Denosumab 60 mg solution for injection
What denosumab is used for:
Denosumab is a protein (monoclonal antibody) that interferes with the action of another protein, in order to treat bone loss and osteoporosis. Treatment with Denosumab makes bone stronger and less likely to break.
Do not use denosumab:
• if you have low calcium levels in the blood (hypocalcemia).
• if you are allergic to denosumab or any of the other ingredients of this medicine
Warnings & Precautions:
Before receiving treatment, tell your doctor or 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
• don’t receive routine dental care or have not had a dental check-up for a long time
• are a smoker (as this may increase the risk of dental problems)
• have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• have cancer
Possible side effects:
Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body.
Other medicines and denosumab:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are being treated with another medicine containing denosumab.
How to use denosumab
The recommended dose is one pre-filled syringe of 60 mg administered once every 6 months, as a single injection under the skin (subcutaneous). The best places to inject are the top of your thighs and the abdomen. Your care giver can also use the outer area of your upper arm. Please consult your doctor on the date for a potential next injection. Each pack of denosumab contains a reminder card, that can be removed from the carton and used to keep a record of the next injection date.
You should also take calcium and vitamin D supplements while being on treatment with Denosumab. Your doctor will discuss this with you.
How to store denosumab:
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the container in the outer carton in order to protect from light.
Your pre-filled syringe may be left outside the refrigerator to reach room temperature (up to 25°C) before injection. This will make the injection more comfortable. Once your syringe has been left to reach room temperature (up to 25°C), it must be used within 30 days.
