Romosozumab-Aqqg (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- EVENITY
Boxed Warning
EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1)]. EVENITY 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, EVENITY should be discontinued.
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), Adverse Reactions (6.1) and Use in Specific Populations (8.7)]. A history of systemic hypersensitivity to romosozumab-aqqg or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events [see Boxed Warning and Warnings and Precautions (5.1)] Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.2)] Hypocalcemia [see Contraindications (4) and Warnings and Precautions (5.3)] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4)] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5)]
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)].