Spherox - patient leaflet, side effects, dosage

Patient leaflet - Spherox

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Spherox 10–70 spheroids/cm implantation suspension spheroids of human autologous matrix-associated chondrocytes

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given with this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If you get any side effects, talk to your doctor or physical therapist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Spherox is and what it is used for

Spherox consists of so-called spheroids. A spheroid looks like a tiny pearl made of cartilage cells and cartilage material derived from your own body. Cartilage tissue is present in every joint as a hard smooth layer on the surface of bone ends. It protects the bones and allows our joints to work smoothly. To make the spheroids, a small cartilage sample is taken from part of one of your joints during a minor operation, and then grown in the laboratory to make the medicine. By surgery the spheroids are implanted to the defected cartilage area and stick to the defect site. They are then expected to repair the defect with healthy and functional cartilage over time.

Spherox is used to repair cartilage defects of knee in adults and in adolescents whose bones in the joint have finished growing. These defects can be caused by acute injury, such as a fall. They can also be caused by repetitive injury, such as long-term incorrect weight bearing on the joint. Spherox is used to treat defects up to 10 cm in size.

Warnings and precautions

Talk to your doctor before you are given Spherox, if you have any other joint problems or excess weight, as this may reduce the success of the procedure.

Spherox should preferably be implanted into an otherwise healthy joint. Other joint problems should be corrected before or at the time of Spherox implantation.

Rehabilitation program

Follow the rehabilitation program, strictly, after implantation. Only resume physical activity when instructed by your doctor. Resuming vigorous activity too soon may reduce the benefit and durability of Spherox.

Other cases in which Spherox cannot be supplied

Even if the cartilage sample has already been taken, it may happen that you cannot be treated with Spherox. This can occur because the sample taken is not of sufficient quality to manufacture the product. Your doctor might have to select an alternative treatment for you.

Children and adolescents

Spherox is not recommended in children or adolescents whose bones in the knee joint have not finished growing.

Other medicines and Spherox

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Spherox is not recommended for pregnant or breast-feeding women, as it is applied during surgery. 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 using this medicine.

Driving and using machines

The surgical procedure will have a major influence on your ability to drive and use machines. Driving cars and using machines may be limited during the rehabilitation period. Strictly follow the advice of your doctor or physical therapist.

3. How to use Spherox

Spherox can only be implanted by a specialist doctor in a medical facility and must only be used in the patient for whom it has been prepared.

The treatment of adults and adolescents (whose bones in the joint have finished growing) with Spherox is a two-step procedure:

Visit 1:

Evaluation of the cartilage defect, sample and blood taking

On the first visit, the doctor will evaluate your cartilage defect during an exploratory operation. This is usually done as keyhole surgery through very small incisions (cuts), using a special instrument to look inside the knee (arthroscopy).

If Spherox is appropriate for you, the doctor takes a small cartilage sample from your joint. Your cartilage cells are extracted from this sample in a laboratory and are then grown to make the spheroids that constitute Spherox. The process takes about 6 to 8 weeks.

Visit 2:

Spherox implantation

Spherox is implanted into the cartilage defect in the joint during the next operation. This may also be carried out by keyhole surgery.

Rehabilitation

In order to allow your joint to recover well, you will have to follow an individual rehabilitation program. This may take up to one year. Your doctor or physical therapist will advise you.

Very important: Carefully comply with the recommendations of your doctor and physical therapist. The risk of treatment failure may increase if you do not follow your rehabilitation schedule.

Be very careful when bending and putting weight on your treated joint. During the rehabilitation period, the amount of weight you can put on the joint will increase gradually. How quickly this occurs depends for example on your body weight and the size of the cartilage defect. Depending on the treated joint, you may have to wear a brace.

Ask your doctor or physical therapist if you have any further questions about treatment with Spherox.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects appearing after the implantation of Spherox are mostly related to the surgery. In general, these side effects are quite mild and disappear during the weeks following surgery.

