US Food and Drug Administration approved the drug Prolia (denosumab) for the treatment of osteoporosis in postmenopausal women at high risk of fractures as well as for the treatment of bone tissue loss in men, prostate cancer patients with similar risk.
Clinical studies have shown that Denosumab works by improving bone mineral density and reducing different types of fractures.
FDA decision is based on the results of three clinical studies involving nearly 8,000 women with postmenopausal osteoporosis. The study showed that the use of the drug increases bone density and reduces the risk of spine fractures by 68% and hip by 40%, non-vertebral fractures by 20% . Prolia (denosumab) is recommended for patients who failed or are intolerant to other osteoporosis treatments.
In spite of the fact that there are many options for postmenopausal osteoarthritis treatment, Prolia cn have an advantage over other PMO drugs due to its suitable dosage regimen.
Prolia is contraindicated in patients with hypocalcemia. If denosumab is indicated, hypocalcemia can significantly progress, especially in case of dysfunction of renal function.
On May 28 The European Commission also approved the application for marketing of Prolia (denosumab) in the EU.
I received my first injection of Prolia on September 20, 2010. Two days later, on Sept. 22,’10, odd red splotches appeared under my stomach and in the folds between my legs and the crotch area. Several were round, dime-sized, and several others were splotches. They did not itch, but a week later, they itched once in awhile. My doctor gave me Mycostatin(external use) ointment and told me to continue using cornstarch for powder, as that is what I have always used, being allergic to perfumes in baby and bath powder.
They have somewhat faded,itching occurs occasionally. Was this triggered by the Prolia ??? I have never, ever had a yeast infection, vaginally or otherwise. I am apprehensive about getting the 2nd shot for the year in March, 2011. What suggestions do you have for me ??
I was taking Fosamax for approx. 5 yrs. and last year the bone scan was quite low, and this year was below 2.5, and that is why my doctor switched me to Prolia injections. I have had NO OTHER reactions to Prolia,
no hives, no rash or blisters.
I would SO appreciate any suggestions or hope you can give me that this will not continue on forever.
Thank you so much, Karen Chapin
lotsapets@reachone.com