Inductos
dibotermin alfa
dibotermin alfa
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. This includes any possible side effects not listed in this leaflet. See section 4.
What InductOs is and what it is used for
What you need to know before you receive InductOs
Contents of the pack and other information
InductOs contains the active substance, dibotermin alfa. It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
InductOs may be used either in lower back spine fusion surgery or to repair fractures of the shin bone.
Lower back spine fusion surgery
If you have a lot of pain from a damaged disc in your lower back, and other treatments have not proven effective, you may be considered for lower back spine fusion surgery. InductOs is used instead of taking a bone graft from your hip; this avoids the problems and pain that can be caused by an operation to collect the bone graft.
When used in lower back fusion surgery, InductOs is used in combination with a medical device, which corrects the position of your spine. If you have any question about the medical device, please ask your doctor.
Fractures of the shin bone
If you have broken your shin bone, InductOs is used, to help your fracture heal and to reduce the need for additional surgeries. It is used in addition to standard treatment and care of shin bone fractures.
if you are allergic to dibotermin alfa or bovine collagen or any of the other ingredients of this medicine (listed in section 6).
if you are still growing (skeletally immature).
if you have an active infection at the surgery site.
if the doctor treating you decides that you have inadequate blood supply at the fracture site.
for treating a fracture that is disease-related (e.g., fractures due to Paget’s disease or cancer).
if you have been diagnosed with or are being treated for cancer.
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 of any 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.
Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications.
Some patients may develop nerve pain due to localised fluid collection, which would require drainage or a surgical procedure to remove the fluid.
Some patients may develop antibodies (made by your body to fight a foreign protein) to InductOs. While no harmful effects have been noted, the long-term effects are unknown.
You should inform your doctor if you have kidney or liver disease.
Localised swelling, in some cases resulting in breathing difficulty, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine. The safety and effectiveness of InductOs in spine surgery in the neck have not been established, and InductOs should not be used in this situation.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
The effects of InductOs on pregnancy are not known. The use of the product in pregnant women is not advised.
It is not known if InductOs passes into breast milk.
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 receiving this medicine.
InductOs will not affect your ability to drive or operate machines.
Some patients may develop antibodies (made by your body to fight a foreign protein) against the collagen in the medicine. In clinical studies, the presence of antibodies to collagen was not associated with side effects, such as allergies, nor was it shown to decrease the effectiveness of InductOs. If you think you have an allergic reaction to collagen, contact your doctor.
This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it
is essentially ‘sodium-free’.
The doctor treating you will implant InductOs during surgery. The medical staff will prepare InductOs in the operating room. The powder is dissolved in the 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 is formed.
If you are receiving InductOs for lower back spine fusion, your surgeon will remove the damaged disc that is causing the pain and replace it with a medical device filled with InductOs. The medical device corrects the position of your spine, and InductOs encourages bone to grow between the two vertebrae to fix them permanently in the correct position.
If you are receiving InductOs for a broken shin bone, your doctor will place InductOs around your broken bone when your fracture is treated. The doctor will determine how much InductOs you will receive, depending on the size and number of fractures. Generally, one 12 mg pack is used; however, a maximum of two 12 mg packs may be used.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital if you have localised swelling, which may result in breathing difficulties, after InductOs has been used in surgery of the upper (neck) region of your spine. The frequency of this side effect is unknown and cannot be estimated from the available data.
Lower back spine fusion surgery
Talk to your doctor if you have any of the following:
Common (may affect up to 1 in 10 people):
Additional bone growth, movement of the implanted medical device, localised fluid build-up and pain radiating from your back to your leg (sciatica)
Unknown (cannot be estimated from available data): Increased breakdown of the bone
Fractures of the shin bone
Talk to your doctor if you have any of the following:
Very common (may affect more than 1 in 10 people): Localised infection
Common (may affect up to 1 in 10 people): Localised fluid build-up
Unknown (cannot be estimated from available data): Increased breakdown of the bone
If you get any side effects, talk to your doctor. 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 Appendix V
By reporting side effects, you can help provide more information on the safety of this medicine.
You will not be required to store this product.
The active substance in 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 ingredients are sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen.
InductOs is supplied to your doctor as a kit for implanting during surgery.
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 it is presented in a plastic blister.
Medtronic BioPharma B.V. Earl Bakkenstraat 10
6422 PJ Heerlen The Netherlands