Inductos

Patient Information Leaflet

InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix

dibotermin alfa
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What InductOs is and what it is used for

InductOs contains the active substance dibotermin alfa. It is a copy of a protein called recombinant human bone morphogenetic protein-2 (BMP-2), which is naturally produced by the body and helps form new bone tissue.
InductOs can be used both in lumbar spinal fusion surgery and to repair fractures of the shin bone (tibia).
Lumbar spinal fusion surgery
If you are experiencing severe pain caused by a damaged spinal disc in the lower back, and other treatments have not been effective, you may be a candidate for lumbar spinal fusion surgery. InductOs is used instead of taking bone graft from your hip; this avoids the problems and pain that can be caused by the procedure to harvest the bone graft.
When used in spinal fusion surgery, InductOs is used together with a medical device that corrects the alignment of your spine. If you have any questions about the medical device, please consult your doctor.
Tibial fractures
If you have a fracture of the tibia, InductOs is indicated to help heal the broken bone and to reduce the need for additional surgeries. It is used as a complementary therapy to standard treatment and care for tibial fractures.

2. What you should know before using InductOs

Do not use InductOs:

• If you are allergic to dibotermin alfa or to bovine collagen, or to any of the other ingredients of this medicine (listed in section 6).
• If you are still growing (skeletally immature).
• If there is an infection at the surgical site.
• If the surgeon treating you considers that the fractured area is inadequately supplied with blood.
• If the fracture to be treated is associated with other diseases (e.g., fractures due to Paget’s disease or due to tumours).
• If you have been diagnosed with cancer or are currently undergoing anticancer therapy.

Warnings and precautions to discuss with your doctor:

• Inform your doctor if you suffer from any autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome, or dermatomyositis/polymyositis.
• Inform your doctor if you have any bone disorders.
• Inform your doctor if you have ever had a tumour.
• This medicine must not be placed in direct contact with certain types of bone. Your surgeon will know which bones to avoid.
• The use of InductOs may cause bone formation in surrounding tissues (called heterotopic ossifications), which could lead to complications.
• Some patients may develop neuralgia due to localized fluid accumulation, which might require drainage or a surgical procedure to remove the fluid.
• Some patients may develop antibodies (produced by your body to fight a foreign protein) against InductOs. While no harmful effects have been observed, the long-term effects are unknown.
• Inform your doctor if you have any kidney or liver disease.
• Localized swelling, which in some cases has led to breathing difficulties, has been reported in patients when InductOs was used in surgery of the upper spine (cervical, neck). The safety and efficacy of InductOs in cervical spinal surgery have not been established, and InductOs must not be used in such situations.

Other medicines and InductOs
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding
The effects of InductOs on pregnancy are unknown. The use of this medicine is not recommended in pregnant women.
It is not known whether InductOs passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before being treated with this medicine.

Effects on the ability to drive vehicles and operate machinery
InductOs will not affect your ability to drive vehicles or operate machinery.

InductOs contains bovine collagen, a protein derived from cattle
Some patients may develop antibodies (produced by the body to fight a foreign protein) against the collagen contained in the medicine. In clinical studies, the presence of antibodies to collagen has not been associated with adverse effects such as allergies, nor with a reduction in the effectiveness of InductOs. If you think you are having an allergic reaction to collagen, consult your doctor.

InductOs contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum dose (two 12 mg kits), i.e., it is practically "sodium-free".

3. How to use InductOs

Your doctor will implant InductOs during the surgical procedure. Medical personnel will prepare InductOs in the operating room. The powder is dissolved in sterile water to form a solution, which is then used to wet the sponge. The wetted sponge can then be implanted where bone growth is needed. Over time, the sponge will gradually disappear as new bone develops.

If you are receiving InductOs for lumbar spinal fusion, the surgeon will remove the damaged intervertebral disc causing your pain and replace it with a medical device containing InductOs. The medical device corrects the position of your spine, and InductOs stimulates bone growth between the two vertebrae, permanently securing them in the correct position.

If you are receiving InductOs for a tibial fracture, your doctor will apply InductOs around the fractured bone during fracture treatment. Your doctor will also determine the amount of InductOs to use based on the type of fracture and the number of broken bones. Generally, the contents of one 12 mg pack are sufficient to treat one fracture; however, up to two 12 mg packs may be used.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Contact your doctor immediately or go to the nearest hospital emergency department if you experience
localized swelling, which may cause breathing difficulties, after receiving InductOs during a procedure
in the upper part of the spine (cervical, neck). The frequency of this side effect is unknown and cannot
be estimated based on the available data.
Other side effects
Spinal fusion procedure in the lower back
Inform your doctor if you experience any of the following side effects:

• Common (may affect up to 1 in 10 people): additional bone growth, movement of the implanted medical device, localized fluid accumulation, and pain radiating from the back to the leg (sciatica)
• Not known (frequency cannot be estimated based on the available data): increased bone resorption activity

Tibial bone fractures
Inform your doctor if you experience any of the following side effects:

• Very common (may affect more than 1 in 10 people): localized infection
  Common (may affect up to 1 in 10 people): localized fluid accumulation
• Not known (frequency cannot be estimated based on the available data): increased bone resorption activity

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may
also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store InductOs

It is not your responsibility to store this product.

6. Contents of the pack and other information

What InductOs contains

• The active substance of InductOs is dibotermin alfa (also known as recombinant human Bone Morphogenetic Protein-2), 4 mg (4 mg pack) or 12 mg (12 mg pack).
• The other components are: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide, polysorbate 80, water for injections, and Type I bovine collagen.

Description of the appearance of InductOs and contents of the pack
InductOs is supplied to the physician as an implant kit for use during surgical intervention.

• Dibotermin alfa is a white powder supplied in a glass vial.
• Water for injections is a colourless, transparent liquid supplied in a glass vial.
• The sponge is white and supplied in a plastic blister.

Marketing Authorisation Holder and Manufacturer
Medtronic BioPharma B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.