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:
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Postmenopausal Osteoporosis – To strengthen bones and reduce fracture risks.
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Osteoporosis in Men – For men at high risk of fractures.
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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.
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Prevention of Skeletal-Related Events (SREs) – In patients with bone metastases from solid tumors.
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Giant Cell Tumor of Bone (GCTB) – Used when surgery is not an option.
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Hypercalcemia of Malignancy – In cancer patients with high calcium levels resistant to other treatments.
Storage Instructions:
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Store in a refrigerator (2°C – 8°C).
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Do not freeze or expose to extreme heat.
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Keep in original packaging to protect from light.
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Before use, let the injection reach room temperature (approx. 30 minutes).
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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:
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Blocking RANKL, which is responsible for the activation of osteoclasts (cells that break down bone).
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Reducing bone turnover, leading to increased bone mass and strength.
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Preventing bone loss in cancer patients receiving hormone therapy.
Side Effects:
Common Side Effects:
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Fatigue and weakness
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Low calcium levels (Hypocalcemia)
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Joint pain and back pain
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Skin rash or itching
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Mild flu-like symptoms
Severe Side Effects (Rare but Serious):
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Severe Hypocalcemia (Muscle cramps, confusion, irregular heartbeat)
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Jaw Bone Problems (Osteonecrosis of the Jaw – ONJ) – May cause jaw pain, swelling, or delayed healing.
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Unusual Bone Fractures – Rare but possible thigh bone fractures.
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Serious Infections – Increased risk of skin infections and urinary tract infections.
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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:
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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:
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120 mg every 4 weeks with an additional loading dose on days 8 and 15 of the first month.
Important:
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Calcium and Vitamin D supplements are recommended during treatment.
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Do not miss scheduled doses to maintain bone protection.
Method of Administration:
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Given subcutaneously (SC) in the upper arm, thigh, or abdomen.
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Administered by a healthcare professional (self-administration is not recommended).
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Before use, let the injection reach room temperature for 30 minutes.
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Do not shake or dilute the solution.
Precautions:
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Check calcium levels regularly – Risk of hypocalcemia.
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Dental check-ups are recommended – To prevent jaw osteonecrosis.
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Not recommended in pregnancy or breastfeeding.
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Patients with kidney disease require close monitoring due to high risk of low calcium levels.
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Avoid invasive dental procedures during treatment.
Drug Interactions:
Denosta 60mg may interact with:
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Calcium & Vitamin D Supplements – Required to reduce hypocalcemia risk.
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Corticosteroids (Prednisone, Dexamethasone) – May worsen bone loss.
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Chemotherapy & Immunosuppressants – Increases infection risk.
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Bisphosphonates (Alendronate, Zoledronic Acid) – Avoid using together.
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Live Vaccines – Risk of reduced immune response.
Inform your doctor about all medications you are taking.
Allergies (Warnings for Allergic Reactions):
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Do not use if allergic to Denosumab or any inactive ingredients.
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Symptoms of an allergic reaction: rash, swelling, difficulty breathing, dizziness.
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Seek emergency medical help if severe allergic reactions occur.
Overdose Information:
Symptoms of overdose:
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Severe low calcium levels (muscle spasms, confusion, seizures)
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Bone pain or unusual fractures
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Severe fatigue or weakness
What to do in case of overdose?
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Seek immediate medical attention.
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Treatment includes IV calcium supplementation and monitoring of electrolytes.
Missed Dose Instructions:
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If a dose is missed, take it as soon as possible.
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Continue regular dosing schedule – do not take an extra dose to compensate.
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Long delays in dosing may increase the risk of fractures.
Additional Notes:
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Ensure adequate intake of calcium and vitamin D.
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Regular dental check-ups are required to monitor for jaw problems.
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Monitor kidney function if at risk of hypocalcemia.
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Patients undergoing chemotherapy or radiation should consult their doctor before use.
