: 04/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*WARNING: POTENTIAL RISK OF MYOCARDIAL
INFARCTION AND STROKE
1 INDICATIONS AND USAGE
1.1 Treatment of Postmenopausal Women withOsteoporosis at High Risk for Fracture
1.2 Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
2.2 Recommended Dosage
2.3 Preparation and Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Major Adverse Cardiac Events (MACE)
5.2 Hypersensitivity Reactions
5.3 Hypocalcemia
5.4 Osteonecrosis of the Jaw
5.5 Atypical Subtrochanteric and Diaphyseal FemoralFractures
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.7 Renal Impairment
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 Pharmacology
14 CLINICAL STUDIES
14.1 Treatment of Osteoporosis in PostmenopausalWomen
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not
listed.
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FULL PRESCRIBING INFORMATION
WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE ANDCARDIOVASCULAR DEATH
• EVENITY may increase the risk of myocardial infarction, stroke, and cardiovasculardeath [see Warnings and Precautions (5.1)]. EVENITY should not be initiated in patientswho have had a myocardial infarction or stroke within the preceding year. Considerwhether the benefits outweigh the risks in patients with other cardiovascular risk factors.
If a patient experiences a myocardial infarction or stroke during therapy, EVENITYshould be discontinued.
1 INDICATIONS AND USAGE
1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk forfracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients whohave failed or are intolerant to other available osteoporosis therapy.
1.2 Limitations of Use
The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration ofEVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted,continued therapy with an anti-resorptive agent should be considered [see Dosage and Administration(2.2) and Clinical Studies (14.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
• Two separate syringes (and two separate subcutaneous injections) are needed to administer thetotal dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after theother.
• EVENITY should be administered by a healthcare provider.
2.2 Recommended Dosage
• The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen,thigh or upper arm. Ad
