Inductos 1.5 mg/ml powder, solvent, and matrix for implantation matrix
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
InductOs 1.5 mg/ml powder, solvent and matrix for preparation of implantation matrix
dibotermin alfa
Read the entire leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What InductOs is and what it is used for
- What you need to know before using InductOs
- How to use InductOs
- Possible adverse effects
- How to store InductOs
- 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 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 lower back spinal fusion surgery and for repairing shinbone fractures.
Lower back spinal fusion surgery
If you have severe pain due to a damaged disc in your lower spine and other treatments have not been effective, you may be considered for lower back spinal fusion surgery. InductOs is used instead of taking a bone graft from your hip, thereby avoiding the complications and pain that may result from a procedure to obtain the bone graft.
When used in lower back spinal fusion surgery, InductOs is combined with a medical device that helps correct the alignment of your spine. If you have any questions about the medical device, please ask your doctor.
Shinbone fractures
If your shinbone has been fractured, InductOs is used to help heal the fracture and to reduce the need for additional surgical procedures. It is used as an addition to standard treatment and care for shinbone fractures.
2. What you need to know before using InductOs
InductOs should not be used in you if:
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You are allergic to dibotermin alfa, bovine collagen, or any of the other components of this medicine (listed in section 6).
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You are still growing (immature skeleton).
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You have an active infection at the surgical site.
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Your doctor determines that you have inadequate blood supply at the fracture site.
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For the treatment of fractures associated with disease (e.g., fractures due to Paget's disease or cancer).
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If you have been diagnosed with or are being treated for cancer.
Warnings and precautions
- You must inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's disease, or dermatomyositis/polymyositis.
- You must inform your doctor if you have any bone disease.
- You must inform your doctor if you have a history of cancer.
- The product 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 lead to bone formation (heterotopic ossification) in underlying tissues, which could result in complications.
- Some patients may develop nerve pain due to localized fluid accumulation, which might require drainage or surgical intervention to remove the fluid.
- Some patients may develop antibodies (produced by the body to fight a foreign protein) against InductOs. Although no harmful effects have been observed, the long-term effects are unknown.
- You must inform your doctor if you have any kidney or liver problems.
- Cases of localized swelling, sometimes leading to breathing difficulties, have been reported when InductOs has been used in surgery of the upper spine (neck region). The safety and efficacy of InductOs in cervical spine surgery are unknown; therefore, InductOs should not be used in these cases.
Other medicines
Inform your doctor if you are currently using, or have recently used, any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
The effects of InductOs during pregnancy are unknown. Use of this 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 are planning to become pregnant, consult your doctor before receiving this medicine.
Driving and using machines
InductOs does not affect your ability to drive or operate machinery.
InductOs contains bovine collagen, a protein derived from cattle
Some patients may develop antibodies (produced by the body to combat a foreign protein) against the collagen in the medicine. In clinical trials, the presence of antibodies against collagen was not associated with adverse effects such as allergic reactions, nor did it demonstrate that these antibodies reduced the efficacy of InductOs. Contact your doctor if you think you may be having an allergic reaction to collagen.
InductOs contains sodium
This medicine contains less than 23 mg (1 mmol) of sodium per maximum dose (two 12 mg containers), i.e., it is practically "sodium-free".
3. How to use InductOs
InductOs is used to promote bone healing and fusion in specific orthopedic and spinal procedures. It contains the active substance recombinant human bone morphogenetic protein-7 (rhBMP-7), which belongs to a group of proteins known as bone morphogenetic proteins (BMPs).
InductOs is applied directly to the site where bone growth is needed, such as in spinal fusion surgery or in the treatment of non-unions (fractures that have failed to heal). The product is typically implanted in combination with a carrier material (such as a collagen sponge) that helps deliver and retain the protein at the target site.
The dosage and method of application depend on the specific medical condition being treated and the surgical procedure. InductOs must only be administered by a qualified healthcare professional experienced in orthopedic or spinal surgery.
Do not use InductOs if you are allergic to recombinant human BMP-7 or to any of the other ingredients listed in section 6.
For full details on how to use InductOs, including warnings and precautions, refer to the complete product information provided with the medicine.
Your treating physician will implant InductOs during surgery. The medical staff will prepare InductOs in the operating room. The powder is dissolved in sterile water to form a solution 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 spinal fusion in the lower back, your surgeon will remove the damaged disc causing your pain and replace it with a medical device filled with InductOs. The medical device corrects the alignment 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 tibial fracture, your doctor will place InductOs around the fractured 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, one 12 mg vial is used; however, up to a maximum of two 12 mg vials may be used.
4. Possible adverse effects
Like all medicines, InductOs can cause adverse effects, although not everyone experiences them.
Serious adverse effects
Tell your doctor immediately or go straight to the nearest hospital emergency department if you experience localized swelling, which could cause breathing difficulties, after receiving InductOs during surgery on the upper (neck) region of the spine. The frequency of this adverse effect is unknown and cannot be estimated from the available data.
Other adverse effects
Spinal fusion surgery
Talk to your doctor if you experience any of the following effects:
- Frequent (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 breakdown
Tibia bone fractures
Talk to your doctor if you experience any of the following effects:
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Very frequent (may affect more than 1 in 10 people): Localized infection
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Frequent (may affect up to 1 in 10 people): Localized fluid accumulation
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Frequency not known (cannot be estimated from the available data): Increased bone breakdown
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of InductOs
It is not necessary to store this medicine.
6. Contents of the pack and other information
Composition of InductOs
- The active substance of InductOs is dibotermin alfa (also called 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 bovine type I collagen.
Appearance of the product and contents of the pack
InductOs is supplied to your doctor as a kit for surgical implantation.
- Dibotermin alfa is a white powder presented in a glass vial
- Water for injections is a clear, colourless liquid presented in a glass vial
- The sponge is white and presented in a plastic blister
Marketing Authorisation Holder and Manufacturer
Medtronic BioPharma B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Date of the most recent review of this summary
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/