Zuellig Pharma
Concise Prescribing Info
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.
Dosage/Direction for Use
SC Administer 210 mg in the abdomen, thigh or upper arm once mthly. Treatment duration: 12 mthly doses.
History of systemic hypersensitivity. Hypocalcemia.
Special Precautions
Hypersensitivity. Discontinue treatment if anaphylactic or allergic reactions, MI or stroke, osteonecrosis occur. Do not initiate in patients who have had MI or stroke w/in the preceding yr. Correct hypocalcemia prior to treatment. Monitor patients for signs & symptoms of hypocalcemia; serum Ca in patients w/ severe renal treatment (eGFR 15-29 mL/min/1.73 m2) or receiving dialysis. Adequately supplement patients w/ Ca & vit D during treatment. Perform routine oral exam prior to initiation of treatment. Concomitant use w/ drugs associated w/ osteonecrosis of the jaw (eg, chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors & corticosteroids). Patients requiring invasive dental procedures. Evaluate patient who presents w/ thigh or groin pain suspected of having atypical fracture. Assess patients presenting w/ an atypical femur fracture for fracture in the contralateral limb. Not indicated for women of reproductive potential. Pregnancy & lactation. Ped patients & elderly.
Adverse Reactions
Arthralgia, headache, muscle spasms, peripheral edema, asthenia, neck pain, insomnia, paresthesia.
ATC Classification
M05BX06 - romosozumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Evenity soln for inj 105 mg/1.17 mL
2 × 1's
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