Denosis 60 Injection

Denosis 60 mg/ml SC Injection

Generic Name: Denosumab
Strength: 60 mg/ml
Dosage Form: Subcutaneous Injection (Pre-filled Syringe)
Manufacturer: Incepta Pharmaceuticals Ltd.
Pack Size: 1 ml pre-filled syringe

Indications

Denosis (Denosumab) 60 mg/ml is a RANK Ligand (RANKL) inhibitor indicated for:

• Postmenopausal Women with Osteoporosis: At high risk for fracture (history of osteoporotic fracture, multiple risk factors, or failed/intolerant to other osteoporosis therapy). Reduces incidence of vertebral, nonvertebral, and hip fractures.
• Men with Osteoporosis: To increase bone mass at high risk for fracture.
• Glucocorticoid-Induced Osteoporosis: In men and women at high risk of fracture on systemic glucocorticoids (≥7.5 mg/day prednisone equivalent for ≥6 months).
• Bone Loss in Prostate Cancer Patients: Receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer.
• Bone Loss in Breast Cancer Patients: Receiving adjuvant aromatase inhibitor 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 increasing bone mass and strength.

Dosage & Administration

Dose: 60 mg given as a single subcutaneous injection every 6 months.

Injection sites: Upper arm, upper thigh, or abdomen. Must be administered by a healthcare professional.

Route: Subcutaneous only — do NOT administer IV, IM, or intradermally.

Calcium and Vitamin D supplementation: All patients should take calcium 1,000 mg daily and at least 400 IU vitamin D daily.

Missed dose: Administer as soon as possible; reschedule subsequent injections every 6 months from the date of the last injection.

Contraindications

• Hypocalcemia: Pre-existing 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

Postmenopausal osteoporosis (>5%): back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, cystitis. Serious: severe hypocalcemia (including fatal cases), osteonecrosis of the jaw, atypical femoral fractures, serious infections (cellulitis), dermatologic reactions, severe bone/joint/muscle pain.

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 for use in pediatric patients (except skeletally mature adolescents with giant cell tumor of bone at 120 mg dose). Geriatric: No overall differences in safety or efficacy. Renal impairment: No dose adjustment needed, but monitor calcium levels carefully in patients with 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: ৳18,000.00 per 1 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.