eatment with alendronatesignificantly increased BMD compared with alendronate alone. The BMD increase with EVENITY overalendronate observed at month 12 was maintained at month 24. The treatment differences in BMD atmonth 24 were 8.1% at the lumbar spine, 3.8% at the total hip, and 3.8% at the femoral neck.
There was no evidence of differences in effects on BMD at the lumbar spine or total hip across subgroupsdefined by baseline age, baseline BMD, or geographic region.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
EVENITY (romosozumab-aqqg) injection is a clear to opalescent, colorless to light yellow solution forsubcutaneous injection supplied in a single-use prefilled syringe.
Each single-use prefilled syringe contains 105 mg of EVENITY in a deliverable volume of 1.17 mL. Todeliver a full dose, inject two 105 mg/1.17 mL EVENITY prefilled syringes, one after the other for a totaldose of 210 mg.
• NDC 55513-880-02: Carton of two 105 mg/1.17 mL single-use prefilled syringes.
The prefilled syringe is not made with natural rubber latex.
16.2 Storage and Handling
• Refrigerate EVENITY at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Do not freeze. Do not shake.
• If removed from the refrigerator, EVENITY can be kept at room temperature up to 25°C (77°F)in the original carton and must be used within 30 days. If not used within 30 days, discardEVENITY.
• Do not expose EVENITY to temperatures above 25°C (77°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Major Adverse Cardiac Events
Advise patients to seek immediate medical attention if they experience signs or symptoms of amyocardial infarction or stroke [see Boxed Warning, Warnings and Precautions (5.1) and AdverseReactions (6.1)].
Hypersensitivity Reactions
Advise patients to seek immediate medical attention if they experience signs or symptoms of ahypersensitivity reaction including angioedema, erythema multiforme, dermatitis, rash, and urticaria[see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Calcium and Vitamin D Supplements to Prevent Hypocalcemia
Advise patients to take calcium and vitamin D supplements daily to reduce the risk of hypocalcemia.
Advise patients to seek immediate medical attention for symptoms of hypocalcemia [see Dosage andAdministration (2.1), Warnings and Precautions (5.3) and Adverse Reactions (6.1)].
Osteonecrosis of the Jaw
Advise patients to practice good oral hygiene during treatment with EVENITY and tell their dentist thatthey are receiving EVENITY before having dental work. [see Warnings and Precautions (5.4) andAdverse Reactions (6.1)].
Atypical Femoral Fracture
Advise patients to report signs and symptoms that could be consistent with impending atypical femoralfracture including new or unusual thigh, hip, or groin pain [see Warnings and Precautions (5.5) andAdverse Reactions (6.1)].
EVENITY™ (romosozumab-aqqg)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
US License No. 1080
Patent: http://pat.amgen.com/EVENITY/
© 2019 Amgen Inc. All rights reserved.
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