Indicated for:

Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture:

• 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.

Treatment to Increase Bone Mass in Men with Osteoporosis:

• Treatment to increase bone mass in men 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.

Treatment of Glucocorticoid-Induced Osteoporosis:

• Treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer:

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

Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer:

• Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily.

Patients receiving Prolia should not receive Xgeva.

Prolia is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia.

In patients predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, severe renal impairment [creatinine clearance < 30 mL/min] or receiving dialysis, treatment with other calcium-lowering drugs), clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended within 14 days of Prolia injection.

Hypocalcemia following Prolia administration is a significant risk in patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis. These patients may also develop marked elevations of serum parathyroid hormone (PTH). Concomitant use of calcimimetic drugs may worsen hypocalcemia risk and serum calcium should be closely monitored.

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. ONJ has been reported in patients receiving denosumab. A routine oral exam should be performed by the prescriber prior to initiation of Prolia treatment. The risk of ONJ may increase with duration of exposure to Prolia.

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. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.

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 suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.

Severe bone, joint and muscle pain may occur. Discontinue use if severe symptoms develop.

Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Treatment with Prolia results in significant suppression of bone turnover and cessation of Prolia treatment results in increased bone turnover above pretreatment values 9 months after the last dose of Prolia. Bone turnover then returns to pretreatment values 24 months after the last dose of Prolia. In addition, bone mineral density returns to pretreatment values within 18 months after the last injection.

New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia discontinuation.
Evaluate an individual’s benefit-risk before initiating treatment with Prolia. If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy

The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw, atypical fractures, and delayed fracture healing.

In a clinical trial serious infections 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.

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 a clinical trial 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.

Pregnancy must be ruled out prior to administration of Prolia. Perform pregnancy testing in all females of reproductive potential prior to administration of Prolia. Prolia can cause fetal harm when administered to pregnant women. Prolia is contraindicated in pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Prolia.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Prolia, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Dosage greater than 60 mg administered as a single subcutaneous injection once every 6 months. GoToSource

• Delay lung cancer progression. GoToSource

• Bisphosphonate-refractory hypercalcemia. GoToSource

• Giant-cell tumor of bone. GoToSource 

• Fibrous bone dysplasia. GoToSource

• Paget’s disease. GoToSource

• Tertiary prevention of urological tumors. GoToSource

Osteonecrosis of the jaw (death of bone tissue). GoToSource

Upper respiratory infections and urinary tract infections. GoToSource

Cellulitis (serious bacterial skin infection). GoToSource

Diverticulitis (inflammation of diverticulum especially in colon) and sepsis (life-threatening response to infection). GoToSource

Skin infections, ear infections, endocarditis (infection of the inner lining of the heart), infective arthritis, breast, reproductive and gastrointestinal cancers, dermatitis and eczema, pancreatitis and cataracts. GoToSource

Hypocalcemia (low calcium levels). GoToSource 

Arthralgia (joint pain) and back pain. GoToSource

Anaphylaxis (including hypotension, shortness of breath, facial and upper airway edema, itching and hives). GoToSource

Atypical femoral fractures. GoToSource

Lawsuits filed for osteonecrosis of the jaw and atypical femur fractures.