Introduction
Wyost (denosumab-bbdz) is a RANK ligand inhibitor biosimilar to Prolia® (denosumab) approved by the FDA for the treatment of osteoporosis in postmenopausal women at high risk for fracture. This fully human monoclonal antibody represents a significant advancement in bone metabolism management, offering a targeted approach to osteoclast inhibition.
Mechanism of Action
Wyost binds with high affinity and specificity to RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand), a key mediator of osteoclast formation, function, and survival. By inhibiting RANKL, Wyost prevents the interaction between RANKL and its receptor RANK on osteoclast precursors and mature osteoclasts. This results in:
- Inhibition of osteoclast formation
- Reduction of osteoclast activity
- Decreased bone resorption
- Increased bone mineral density
Indications
Wyost is indicated for:
- Treatment of osteoporosis in postmenopausal women at high risk for fracture
- To increase bone mass in men with osteoporosis at high risk for fracture
- Treatment of bone loss in patients receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer
Dosage and Administration
Standard dosing: 60 mg administered subcutaneously every 6 months Administration:- Administer via subcutaneous injection in the upper arm, upper thigh, or abdomen
- Allow Wyost to reach room temperature (15-30 minutes) before administration
- Do not shake the solution
- Visually inspect for particulate matter and discoloration before administration
- Renal impairment: No dosage adjustment necessary
- Hepatic impairment: No dosage adjustment necessary
- Geriatric patients: No dosage adjustment necessary
Pharmacokinetics
Absorption: Following subcutaneous administration, bioavailability is approximately 62% Distribution: Volume of distribution is approximately 7.5 L Metabolism: Expected to be metabolized via proteolytic pathways similar to other immunoglobulin G monoclonal antibodies Elimination: Terminal half-life is approximately 25.4 days Excretion: Cleared via the reticuloendothelial systemContraindications
- Hypersensitivity to denosumab or any component of the formulation
- Pre-existing hypocalcemia (must be corrected prior to initiation)
- Pregnancy
Warnings and Precautions
Hypocalcemia: May occur, particularly in patients with severe renal impairment. Ensure adequate calcium and vitamin D supplementation. Osteonecrosis of the jaw: Has been reported, predominantly in cancer patients receiving higher doses Atypical femoral fractures: Have been reported with long-term use Serious infections: May increase risk of serious infections, including skin infections Hypersensitivity reactions: Anaphylaxis has been reported Severe dermatological reactions: Including dermatitis, rash, and eczemaDrug Interactions
Calcium-lowering medications: Concurrent use may increase risk of hypocalcemia Immunosuppressants: May increase risk of serious infections Live vaccines: Avoid concurrent administration due to potential for reduced vaccine efficacyAdverse Effects
Common adverse reactions (≥5%):- Back pain (34.7%)
- Pain in extremity (11.7%)
- Musculoskeletal pain (7.6%)
- Hypercholesterolemia (7.2%)
- Cystitis (5.9%)
- Hypocalcemia
- Serious infections
- Dermatological reactions
- Osteonecrosis of the jaw
- Atypical femoral fractures
Monitoring Parameters
- Serum calcium levels prior to each dose and within 2 weeks after initial dose
- Bone mineral density (BMD) assessment every 1-2 years
- Renal function
- Signs and symptoms of hypocalcemia
- Oral health examination prior to initiation and periodically during treatment
- Signs of infection
- Skin reactions
Patient Education
- Importance of adequate calcium (1200 mg daily) and vitamin D (800-1000 IU daily) intake
- Report signs of hypocalcemia (muscle spasms, twitching, numbness, tingling)
- Maintain good oral hygiene and regular dental check-ups
- Report any thigh or groin pain
- Monitor for signs of infection
- Understand the dosing schedule (every 6 months)
- Do not stop calcium and vitamin D supplements unless directed by healthcare provider
- Inform all healthcare providers about Wyost treatment
References
1. FDA Approval Letter: Wyost (denosumab-bbdz) 2. Wyost Prescribing Information. Sandoz Inc. 3. Cummings SR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009;361(8):756-765. 4. Bone HG, et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomised FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017;5(7):513-523. 5. Watts NB, et al. Insights into the pharmacology of denosumab. Clin Pharmacol. 2012;4:47-53.
This monograph is intended for educational purposes only. Healthcare providers should consult the full prescribing information and clinical guidelines before making treatment decisions.