Rozel 60mg 1ml Injection

Rozel 60mg 1ml Injection contains Denosumab (60mg/ml), a monoclonal antibody used to treat osteoporosis and other bone-related conditions by reducing bone breakdown.

Benefits

Rozel Injection helps strengthen bones and significantly reduces the risk of fractures in individuals prone to bone weakening. It works by targeting a specific protein involved in bone resorption, thereby increasing bone density and improving overall bone health.

Uses and Indications

• Treatment of osteoporosis in postmenopausal women at high risk of fracture.
• Treatment of osteoporosis in men at increased risk of fractures.
• Treatment of bone loss in men with prostate cancer receiving hormone ablation therapy, 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.
• Treatment of giant cell tumor of bone (GCTB) that cannot be removed surgically or when surgery poses significant risks.
• Treatment of hypercalcemia associated with cancer that has not responded to bisphosphonate treatment.
• Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

The Rozel 60mg 1ml Injection contains:

• Denosumab 60 mg/mL (active ingredient).
• Excipients: Sorbitol, Polysorbate 20, Glacial acetic acid, Sodium hydroxide, Water for injection.

Dosage and Administration

1. The recommended dose is 60 mg, administered as a single subcutaneous (SC) injection once every six months.
2. The injection should be given by a healthcare professional into the thigh, abdomen, or upper arm. Do not self-administer this medicine.
3. Patients should receive adequate calcium (at least 1000 mg) and vitamin D (at least 400 IU) supplementation daily during treatment to support bone health.

Storage and Disposal

• Store in a refrigerator between 2°C and 8°C. Do not freeze.
• Keep the medicine in its original carton to protect it from light.
• Keep out of the reach and sight of children.

Precautions and Safety

• Inform your doctor if you have or have ever had low calcium levels in your blood (hypocalcemia), as this condition must be corrected before starting treatment. Your doctor will monitor calcium levels during therapy.
• Be aware of the potential for serious infections; avoid close contact with sick individuals.
• Report any new or unusual pain in your hip, groin, or thigh, as this could indicate an atypical thigh bone fracture.
• Discuss any planned dental procedures with your doctor, as there is a rare risk of osteonecrosis of the jaw.
• Seek immediate medical attention if you experience symptoms of an allergic reaction, such as rash, lightheadedness, dizziness, swelling of the face, tongue, or throat, trouble breathing, or chest pain after injection.

Side Effects and Risks

• Common side effects may include back pain, joint pain, pain in arms or legs, headache, constipation, abdominal discomfort, and skin rash.
• Other reported side effects include urinary tract infections, high cholesterol, eczema, upper respiratory tract infection, sciatica, and hair loss.
• Serious side effects, though rare, can include severe hypocalcemia, atypical femur fractures, and osteonecrosis of the jaw.

Disclaimer

Use this medicine only under the prescription and guidance of a qualified doctor or pharmacist.