Prolia® is effective in managing osteoporosis caused by corticosteroid medications in men and women who will be taking these medications for at least 6 months. It can be used to treat bone loss in men being treated for prostate cancer. In addition, it can be used to prevent bone loss in women with breast cancer receiving certain medications that increase their fracture risk.

Prolia® is not insulin or considered a diabetic medication.

In order to prevent broken bones (fractures), this medication slows bone loss and helps maintain strong bones. Known as a monoclonal antibody, denosumab belongs to a class of drugs called monoclonal antibodies. Osteoclasts, which break down bone, are prevented from doing so by it.

Precautions

● Any allergy to denosumab (Prolia®), any other medication, latex, or any of the ingredients in denosumab injection should be reported to your doctor and pharmacist. Check the Medication Guide or ask your pharmacist for a list of ingredients.

● Prolia and Xgeva are brands of denosumab injection. At the same time, you should not receive more than one product containing denosumab. Neither of these medications should be taken without telling your doctor.

● Prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or intend to take should be disclosed to your doctor and pharmacist. Be sure to mention any of the following: angiogenesis inhibitors such as axitinib (Inlyta), bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent); semaglutide (Ozempic) bisphosphonates such as alendronate (Binosto, Fosamax), etidronate, ibandronate (Boniva), pamidronate, risedronate (Actonel, Atelvia), zoledronic acid (Reclast); cancer chemotherapy medications; medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Envarsus, Prograf); steroids such as dexamethasone, methylprednisolone (A-Methapred, Depo-Medrol, Medrol, Solu-Medrol), and prednisone (Rayos); or medications used to lower your calcium levels, such as cinacalcet (Sensipar). In some cases, your doctor may need to adjust the dose of your medication or monitor you carefully for side effects.

● If you have a low calcium level in your blood or have ever had one, inform your doctor. During treatment, your doctor will likely check your calcium level and will probably tell you not to receive denosumab injection if the level is too low.

● Tell your doctor if you are receiving dialysis treatments or if you have or have ever had anemia (a condition in which the red blood cells do not provide enough oxygen to all parts of the body); cancer; any type of infection, particularly in your mouth; problems with your mouth, teeth, gums, or dentures; any type of surgery (teeth extracted, dental implants); any condition that prevents your blood from clotting normally; any condition that diminishes your immune system; surgery on your thyroid gland or parathyroid gland (small gland in your neck); surgery to remove part of your small intestine; stomach or intestinal problems that prevent your body from absorbing nutrients ; polymyalgia rheumatica (disorder that causes muscle pain and weakness); diabetes, or parathyroid or kidney disease.

● If you are pregnant, planning to become pregnant, or breastfeeding, tell your doctor. Prior to starting denosumab injection treatment, you must have a negative pregnancy test. While receiving denosumab injections, you should not become pregnant. When receiving denosumab injections and for at least five months after completing treatment, you should use reliable birth control methods to prevent pregnancy. Contact your doctor immediately if you become pregnant while receiving denosumab injection, or within five months of treatment. Fetuses may be harmed by denosumab. Please see the pregnancy tab for more information.

● Having dental surgery or receiving treatment while receiving denosumab injection may result in osteonecrosis of the jaw (ONJ), a serious condition of the jaw bone. Before receiving denosumab injections, a dentist should examine your teeth and perform any necessary treatments, such as cleaning or repairing ill-fitting dentures. While receiving denosumab injections, brush your teeth and clean your mouth properly. If you are receiving this medication, talk to your doctor before having any dental work done.

Indications

Osteoporosis Treatment in Postmenopausal Women

It is indicated for postmenopausal women with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture; or for those who have failed or are intolerant to other available osteoporosis therapies. Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.

Osteoporosis Treatment To Increase Bone Mass

This drug is indicated for increasing bone mass in men with osteoporosis who have a history of osteoporotic fractures or multiple risk factors for fractures; or for patients who have not responded to other therapies for osteoporosis.

Treatment of Osteoporosis Induced by Glucocorticoids

A patient at high risk of fracture who is either initiating or continuing systemic glucocorticoids equivalent to 7.5 mg or greater of prednisone a day and is expected to remain on these glucocorticoids for at least 6 months can receive Prolia® for the treatment of glucocorticoid-induced osteoporosis. Patients at high risk of fracture are those who have had osteoporotic fractures in the past, who have multiple risk factors for fracture, or who have failed or are intolerant to other osteoporosis treatments.

Treatment Of Bone Loss In Men Receiving Androgen Deprivation Therapy For Prostate Cancer

Prolia® is indicated to increase bone mass in men at high risk for fractures receiving androgen deprivation therapy for nonmetastatic prostate cancer. Prolia® also reduced the incidence of vertebral fractures in these patients.

Adjuvant Aromatase Inhibitor Therapy and Bone Loss in Breast Cancer Patients

Breast cancer patients receiving adjuvant aromatase inhibitor therapy may benefit from Prolia® for increasing bone mass.

Usage