If you get any of the following serious side effects, you should immediately contact a doctor:

hypersensitivity (allergy) (symptoms: e.g. skin reactions, low blood pressure, constriction of airways, swollen tongue or throat, weak and rapid pulse, sickness, vomiting, diarrhoea, dizziness, fainting, fever)
blood clot in a deep vein (symptoms: e.g. swelling, pain, increased warmth in the affected area)

Other side effects

Side effects can occur with the following frequencies:

Common : may affect up to 1 in 10 people

accumulation of fluid in the joint
pain in the joint
swelling in the joint
accumulation of excess fluid in the bone marrow
pain

Uncommon : may affect up to 1 in 100 people

increase in size of the cartilage cells, softening of cartilage. You may in that case notice symptoms, for example swelling or pain of the tissues around the joint.
cracking sounds in the joint
joint lock
impairment of walking
tissue lump that may occur in the joint
loss of the implanted cells
any disease of cartilage
ligament disorder
tendon inflammation
muscle weakness
pain of the front knee or kneecap
swelling due to obstructed flow of tissue fluid via the lymph vessels
scar tissue pain
blockage of a blood vessel in the lung
fragment of cartilage or bone that freely floats in the knee joint space
inflammation of the inner layer of the joint capsule

Rare : may affect up to 1 in 1000 people

disorder of bone formation, death of bone tissue, bone formation outside the skeleton. You may in that case notice symptoms, for example swelling or pain of the tissues around the joint.
infection at the site of implantation
partial or complete detachment of the tissue beneath the bone and surrounding cartilage
inflammation of the joint caused by bacteria
inflammation of the bone marrow caused by bacteria
inflammation of the skin and/or the soft tissue caused by bacteria
pain below the kneecap due to inflammation of the soft tissue
inflammation of veins combined with the formation of a blood clot located near the surface of the skin (symptoms: e.g. redness and/or warmth of the skin along the vein, tenderness, pain)
wound-related complication
reopening of a closed wound
internal bleedings

Very rare : may affect up to 1 in 10.000 people

uneasiness

Not known: frequency cannot be determined

excessive scar tissue formation within the joint and/or surrounding of soft tissues
inflammation of the lung

Reporting side effects

If you get any side effects, talk to your doctor or physical therapist. 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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spherox

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

Store and transport refrigerated (1 °C to 10 °C).

Do not freeze. Do not irradiate.

Do not open the outer packaging before use to prevent microbial contamination.

6. Contents of the pack and other information

What Spherox contains

The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body.

Spherox contains 10–70 spheroids per cm2 of the cartilage defect.

The other ingredient is sodium chloride used as transport solution.

What Spherox looks like and contents of the package

Implantation suspension.

Spherox contains so-called spheroids that consist of living cartilage cells with a non-cellular portion for the repair of cartilage defects. The spheroids look like small white to yellowish pearls. They are transported in a clear colourless solution. Spherox is delivered to the doctor in a container ready for application. The container may be a syringe or a special application system called co.fix that is a catheter with a stem length of 150 mm.

The applicator co.fix 150 is packed in a sterile tube and additionally surrounded by an extra bag. The pre-filled syringe is packed in a sterile tube and additionally surrounded by an extra bag.

Marketing Authorisation Holder and Manufacturer

CO.DON AG

WarthestraBe 21

14513 Teltow, Germany

Tel.: +49 3328 43460

Fax: +49 3328 434643

E-mail:

Manufacturer

CO.DON AG

Deutscher Platz 5d

04103 Leipzig, Germany

This leaflet was last revised in

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

CLINICAL PARTICULARS

4.1 Therapeutic indications

Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults and adolescents with closed epiphyseal growth plate in the affected joint.

4.2 Posology and method of administration

Spherox is intended for autologous use only. It must be administered by a specialised orthopedic surgeon and in a medical facility.

Posology

10–70 spheroids are applied per square centimetre defect.

Paediatric population

The safety and efficacy of Spherox in children and adolescents with still open epiphyseal growth plate in the affected joint have not been established. No data are available.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

6.2 Incompatibilities

In absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.

6.3 Shelf life

72 hours

MARKETING AUTHORISATION NUMBER(S)

EU/1/17/1181/001

EU/1/17/1181/002

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

OTHER SPECIAL WARNING(S), IF NECESSARY

For autologous use only.

OTHER