Product Introduction:
Denosurel 120mg is a bone-targeted therapy used for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors, treatment of giant cell tumor of bone (GCTB), and management of hypercalcemia of malignancy. It works by inhibiting osteoclast activity, thereby reducing bone loss and fractures.
Uses of Denosurel 120mg Injection:
Denosurel 120mg is prescribed for:
-
Bone Metastases from Solid Tumors – Prevents bone complications in cancer patients.
-
Giant Cell Tumor of Bone (GCTB) – Used in adults and adolescents when surgery is not an option.
-
Hypercalcemia of Malignancy (HCM) – Treats high calcium levels in cancer patients when standard therapy fails.
-
Prevention of Skeletal-Related Events (SREs) – Reduces the risk of fractures, spinal cord compression, and the need for radiation therapy in cancer patients.
Storage Instructions:
-
Store in a refrigerator (2°C – 8°C).
-
Do not freeze or expose to high temperatures.
-
Keep in original packaging to protect from light.
-
Before use, allow the injection to reach room temperature (about 30 minutes).
-
Do not shake the vial or syringe.
How Denosurel 120mg Works (Mechanism of Action):
Denosumab is a RANK Ligand (RANKL) inhibitor that prevents osteoclast activation and bone resorption. It works by:
-
Blocking RANKL, which is responsible for stimulating osteoclasts (cells that break down bone).
-
Reducing bone breakdown, leading to stronger bones and a lower risk of fractures.
-
Slowing tumor-related bone destruction, which is beneficial for patients with bone metastases and GCTB.
Side Effects:
Common Side Effects:
-
Low calcium levels (Hypocalcemia)
-
Fatigue and weakness
-
Joint and muscle pain
-
Nausea
-
Flu-like symptoms
-
Skin rash or itching
Severe Side Effects (Rare but Serious):
-
Severe Hypocalcemia (muscle cramps, confusion, irregular heartbeat, seizures)
-
Osteonecrosis of the Jaw (ONJ) – A rare but serious condition causing jaw pain and delayed healing.
-
Atypical Bone Fractures – Unusual thigh bone fractures may occur.
-
Serious Infections – Increased risk of skin, urinary tract, or lung infections.
-
Severe Allergic Reactions – Swelling of the face, difficulty breathing, dizziness.
Seek immediate medical attention if any severe side effects occur.
Dosage (Typical Recommended Dose):
For Bone Metastases from Solid Tumors:
-
120 mg every 4 weeks as a subcutaneous injection.
For Giant Cell Tumor of Bone (GCTB):
-
120 mg every 4 weeks, with additional doses on days 8 and 15 of the first month.
For Hypercalcemia of Malignancy (HCM):
-
120 mg every 4 weeks until calcium levels normalize.
Important:
-
Calcium and Vitamin D supplements are recommended during treatment.
-
Regular blood tests are required to monitor calcium levels.
Method of Administration:
-
Given subcutaneously (SC) in the upper arm, thigh, or abdomen.
-
Administered by a healthcare professional (self-administration is not recommended).
-
Before use, allow the injection to reach room temperature for 30 minutes.
-
Do not shake or dilute the solution.
Precautions:
-
Monitor calcium levels regularly to prevent hypocalcemia.
-
Dental check-ups are recommended to prevent jaw osteonecrosis.
-
Avoid invasive dental procedures while on treatment.
-
Not recommended in pregnancy or breastfeeding.
-
Patients with kidney disease require close monitoring due to increased risk of hypocalcemia.
Drug Interactions:
Denosurel 120mg may interact with:
-
Calcium & Vitamin D Supplements – Essential to reduce hypocalcemia risk.
-
Corticosteroids (Prednisone, Dexamethasone) – May worsen bone loss.
-
Chemotherapy & Immunosuppressants – Increases infection risk.
-
Bisphosphonates (Zoledronic Acid, Alendronate) – Avoid using together.
-
Live Vaccines – May reduce immune response.
Inform your doctor about all medications you are taking.
Allergies (Warnings for Allergic Reactions):
-
Do not use if allergic to Denosumab or any inactive ingredients.
-
Symptoms of an allergic reaction: rash, swelling, difficulty breathing, dizziness.
-
Seek emergency medical help if severe allergic reactions occur.
Overdose Information:
Symptoms of overdose:
-
Severe low calcium levels (muscle spasms, confusion, seizures, irregular heartbeat)
-
Bone pain or unusual fractures
-
Severe fatigue or weakness
What to do in case of overdose?
-
Seek immediate medical attention.
-
Treatment includes IV calcium supplementation and electrolyte monitoring.
Missed Dose Instructions:
-
If a dose is missed, take it as soon as possible.
-
Do not double the dose to compensate for a missed one.
-
Long delays in dosing may increase the risk of fractures.
Additional Notes:
-
Ensure adequate intake of calcium and vitamin D.
-
Regular dental check-ups are required to monitor for jaw problems.
-
Monitor kidney function if at risk of hypocalcemia.
-
Patients undergoing chemotherapy or radiation should consult their doctor before use.
