1.5 mg/ml powder, liquid, and matrix to the matrix for implantation
dibotermin alfa
1. What InductOs is and what it is used for
InductOs contain the active substance, dibotermin alfa. It is a copy of a protein called bone morphogenetic protein 2 (BMP-2) that is formed naturally in the body and helps with the formation of new bone tissue.
InductOs can be used either in a rigid operation in the lower back or to heal fractures of the tibia.
Frame surgery in the lower back
If you have a lot of pain from damaged discs in the lower back and other treatments have not helped you, rigid surgery in the lower back may be an option for you. InductOs are used instead of taking bone grafts from your iliac crest, to avoid problems and pain that such surgery can cause.
When used for stiff back surgery, InductOs are used together with a medical device (metal sleeve) that helps keep your spine in the right position. Contact your doctor if you have any questions about the medical device.
Fracture of the tibia
If you have broken the tibia, inductors are used to help the fracture heal and reduce the need for new surgery. It is used as a supplement to the normal treatment and in the treatment of fractures of the tibia.
2. What you need to know before using InductOs
You should not use InductOs
- 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 (have an immature skeleton).
- if you have an ongoing infection at the surgery site.
- if the doctor treating you assesses that you have insufficient blood supply at fracture one.
- to treat fractures that are disease related (eg fractures due to Paget’s disease or cancer).
- if you have been diagnosed with cancer or are being treated for cancer.
Warnings and cautions
- You should tell your doctor if you have an autoimmune disease, such as rheumatoid arthritis , systemic lupus erythematosus ( SLE ), scleroderma, Sjögren’s syndrome and dermatomyositis / polymyositis.
- You should inform your doctor if you have any form of bone disease.
- You should tell your doctor if you have or have ever had any type of cancer.
- The drug should not be placed in direct contact with certain types of bones. Your surgeon knows which bones to avoid.
- Use of InductOs can cause bone formation (heterotopic ossification) in the surrounding tissues , which can result in complications.
- Some patients may develop nerve pain due to local fluid accumulation that requires drainage or surgical procedures to remove the fluid.
- Some patients may develop antibodies (made in your body to fight foreign protein ) against InductOs. No adverse effects of this have been noted, but the long-term effects are unknown.
- Tell your doctor if you have kidney or liver disease.
- Local swelling, which in some cases has resulted in difficulty breathing, has been reported in patients receiving InductOs during surgery of the upper spine (neck). The safety and efficacy of InductOs in connection with surgery of the cervical spine have not been established and InductOs should not be used in this condition.
Other medicines and InductOs
Tell your doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
The effects of InductOs during pregnancy are not known. InductOs should not be used during pregnancy.
It is not known whether InductOs are excreted in human milk.
If you are pregnant or breastfeeding, 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
InductOs do not affect your ability to drive or use machines.
InductOs contains collagen, a protein from cattle
Some patients may develop antibodies (made in your body to fight foreign protein ) against the collagen in the medicine.
In clinical trials, the presence of antibodies to collagen was not associated with side effects, e.g. allergies, no reduction in the effect of InductOs could be observed. If you think you have an allergic reaction to collagen, consult a doctor.
InductOs contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two packs of 12 mg), ie essentially ‘sodium-free. it is largely “sodium-free”.
3. How to use InductOs
The doctor treating you implants InductOs during surgery. The medical staff prepares InductOs in the operating room. The powder is dissolved in the sterile water so that it becomes a solution that is absorbed by the fungus. The wet sponge is then implanted where you want the bones to grow. Over time, the fungus gradually disappears as new bone is formed.
If you receive InductOs for lower back surgery, a surgeon will remove the damaged disc that is causing the pain, and replace it with a medical device that is filled with InductOs. The medical device keeps the spine in the right position, and InductOs stimulate bones to grow between the two vertebrae so that they are permanently fixed in the correct position.
If you receive InductOs for a broken tibia, your doctor will surgically place InductOs around your broken bone when it is being treated. Your doctor will decide how much InductOs are needed, depending on the size of the broken bone and the number of broken bones. As a rule, a broken bone is treated with the contents of a 12 mg pack. A maximum of two 12 mg packs can be used.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Tell a doctor immediately or go to the nearest hospital emergency department immediately if you experience local swelling. The swelling can lead to difficulty breathing if InductOs have been used in neck surgery. The frequency of this adverse reaction is unknown and cannot be estimated from the available data.
Other side effects are
Fusion surgery of the lumbar spine
Talk to a doctor if you experience any of the following:
• Common (may affect up to 1 in 10 users)
Extra bone formation and movement of the implanted medical device, local fluid accumulation, and pain radiating from the back to the bone (sciatica)
• Has been reported (frequency can not be calculated from available data)
Increased bone breakdown
Tibial fracture
Talk to a doctor if you experience any of the following:
• Very common (may affect more than 1 user in 10)
Local infection
• Common (may affect up to 1 in 10 users):
Local fluid accumulation
• Has been reported (frequency can not be calculated from available data)
Increased bone breakdown
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store InductOs
You do not need to store this product.
6. Contents of the packaging and other information
Content declaration
- The active substance in 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 ingredients are sucrose, glycine , glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen .
What the medicine looks like and contents of the pack
InductOs are provided to your doctor as a preparation kit for implantation during surgery.
• Dibotermin alfa is a white powder that is contained in a glass bottle.
Water for injections is a clear, colorless liquid in a glass bottle.
• The sponge is white and is in a plastic blister.
Marketing Authorization Holder and Manufacturer
Medtronic BioPharma BV
Earl Bakkenstraat 10
6422 PJ Heerlen
Netherlands