Prolia Denosumab 60 mg/mL Prefilled Syringe Injection by Amgen (RX) **Requires Refrigeration**

Prolia® (denosumab) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia (denosumab) 60 mg/mL is a prescription medication manufactured by Amgen, available in a prefilled syringe for subcutaneous injection. This biologic agent is primarily used to treat osteoporosis in postmenopausal women and men at high risk for fractures. It works by inhibiting a specific protein involved in bone resorption, ultimately improving bone density and reducing the likelihood of fractures.

• Active Ingredient: Denosumab
• Dosage:  60 mg/mL per prefilled syringe
• Administration: Subcutaneous injection, typically administered once every six months
• Brand: Prolia®
• Manufacturer: Amgen Inc
• Application: Bone Resorption Inhibitor
• Container Type: Prefilled Syringe
• Dosage Form: Injection
• Preservative Free
• NDC Number: 55513-0710-01
• UPC: 355513710015
• Storage Requirements: Requires Refrigeration

Indications:

• Treatment of osteoporosis in postmenopausal women at high risk for fracture.
• Increase in bone mass in men with osteoporosis at high risk for fracture.
• Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer.
• Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer.

Mechanism of Action:

Denosumab is a monoclonal antibody that targets and binds to RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand), a protein essential for the formation, function, and survival of osteoclasts (cells responsible for bone resorption). By inhibiting RANKL, Prolia effectively decreases the breakdown of bone, leading to increased bone mass and strength.

Administration Instructions:

• Administered by a healthcare professional or with proper training for self-administration
• Injection site should be the upper arm, upper thigh, or abdomen
• Follow proper sterilization techniques to minimize the risk of infection

 Side Effects:

Common side effects may include back pain, musculoskeletal pain, elevated cholesterol levels, and urinary tract infections. Serious adverse reactions could involve hypocalcemia (low blood calcium levels), serious infections, dermatologic reactions, and osteonecrosis of the jaw.

Storage:

• Store in a refrigerator between 2°C to 8°C (36°F to 46°F)
• Do not freeze
• Protect from light
• Keep the syringe in the outer carton until ready for use

Contraindications:

• Hypersensitivity to denosumab or any inactive ingredient in Prolia
• Patients with hypocalcemia must have their condition corrected before receiving Prolia

Precautions:

• Ensure adequate intake of calcium and vitamin D to mitigate the risk of hypocalcemia
• Regular monitoring of calcium levels, especially in individuals at risk
• Inform your healthcare provider of any medical conditions, including existing dental problems or upcoming dental procedures

Prolia represents an important advancement in the management of osteoporosis and other related conditions, offering a significant improvement in patient outcomes through its targeted approach to bone preservation.