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For the treatment of postmenopausal women with osteoporosis at high risk for fracture Prolia® has been studied in patients who received prior alendronate therapy Patients Continuing on Alendronate Therapy or Transitioning to Prolia® Were Evaluated1 Weekly alendronate 70 mg and placebo SC Q6M All patients on alendronate Weekly oral placebo and denosumab 60 mg SC Q6M Transition Study• 1-year, multicenter, international, randomized, double-blind, double-dummy, parallel-group phase 3 trial1 – Key inclusion criteria included postmenopausal women with a BMD T-score of ≤ -2.0 and ≥ -4.0 at the lumbar spine or total hip • Overall, a similar number of subjects in each treatment group reported adverse events during the study (78% denosumab, 79% alendronate)1 – Serious adverse events were reported in 5.9% of denosumab-treated subjects and 6.4% of alendronate-treated subjects. The incidence of serious adverse events of infections and neoplasms was similar between groups – The most frequent adverse events in the denosumab and alendronate groups, respectively, were nasopharyngitis (13.4% and 10.8%), back pain (10.7% and 11.6%), bronchitis (6.3% and 5.6%), arthralgia (5.9% and 10.4%), constipation (5.1% and 4.8%), and pain in an extremity (4.7% and 8.4%) Patients can transition from alendronate to Prolia® without a washout period.
Prolia® (denosumab) is indicated for the treatment of 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 available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.
Indication and Important Safety Information Indication: Prolia® (denosumab) is indicated for the treatment of 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 available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.
Contraindications: Prolia® is contraindicated in patients with hypocalcemia. Pre-existing
hypocalcemia must be corrected prior to initiating Prolia®. Prolia® is contraindicated in women who are pregnant and may cause fetal harm. Prolia® is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria.
Same Active Ingredient: Prolia® contains the same active ingredient (denosumab) found in
XGEVA®. Patients receiving Prolia® should not receive XGEVA®.
Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported
with Prolia®. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritis, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia®.
Hypocalcemia: Hypocalcemia may worsen with the use of Prolia®, especially in patients with
severe renal impairment. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, clinical monitoring of calcium and mineral levels is highly recommended. Adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated
with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving Prolia®. An oral exam should be performed by the prescriber prior to initiation of Prolia®. A dental examination with appropriate preventive dentistry should be considered prior to treatment in patients with risk factors for ONJ. Good oral hygiene practices should be maintained during treatment with Prolia®. For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Prolia® should be considered based on individual benefit-risk assessment.
Atypical Femoral Fractures: Atypical low-energy, or low trauma fractures of the shaft have been
reported in patients receiving Prolia®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with anti-resorptive agents.
During Prolia® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of Prolia® therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Important Safety Information (cont.) Serious Infections: In a clinical
trial (N = 7808), serious infections Prolia® (N = 3886)1,2 Placebo (N = 3876)1,2 leading to hospitalization were reported more frequently in the Prolia® group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia®. Endocarditis was also reported more frequently in Prolia®-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.
Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on Prolia®, prescribers should assess the need for continued Prolia® therapy.
Dermatologic Adverse Reactions:
Epidermal and dermal adverse Prolia® (N = 3886)1,2 Placebo (N = 3876)1,2 events such as dermatitis, eczema and rashes occurred at a significantly higher rate with Prolia placebo. Most of these events were not specific to the injection site. Consider discontinuing Prolia® if severe symptoms develop.
Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has
been reported in patients taking Prolia®. Consider discontinuing use if severe symptoms develop.
Suppression of Bone Turnover: Prolia® resulted in significant suppression of bone remodeling
as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.
Important Safety Information (cont.) Adverse Reactions: The most
common adverse reactions Prolia® (N = 3886)1 Placebo (N = 3876)1 (> 5% and more common than placebo) are back pain, pain Pain in extremity: in extremity, musculoskeletal Musculoskeletal pain: pain, hypercholesterolemia, and cystitis. Pancreatitis has been reported with Prolia®.
The overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia® groups. A causal relationship to drug exposure has not been established. Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.
Prolia® Postmarketing Active Safety Surveillance Program: The surveillance program is
available to collect information from prescribers on specific adverse events. Please see or call 1-800-772-6436 for more information.
References: 1. Prolia® (denosumab) prescribing information, Amgen. 2. Data on file, Amgen.
  • A-PROLIA-US-PI-v7-MSK Pain+REMS SLC+PTH SLC-C 2014-0616.pdf
  • A-PROLIA-US-MG-v7-MSK Pain+REMS SLC+PTH SLC-C 2014-0616
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