ROMOSOZUMAB-AQQG

Other

Brand names: Evenity

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg 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 [see Nonclinical Toxicology (13.2) and Clinical Studies (14.1) ] .

Indications

1 INDICATIONS AND USAGE EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture

defined as a history of osteoporotic fracture

or multiple risk factors for fracture

or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted

defined as a history of osteoporotic fracture

or multiple risk factors for fracture

Contraindications

• 4 CONTRAINDICATIONS EVENITY is contraindicated in patients with: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY [see Warnings and Precautions (5.3)
• erythema multiforme
• and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Hypocalcemia ( 4 ) Known hypersensitivity to EVENITY ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Major Adverse Cardiac Events (MACE): Monitor for symptoms of MI and stroke and seek prompt medical attention if symptoms occur
Consider discontinuation of therapy based on benefit-risk assessment
1 Major Adverse Cardiac Events (MACE) In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY compared to those treated with alendronate [see Boxed Warning and Adverse Reactions (6
Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors

Known Side Effects

5 documented side effects by frequency

Falls

>10%

Joint Pain

1-10%

Injection Site Pain

1-10%

Headache

1-10%

Limb Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous