PROLIA® (Non-English)

PROLIA® (Non-English) (denosumab injection) is a prescription medication used to treat osteoporosis and bone loss conditions in adults at high risk of fracture. It is administered as a 60 mg subcutaneous injection every six months, and works by inhibiting RANK ligand, a protein that activates cells responsible for bone breakdown. This results in increased bone mass and strength, reducing the risk of fractures in the spine, hip, and other areas. PROLIA® (Non-English) is commonly prescribed to postmenopausal women, men with osteoporosis, and patients undergoing hormone-depleting therapies for breast or prostate cancer, or long-term corticosteroid use.

• Form: Prefilled syringe with 60 mg denosumab
• Target group: Adults with high fracture risk
• Use frequency: Once every 6 months
• Effect: Increases bone density and reduces fracture risk

PROLIA® (Non-English) is administered as a subcutaneous injection once every 6 months, typically in the abdomen, thigh, or upper arm. Supplementation with calcium and vitamin D is required during treatment.

• Dosage: 60 mg every 6 months
• Injection sites: Abdomen, upper thigh, or upper arm
• Administered by: Healthcare professional or trained self-injection
• Supplementation: Calcium and vitamin D required
• Missed dose: Administer as soon as possible and continue every 6 months from last injection

PROLIA® (Non-English) is indicated for increasing bone mass and reducing fracture risk in patients with various types of osteoporosis or treatment-induced bone loss. It is not suitable for children or pregnant women.

Indications:

• Postmenopausal osteoporosis
• Male osteoporosis at high fracture risk
• Bone loss due to androgen deprivation therapy (prostate cancer)
• Bone loss due to aromatase inhibitors (breast cancer)
• Corticosteroid-induced bone loss in men and women

Contraindications:

• Hypocalcemia (low blood calcium)
• Pregnancy or breastfeeding
• Allergy to denosumab
• Pediatric use (<18 years old)
• Concurrent use of denosumab under the brand name XGEVA

Side Effects:

• Common: Joint/muscle/back pain, skin infections, eczema
• Serious: Hypocalcemia, osteonecrosis of the jaw (ONJ), atypical femur fractures, severe allergic reactions, infections
• Dental complications: Higher risk if invasive dental procedures are performed during treatment

PROLIA® (Non-English) contains denosumab, a monoclonal antibody targeting RANK ligand, and several stabilizing excipients.

• Active ingredient: Denosumab 60 mg
• Other ingredients:
  • Sorbitol
  • Acetate
  • Polysorbate 20
  • Sodium hydroxide
  • Water for injection
• Form: Colorless to pale yellow liquid in a prefilled syringe

Each PROLIA® (Non-English) package contains a single-use prefilled syringe and instructions for safe handling and administration.

• 1 prefilled syringe with 60 mg/1 mL denosumab
• With needle guard for safe disposal
• Packaged in a protective carton
• Latex-free components

Yes, PROLIA® (Non-English) may cause mild to serious side effects, including local injection site reactions and systemic complications.

Common Side Effects:

• Joint, back, or limb pain
• Eczema
• Infections (e.g., urinary or respiratory)
• Injection site redness or swelling

Serious Side Effects:

• Hypocalcemia
• Osteonecrosis of the jaw (ONJ)
• Atypical femur fractures
• Severe allergic reactions
• Multiple vertebral fractures after stopping treatment

Proper storage ensures PROLIA® (Non-English) remains effective and safe to use. Follow refrigeration guidelines strictly.

• Refrigerated storage: 2°C to 8°C (36°F to 46°F)
• Do not freeze
• Once removed: May be kept at room temperature (up to 25°C) for up to 30 days
• Protect from light (keep in original carton)
• Do not use past expiration date