The incidence of opportunistic infections was similar to that reported with placebo.The safety of Prolia in the treatment of men with osteoporosis was assessed in a 1-year randomized, double-blind, placebo-controlled study. Endocarditis was reported in no placebo patients and 3 patients receiving Prolia.Skin infections, including erysipelas and cellulitis, leading to hospitalization were reported more frequently in patients treated with Prolia (< 0.1% placebo vs. 0.4% Prolia). Cessation of Prolia treatment results in markers of bone resorption increasing above pretreatment values then returning to pretreatment values 24 months after the last dose of Prolia. All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.The incidence of serious adverse events was 9.2% in the placebo group and 14.7% in the Prolia group. Do not freeze. All men were instructed to take at least 1000 mg of calcium and 800 IU of vitamin D supplementation per day.The incidence of all-cause mortality was 0.8% (n = 1) in the placebo group and 0.8% (n = 1) in the Prolia group. Denosumab should be administered by a healthcare professional. Available for Android and iOS devices. Prolia is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at … As with all therapeutic proteins, there is potential for immunogenicity. However, pregnant RANKL knockout mice showed altered maturation of the maternal mammary gland, leading to impaired lactation Therefore, male condom use would not be necessary as it is unlikely that a female partner or fetus would be exposed to pharmacologically relevant concentrations of denosumab via seminal fluid Prolia is not recommended in pediatric patients. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia discontinuation. Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. The medicine is also approved to increase bone mass in men receiving androgen deprivation therapy for prostate cancer who are at high risk of fracture and to increase bone mass in women at high risk for fracture receiving aromatase inhibitor therapy for breast cancer. This medicine is not approved for use in children. The most common adverse reactions leading to discontinuation of Prolia in patients with postmenopausal osteoporosis are back pain and constipation. © 2020 American College of Rheumatology. Seventy-nine percent of patients received ADT for more than 6 months at study entry. Each 1 mL single-use prefilled syringe of Prolia contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, 0.01% polysorbate 20, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.Carcinogenesis, Mutagenesis, Impairment of Fertility      Treatment to Increase Bone Mass in Men with OsteoporosisProlia is supplied in a single-use prefilled syringe with a safety guard. In patients who develop serious infections while on Prolia, prescribers should assess the need for continued Prolia therapy.In a large clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate in the Prolia group compared to the placebo group. In clinical studies, subjects with impaired renal function were more likely to have greater reductions in serum calcium levels compared to subjects with normal renal function. Discontinuation of Prolia therapy should be considered based on individual benefit-risk assessment.Atypical low-energy or low trauma fractures of the shaft have been reported in patients receiving Prolia Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. Using an electrochemiluminescent bridging immunoassay, less than 1% (55 out of 8113) of patients treated with Prolia for up to 5 years tested positive for binding antibodies (including pre-existing, transient, and developing antibodies). Latex Allergy: People sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex). Following a recovery period from birth out to 6 months of age, the effects on bone quality and strength returned to normal; there were no adverse effects on tooth eruption, though dental dysplasia was still apparent; axillary and inguinal lymph nodes remained absent, while mandibular and mesenteric lymph nodes were present, though small; and minimal to moderate mineralization in multiple tissues was seen in one recovery animal. Prior to administration, Prolia may be allowed to reach room temperature (up to 25°C/77°F) in the original container. Do not use Prolia after the expiry date printed on the label. Watch past educational presentations and see live events in real timeReference our medication guides for helpful informationExplore available award and grant opportunities for fellows-in-training.The best care starts with the best information. Prolia contains the same active ingredient (denosumab) found in Xgeva. Adverse reactions reported in ≥ 2% of postmenopausal women with osteoporosis and more frequently in the Prolia-treated women than in the placebo-treated women are shown in the table below. A total of 120 women were exposed to placebo and 129 women were exposed to Prolia administered once every 6 months as a single 60 mg subcutaneous dose. For these reasons, comparison of antibodies to denosumab with the incidence of antibodies to other products may be misleading.The effects of denosumab on prenatal development have been studied in both cynomolgus monkeys and genetically engineered mice in which RANK ligand (RANKL) expression was turned off by gene removal (a “knockout mouse”).