Denosurel 120mg Injection may be used for:

• Preventing skeletal-related events in people with multiple myeloma

• Preventing skeletal-related events in people with bone metastases from solid tumours

• Treating giant cell tumour of bone when it cannot be removed surgically or surgery is likely to cause severe complications

• Treating hypercalcaemia of malignancy that has not responded adequately to bisphosphonate treatment, where this use is prescribed by the treating specialist

The specific indication, dose and duration of treatment depend on the patient's condition and response to therapy.

Denosurel contains Denosumab, which binds to RANKL and prevents it from activating its receptor, RANK. RANKL-RANK signalling is important for the formation, activity and survival of osteoclasts.

By blocking this pathway, Denosumab reduces osteoclast activity and slows the breakdown of bone. This helps reduce bone destruction and the risk of skeletal complications associated with certain cancers.

Tell your doctor about all medicines, supplements and other treatments you are receiving before starting Denosurel.

• Other Denosumab-containing medicines: Denosurel should not be used together with other medicines containing Denosumab.

• Medicines affecting calcium levels: Tell your doctor if you take medicines that may alter calcium levels, as Denosumab can cause hypocalcaemia.

• Calcium and vitamin D supplements: Your doctor may recommend calcium and vitamin D supplementation during treatment to help prevent low calcium levels.

• Store Denosurel 120mg Injection in a refrigerator between 2°C and 8°C.

• Do not freeze.

• Keep the injection in its original package to protect it from light.

• Do not shake the vial.

• Keep it out of the reach of children.

• The injection should be visually inspected before administration and should not be used if it is discoloured or contains excessive visible particles.

Denosurel 120mg Injection is administered as a subcutaneous injection by a healthcare professional. It should not be given into a vein, muscle or skin layer other than the subcutaneous tissue.

For prevention of skeletal-related events in multiple myeloma or bone metastases from solid tumours, the usual dose is 120 mg once every 4 weeks.

For giant cell tumour of bone and hypercalcaemia of malignancy, the usual regimen is 120 mg every 4 weeks, with additional 120 mg doses on Days 8 and 15 during the first month. Your doctor will determine the appropriate regimen for your condition.

Calcium and vitamin D supplementation may be prescribed during treatment. Calcium levels should be monitored, particularly in people at increased risk of hypocalcaemia.

Denosumab can cause side effects, although not everyone experiences them.

Common side effects

• Fatigue

• Musculoskeletal pain

• Back pain

• Headache

• Nausea

• Diarrhoea

• Anaemia

• Low phosphate levels

• Injection-site reactions

• Upper respiratory tract infections

• Rash

The type and frequency of side effects can vary depending on the condition being treated.

Serious side effects

Seek immediate medical attention if you develop:

• Severe hypocalcaemia, which may cause muscle spasms, cramps, tingling, seizures or abnormal heart rhythm

• Severe allergic reaction, including swelling of the face, lips, tongue or throat and difficulty breathing

• Osteonecrosis of the jaw, particularly if there is persistent jaw pain, swelling, loose teeth or poor healing after dental procedures

• Atypical femoral fracture, which may cause new or unusual pain in the thigh, hip or groin

• Symptoms of other serious complications following treatment

Severe hypocalcaemia is particularly important in people with severe kidney impairment or those receiving dialysis.

• Denosurel should be administered only by a healthcare professional.

• Take calcium and vitamin D supplements exactly as prescribed by your doctor.

• Your doctor may monitor your calcium levels during treatment, particularly if you have kidney disease.

• Tell your doctor if you have severe kidney disease or are receiving dialysis because the risk of severe hypocalcaemia is higher in these patients.

• Maintain good oral hygiene and attend regular dental check-ups.

• Tell your dentist that you are receiving Denosumab before undergoing dental treatment.

• Avoid invasive dental procedures where possible during treatment unless they are medically necessary.

• Tell your doctor if you develop persistent jaw pain, loose teeth or poor healing in the mouth.

• Report new or unusual pain in the thigh, hip or groin, as this may require assessment for an atypical femoral fracture.

• Do not stop Denosumab treatment without speaking to your doctor. Stopping treatment can increase the risk of multiple vertebral fractures in some patients.