Denosumab — Membership Pricing

Other medications in Bone Health

• Etidronate
• Romosozumab
• Teriparatide
• Zoledronic Acid
• Abaloparatide
• Calcitonin
• Calcium Carbonate

What Denosumab is approved for (FDA label)

Bilprevda is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Bilprevda is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Bilprevda is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Source: Read the full FDA label on DailyMed. Label effective date: August 18, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Denosumab (FDA label)

Injection: 120 mg/1.7 mL (70 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial. Injection: 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: b1f0590e-f5bb-44ac-99a0-4aa4596c7e54. SPL document ID: 5959022d-c2d4-11ec-e063-6294a90a6cd6. Label effective date: August 18, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Denosumab (FDA label)

The following adverse reactions are discussed below and elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions ( 5.2 )] Hypocalcemia [see Warnings and Precautions ( 5.3 ) and Use in Specific Populations ( 8.6 )] Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.4 )] Atypical Subtrochanteric and Diaphyseal Femoral Fracture [see Warnings and Precautions ( 5.5 )] Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons [see Warnings and Precautions ( 5.6 ) and Use in Specific Populations ( 8.4 )] Multiple vertebral fractures (MVF) following treatment discontinuation [see Warnings and Precautions ( 5.7 )] Bone Metastasis from Solid Tumors: Most common adverse reactions (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. ( 6.1 ) Multiple Myeloma: Most common adverse reactions (≥ 10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. ( 6.1 ) Giant Cell Tumor of Bone: Most common adverse reactions (≥ 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. ( 6.1 ) Hypercalcemia of Malignancy: Most common adverse reactions (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: b1f0590e-f5bb-44ac-99a0-4aa4596c7e54. SPL document ID: 5959022d-c2d4-11ec-e063-6294a90a6cd6. Label effective date: August 18, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Denosumab (FDA label)

Hypocalcemia. ( 4.1 ) Known clinically significant hypersensitivity to denosumab products. ( 4.2 ) 4.1 Hypocalcemia Pre-existing hypocalcemia must be corrected prior to initiating therapy with Bilprevda [see Warnings and Precautions ( 5.3 )] . 4.2 Hypersensitivity Bilprevda is contraindicated in patients with known clinically significant hypersensitivity to denosumab products [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] .

Source: FDA prescribing information (DailyMed). Set ID: b1f0590e-f5bb-44ac-99a0-4aa4596c7e54. SPL document ID: 5959022d-c2d4-11ec-e063-6294a90a6cd6. Label effective date: August 18, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Denosumab (FDA label)

Drug Products with Same Active Ingredient: Patients receiving Bilprevda should not receive other denosumab products concomitantly. ( 5.1 ) Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs. ( 5.2 ) Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Bilprevda. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. ( 5.3 ) Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Bilprevda. Monitor for symptoms.

Source: FDA prescribing information (DailyMed). Set ID: b1f0590e-f5bb-44ac-99a0-4aa4596c7e54. SPL document ID: 5959022d-c2d4-11ec-e063-6294a90a6cd6. Label effective date: August 18, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.