Denoci® Denosumab Injection

Description

What is Denosumab Injection?

Denosumab is a fully human monoclonal antibody designed to target and inhibit the RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) protein. RANKL is responsible for promoting the formation, function, and survival of osteoclasts—the cells that break down bone tissue. By blocking RANKL, Denosumab reduces bone resorption and helps strengthen bones.

It is administered as a subcutaneous injection, typically once every six months, making it a convenient long-term treatment option. There are two main formulations:

• Prolia (60 mg): Used for osteoporosis and bone loss.

• Xgeva (120 mg): Used for cancer-related bone conditions.

Denosumab Brand Names by Region

• United States, Canada, EU, UK, Australia: Prolia (60 mg), Xgeva (120 mg)

Approved Uses (On-Label Indications)

1. Osteoporosis in Postmenopausal Women
   Prolia is FDA-approved for the treatment of postmenopausal women with osteoporosis at high risk of fracture. Clinical trials have shown that Prolia significantly reduces the incidence of vertebral, non-vertebral, and hip fractures over time.

2. Osteoporosis in Men
   Denosumab is approved to treat men with osteoporosis who are at high risk of fracture.

3. Glucocorticoid-Induced Osteoporosis
   It is used to treat bone loss due to long-term steroid therapy in men and women.

4. Bone Loss in Prostate and Breast Cancer Patients
   For patients undergoing hormone ablation therapy, Denosumab helps prevent rapid bone degradation.

5. Skeletal-Related Events (SREs) in Cancer
   Xgeva (120 mg) is used to prevent skeletal complications such as fractures in patients with bone metastases from solid tumors, including breast, prostate, and lung cancers.

6. Giant Cell Tumor of Bone (GCTB)
   Denosumab is approved for unresectable or surgically challenging GCTB in adults and adolescents with mature skeletons.

References:
FDA Label for Prolia
European Medicines Agency – Prolia

Off-Label Uses

While not FDA-approved, Denosumab has shown promise in:

• Rheumatoid Arthritis: For preventing bone erosions.

• Osteogenesis Imperfecta: As an alternative to bisphosphonates in some patients.

• Paget’s Disease: In rare cases where standard treatment is contraindicated.

These off-label uses are still under clinical review and should be approached with caution under physician supervision.

Reference:
NIH Clinical Trials Database

Denosumab Mechanism of Action

Denosumab binds to RANKL with high affinity and specificity, preventing its interaction with the RANK receptor on osteoclasts and their precursors. This action inhibits osteoclast formation, function, and survival, leading to decreased bone resorption and increased bone mass and strength in both cortical and trabecular bone.

Reference:
PubMed: Denosumab Review

Denosumab Injection Cost and Price Information

• Prolia 60 mg price: Varies by region. In the U.S., the average retail price is around $1,300 per injection. Insurance and discount programs may reduce this.

• Xgeva 120 mg price: Approximately $2,600 per injection in the U.S.

• Denosumab injection cost in Canada, EU, and Australia is often significantly lower due to national healthcare subsidies.

Buy Prolia Online from licensed pharmacies with a valid prescription. Check with your regional provider or pharmacy for the most updated Prolia cost and availability.

Side Effects and Warnings

Common side effects include:

• Back pain

• Joint pain

• High cholesterol

• Urinary tract infections

Serious adverse events may include:

• Hypocalcemia (low calcium levels)

• Osteonecrosis of the jaw (especially in cancer patients)

• Atypical femoral fractures

• Skin infections (e.g., cellulitis)

Regular calcium and vitamin D supplementation is recommended. Patients should have dental exams prior to starting therapy to mitigate risk of jaw complications.

Reference:
Mayo Clinic – Denosumab Side Effects

Administration and Dosage

• Prolia (60 mg): Injected subcutaneously once every 6 months.

• Xgeva (120 mg): Injected subcutaneously every 4 weeks.

Injection should be administered by a healthcare professional or under guidance.

Contraindications

Denosumab is contraindicated in:

• Patients with hypocalcemia

• Pregnancy and breastfeeding (category X for Prolia)

• Known hypersensitivity to the drug or its components

Monitoring of calcium levels before and during treatment is essential.

Why Choose Denosumab Over Bisphosphonates?

Unlike bisphosphonates, which incorporate into bone matrix and persist long-term, Denosumab offers a reversible and more targeted mechanism. It is ideal for patients with renal impairment, as it is not cleared through the kidneys.

FAQ

What is Denosumab used for?
Denosumab is used to treat osteoporosis, prevent fractures, and manage bone complications in cancer patients with bone metastases.

What is the brand name of Denosumab?
Denosumab is marketed as Prolia (60 mg) and Xgeva (120 mg).

What is the generic name for Prolia?
The Prolia generic name is Denosumab.

How does Denosumab work?
It blocks RANKL, a protein involved in bone breakdown, thus reducing bone loss and increasing bone strength.

Can I buy Prolia online?
Yes, you can buy Prolia online from licensed pharmacies with a valid prescription.

What is the Prolia cost?
Prolia cost depends on your location and insurance. The Prolia 60 mg price averages $1,300 per dose in the U.S.