骨質疏鬆症 osteoporosis in postmenopausal females
For patients at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or who have failed or are intolerant to other available osteoporosis therapy.

Monoclonal Antibody; Sclerostin Inhibitor
Romosozumab inhibits sclerostin, a regulatory factor in bone metabolism that inhibits Wnt/Beta-catenin signaling pathway regulating bone growth; romosozumab increases bone formation and to a lesser extent, decreases bone resorption.

Onset: Peak increase in bone formation marker procollagen type 1 N-telopeptide (P1NP) and peak decrease in bone resorption marker type 1 collagen C-telopeptide (CTX) observed 2 weeks after initiation. Increased histomorphometric indices of bone formation observed 2 months after therapy initiation.
Duration: CTX decrease persists throughout 12 months of therapy; P1NP returns to baseline by 9 months and declines at 12 months; anabolic effect wanes after 12 months of treatment. After discontinuation of therapy, an increase in CTX above baseline value occurs within 3 months. CTX, P1NP, and bone mineral density (BMD) return to baseline within ~12 months of discontinuing therapy.
Distribution: Vdss: ~3.92 L
Metabolism: Has not been characterized; expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG
Half-life elimination: 12.8 days after 3 doses over 12-week period (ie, 1 dose every 4 weeks)
Time to peak: Median: 5 days (range: 2 to 7 days)

1. Hypersensitivity (eg, angioedema, erythema multiforme, urticaria) to romosozumab or any component of the formulation
2. Uncorrected hypocalcemia

Romosozumab is not indicated for use in females of reproductive potential.

Romosozumab is not indicated for use in females of reproductive potential.

Common:
Arthralgia
Others:
Cardiovascular: Cardiac disorder, peripheral edema
Central nervous system: Headache, insomnia, paresthesia
Dermatologic: Skin rash
Hypersensitivity: Hypersensitivity reaction
Local: Injection site reaction, pain at injection site, erythema at injection site
Neuromuscular & skeletal: Muscle spasm, asthenia, neck pain
<1%, postmarketing, and/or case reports:
Acute myocardial infarction, angioedema, cerebrovascular accident, dermatitis, erythema multiforme, femur fracture, hypocalcemia, osteonecrosis of the jaw, urticaria

General dosage:
SubQ two consecutive injections (105 mg each) for a total dose of 210 mg once monthly.
Discontinuation/interruption of therapy:
Because the benefits of anabolic therapy are quickly lost after discontinuation (eg, within 12 months), it is generally recommended to initiate antiresorptive therapy (eg, bisphosphonate or denosumab) to maintain bone mineral density gains following a course of romosozumab.
Missed dose:
If a dose is missed, administer as soon as it can be rescheduled; subsequent doses should be scheduled every month from the date of last dose.

1. No dosage adjustment necessary
2. Patients with eGFR <30 mL/minute/1.73 m² or receiving dialysis should be monitored closely for hypocalcemia.

There are no dosage adjustments provided in the manufacturer's labeling.