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Indications

Prolia® 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 Read More

Prolia® 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.

Prolia® is indicated for 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.

Prolia® is indicated as a 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.

Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Close

Prolia(R) (denosumab) injection; syringe
Single-use
prefilled 1 mL syringe
1 Shot Every
6
Months1

For the treatment of postmenopausal women with osteoporosis at high risk for fracture

Be confident your Prolia® patients are receiving 6 months of therapy with each injection1

Prolia® is administered as 1 shot every 6 months1

  • 60 mg subcutaneous injection in the upper arm, upper thigh, or abdomen by a healthcare professional
    • Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia®
    • Adequately supplement all patients with calcium and vitamin D
    • Multiple vertebral fractures have been reported following Prolia® discontinuation
  • As a subcutaneous injection, Prolia® does not undergo first-pass metabolism2
  • May lessen patient pill burden

Important Safety Information

Following discontinuation of Prolia® treatment, fracture risk increases, including the risk of multiple vertebral fractures. Evaluate an individual’s benefit/risk before initiating treatment with Prolia®. If Prolia® treatment is discontinued, consider transitioning to an alternative antiresorptive therapy.

Help your patients remember to keep their next injection appointments every 6 months

This image is for illustration purposes only and represents a snapshot in time. Actual dosing and duration of a particular patient’s therapy should be based upon the product’s approved labeling and the independent clinical decision of the provider.

Single-use prefilled 1 mL syringe
Illustration representing snapshot in time of Prolia® dosing.

Prolia® is administered every 6 months due to its pharmacokinetic and pharmacodynamic profile1,3

Prolia® Effects on Serum CTx Levels Over the 6-month Dosing Interval3,4

Prolia® Effects on Serum CTx Levels Over the 6-month Dosing Interval. See references (3,4) below.
  • After a single 60 mg subcutaneous injection, serum denosumab concentrations showed a mean half-life of 25.4 days1
  • No change in denosumab pharmacokinetics with time was observed upon multiple dosing of 60 mg subcutaneously administered once every 6 months1

Important Safety Information

Following discontinuation of Prolia® treatment, fracture risk increases, including the risk of multiple vertebral fractures. Evaluate an individual’s benefit/risk before initiating treatment with Prolia®. If Prolia® treatment is discontinued, consider transitioning to an alternative antiresorptive therapy.

Prolia® is an antiresorptive RANK Ligand inhibitor.
Prolia® is different than a bisphosphonate because of its mechanism of action.1*

*Mechanism of action differences are not meant to imply clinical efficacy.

No dose adjustment is necessary in patients with renal impairment1

Patients with severe renal impairment (CrCl < 30 mL/min) are at increased risk for hypocalcemia1

  • Clinical monitoring of calcium, phosphorus, and magnesium is highly recommended in patients with severe renal impairment

Age-specific Prevalence of Renal Impairment in Postmenopausal Women With Osteoporosis5†

Data from a subset of postmenopausal women with osteoporosis who have CrCl ≤ 60 mL/min from the Third National Health and Nutrition Examination Survey (NHANES III).

Prolia® (denosumab) is not cleared by the kidneys.6

Prolia® is contraindicated in patients with hypocalcemia.1

  • Pre-existing hypocalcemia must be corrected prior to initiating Prolia®
  • Adequately supplement all patients with calcium and vitamin D

Important Safety Information

Contraindications: Prolia® is contraindicated in patients with hypocalcemia, women who are pregnant, and patients with a history of systemic hypersensitivity to any component of the product. Patients receiving Prolia® should not receive XGEVA®.