Denosis 120 Injection

Denosis 120 mg/1.7 ml SC Injection

Generic Name: Denosumab
Strength: 120 mg/1.7 ml
Dosage Form: Subcutaneous Injection (Pre-filled Syringe)
Manufacturer: Incepta Pharmaceuticals Ltd.
Pack Size: 1.7 ml pre-filled syringe

Indications

Denosis (Denosumab) 120 mg is a RANK Ligand (RANKL) inhibitor indicated for:

• Prevention of Skeletal-Related Events (SREs): In patients with multiple myeloma and in patients with bone metastases from solid tumors.
• Giant Cell Tumor of Bone (GCTB): Treatment of adults and skeletally mature adolescents with unresectable GCTB or where surgical resection is likely to result in severe morbidity.
• Hypercalcemia of Malignancy: Refractory to bisphosphonate therapy.

Pharmacology

Denosumab is a fully human IgG2 monoclonal antibody that binds with high affinity and specificity to RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand). By preventing RANKL from activating its receptor RANK on osteoclast surfaces, Denosumab inhibits osteoclast formation, function, and survival — thereby decreasing bone resorption and preventing skeletal-related events in oncology settings.

Dosage & Administration

Route: Subcutaneous injection only — do NOT administer IV, IM, or intradermally. Must be administered by a healthcare professional.

Injection sites: Upper arm, upper thigh, or abdomen.

• Bone Metastases & Multiple Myeloma: 120 mg every 4 weeks SC injection.
• Giant Cell Tumor of Bone: 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.
• Hypercalcemia of Malignancy: 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.

Supplement with calcium and vitamin D as necessary to treat or prevent hypocalcemia.

Contraindications

• Hypocalcemia: Must be corrected before initiating therapy.
• Hypersensitivity: Contraindicated in patients with known systemic hypersensitivity (anaphylaxis, facial swelling, urticaria) to any component.
• Pregnancy: May cause fetal harm; pregnancy testing required in women of reproductive potential before initiation.

Side Effects

Bone metastasis (>25%): fatigue/asthenia, hypophosphatemia, nausea. Multiple myeloma (>10%): diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory infection, rash, headache. GCTB (>10%): arthralgia, headache, nausea, back pain, fatigue, pain in extremity. Hypercalcemia of malignancy (>20%): nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, diarrhea.

Serious reactions: severe hypocalcemia (potentially fatal), osteonecrosis of the jaw, atypical femoral fractures, serious infections (cellulitis), dermatologic reactions (dermatitis, rash, eczema), severe bone/joint/muscle pain, rebound hypercalcemia after GCTB treatment discontinuation.

Drug Interactions

No clinically significant drug interactions identified. Denosumab does not affect CYP3A4-metabolized drugs.

Pregnancy & Lactation

May cause fetal harm. Women of reproductive potential must use effective contraception during therapy and for at least 5 months after the last dose. Consider risks and benefits before breastfeeding during treatment.

Use in Special Populations

Pediatric: Not approved except for skeletally mature adolescents with GCTB. Geriatric: No overall differences in safety or efficacy. Renal impairment: No dose adjustment needed; monitor calcium carefully if creatinine clearance <30 mL/min or on dialysis.

Storage

Store at 2°C to 8°C (refrigerated) in original carton. Do not freeze. Once removed from refrigerator, do not expose to temperatures above 25°C or direct light — use within 14 days. Discard if not used within 14 days. Avoid vigorous shaking.

Pricing

Unit Price: ৳35,000.00 per 1.7 ml pre-filled syringe

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.