Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - alofisel

Document Subject

Generated Narrative: MedicinalProductDefinition mpf00c2d057b37e01d3588f608535352b2

identifier: http://ema.europa.eu/identifier/EU/1/17/1261/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Alofisel 5 × 106 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

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f00c2d057b37e01d3588f608535352b2

identifier: http://ema.europa.eu/identifier/EU/1/17/1261/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - alofisel

Attesters

What is in this leaflet

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

The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory. Adult stem cells are a special type of cells found in many adult tissues, whose primary role is the repair of the tissue in which they are found.

Alofisel is a medicine used for the treatment of complex perianal fistulas in adult patients with Crohn s disease (a disease causing inflammation of the gut) when the other symptoms of the disease are controlled or have a mild intensity. Perianal fistulas are abnormal channels that connect parts of the lower bowel (rectum and anus) and the skin near the anus, so that one or more openings appear near the anus. Perianal fistulas are described as complex if they have multiple channels and openings, if they penetrate deep inside your body or if they are associated with other complications such as collections of pus (infected liquid also called abscesses). Perianal fistulas can cause pain, irritation and discharge of pus through the openings to the skin.

Alofisel is used when the fistulas have not responded sufficiently well to previous treatment. When injected close to the perianal fistulas, Alofisel reduces their inflammation, increasing the likelihood of the fistulas healing.

You must not be given Alofisel

if you are allergic to darvadstrocel, bovine serum or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or surgeon before you are given Alofisel.

Alofisel may contain traces of either gentamicin or benzylpenicillin and streptomycin (antibiotics). This should be considered if you are allergic to these antibiotics, as these antibiotics are used in the manufacturing process of this medicine.

Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised. The product is checked at different stages during its manufacture to ensure that it is free of infection. Because the final check takes place just before Alofisel is sent to the hospital, the results of this last check are not known when it is given to you. In the unlikely event that the results detected an infection, your treatment team will be informed who will tell you if you need any laboratory tests of treatment for the infection. If after the procedure you feel ill or have fever, please inform your physician as soon as you can.

Before receiving Alofisel you will undergo the preparation of your fistulas. You may experience pain in the rectum or anus, and pain occurring after fistula preparation.

After you receive Alofisel do not donate blood, organs, tissues or cells for transplants.

Children and adolescents

This medicine should not be given to children and adolescents below 18 years of age. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/surgeon for advice before you are given this medicine. Treatment with Alofisel is not recommended during pregnancy. Women of childbearing age should use effective contraception during treatment with Alofisel.

The effect of Alofisel on breast-feeding women is not known, and it may harm your breast-fed child. Your doctor will help you decide whether to stop breast-feeding, or whether to stop taking Alofisel, considering the benefit of breast-feeding to the baby and the benefit of Alofisel to the mother.

Driving and using machines

Alofisel is not likely to affect your ability to drive or use tools or machines.

Alofisel will always be given to you by a healthcare professional.

You may have had an initial consultation with the Surgeon 2 to 3 weeks prior to Alofisel administration. The following information is related to the day when Alofisel is administered.

Alofisel is injected by a surgeon in the fistula tract tissue.

The recommended dose is 4 vials of 6 mL (120 106 cells).

Before treatment with Alofisel, you will be given an anaesthetic.

Once you have been anaesthetised (general or regional anaesthesia), your surgeon will:

• prepare the fistulas with sodium chloride 9 mg/mL (0.9%) solution and remove any scar tissue.
• stitch up the inner openings of the fistulas.
• inject Alofisel. Half of the dose will be injected into the tissue around the inner openings of the fistulas, and half of the dose in the tissue walls along the fistulas.
• massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus.

If you have any further questions on the use of this medicine, ask your doctor or surgeon.

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

Some side effects of Alofisel treatment are related to the preparation of your fistulas. In general, these side effects are quite mild and disappear in the days following the fistula procedure. These side effects may occur up to seven days after the procedure.

Common side effects (may affect up to 1 to 10 patients):

• anal abscess
• anal fistula
• proctalgia (pain in the rectum or anus).
• procedural pain (pain after fistula preparation)

Reporting of side effects

If you get any side effects, talk to your doctor or surgeon. 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.

The following information is intended for doctors only.

Do not use this medicine after the expiry date which is stated on the label and the carton.

Store between 15 C and 25 C.

Do not refrigerate or freeze.

Keep the medicine inside the cardboard box to protect from light and moisture, and within the shipping container at all times until its administration, to maintain the required temperature.

Alofisel must not be irradiated or otherwise sterilised.

What Alofisel contains

The active ingredient is darvadstrocel which consists of human stem cells obtained from the fat tissue of a healthy adult donor that are subsequently grown (expanded) in the laboratory and provided at a concentration of 5 106 cells per millilitre in vials which each contain 6 millilitres, i.e. 30 106 cells per vial.

There are two excipients used for storage of the cells: one is a liquid called Dulbecco s Modified Eagle s Medium containing nutrients for the cells (amino acids, vitamins, salts and carbohydrates), and the other is human albumin, which is a natural protein found in the human body.

What Alofisel looks like and contents of the pack

Alofisel is a dispersion for injection. During shipment, the cells may have settled in the bottom of the vials forming a sediment and will need to be resuspended. After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous dispersion.

Alofisel is supplied on an individual patient basis. An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.

Marketing Authorisation Holder

Takeda Pharma A/S Delta Park 2665 Vallensbaek Strand Denmark

Manufacturer

TiGenix S.A.U. C/Marconi 1 Parque Tecnol gico de Madrid 28760 Tres Cantos, Madrid Spain

Takeda Ireland Ltd.
Grange Castle Business Park
Nangor Road, Dublin 22, D22 XRIreland

This leaflet was last revised in.

Other sources of information

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