Product Introduction:
Denosurel 120mg is a bone-targeted therapy used for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors, treatment of giant cell tumor of bone (GCTB), and management of hypercalcemia of malignancy. It works by inhibiting osteoclast activity, thereby reducing bone loss and fractures.
Uses of Denosurel 120mg Injection:
Denosurel 120mg is prescribed for:
-
Bone Metastases from Solid Tumors – Prevents bone complications in cancer patients.
-
Giant Cell Tumor of Bone (GCTB) – Used in adults and adolescents when surgery is not an option.
-
Hypercalcemia of Malignancy (HCM) – Treats high calcium levels in cancer patients when standard therapy fails.
-
Prevention of Skeletal-Related Events (SREs) – Reduces the risk of fractures, spinal cord compression, and the need for radiation therapy in cancer patients.
Storage Instructions:
-
Store in a refrigerator (2°C – 8°C).
-
Do not freeze or expose to high temperatures.
-
Keep in original packaging to protect from light.
-
Before use, allow the injection to reach room temperature (about 30 minutes).
-
Do not shake the vial or syringe.
How Denosurel 120mg Works (Mechanism of Action):
Denosumab is a RANK Ligand (RANKL) inhibitor that prevents osteoclast activation and bone resorption. It works by:
-
Blocking RANKL, which is responsible for stimulating osteoclasts (cells that break down bone).
-
Reducing bone breakdown, leading to stronger bones and a lower risk of fractures.
-
Slowing tumor-related bone destruction, which is beneficial for patients with bone metastases and GCTB.
Side Effects:
Common Side Effects:
-
Low calcium levels (Hypocalcemia)
-
Fatigue and weakness
-
Joint and muscle pain
-
Nausea
-
Flu-like symptoms
-
Skin rash or itching
Severe Side Effects (Rare but Serious):
-
Severe Hypocalcemia (muscle cramps, confusion, irregular heartbeat, seizures)
-
Osteonecrosis of the Jaw (ONJ) – A rare but serious condition causing jaw pain and delayed healing.
-
Atypical Bone Fractures – Unusual thigh bone fractures may occur.
-
Serious Infections – Increased risk of skin, urinary tract, or lung infections.
-
Severe Allergic Reactions – Swelling of the face, difficulty breathing, dizziness.
Seek immediate medical attention if any severe side effects occur.
Dosage (Typical Recommended Dose):
For Bone Metastases from Solid Tumors:
-
120 mg every 4 weeks as a subcutaneous injection.
For Giant Cell Tumor of Bone (GCTB):
-
120 mg every 4 weeks, with additional doses on days 8 and 15 of the first month.
For Hypercalcemia of Malignancy (HCM):
-
120 mg every 4 weeks until calcium levels normalize.
Important:
-
Calcium and Vitamin D supplements are recommended during treatment.
-
Regular blood tests are required to monitor calcium levels.
Method of Administration:
-
Given subcutaneously (SC) in the upper arm, thigh, or abdomen.
-
Administered by a healthcare professional (self-administration is not recommended).
-
Before use, allow the injection to reach room temperature for 30 minutes.
-
Do not shake or dilute the solution.
Precautions:
-
Monitor calcium levels regularly to prevent hypocalcemia.
-
Dental check-ups are recommended to prevent jaw osteonecrosis.
-
Avoid invasive dental procedures while on treatment.
-
Not recommended in pregnancy or breastfeeding.
-
Patients with kidney disease require close monitoring due to increased risk of hypocalcemia.
Drug Interactions:
Denosurel 120mg may interact with:
-
Calcium & Vitamin D Supplements – Essential to reduce hypocalcemia risk.
-
Corticosteroids (Prednisone, Dexamethasone) – May worsen bone loss.
-
Chemotherapy & Immunosuppressants – Increases infection risk.
-
Bisphosphonates (Zoledronic Acid, Alendronate) – Avoid using together.
-
Live Vaccines – May reduce immune response.
Inform your doctor about all medications you are taking.
Allergies (Warnings for Allergic Reactions):
-
Do not use if allergic to Denosumab or any inactive ingredients.
-
Symptoms of an allergic reaction: rash, swelling, difficulty breathing, dizziness.
-
Seek emergency medical help if severe allergic reactions occur.
Overdose Information:
Symptoms of overdose:
-
Severe low calcium levels (muscle spasms, confusion, seizures, irregular heartbeat)
-
Bone pain or unusual fractures
-
Severe fatigue or weakness
What to do in case of overdose?
-
Seek immediate medical attention.
-
Treatment includes IV calcium supplementation and electrolyte monitoring.
Missed Dose Instructions:
-
If a dose is missed, take it as soon as possible.
-
Do not double the dose to compensate for a missed one.
-
Long delays in dosing may increase the risk of fractures.
Additional Notes:
-
Ensure adequate intake of calcium and vitamin D.
-
Regular dental check-ups are required to monitor for jaw problems.
-
Monitor kidney function if at risk of hypocalcemia.
-
Patients undergoing chemotherapy or radiation should consult their doctor before use.
