Xgeva® (Denosumab)

Xgeva® (Denosumab)

Description

Denosumab 120mg Injection — RANK Ligand Inhibitor for Bone Metastases and Giant Cell Tumour of Bone

Additional Information

Xgeva® (Denosumab 120mg) — Prevention of Skeletal Related Events in Bone Metastases

The Leading Bone-Targeted Therapy for Cancer Patients with Bone Involvement

Xgeva® (Denosumab 120mg) is a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), used to prevent skeletal related events (SREs) in patients with bone metastases from solid tumours, to treat giant cell tumour of bone (GCTB), and to treat hypercalcaemia of malignancy refractory to bisphosphonate therapy.

A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Xgeva (Denosumab 120mg) to hospitals, oncology centres, and pharmacies across India. Manufactured by Amgen, Xgeva is one of the most important bone-targeted therapies in oncology practice.

Important: Xgeva (120mg every 4 weeks) is a different product from Prolia (Denosumab 60mg every 6 months) and is used for different indications. Do not substitute one for the other.


What is Xgeva (Denosumab 120mg)?

Xgeva contains Denosumab 120mg — a higher dose than Prolia — administered every 4 weeks for oncology indications. In patients with cancer, tumour cells in bone trigger excessive RANKL expression by stromal cells and osteoblasts, leading to pathological osteoclast activation. This results in bone destruction, pain, fractures, spinal cord compression, and hypercalcaemia — collectively known as skeletal related events (SREs).

By inhibiting RANKL, Xgeva reduces osteoclast-mediated bone destruction in cancer patients, preventing SREs and improving quality of life and survival outcomes.

Full prescribing information is available at the FDA label for Xgeva.


Clinical Studies and Evidence

Study 20050103 (Xgeva vs Zoledronic Acid in Breast Cancer Bone Metastases) Published in The Lancet Oncology (2010), this Phase 3 trial demonstrated Xgeva was superior to Zoledronic Acid in delaying time to first SRE in patients with breast cancer and bone metastases, with a 23% reduction in risk of first on-study SRE.

Study 20050244 (Xgeva vs Zoledronic Acid in Prostate Cancer Bone Metastases) Published in The Lancet (2011), this Phase 3 trial showed Xgeva significantly delayed time to first SRE compared to Zoledronic Acid in patients with castration-resistant prostate cancer and bone metastases.

Study 20050292 (Xgeva vs Zoledronic Acid in Other Solid Tumours) This trial in patients with bone metastases from solid tumours (excluding breast and prostate) and multiple myeloma demonstrated Xgeva was non-inferior to Zoledronic Acid in delaying time to first SRE, with superiority trends in several subgroups.

Giant Cell Tumour of Bone (GCTB) Study Published in The Lancet Oncology (2013), this study demonstrated that Xgeva produced tumour responses in 96% of patients with unresectable or recurrent GCTB, establishing it as the standard treatment for this rare bone tumour.


Available Strengths

Xgeva is available as:

  • 120mg/1.7mL solution in a single-use vial

The recommended dose is 120mg subcutaneously every 4 weeks — with additional 120mg doses on days 8 and 15 of the first month for hypercalcaemia of malignancy. Patients should receive calcium and vitamin D supplementation unless hypercalcaemia is present.


Indications — What Xgeva is Used For

Prevention of Skeletal Related Events (SREs)

  • Prevention of SREs (pathological fracture, radiation to bone, surgery to bone, spinal cord compression) in adults with bone metastases from solid tumours including:
    • Breast cancer bone metastases
    • Prostate cancer bone metastases
    • Non-small cell lung cancer bone metastases
    • Other solid tumour bone metastases

Giant Cell Tumour of Bone (GCTB)

  • Treatment of adults and skeletally mature adolescents with unresectable GCTB
  • Treatment of GCTB where surgical resection is likely to result in severe morbidity

Hypercalcaemia of Malignancy

  • Treatment of hypercalcaemia of malignancy refractory to bisphosphonate therapy

For detailed indication information refer to NCI Denosumab Drug Information.


Key Benefits of Xgeva

Superior to Zoledronic Acid in Breast and Prostate Cancer Head-to-head trials demonstrate Xgeva is superior to the previous standard of care (Zoledronic Acid) in delaying SREs in breast and prostate cancer bone metastases — without requiring renal dose adjustment.

No Renal Dose Adjustment Required Unlike Zoledronic Acid (Zometa) which requires dose reduction or is contraindicated in renal impairment, Xgeva can be used at the full dose regardless of renal function — a significant clinical advantage in cancer patients who often have compromised kidney function.

Subcutaneous Administration Xgeva is given as a subcutaneous injection rather than an intravenous infusion, eliminating the need for IV access and infusion chair time.

Effective in GCTB Xgeva is the only approved systemic treatment for unresectable or recurrent Giant Cell Tumour of Bone, producing responses in 96% of patients.

Reduces Pain and Improves Quality of Life By preventing SREs Xgeva reduces bone pain, maintains mobility, and improves quality of life in cancer patients with bone involvement.


How Xgeva Works

In cancer patients with bone metastases the mechanism of bone destruction involves:

  • Tumour cells secreting factors that stimulate RANKL expression by bone stromal cells
  • Elevated RANKL driving excessive osteoclast activation and bone resorption
  • Bone-derived growth factors released during resorption stimulating further tumour growth
  • This creates a vicious cycle of bone destruction and tumour progression

In Giant Cell Tumour of Bone:

  • GCTB stromal cells overexpress RANKL
  • This drives recruitment and activation of osteoclast-like giant cells that destroy bone
  • Xgeva blocks RANKL, reducing giant cell numbers and tumour-associated bone destruction

Xgeva interrupts this cycle by binding to and neutralising RANKL, preventing osteoclast activation and breaking the tumour-bone destruction cycle.


