XGEVA 120 MG 1 FLC

XGEVA (denosumab) is a monoclonal antibody medication used primarily to prevent skeletal-related events in patients with bone metastases from solid tumors and to treat giant cell tumors of bone. XGEVA works by inhibiting the activity of a protein called RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), which plays a crucial role in bone destruction and loss. It is administered as a subcutaneous injection once every four weeks.

How XGEVA Works

Mechanism of Action

1. RANKL Inhibition:
   • XGEVA contains denosumab, a human monoclonal antibody that specifically binds to and inhibits RANKL, a protein essential for the formation, function, and survival of osteoclasts (cells responsible for bone resorption).
2. Reduction of Bone Destruction:
   • By inhibiting RANKL, XGEVA decreases osteoclast activity, which reduces bone resorption. This helps to prevent the breakdown of bone commonly seen in conditions like bone metastases and giant cell tumors of bone.
3. Prevention of Skeletal-Related Events:
   • In patients with cancer that has spread to the bones, XGEVA reduces the risk of complications such as fractures, spinal cord compression, and the need for radiation or surgery to bone.
4. Treatment of Giant Cell Tumor of Bone:
   • XGEVA is effective in reducing tumor size and bone destruction in patients with giant cell tumors of bone that are not amenable to surgery.

Side Effects

Common Side Effects

• Fatigue:
  • Patients may experience tiredness or weakness after receiving the injection.
• Nausea:
  • Mild to moderate nausea is commonly reported.
• Hypocalcemia (Low Blood Calcium Levels):
  • This is one of the most significant side effects, requiring calcium and vitamin D supplementation.
• Pain in the Bones, Joints, and Muscles:
  • Pain, particularly in areas affected by cancer or bone metastases, can occur.
• Dyspnea (Shortness of Breath):
  • Some patients report difficulty breathing.
• Diarrhea:
  • Mild gastrointestinal disturbances like diarrhea can occur.

Serious Side Effects

• Osteonecrosis of the Jaw (ONJ):
  • A severe condition involving bone damage in the jaw, often associated with dental procedures or poor oral hygiene.
• Serious Infections:
  • Increased risk of serious infections, including those affecting the skin, abdomen, and urinary tract.
• Hypocalcemia:
  • Severe cases can lead to tetany, seizures, and cardiac complications if not managed promptly.
• Atypical Femur Fractures:
  • Rare but severe thigh bone fractures can occur after long-term use.
• Hypersensitivity Reactions:
  • Including anaphylaxis, angioedema, and other severe allergic reactions.

Indications

XGEVA is indicated for:

• Prevention of Skeletal-Related Events in Patients with Bone Metastases from Solid Tumors:
  • Helps reduce complications like fractures, spinal cord compression, and the need for bone surgery or radiation.
• Treatment of Giant Cell Tumor of Bone:
  • For adults and skeletally mature adolescents when surgery is not an option or would cause severe morbidity.
• Hypercalcemia of Malignancy:
  • Used when bisphosphonate therapy is ineffective, particularly in patients with high calcium levels due to cancer.

Contraindications

XGEVA should not be used in the following conditions:

• Hypocalcemia:
  • Contraindicated in patients with pre-existing low blood calcium levels; calcium must be corrected before starting therapy.
• Pregnancy:
  • Not recommended during pregnancy due to the potential risk to the fetus.
• Hypersensitivity to Denosumab:
  • Patients with known hypersensitivity reactions, including anaphylaxis, to denosumab or any component of the product should not use XGEVA.
• Severe Renal Impairment:
  • Patients with severe kidney issues, especially those not on dialysis, are at increased risk of hypocalcemia.

Price in Different Countries

The cost of XGEVA 120 mg 1 FLC can vary significantly based on the country, healthcare system, and insurance coverage. Below is a table showing approximate prices in different countries.

Country	Price (Per Vial)	Reference
United States	$2,000 – $2,500	GoodRx
United Kingdom	£1,500 – £1,800	NHS UK
Canada	CAD $2,500 – $3,000	Canada Drugs
Australia	AUD $2,800 – $3,200	PBS Australia
India	₹180,000 – ₹220,000	1mg

Top 5 Global Brands

1. XGEVA (Denosumab) – Amgen:
   • The most recognized brand for preventing skeletal complications in cancer patients and treating giant cell tumors of bone.
2. Prolia – Amgen:
   • While Prolia contains denosumab, it is specifically indicated for osteoporosis rather than cancer-related bone issues, but it highlights the same active ingredient.
3. RANKL Inhibitors (Generic Versions):
   • Generic versions are emerging in various markets, providing similar therapeutic effects.
4. Denosumab Biosimilars:
   • As patents expire, biosimilars are expected to play a more significant role globally.
5. Bone-Modifying Agents – Various Manufacturers:
   • Alternative agents within the same class targeting bone resorption.