What is it and how is it used?
Opgenra must not be used
- if you are allergic (hypersensitive) to eptotermin alfa or to any of the ingredients of Opgenra (see section 6).
- if you have an autoimmune disease (disease arising from or directed against your own tissues), including Crohn?s disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren?s syndrome and dermatomyositis/ polymyositis.
- if you have an active infection in your spine or have been told that you have an active internal (systemic) infection.
- if you have inadequate skin coverage and inadequate blood supply at the site of surgery (your doctor should have told you if this is the case).
- if you require a spinal fusion because of a metabolic bone disease or tumours
- have any tumours in the area intended for surgery.
- if you are receiving chemotherapy, radiation treatment or immunosuppression .
- have had Opgenra, eptotermin alfaor any similar medicine before.
- if you are a child.
- if you are an adolescent and your skeleton is not yet be fully formed (you are still growing).
Take special care with Opgenra:The following are precautions for use of Opgenra to be discussed with your doctor.
- There is a possibility that new antibodies can form in your body when Opgenra is used. Your doctors will monitor you if they suspect this is the case.
- Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you.
- Repeated use of Opgenra cannot be recommended. Laboratory studies have demonstrated that there is a theoretical risk of developing autoimmunity towards the natural (endogenous) BMP proteins in your body following repeat exposure to this medicine.
Use of Opgenra does not guarantee fusion; additional surgeries may be required.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Opgenra should not be used during pregnancy unless the benefits to the mother outweigh the risks to the unborn child. Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before undergoing treatment with Opgenra. Women of childbearing potential are advised to use effective contraception for a period of 2 years after their treatment.
Do not breast-feed your baby during Opgenra therapy. As the potential for harm to the breast fed infant is unknown, women should not breast-feed during the period immediately following treatment with Opgenra. If you are nursing, you should receive Opgenra only if your treating physician or surgeon considers the benefits to you outweigh the risks to your child.
Driving and using machines
Studies on the effects on the ability to drive and use machines have not been performed with Opgenra.