INDUCTOS 1.5 mg/ml POWDER, SOLVENT AND MATRIX FOR IMPLANTATION MATRIX

Introduction

Package Leaflet: Information for the Patient

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

dibotermina alfa

Read the entire package leaflet carefully before using this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is InductOs and what is it used for
2. What you need to know before using InductOs
3. How to use InductOs
4. Possible side effects
5. Storage of InductOs
6. Package contents and additional information

1. What is InductOs and what is it used for

InductOs contains the active substance dibotermina alfa. It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is naturally produced by the body and helps to form new bone tissue.

InductOs can be used for both lumbar spinal fusion surgery and for repairing fractures of the tibia.

Lumbar spinal fusion surgery

If you have severe pain due to a damaged disc in your lower back and other treatments have not been effective, your case may be considered for lumbar spinal fusion surgery. InductOs is used instead of using a bone graft from your hip, which avoids the problems and pain that can be caused by an operation to obtain the bone graft.

When used in lumbar spinal fusion surgery, InductOs is combined with a medical device that corrects the position of your spine. If you have any questions about the medical device, ask your doctor.

Tibia fractures

If you have broken your tibia, InductOs is used to help heal the fracture and reduce the need for subsequent surgical operations. It is used in addition to standard treatment and care for tibia fractures.

2. What you need to know before using InductOs

InductOs should not be applied to you

• If you are allergic to dibotermina alfa, or to bovine collagen or any of the other components of this medication (listed in section 6).
• If you are still growing (immature skeleton).
• If you have an active infection at the surgical site.
• If your doctor decides that you have inadequate blood supply to the fracture site.

• For the treatment of a fracture related to a disease (e.g., fractures due to Paget's disease or cancer).

• If you have been diagnosed with or are being treated for cancer.

Warnings and precautions

• You should inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome, or dermatomyositis/polymyositis.
• You should inform your doctor if you have any bone disease.
• You should inform your doctor if you have a history of cancer.
• The product should not be placed in direct contact with certain types of bones. Your surgeon will know which bones to avoid.
• The use of InductOs may cause bone formation (heterotopic ossification) in the underlying tissues, which can lead to complications.
• Some patients may develop nerve pain due to localized fluid accumulation, which may require drainage or surgical removal of the fluid.
• Some patients may develop antibodies (produced by the body to fight a foreign protein) to InductOs. Although no harmful effects have been noted, the long-term effects are unknown.
• You should inform your doctor if you have any kidney or liver problems.
• There have been reports of patients with localized swelling, which in some cases have caused breathing difficulties, when InductOs was used in surgery on the upper part of the spine (neck). The safety and efficacy of InductOs in neck spine surgery are unknown, and therefore InductOs should not be used in these cases.

Other medications

Inform your doctor if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

The effects of InductOs during pregnancy are unknown. The use of the product is not recommended in pregnant women.

It is unknown whether InductOs passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medication.

Driving and using machines

InductOs does not affect your ability to drive and use machines.

InductOs contains bovine collagen, a protein obtained from cattle

Some patients may develop antibodies (produced by the body to fight a foreign protein) against the collagen in the medication. In clinical trials, the presence of antibodies against collagen was not associated with adverse effects such as allergies, and it was not shown that the presence of these antibodies reduced the efficacy of InductOs. Contact your doctor if you think you have an allergic reaction to collagen.

InductOs contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per maximum dose (two 12 mg packages), which means it is essentially "sodium-free".

3. How to use InductOs

The doctor treating you will implant InductOs during the operation. The medical team will prepare InductOs in the operating room. The powder is dissolved in sterile water to form a solution that is used to soak the sponge. The soaked sponge is then implanted where bone growth is needed. Over time, the sponge will gradually disappear as new bone forms.

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

If you are receiving InductOs for the treatment of a tibia fracture, your doctor will place InductOs around the broken bone when treating the fracture. Your doctor will determine the amount of InductOs you will receive, depending on the size and number of fractures. Generally, a single 12 mg package is used; however, up to a maximum of two 12 mg packages may be used.

4. Possible side effects

Like all medications, InductOs can cause side effects, although not everyone will experience them.

Serious side effects

Tell your doctor immediately or go to the emergency department of the nearest hospital if you experience localized swelling that could cause breathing difficulties after using InductOs in an operation on the upper part of the spine (neck). The frequency of this side effect is unknown and cannot be estimated from the available data.

Other side effects

Lumbar spinal fusion surgery

Consult 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)

• Frequency not known (cannot be estimated from the available data): Increased bone resorption

Tibia fractures

Consult 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

• Frequency not known (cannot be estimated from the available data): Increased bone resorption

Reporting side effects

If you experience any side effects, consult your doctor, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of InductOs

You do not need to store this medication

6. Package contents and additional information

Composition of InductOs

• The active substance of InductOs is dibotermina alfa (also called recombinant human bone morphogenetic protein 2) 4 mg (4 mg package) or 12 mg (12 mg package).
• The other components are: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide, and polysorbate 80, water for injections, and bovine collagen type I.

Appearance and package contents

InductOs is provided to your doctor as a kit for surgical implantation.

• Dibotermina alfa is a white powder that comes in a glass vial
• The water for injections is a clear, colorless liquid that comes in a glass vial
• The sponge is white and comes in a plastic blister pack

Marketing authorization holder and manufacturer

Medtronic BioPharma B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen

Netherlands

Date of last revision of this package leaflet

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/