Version May 2024
Romosozumab may increase the risk of myocardial infarction, stroke, and cardiovascular death. Romosozumab should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, romosozumab should be discontinued.
Note: Correct hypocalcemia and vitamin D deficiency (eg, to a 25-hydroxyvitamin D level ≥20 ng/mL [≥50 nmol/L]) prior to initiating therapy and ensure adequate calcium and vitamin D intake during therapy (Ref).
Osteoporosis, postmenopausal, fracture risk reduction:
Note: For use as initial therapy in patients with very high fracture risk, including those with a T-score less than –3, a T-score less than –2.5 with fragility fracture history, or severe or multiple prior vertebral fractures. May also be used as an alternative agent in patients with high fracture risk in whom first-line therapies are ineffective or cannot be used. Do not use in patients at high risk of cardiovascular disease and stroke (eg, prior history of myocardial infarction or stroke) (Ref).
SUBQ: 210 mg once monthly for up to 12 months; each monthly dose is given as two separate 105-mg injections administered immediately one after the other.
Discontinuation/interruption of therapy: Following a course of romosozumab, switch to antiresorptive therapy (eg, with a bisphosphonate or denosumab) to maintain bone density gains (Ref).
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.
No dosage adjustment necessary; 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.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Neuromuscular & skeletal: Arthralgia (8% to 13%)
1% to 10%:
Cardiovascular: Cardiac disorder (2%), peripheral edema (2%)
Central nervous system: Headache (5% to 7%), insomnia (2%), paresthesia (1%)
Dermatologic: Skin rash (1%)
Hypersensitivity: Hypersensitivity reaction (7%)
Local: Injection site reaction (5%), pain at injection site (2%), erythema at injection site (1%)
Neuromuscular & skeletal: Muscle spasm (3% to 5%), asthenia (3%), neck pain (2%)
<1%, postmarketing, and/or case reports: Acute myocardial infarction, angioedema, cerebrovascular accident, dermatitis, erythema multiforme, femur fracture, hypocalcemia, osteonecrosis of the jaw, urticaria
Hypersensitivity (eg, angioedema, erythema multiforme, urticaria) to romosozumab or any component of the formulation; uncorrected hypocalcemia
Concerns related to adverse effects:
• Bone fractures: Atypical femur fractures have been reported in patients receiving romosozumab. The fractures may occur anywhere along the femoral shaft (may be bilateral) and commonly occur with minimal to no trauma to the area. Some patients experience prodromal pain weeks or months before the fracture occurs. New or unusual thigh, hip, or groin pain should be reported to health care provider; any patient with thigh or groin pain should be suspected of having an atypical femur fracture and should be evaluated to rule out an incomplete femur fracture. If an atypical fracture is present, assess for signs/symptoms of fracture in contralateral limb. Consider interruption of therapy based on benefits/risks.
• Cardiovascular events: [US Boxed Warning]: Romosozumab may increase the risk of MI, stroke, and cardiovascular death and should not be initiated in patients who have had an MI or stroke within the previous year. Consider benefits/risks of therapy in patients with other cardiovascular risk factors. Discontinue use if MI or stroke occurs during therapy.
• Hypocalcemia: Hypocalcemia may occur. Correct hypocalcemia prior to initiation of therapy (contraindicated in patients with uncorrected hypocalcemia). Ensure adequate supplementation with calcium and vitamin D during therapy and monitor calcium levels closely, particularly in patients predisposed to hypocalcemia (eg, severe renal impairment and/or receiving dialysis).
• Hypersensitivity: Hypersensitivity reactions (eg, angioedema, erythema multiforme, urticaria, rash, dermatitis) have occurred; discontinue use for serious reactions (eg, anaphylaxis) and treat appropriately.
• Osteonecrosis of the jaw: Osteonecrosis of the jaw (ONJ), also referred to as medication-related osteonecrosis of the jaw (MRONJ), has been reported in patients receiving romosozumab. Known risk factors for MRONJ include tooth extraction or other invasive dental procedures, cancer diagnosis, radiotherapy, concomitant therapy (eg, angiogenesis inhibitors, bisphosphonates, chemotherapy, corticosteroids, denosumab), poor oral hygiene, and comorbid disorders (anemia, coagulopathy, infection, preexisting dental or periodontal disease). Routine oral exam is recommended prior to initiation of therapy; patients should maintain good oral hygiene during treatment. Consider risk/benefits of therapy in patients requiring invasive dental procedures. Patients developing ONJ during therapy should receive care by an oral surgeon or dentist; consider discontinuation of therapy based on risk/benefit assessment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous [preservative free]:
Evenity: Romosozumab-aqqg 105 mg per 1.17 mL (1.17 mL)
No
Solution Prefilled Syringe (Evenity Subcutaneous)
105MG/1.17ML (per mL): $1,248.39
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Subcutaneous:
Evenity: Romosozumab-aqqg 105 mg per 1.17 mL (1.17 mL)
SUBQ: Each monthly dose consists of 2 consecutive SUBQ injections.
Remove 2 syringes from carton and allow to sit at room temperature for at least 30 minutes before administration. Administer into the abdomen, thigh, or outer area of upper arm; should only be administered by a health care professional. Rotate injection sites; if the same injection site is chosen, do not inject into the same spot used for the first injection. Avoid areas of skin that are tender, bruised, red, hard, scarred, or with stretch marks. Solution in syringe should appear clear to opalescent, colorless to light yellow; do not use if cloudy, discolored, or contains particulate matter.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761062s000lbl.pdf#page=19, must be dispensed with this medication.
Osteoporosis, postmenopausal, fracture risk reduction: Treatment of postmenopausal osteoporosis in patients who are at high risk for fracture, or in patients in whom other available osteoporosis therapy has failed or cannot be taken.
Limitations of use: The anabolic effect of romosozumab wanes after 12 monthly doses of therapy. Therefore, the duration of romosozumab use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Romosozumab is not indicated for use in females of reproductive potential.
Romosozumab is a humanized monoclonal antibody (IgG2). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Romosozumab is not indicated for use in females of reproductive potential.
It is not known if romosozumab is present in breast milk.
Romosozumab is not indicated for use in females of reproductive potential.
Osteoporosis prevention or treatment: Ensure adequate calcium and vitamin D intake; if dietary intake is inadequate, dietary supplementation is recommended. Females and males should consume:
Calcium: 1,000 mg/day (males: 50 to 70 years of age) or 1,200 mg/day (females ≥51 years of age and males ≥71 years of age) (IOM 2011; NOF [Cosman 2014]).
Vitamin D: 800 to 1,000 units daily (age ≥50 years) (NOF [Cosman 2014]). Recommended dietary allowance (RDA): 600 units daily (age ≤70 years) or 800 units daily (age ≥71 years) (IOM 2011).
Signs/symptoms of hypersensitivity; signs/symptoms of adverse cardiovascular events; serum calcium.
Bone mineral density (clinical trials assessed at baseline and then at 6 or 12 months [Cosman 2016; Saag 2017]); may consider monitoring biochemical markers of bone turnover (eg, fasting serum CTX, serum P1NP) at baseline, 3 months, and 6 months to assess treatment response (Cosman 2016; ES [Eastell 2019]; Saag 2017).
Romosozumab inhibits sclerostin, a regulatory factor in bone metabolism that inhibits Wnt/Beta-catenin signaling pathway regulating bone growth (MacDonald 2009; McClung 2018); 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)
Weight: The exposure of romosozumab decreases with increasing body weight.
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