Any patient who presents with thigh or groin pain should beĮvaluated to rule out an incomplete femur fracture. Causality has not beenĮstablished as these fractures also occur in osteoporotic patients who have not been treatedĭuring Prolia ® treatment, patients should be advised to report new or unusual Have been reported in patients receiving Prolia ®.
Discontinuation of Prolia ® should be consideredīased on individual benefit-risk assessment.Ītypical Femoral Fractures: Atypical low-energy, or low trauma fractures of the shaft Should receive care by a dentist or an oral surgeon. Patients who are suspected of having or who develop ONJ The risk of ONJ may increase with duration of exposure toįor patients requiring invasive dental procedures, clinical judgment should guide the Good oral hygiene practices should be maintained during treatment with Such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g.,Ĭhemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbidĭisorders. Preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ Prescriber prior to initiation of Prolia ®. Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generallyĪssociated with tooth extraction and/or local infection with delayed healing, and has been Risk and serum calcium should be closely monitored. Concomitant use of calcimimetic drugs may worsen hypocalcemia In patients predisposed to hypocalcemia andĭisturbances of mineral metabolism, including treatment with other calcium-lowering drugs,Ĭlinical monitoring of calcium and mineral levels is highly recommended within 14 days of In patients with severe renal impairment.
Hypocalcemia: Hypocalcemia may worsen with the use of Prolia ®, especially Other clinically significant allergic reaction occurs, initiate appropriate therapy and Tightness, facial and upper airway edema, pruritus, and urticaria. Symptoms have included hypotension, dyspnea, throat Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis hasīeen reported with Prolia ®. Patients receiving Prolia ® should not receive Same Active Ingredient: Prolia ® contains the same active ingredient Reactions have included anaphylaxis, facial swelling and urticaria. In patients with a history of systemic hypersensitivity to any component of the product. Prior to initiating treatment with Prolia ®. In women of reproductive potential, pregnancy testing should be performed Prolia ® is contraindicated in women who are pregnant and mayĬause fetal harm. Pre-existing hypocalcemia must be corrected prior to initiating
LearnĬontraindications: Prolia ® is contraindicated in patients with Prolia ® is indicated as a treatment to increase bone mass in women at high riskįor fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Patients Prolia ® also reduced the incidence of vertebral fractures. Prolia ® is indicated as a treatment to increase bone mass in men at high risk forįracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. High risk of fracture is defined asĪ history of osteoporotic fracture, multiple risk factors for fracture, or patients who haveįailed or are intolerant to other available osteoporosis therapy. Systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone andĮxpected to remain on glucocorticoids for at least 6 months. In men and women at high risk of fracture who are either initiating or continuing
Prolia ® is indicated for the treatment of glucocorticoid-induced osteoporosis Or multiple risk factors for fracture or patients who have failed or are intolerant to other Osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, Prolia ® is indicated for treatment to increase bone mass in men with Postmenopausal women with osteoporosis, Prolia ® reduces the incidence of Indicated for the treatment of postmenopausal women with osteoporosis at high risk forįracture, defined as a history of osteoporotic fracture, or multiple risk factors forįracture or patients who have failed or are intolerant to other available osteoporosis therapy.
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