EVENITY (2 SYRINGES) (romosozumab-aqqg)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Acute myocardial infarction
Cerebrovascular accident
History of cerebrovascular accident

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Aseptic necrosis of jaw bone
Atypical femoral fracture
Hypocalcemia

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Acute myocardial infarction Anaphylaxis Angioedema Aseptic necrosis of jaw bone Atypical femoral fracture Cerebrovascular accident Erythema multiforme Hypocalcemia

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
Arthralgia Headache disorder	General weakness Injection site sequelae Insomnia Muscle spasm Neck pain Paresthesia Peripheral edema Skin inflammation Skin rash

Rare/Very Rare
Urticaria

In animal reproduction studies, skeletal abnormalities (e.g., syndactyly, polydactyly) were observed in the offspring of pregnant rats receiving romosozumab-aqqg during the period of organogenesis at exposure levels of at least 32 times the exposure at the recommended human dosage; minimal to slight decreases in femoral bone mineral density and/or cortical circumference were observed when the drug was administered to female rats beginning prior to mating and continuing through lactation at exposure levels equivalent to 1.5-56 times the exposure at the recommended human dosage. Romosozumab is not indicated for use in women of childbearing potential.

When romosozumab-aqqg was administered to female rats beginning 6 weeks before cohabitation and continuing through mating and lactation at exposure levels equivalent to 1.5-56 times the exposure at the recommended human dosage, the drug was detected in the serum of rat pups on postnatal day 21 at exposure levels of 0.01-2.4

times maternal exposure; concentrations were dose dependent and resulted from exposure during gestation and/or nursing. Romosozumab is not indicated for use in women of childbearing potential.

Of the 6544 postmenopausal women with osteoporosis studied in clinical trials of romosozumab-aqqg, 80% were 65 years of age or older and 37% were 75 years of age or older. Although no overall differences in safety or efficacy were observed between these women and younger women, and other clinical experience revealed no age-related differences in response, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.