Romosozumab
Indications
Romosozumab is used for:
Osteoporosis
Adult Dose
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
Child Dose
Renal Dose
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
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
Contra Indications
Hypocalcemia; preexisting hypocalcemia must be corrected before initiating
Systemic hypersensitivity (eg, angioedema, erythema multiforme, urticaria)
Precautions
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
Pregnancy-Lactation
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
Interactions
Adverse Effects
Side effects of Romosozumab :
>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%)
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