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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

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

Prolia® Adverse Reactions

The following adverse reactions were reported in ≥ 2% of postmenopausal women with osteoporosis and more frequently in the Prolia®-treated women than in the placebo-treated patients.1

Adverse Reactions
Prolia®
(N = 3886) n (%)
Placebo
(N = 3876) n (%)
Back pain
1347 (34.7)
1340 (34.6)
Pain in extremity
453 (11.7)
430 (11.1)
Musculoskeletal pain
297 (7.6)
291 (7.5)
Hypercholesterolemia
280 (7.2)
236 (6.1)
Cystitis
228 (5.9)
225 (5.8)
Vertigo
195 (5.0)
187 (4.8)
Upper respiratory tract infection
190 (4.9)
167 (4.3)
Edema, peripheral
189 (4.9)
155 (4.0)
Sciatica
178 (4.6)
149 (3.8)
Pneumonia
152 (3.9)
150 (3.9)
Bone pain
142 (3.7)
117 (3.0)
Abdominal pain, upper
129 (3.3)
111 (2.9)
Anemia
129 (3.3)
107 (2.8)
Insomnia
126 (3.2)
122 (3.1)
Myalgia
114 (2.9)
94 (2.4)
Angina pectoris
101 (2.6)
87 (2.2)
Rash
96 (2.5)
79 (2.0)
Pharyngitis
91 (2.3)
78 (2.0)
Asthenia
90 (2.3)
73 (1.9)
Pruritus
87 (2.2)
82 (2.1)
Flatulence
84 (2.2)
53 (1.4)
Spinal osteoarthritis
82 (2.1)
64 (1.7)
Gastroesophageal reflux disease
80 (2.1)
66 (1.7)
Atrial fibrillation
79 (2.0)
77 (2.0)
Herpes zoster
79 (2.0)
72 (1.9)