 65 years of age or older, so your doctor can monitor you for serious side effects. Ebvallo should be used with caution in elderly patients. Talk to your doctor or nurse after you are given Ebvallo if:

• you have signs and symptoms of tumour flare reaction. Depending on the location of the tumour, Ebvallo can cause a side effect called tumour flare reaction. The tumour or enlarged lymph nodes may become suddenly painful or increase in size and could cause problems for organs next to the tumour. Tumour flare reaction generally occurs in the first few days after receiving Ebvallo. Your doctor will monitor you after the first few doses to see if your tumour or lymph node could get big enough to cause problems. Your doctor may give you other medicines to treat/prevent tumour flare reaction.

• you have signs and symptoms of graft-versus-host disease (GvHD), such symptoms include skin rash, abnormal liver enzymes in the blood, yellowing of the skin, nausea, vomiting, diarrhoea and bloody stools.

• you have signs and symptoms of a serious immune reaction called cytokine release syndrome (CRS), such as fever, chills, low blood pressure and shortness of breath.

• you have signs and symptoms of a serious immune reaction called immune effector cell-associated neurotoxicity syndrome (ICANS), such as depressed level of consciousness, confusion, seizures and swelling of the brain.

• you have signs and symptoms of infusion-related reactions, such as fever.

An ingredient of Ebvallo called dimethyl sulfoxide (DMSO) may cause an allergic reaction. Your doctor or nurse will monitor you for signs and symptoms of an allergic reaction. See section 2 Ebvallo contains sodium and dimethyl sulfoxide (DMSO) .

Ebvallo is tested for the presence of infectious microbes, but a small risk of infection remains. Your doctor or nurse will monitor you for signs and symptoms of infections and provide treatment as needed.

After treatment with Ebvallo, you must not donate blood, organs, tissues or cells.

Other medicines and Ebvallo Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Before you are given Ebvallo, tell your doctor or nurse if you are taking medicines such as chemotherapy or corticosteroids. If you are taking chemotherapy, this medicine may affect how well Ebvallo works. If you are taking corticosteroids, your doctor will reduce the dose of corticosteroids.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. This is because the effects of this medicine in pregnant or breast-feeding women are not known, and it may harm your unborn baby or your breast-fed child. Ebvallo is not recommended during pregnancy and in women who could become pregnant not using contraception.

• If you are pregnant or think you may be pregnant after you have started treatment with Ebvallo, talk to your doctor immediately.
• Discuss the need for contraception with your doctor.
• Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding or whether to stop taking Ebvallo, considering the benefit of breast- feeding the baby and the benefit of Ebvallo to the mother.

Driving and using machines
Ebvallo has minor influence on the ability to drive or use machines. If you experience changes in your thinking or level of alertness after being treated with this medicine, do not drive or operate machines and tell your doctor immediately.

Ebvallo contains sodium and dimethyl sulfoxide (DMSO) This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium- free .

This medicine contains 100 mg DMSO per mL. See Section 2 Warnings and precautions .

Ebvallo will always be given to you by a doctor or nurse in a treatment centre.

Your doctor or nurse will give you Ebvallo by injection into a vein. This usually takes 5 to 10 minutes for each injection.

Each cycle of treatment consists of 35 days. You will be given 1 injection per week for 3 weeks, followed by approximately 2 weeks of observation to see if you will need more than one cycle. Your doctor will decide the number of cycles you will receive based on how your disease responds to Ebvallo.

Before you are given Ebvallo Your doctor or nurse will monitor your vital signs prior to each injection.

After you are given Ebvallo Your doctor or nurse will monitor your vital signs, including blood pressure, for about 1 hour following the injection.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects Tell your doctor immediately if you get any of the following side effects after receiving Ebvallo:

• Tumour flare reaction with symptoms such as shortness of breath, changes in your thinking or level of alertness, pain at the tumour site, tender swollen lymph nodes at the tumour site, low grade fever
• Graft-versus-host disease (GvHD) with symptoms such as skin rash, abnormal liver enzymes in the blood, yellowing of the skin, nausea, vomiting, diarrhoea and bloody stools

Other possible side effects

Very common (may affect more than 1 in 10 people)

• Fever
• Diarrhoea
• Tiredness
• Feeling sick (nausea)
• Low levels of red blood cells (anaemia)
• Decreased appetite
• Decreased levels of sodium in the blood
• Abdominal pain or discomfort
• Decreased number of white blood cells (including neutrophils)
• Increased liver enzymes in the blood
• Constipation
• Increased levels of the enzyme alkaline phosphatase in the blood
• Decreased oxygen levels
• Dehydration
• Low blood pressure
• Stuffy nose
• Skin rash which may be red, bumpy or pus-filled

Common (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Decreased levels of magnesium, potassium or calcium in the blood
• Itching
• Chills
• Decreased number of white blood cells (lymphocytes)
• Decreased number of white blood cells (neutrophils) with fever
• Muscular weakness
• Joint pain, swelling and stiffness
• Increased levels of creatinine in the blood
• Wheezing
• Confusion and disorientation
• Back pain
• Muscle pain
• Nose and throat infection
• Chest pain
• Increased levels of lactate dehydrogenase in the blood
• Inflammation of the colon
• Pain
• Decreased number of platelets in the blood
• Bloating
• Delirium
• Depressed level of consciousness
• Hot flush
• Inflammation of the lungs
• Sleepiness
• Fast heartbeat
• Tumour pain
• Decreased levels of fibrinogen in the blood (a protein involved in blood clotting)
• Flatulence
• Swelling
• Skin ulcer
• Blue skin colour due to low oxygen levels
• Difficult or painful bowel movement
• General physical health deterioration
• Numbness, tingling or burning sensation in hands or feet
• Bleeding in the lungs
• Skin discolouration
• Skin infection
• Destruction of soft tissue
• Persistent cough Reporting of side effects
  If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals. Do not use this medicine after the expiry date. The expiry date is provided on the Lot Information Sheet (LIS) and carton.

Store Ebvallo frozen in the vapour phase of liquid nitrogen at -150 C or below until thawed for use.
The medicine should be thawed and diluted within 1 hour from the start of thaw. Administration must be completed within 3 hours from the start of thaw.

Store between 15 C to 25 C after thawing and dilution are complete. Protect product from light. Do not refreeze. Do not irradiate.

What Ebvallo contains

• Ebvallo contains tabelecleucel at an approximate concentration of 2.8 107 7.3 107 cells/mL.
• The other ingredients (excipients) are: dimethyl sulfoxide, human serum albumin, phosphate buffered saline. See section 2 Ebvallo contains sodium and dimethyl sulfoxide (DMSO) .

What Ebvallo looks like and contents of the pack Ebvallo is a translucent, colourless to slightly yellow cell dispersion for injection.

Ebvallo is provided in individual patient cartons containing 1 vial to 6 vials according to the patient- specific dose required. Each vial contains 1 mL of this medicine.

Marketing Authorisation Holder PIERRE FABRE MEDICAMENT Les Cauquillous 81500 Lavaur France

Manufacturer PIERRE FABRE MEDICAMENT PRODUCTION Parc industriel de la Chartreuse 81100 Castres France

This leaflet was last revised in

This medicine has been authorised under exceptional circumstances . This means that because of the rarity of this disease, it has been impossible to get complete information on this medicine. The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: