Prolia 60 mg/mL - Denosumab Prefilled Syringe for Subcutaneous Injection

Prolia Injection 60 Mg/Ml

Description:

Prolia Injection 60 mg/ml is a prescription injectable medicine containing denosumab, a human monoclonal antibody used to treat osteoporosis and other serious bone conditions. It belongs to a class of medicines known as RANKL inhibitors and works by reducing bone breakdown, increasing bone mass and strength, and lowering the risk of fractures. Prolia is administered as a pre-filled syringe by a healthcare professional, typically once every 6 months, for long-term management of osteoporosis and treatment-induced bone loss in adults at high risk of fractures.

Indications:

• Treatment of osteoporosis in postmenopausal women at high risk of fractures (e.g., history of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other osteoporosis therapies).
• Treatment of osteoporosis in adult men at high risk of fractures.
• Treatment of bone loss associated with long-term systemic glucocorticoid (steroid) therapy in adults at increased risk of fracture.
• Treatment of bone loss in men receiving androgen-deprivation therapy for non-metastatic prostate cancer who are at increased risk of fractures.
• Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at increased risk of fractures.
• Helps increase bone mineral density (BMD) and reduce the incidence of vertebral, non-vertebral, and hip fractures in appropriate patients.

Active Ingredients / Key Components:

• Denosumab – 60 mg per pre-filled syringe (concentration: 60 mg/ml).
• Excipients (inactive ingredients): Detailed excipient list and their concentrations , please check the product leaflet or the manufacturer’s official website. Refer to the official package leaflet for the full list of excipients.

Dosage & Administration / How to Use:

• Recommended dose for osteoporosis and treatment-induced bone loss in adults: 60 mg denosumab administered as a single subcutaneous injection once every 6 months.
• Route of administration: Subcutaneous injection (under the skin), usually in the upper arm, upper thigh, or abdomen.
• Prolia should be administered by a healthcare professional or under their supervision, following aseptic technique.
• Patients should receive adequate calcium and vitamin d supplementation during treatment to reduce the risk of hypocalcemia, unless contraindicated. Typical supplementation is often at least 1000 mg elemental calcium and 400–800 iu vitamin d daily, but exact doses must be determined by the treating physician.
• Do not shake the pre-filled syringe. Allow the syringe to reach room temperature (about 15–30 minutes) before injection. Do not warm by any external heat source.
• Inspect the solution visually before use. Do not use if the solution is cloudy, discolored, or contains particulate matter.
• Missed dose: If a dose is missed, it should be administered as soon as possible. Thereafter, schedule subsequent injections every 6 months from the date of the last injection. Always follow your doctor’s instructions.
• Do not self-inject unless you have been properly trained by a healthcare professional and your doctor has approved home administration.

Clinical Benefits:

• Reduces bone resorption by inhibiting RANKL, thereby decreasing the activity and formation of osteoclasts (bone-resorbing cells).
• Increases bone mineral density in the spine, hip, and other skeletal sites, improving overall bone strength.
• Significantly lowers the risk of vertebral, non-vertebral, and hip fractures in patients with osteoporosis at high fracture risk.
• Helps prevent further bone loss in patients receiving hormone-deprivation therapies (such as aromatase inhibitors in breast cancer or androgen-deprivation therapy in prostate cancer).
• Convenient dosing schedule (once every 6 months) may support better long-term adherence compared with more frequent osteoporosis treatments.

Warnings & Contraindications:

• Contraindicated in patients with hypocalcemia (low blood calcium). Serum calcium must be corrected before starting Prolia and monitored during therapy.
• Use with caution in patients with severe renal impairment or on dialysis, as they are at increased risk of hypocalcemia. Close monitoring of calcium, phosphorus, and magnesium is recommended.
• May increase the risk of serious infections, particularly in patients with compromised immune systems or on immunosuppressive therapy. Report signs of infection (fever, chills, persistent sore throat, skin infections, urinary symptoms) promptly.
• Cases of osteonecrosis of the jaw (ONJ) have been reported, especially in patients with risk factors such as invasive dental procedures, poor oral hygiene, cancer, chemotherapy, corticosteroids, or previous bisphosphonate use. A dental examination and preventive dental care are recommended before starting treatment. Avoid invasive dental procedures during treatment if possible.
• Atypical femoral fractures have been reported. Patients should report new or unusual thigh, hip, or groin pain.
• Skin reactions such as dermatitis, eczema, and rashes may occur. Seek medical advice if severe or persistent skin symptoms develop.
• Rebound increase in bone turnover and risk of multiple vertebral fractures have been reported after discontinuation. Do not stop Prolia without consulting your doctor; alternative osteoporosis therapy may be required after stopping.
• Pregnancy and breastfeeding: Prolia is not recommended during pregnancy and should not be used in women who are breastfeeding unless clearly needed and prescribed by a specialist. Effective contraception is advised during treatment and for at least 5 months after the last dose for women of childbearing potential.
• Consult your doctor before use if you are pregnant, planning pregnancy, breastfeeding, have kidney disease, parathyroid disorders, malabsorption syndromes, history of thyroid or parathyroid surgery, or any condition affecting calcium metabolism.
• Not intended to diagnose, treat, cure, or prevent any disease without a doctor’s prescription and supervision.
• Keep out of reach of children.

Side Effects:

• Common side effects: Joint pain (arthralgia), muscle pain (myalgia), back pain, limb pain (arms or legs), high cholesterol levels, urinary tract infections, upper respiratory tract infections, and skin rashes or eczema.
• Less common but important side effects: Hypocalcemia (low blood calcium) which may cause muscle spasms, cramps, tingling in fingers, toes, or around the mouth; serious infections (cellulitis, ear infections); osteonecrosis of the jaw; atypical femoral fractures; and severe allergic reactions.
• Seek immediate medical attention if you experience symptoms of severe allergic reaction (difficulty breathing, swelling of face/lips/tongue/throat, severe rash), signs of severe infection (fever, chills, redness or swelling of skin, severe pain), symptoms of hypocalcemia, or sudden/unusual thigh, hip, or groin pain.
• This is not a complete list of side effects. Always read the patient information leaflet and consult your doctor or pharmacist if you notice any unexpected or persistent symptoms.

Storage Instructions:

Store in a refrigerator at 2–8°c. Do not freeze. Keep the pre-filled syringe in the original carton to protect it from light. If necessary, Prolia may be kept at room temperature (up to 25°c) in the original carton for a single period of up to 30 days; once removed from the refrigerator and stored at room temperature, it must be used within this period and must not be returned to the refrigerator. Do not use if it has been frozen. Keep container out of sight and reach of children.

Specifications:

• Product form: Pre-filled syringe for subcutaneous injection.
• Strength: 60 mg denosumab per ml (60 mg/1 pre-filled syringe).
• Pack size: 1 pre-filled syringe (single-dose).
• Route of administration: Subcutaneous.
• Intended use: Prescription-only medicine for adult osteoporosis and treatment-induced bone loss under medical supervision.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.