Xgeva vs Prolia vs Zometa — Key Differences

Feature Xgeva (Denosumab 120mg) Prolia (Denosumab 60mg) Zometa (Zoledronic Acid)
Indication Bone metastases, GCTB Osteoporosis Bone metastases, osteoporosis
Dose 120mg every 4 weeks 60mg every 6 months 4mg IV every 3-4 weeks
Administration Subcutaneous injection Subcutaneous injection IV infusion (15 minutes)
Renal Adjustment Not required Not required Required
SRE Reduction vs Zometa Superior (breast, prostate) N/A Standard of care
Available at A.K. Pharma Request Quote Request Quote Contact us

Dosage and Administration

  • Bone Metastases / GCTB: 120mg subcutaneously every 4 weeks
  • Hypercalcaemia of Malignancy: 120mg subcutaneously every 4 weeks with additional doses on days 8 and 15 of the first month
  • Injection Sites: Upper arm, upper thigh, or abdomen
  • Calcium and Vitamin D: Supplement with at least 500mg calcium and 400 IU vitamin D daily unless hypercalcaemia present
  • Do not substitute for Prolia — different dose, frequency, and indication

Full dosing guidelines available at Drugs.com Denosumab (Xgeva) Dosage.


Who Should Use Xgeva

Xgeva is prescribed for:

  • Cancer patients with bone metastases from solid tumours at risk of SREs
  • Patients with unresectable or recurrent Giant Cell Tumour of Bone
  • Cancer patients with hypercalcaemia refractory to bisphosphonate therapy
  • Cancer patients with renal impairment who cannot receive Zoledronic Acid

Xgeva is prescribed by oncologists, orthopaedic oncologists, and palliative care physicians. A.K. Pharma supplies Xgeva to oncology centres, hospitals, and pharmacies across Delhi and India.


Possible Side Effects

Common side effects include fatigue, nausea, decreased appetite, dyspnoea, peripheral oedema, and hypocalcaemia.

Serious side effects include:

  • Hypocalcaemia — monitor serum calcium before each dose, particularly in patients with renal impairment
  • Osteonecrosis of the jaw (ONJ) — assess dental health before starting, avoid invasive dental procedures during treatment
  • Atypical femoral fractures — monitor for thigh or groin pain
  • Serious infections — patients are at increased risk of skin infections

Full side effect information available at FDA Xgeva Safety Information.


Precautions

  • Correct hypocalcaemia before initiating Xgeva
  • Perform dental examination and necessary dental procedures before starting treatment
  • Monitor serum calcium, phosphorus, and magnesium — particularly in patients with renal impairment
  • Do not use in pregnancy — highly effective contraception required during treatment and for at least 5 months after last dose
  • Do not substitute for Prolia — different indication and dosing
  • Monitor for ONJ throughout treatment — particularly in patients receiving chemotherapy, corticosteroids, or with poor oral hygiene

Storage and Handling

  • Store in refrigerator between 2°C and 8°C
  • Do not freeze — discard if frozen
  • Keep in original carton to protect from light
  • Allow to reach room temperature before injection — approximately 15-30 minutes
  • Use within 14 days once removed from refrigerator
  • Single-use vial — discard unused portion

As a responsible medicine distributor in Delhi, A.K. Pharma maintains strict cold chain requirements during storage and supply of Xgeva, ensuring product integrity for every unit supplied.


Manufacturer Information

Xgeva (Denosumab 120mg) is manufactured by Amgen Inc., a global biotechnology company. Xgeva received FDA approval in November 2010 for prevention of SREs in bone metastases. A.K. Pharma supplies only genuine Xgeva sourced from authorized distributors.


Related Cancer and Bone Medicines Available at A.K. Pharma


Frequently Asked Questions

Q. What is Xgeva used for? Xgeva (Denosumab 120mg) is used to prevent skeletal related events in patients with bone metastases from solid tumours, to treat Giant Cell Tumour of Bone, and to treat hypercalcaemia of malignancy. More information available at NCI Drug Information.

Q. What is the difference between Xgeva and Prolia? Both contain Denosumab but at different doses for different indications. Xgeva (120mg every 4 weeks) is for cancer patients with bone metastases. Prolia (60mg every 6 months) is for osteoporosis. They must not be substituted for each other.

Q. How is Xgeva better than Zoledronic Acid (Zometa)? Xgeva is superior to Zoledronic Acid in delaying SREs in breast and prostate cancer bone metastases based on Phase 3 head-to-head trials. Additionally Xgeva does not require renal dose adjustment, making it preferable in cancer patients with kidney impairment.

Q. Is Xgeva available in India? Xgeva can be supplied to hospitals, oncology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.

Q. What is the price of Xgeva in India? Xgeva price in India varies by pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Xgeva from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Xgeva in bulk? Yes. A.K. Pharma supplies Xgeva in bulk to oncology centres, hospitals, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.


Why Order Xgeva from A.K. Pharma?

  • Licensed medicine distributor in Delhi with all required drug licenses
  • 100% genuine Xgeva sourced from authorized Amgen distributors
  • Cold chain maintained throughout storage and delivery
  • Bulk supply available for oncology centres and hospitals
  • Prompt response to all quote requests
  • Serving oncologists across Delhi NCR and all major cities in India

Contact A.K. Pharma for Xgeva Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in

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