Indications for EVENITY:
In postmenopausal women with osteoporosis: 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 therapy.
Limitations of Use:
Duration limited to 12 monthly doses; consider anti-resorptive agent if continued therapy for osteoporosis warranted.
Should be administered by a healthcare professional. Give as SC inj in abdomen, thigh or upper arm; rotate inj sites. 210mg once monthly (given as 2 separate syringes consecutively) for 12 months. Supplement with calcium and Vit.D during treatment.
Potential risk of myocardial infarction, stroke and cardiovascular death.
Increased risk of major adverse cardiac events; monitor. MI or stroke within previous year: do not initiate. Discontinue if MI, stroke, anaphylaxis, other hypersensitivity reaction occurs. Correct hypocalcemia prior to initiating; monitor for signs/symptoms. Monitor for osteonecrosis of the jaw (ONJ). Do baseline oral exam if risks for ONJ exist (eg, tooth extraction, oral surgery, poor oral hygiene, and/or other pre-existing dental disease, infection, cancer, radiotherapy, anemia, coagulopathy); discontinue based on risk/benefit assessment. Maintain good oral hygiene. Evaluate for atypical fractures if thigh/groin pain develops; consider interrupting therapy based on risk/benefit assessment. Do not inj areas where skin is tender, bruised, red, hard, or scars or stretch marks. Severe renal impairment or on dialysis: monitor serum calcium and adequately supplement with Vit.D and calcium. Women of reproductive potential, pregnancy, nursing mothers: not indicated.
Increased risk of ONJ with concomitant corticosteroids, chemotherapy, bisphosphonates, angiogenesis inhibitors or denosumab.
Arthralgia, headache, muscle spasms, peripheral edema, asthenia, neck pain, insomnia, paresthesia; hypersensitivity, atypical subtrochanteric and diaphyseal femoral fractures.
Single-use prefilled syringes—2