Product Introduction:
Denosta 60mg is an anti-resorptive bone drug used for managing osteoporosis in postmenopausal women, bone loss in cancer patients, and bone metastases. It is a human monoclonal antibody that prevents bone destruction by inhibiting osteoclast activity.
Uses of Denosta 60mg Injection:
Denosta 60mg is prescribed for:
-
Postmenopausal Osteoporosis – To strengthen bones and reduce fracture risks.
-
Osteoporosis in Men – For men at high risk of fractures.
-
Bone Loss in Cancer Patients – Used in men receiving androgen deprivation therapy (ADT) for prostate cancer and women undergoing aromatase inhibitor therapy for breast cancer.
-
Prevention of Skeletal-Related Events (SREs) – In patients with bone metastases from solid tumors.
-
Giant Cell Tumor of Bone (GCTB) – Used when surgery is not an option.
-
Hypercalcemia of Malignancy – In cancer patients with high calcium levels resistant to other treatments.
Storage Instructions:
-
Store in a refrigerator (2°C – 8°C).
-
Do not freeze or expose to extreme heat.
-
Keep in original packaging to protect from light.
-
Before use, let the injection reach room temperature (approx. 30 minutes).
-
Do not shake the vial or syringe.
How Denosta 60mg 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 the activation of osteoclasts (cells that break down bone).
-
Reducing bone turnover, leading to increased bone mass and strength.
-
Preventing bone loss in cancer patients receiving hormone therapy.
Side Effects:
Common Side Effects:
-
Fatigue and weakness
-
Low calcium levels (Hypocalcemia)
-
Joint pain and back pain
-
Skin rash or itching
-
Mild flu-like symptoms
Severe Side Effects (Rare but Serious):
-
Severe Hypocalcemia (Muscle cramps, confusion, irregular heartbeat)
-
Jaw Bone Problems (Osteonecrosis of the Jaw – ONJ) – May cause jaw pain, swelling, or delayed healing.
-
Unusual Bone Fractures – Rare but possible thigh bone fractures.
-
Serious Infections – Increased risk of skin infections and urinary tract infections.
-
Allergic Reactions – Swelling of face, difficulty breathing, dizziness.
Seek immediate medical attention if any severe side effects occur.
Dosage (Typical Recommended Dose):
For Osteoporosis & Bone Loss:
-
60 mg once every 6 months as a subcutaneous injection in the upper arm, thigh, or abdomen.
For Bone Metastases & Giant Cell Tumor of Bone:
-
120 mg every 4 weeks with an additional loading dose on days 8 and 15 of the first month.
Important:
-
Calcium and Vitamin D supplements are recommended during treatment.
-
Do not miss scheduled doses to maintain bone protection.
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, let the injection reach room temperature for 30 minutes.
-
Do not shake or dilute the solution.
Precautions:
-
Check calcium levels regularly – Risk of hypocalcemia.
-
Dental check-ups are recommended – To prevent jaw osteonecrosis.
-
Not recommended in pregnancy or breastfeeding.
-
Patients with kidney disease require close monitoring due to high risk of low calcium levels.
-
Avoid invasive dental procedures during treatment.
Drug Interactions:
Denosta 60mg may interact with:
-
Calcium & Vitamin D Supplements – Required to reduce hypocalcemia risk.
-
Corticosteroids (Prednisone, Dexamethasone) – May worsen bone loss.
-
Chemotherapy & Immunosuppressants – Increases infection risk.
-
Bisphosphonates (Alendronate, Zoledronic Acid) – Avoid using together.
-
Live Vaccines – Risk of reduced 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)
-
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 monitoring of electrolytes.
Missed Dose Instructions:
-
If a dose is missed, take it as soon as possible.
-
Continue regular dosing schedule – do not take an extra dose to compensate.
-
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:
Denosta 60mg is an anti-resorptive bone drug used for managing osteoporosis in postmenopausal women, bone loss in cancer patients, and bone metastases. It is a human monoclonal antibody that prevents bone destruction by inhibiting osteoclast activity.
Uses of Denosta 60mg Injection:
Denosta 60mg is prescribed for:
-
Postmenopausal Osteoporosis – To strengthen bones and reduce fracture risks.
-
Osteoporosis in Men – For men at high risk of fractures.
-
Bone Loss in Cancer Patients – Used in men receiving androgen deprivation therapy (ADT) for prostate cancer and women undergoing aromatase inhibitor therapy for breast cancer.
-
Prevention of Skeletal-Related Events (SREs) – In patients with bone metastases from solid tumors.
-
Giant Cell Tumor of Bone (GCTB) – Used when surgery is not an option.
-
Hypercalcemia of Malignancy – In cancer patients with high calcium levels resistant to other treatments.
Storage Instructions:
-
Store in a refrigerator (2°C – 8°C).
-
Do not freeze or expose to extreme heat.
-
Keep in original packaging to protect from light.
-
Before use, let the injection reach room temperature (approx. 30 minutes).
-
Do not shake the vial or syringe.
How Denosta 60mg 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 the activation of osteoclasts (cells that break down bone).
-
Reducing bone turnover, leading to increased bone mass and strength.
-
Preventing bone loss in cancer patients receiving hormone therapy.
Side Effects:
Common Side Effects:
-
Fatigue and weakness
-
Low calcium levels (Hypocalcemia)
-
Joint pain and back pain
-
Skin rash or itching
-
Mild flu-like symptoms
Severe Side Effects (Rare but Serious):
-
Severe Hypocalcemia (Muscle cramps, confusion, irregular heartbeat)
-
Jaw Bone Problems (Osteonecrosis of the Jaw – ONJ) – May cause jaw pain, swelling, or delayed healing.
-
Unusual Bone Fractures – Rare but possible thigh bone fractures.
-
Serious Infections – Increased risk of skin infections and urinary tract infections.
-
Allergic Reactions – Swelling of face, difficulty breathing, dizziness.
Seek immediate medical attention if any severe side effects occur.
Dosage (Typical Recommended Dose):
For Osteoporosis & Bone Loss:
-
60 mg once every 6 months as a subcutaneous injection in the upper arm, thigh, or abdomen.
For Bone Metastases & Giant Cell Tumor of Bone:
-
120 mg every 4 weeks with an additional loading dose on days 8 and 15 of the first month.
Important:
-
Calcium and Vitamin D supplements are recommended during treatment.
-
Do not miss scheduled doses to maintain bone protection.
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, let the injection reach room temperature for 30 minutes.
-
Do not shake or dilute the solution.
Precautions:
-
Check calcium levels regularly – Risk of hypocalcemia.
-
Dental check-ups are recommended – To prevent jaw osteonecrosis.
-
Not recommended in pregnancy or breastfeeding.
-
Patients with kidney disease require close monitoring due to high risk of low calcium levels.
-
Avoid invasive dental procedures during treatment.
Drug Interactions:
Denosta 60mg may interact with:
-
Calcium & Vitamin D Supplements – Required to reduce hypocalcemia risk.
-
Corticosteroids (Prednisone, Dexamethasone) – May worsen bone loss.
-
Chemotherapy & Immunosuppressants – Increases infection risk.
-
Bisphosphonates (Alendronate, Zoledronic Acid) – Avoid using together.
-
Live Vaccines – Risk of reduced 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)
-
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 monitoring of electrolytes.
Missed Dose Instructions:
-
If a dose is missed, take it as soon as possible.
-
Continue regular dosing schedule – do not take an extra dose to compensate.
-
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.
