Warnings and precautions
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bondronat for cancer-related conditions. ONJ can also occur after stopping treatment.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Before receiving treatment, tell your doctor/nurse (health care professional) if:
- you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
- you don’t receive routine dental care or have not had a dental check up for a long time
- you are a smoker (as this may increase the risk of dental problems)
- you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
- you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
- you have cancer
Your doctor may ask you to undergo a dental examination before starting treatment with Bondronat.
While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bondronat.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Talk to your doctor, pharmacist or nurse before receiving Bondronat:
- if you are allergic to any other bisphosphonates
- if you have high or low levels of vitamin D, calcium or any other minerals
- if you have kidney problems
- If you have heart problems and the doctor recommended to limit your daily fluid intake
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.
If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).
Other medicines and Bondronat
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Bondronat can affect the way some other medicines work. Also, some other medicines can affect the way Bondronat works.
In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called ‘aminoglycoside’ such as gentamicin. This is because aminoglycosides and Bondronat can both lower the amount of calcium in your blood.
Pregnancy and breast-feeding
Do not receive Bondronat if you are pregnant, planning to get pregnant or if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You can drive and use machines as it’s expected that Bondronat has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machines or tools.
Bondronat contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free’.