romosozumab (Rx)

Brand and Other Names:Evenity, romosozumab-aqqg
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 105mg/1.17mL (single-use prefilled syringe)
  • Syringe is not made with natural rubber latex

Osteoporosis

Indicated for osteoporosis treatment in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture; also indicated for patients in whom other available osteoporosis therapy has failed or who are intolerant of other available osteoporosis therapy

210 mg SC qMonth x 12 months

Adequately supplement patient with calcium and vitamin D during treatment

Dosage Modifications

Renal impairment

  • No dose adjustment required
  • Severe renal impairment (eGFR 15-29 mL/min/1.73 m²) or receiving dialysis: Greater risk of developing hypocalcemia; monitor calcium concentrations and adequately supplement calcium and vitamin D in these patients

Dosing Considerations

Limitations of use

  • Anabolic effect wanes after 12 monthly doses; therefore, duration of use should be limited to 12 monthly doses
  • If osteoporosis therapy remains warranted, consider continued treatment with an antiresorptive agent

Safety and efficacy not established

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Adverse Effects

>10%

Arthralgia (8.1-13.1%)

1-10%

Headache (5.2-6.6%)

Hypersensitivity (6.5%)

Injection site reactions (4.9%)

Muscle spasms (3.4-4.6%)

Asthenia (2.3-2.5%)

Peripheral edema (1.7-2.4%)

Neck pain (1.7-2.2%)

Insomnia (1.7-2%)

Paresthesia (1.4-2%)

<1%

Hypocalcemia (0.2%)

Major adverse cardiac event (MACE)

  • Study 1
    • Myocardial infarction (MI): 0.3% (0.2% placebo)
    • Stroke: 0.2% (0.3% placebo)
    • Cardiovascular (CV) death 0.5% (0.4% placebo)
  • Study 2
    • MI: 0.8% (0.2% alendronate)
    • Stroke: 0.6% (0.3% alendronate)
    • CV death 0.8% (0.6% alendronate)
    • Positively adjudicated MACE: 2% (1.1% alendronate); hazard ratio 1.87

Frequency Not Defined

Osteonecrosis of the jaw (ONJ)

Atypical femoral fracture

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Warnings

Black Box Warnings

May increase the risk of MI, stroke, and CV death

Do not initiate in patients who have had an MI or stroke within the preceding year

Consider whether the benefits outweigh the risks in patients with other CV risk factors

If a patient experiences an MI or stroke during therapy, discontinue drug immediately

Contraindications

Hypocalcemia; preexisting hypocalcemia must be corrected before initiating

Systemic hypersensitivity (eg, angioedema, erythema multiforme, urticaria)

Cautions

A higher rate of MACE, a composite endpoint of CV death, nonfatal MI, and nonfatal stroke was observed in a randomized controlled trial in postmenopausal women treated with romosozumab compared with alendronate

Hypersensitivity reactions reported, including angioedema, erythema multiforme, dermatitis, rash, and urticaria; discontinue drug and initiate appropriate treatment if anaphylaxis or other clinically significant allergic reaction occurs

Hypocalcemia reported; correct hypocalcemia before initiating; monitor for signs and symptoms of hypocalcemia; ensure adequate supplementation with calcium and vitamin D during therapy

Atypical low-energy or low-trauma femoral shaft fractures reported; many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs

Osteonecrosis of the jaw

  • ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has been reported in patients receiving romosozumab
  • Perform routine oral examination before initiating treatment; concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase ONJ risk
  • Other risk factors include cancer, radiotherapy, poor oral hygiene, preexisting dental disease or infection, anemia, and coagulopathy
  • For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan
  • Discontinuation should be considered based on benefit-risk assessment
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Pregnancy

Pregnancy

Not indicated for use in women of reproductive potential

In animal reproduction studies, weekly administration to pregnant rats during the period of organogenesis at exposures >32 times the clinical exposure produced skeletal abnormalities in the offspring

Administration to rats prior to mating and through to the end of lactation produced minimal-to-slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.5-56 times the expected exposure in humans

Lactation

Not indicated for use in women of reproductive potential

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Monoclonal antibody (IgG2) that binds sclerostin, a regulatory factor in bone metabolism

Sclerostin inhibition increases bone formation and, to a lesser extent, decreases bone resorption

Animal studies showed that romosozumab stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity, resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength

Absorption

Peak plasma time: 5 days

Peak plasma concentration: 22.2 mcg/mL

AUC: 389 mcg·day/mL

Steady-state achieved by 3 months following monthly injections

Development of antibodies to romosozumab led to decreased mean concentrations up to 22%

Distribution

Vd: ~3.92 L

Metabolism

Not characterized; IgG2 expected to be degraded into small peptides and amino acids via catabolic pathways similar to endogenous IgG

Elimination

Half-life: 12.8 days

Clearance: 0.38 mL/hr/kg

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Administration

SC Preparation

Remove 2 syringes from carton and visually inspect for particles and discoloration; solution should appear clear to opalescent, colorless to light yellow

Do not use if solution is cloudy, discolored, or contains particles

Do not use if syringe is cracked or broken, gray needle cap is missing or not securely attached, or passed the expiration date

Always hold syringe by the barrel to remove from the tray; do not grasp by plunger rod or gray needle cap

Do not remove gray needle cap until ready to inject

Allow to sit at room temperature for at least 30 minutes before injecting; do not warm in any other way

Clean injection site with alcohol wipes; let skin dry

Choose different injection site for each injection; if same injection location, do not inject near previous injection site

Do not inject in areas where skin is tender, bruised, red, or hard; avoid scars or stretch marks

SC Administration

Administered SC once monthly by healthcare professional

Total dose of 210 mg SC requires 2 separate 105-mg prefilled syringes (and 2 separate SC injections)

Inject two 105-mg prefilled syringes, one after the other, in abdomen (except for 2-inch area around navel), thigh, or outer area of upper arm

Missed dose: Administer as soon as possible; thereafter, schedule doses once monthly from the date of the last dose

Storage

Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light

Do not freeze

Do not shake

If removed from refrigerator, can be kept at room temperature up to 25°C (77°F) in original carton and must be used within 30 days; if not used within 30 days, discard

Do not expose to temperatures >25°C (77°F)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.