5 million cells/ml suspension for injection 
darvadstrocel

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or surgeon.

– If you get any side effects, talk to your doctor or doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Alofisel is and what it is used for 
2. What you need to know before you receive Alofisel 
3. How to get Alofisel 
4. Possible side effects 
5. How to store Alofisel 
6. Contents of the packaging and other information 

1. What Alofisel is and what it is used for

Alofisel is a medicine used to treat complex perianal fistulas in adult patients with Crohn’s disease (a disease that causes inflammation of the intestines) when other symptoms of the disease are under control or are mild. Perianal fistulas are abnormal channels that connect parts of the lower intestine (rectum and rectal opening) and the skin near the rectum so that one or more openings appear near the rectum. Perianal fistulas are described as complex if they have several channels or openings, if they go deep into the body or if they are associated with other complications such as. accumulations (infected fluid also referred to as “abscesses”). Perianal fistulas can cause pain, irritation, and depletion of var through openings in the skin.

Alofisel is used when the fistulas have not responded satisfactorily to previous treatment. Alofisel injected near the perianal fistulas reduces inflammation which increases the likelihood of the healing of the fistula.

Alofisel is used after the fistula has been pre-treated appropriately, see section 3.

The active ingredient in Alofisel is darvadstrocel, which consists of stem cells from adipose tissue from a healthy adult donor (so-called allogeneic stem cells ) and which is then grown in a laboratory. Stem cells are a special type of cell found in many tissues in adults, whose main role is to repair tissue in which they originate.

2. What you need to know before you receive Alofisel

You must not be given Alofisel:

  • if you are allergic to Alofisel, bovine serum ( bovine blood fluid), or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or surgeon before receiving 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 they are used in the manufacture of the medicine.

Alofisel is a treatment with living cells and the final drug can therefore not be sterilized. The drug is checked at various stages during manufacture to ensure that it is free from infection. Because the final check-up takes place just before Alofisel is sent to the hospital, the results of the last check-up will not be ready when it is given to you. If it is unlikely that the results indicate an infection, the healthcare professionals who tell you will be informed if you need laboratory tests or are being treated for an infection. If you feel unwell or have a fever after the procedure, tell your doctor as soon as you can.

Children and young people

This medicine should not be given to children and adolescents (under 18 years of age) as the potential benefits and risks are not known.

Pregnancy, breastfeeding and fertility

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 taking this medicine. Alofisel treatment is not recommended during pregnancy or breast-feeding. Fertile women should use effective contraception under treatment with Alofisel.

Driving and using machines

Alofisel is unlikely to affect your ability to drive or use machines.

Traceability

To facilitate the traceability of biological drugs, the name and manufacturing batch number of the drug must be documented.

3. How to get Alofisel

You may have had an initial doctor’s appointment with a surgeon 2-3 weeks before Alofisel is to be given. The following information applies to the day Alofisel is given.

Alofisel is injected by a surgeon into the tissue around the fistula passage.

The recommended dose is 120 million cells.

Anesthetic is given before treatment with Alofisel.

Once you have been anesthetized (anesthesia or local anesthesia), the surgeon will:

  • clean the fistula with saline and remove any scar tissue
  • sew together the inner openings of the fistulas
  • inject Alofisel, half the dose is injected into the tissue around the inner openings of the fistulas and the other half into the walls of the tissue along with the fistulas
  • Massage the area where the fistulas open into the skin near the anal opening gently for 20 to 30 seconds. 

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

4. Possible side effects

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

Some side effects of Alofisel treatment are related to the cleansing of the fistulas. In general, these side effects are mild and disappear within a few days after cleansing.

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

  • analabscess (goods collection)
  • anal fistula
  • proctalgia (pain in the rectum or anal opening)
  • pain associated with treatment (pain after cleaning the fistula).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alofisel

Keep this medicine out of the sight and reach of children. 

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

Do not store above 25 ° C and at least 15 ° C.

Store in a cold place. Do not freeze. 

Store in the outer carton.

Alofisel must not be irradiated or sterilized in any other way.

As this medicine is used during surgery, the hospital staff is responsible for the proper storage of the medicine before and during use and also for proper waste management.

6. Contents of the packaging and other information

Content declaration

  • The active substance in Alofisel is darvadstrocel, which consists of stem cells from the adipose tissue of a healthy adult which is then cultured (expanded) in a laboratory and given in a concentration of 5 million cells per milliliter in vials containing 6 milliliters each, ie. 30 million cells per vial.
  • There are two excipients used to store the cells: one is a liquid called DMEM (Dulbecco’s Modified Eagle’s Medium) which contains nutrients for the cells ( amino acids, vitamins, salts, and carbohydrates), and the other is human albumin, which is a natural protein found in the body.

What the medicine looks like and the contents of the pack

Alofisel is an injection, suspension. During transport, the cells may have settled to the bottom of the vials and formed sediment and must then be resuspended. When the cells have been resuspended (by tapping gently with a finger), Alofisel is a white to a yellowish homogeneous solution.

Alofisel is supplied to individual patients. An individual dose of Alofisel consists of 4 glass vials, each containing 6 milliliters of Alofisel, packed in a carton.

Marketing Authorisation Holder

TakedaPharma A / S 

Delta Park 45

2665 Vallensbaek Strand

Denmark

Manufacturer

TiGenix SAU 

C / Marconi 1

Madrid Technical Park 

28760 Tres Cantos, Madrid 

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Takeda Pharma AB 

Tel: +46 8 731 28 00

Muhammad Nadeem

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