ntinue drug or nursing (8.3)
Pediatric patients: Safety and efficacy not established (8.4)
Renal impairment: No dose adjustment is necessary in patients with renal impairment. Patients with creatinine clearance < 30 mL/min or receiving dialysis are at risk for hypocalcemia. Supplement with calcium and vitamin D and consider monitoring serum calcium (8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 06/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypocalcemia
5 WARNINGS AND PRECAUTIONS
5.1 Hypocalcemia and Mineral Metabolism
5.2 Serious Infections
5.3 Dermatologic Adverse Reactions
5.4 Osteonecrosis of the Jaw
5.5 Suppression of Bone Turnover
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Postmenopausal Women with Osteoporosis
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Hypocalcemia
17.2 Serious Infections
17.3 Dermatologic Reactions
17.4 Osteonecrosis of the Jaw
17.5 Schedule of Administration
MEDICATION GUIDE
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - PREFILLED SYRINGE, 60 MG
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, as defined by factors such 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 [see Clinical Studies (14.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Prolia should be administered by a healthcare professional.
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 [see Warnings and Precautions (5.1)].
If a dose of Prolia is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection.
2.2 Preparation and A
