Evenity Injection

Romosozumab
105mg/1.17ml
AMGEN INC.
Pack size 2 Prefilled Syringes
Dispensing mode POM
Source USA
AgentCITY MEDICAL STORE
Retail Price 2484.00 AED

Indications

Evenity Injection 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

Note

Evenity 105mg/1.17ml Injection manufactured by AMGEN INC. . Its generic name is Romosozumab. Evenity is availble in United Arab Emirates. Farmaco UAE drug index information on Evenity Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Romosozumab :