The efficacy and safety of Prolia in the treatment of bone loss in women receiving adjuvant aromatase inhibitor (AI) therapy for breast cancer was assessed in a 2-year, randomized (1:1), double-blind, placebo-controlled, multinational study. Women had baseline BMD T-scores between -1.0 to -2.5 at the lumbar spine, total hip, or femoral neck, and had not experienced fracture after age 25. The mean baseline lumbar spine BMD T-score was -1.1, and 2.0% of women had a vertebral fracture at baseline. The 252 women enrolled ranged in age from 35 to 84 years (median 59 years). Women were randomized to receive subcutaneous injections of either placebo (n = 125) or Prolia 60 mg (n = 127) once every 6 months for a total of 4 doses. Randomization was stratified by duration of adjuvant AI therapy at trial entry (≤ 6 months vs. > 6 months). Sixty-two percent of patients received adjuvant AI therapy for more than 6 months at study entry. All women received at least 1000 mg calcium and 400 IU vitamin D supplementation daily.
Effect on Bone Mineral Density (BMD)
The primary efficacy variable was percent change in lumbar spine BMD from baseline to month 12. Lumbar spine BMD was higher at 12 months in Prolia-treated patients as compared to placebo-treated patients [-0.7% placebo, +4.8% Prolia; treatment difference 5.5% (95% CI: 4.8, 6.3); p < 0.0001].
With approximately 81% of patients followed for 2 years, treatment differences in BMD at 2 years were 7.6% (-1.4% placebo, +6.2% Prolia) at the lumbar spine, 4.7% (-1.0% placebo, +3.8% Prolia) at the total hip, and 3.6% (-0.8% placebo, +2.8% Prolia) at the femoral neck.
Prolia is supplied in a single-dose prefilled syringe with a safety guard. The gray needle cap on the single-dose prefilled syringe contains dry natural rubber (a derivative of latex).
|60 mg/1 mL in a single-dose prefilled syringe||1 per carton||NDC 55513-710-01|
Store Prolia in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Prior to administration, Prolia may be allowed to reach room temperature (up to 25°C/77°F) in the original container. Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C/77°F and must be used within 14 days. If not used within the 14 days, Prolia should be discarded. Do not use Prolia after the expiry date printed on the label.
Protect Prolia from direct light and heat.
Avoid vigorous shaking of Prolia.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Drug Products with Same Active Ingredient
Advise patients that denosumab is also marketed as Xgeva, and if taking Prolia, they should not receive Xgeva [see Warnings and Precautions (5.1)].
Advise patients to seek prompt medical attention if signs or symptoms of hypersensitivity reactions occur. Advise patients who have had signs or symptoms of systemic hypersensitivity reactions that they should not receive denosumab (Prolia or Xgeva) [see Warnings and Precautions (5.2), Contraindications (4)].
Advise the patient to adequately supplement with calcium and vitamin D and instruct them on the importance of maintaining serum calcium levels while receiving Prolia [see Warnings and Precautions (5.3), Use in Specific Populations (8.6)]. Advise patients to seek prompt medical attention if they develop signs or symptoms of hypocalcemia.
Osteonecrosis of the Jaw
Advise patients to maintain good oral hygiene during treatment with Prolia and to inform their dentist prior to dental procedures that they are receiving Prolia. Patients should inform their physician or dentist if they experience persistent pain and/or slow healing of the mouth or jaw after dental surgery [see Warnings and Precautions (5.4)].
Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Advise patients to report new or unusual thigh, hip, or groin pain [see Warnings and Precautions (5.5)].
Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment
Advise patients not to interrupt Prolia therapy without talking to their physician [see Warnings and Precautions (5.6)].
Advise patients to seek prompt medical attention if they develop signs or symptoms of infections, including cellulitis [see Warnings and Precautions (5.7)].
Dermatologic Adverse Reactions
Advise patients to seek prompt medical attention if they develop signs or symptoms of dermatological reactions (dermatitis, rashes, and eczema) [see Warnings and Precautions (5.8)].
Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking Prolia. Patients should report severe symptoms if they develop [see Warnings and Precautions (5.9)].
Counsel females of reproductive potential to use effective contraceptive measure to prevent pregnancy during treatment and for at least 5 months after the last dose of Prolia. Advise the patient to contact their physician immediately if pregnancy does occur during these times. Advise patients not to take Prolia while pregnant or breastfeeding. If a patient wishes to start breastfeeding after treatment, advise her to discuss the appropriate timing with her physician [see Contraindications (4), Use in Specific Populations (8.1)].
Schedule of Administration
Advise patients that if a dose of Prolia is missed, the injection should be administered as soon as convenient. Thereafter, schedule injections every 6 months from the date of the last injection.
One Amgen Center DriveThousand Oaks, California 91320-1799
© 2010-2021 Amgen Inc. All rights reserved.
1xxxxxx – v21
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 10/2019|
|Medication GuideProlia® (PRÓ-lee-a)(denosumab)Injection, for subcutaneous use|
|If you receive Prolia, you should not receive XGEVA ® . Prolia contains the same medicine as Xgeva (denosumab).Prolia can cause serious side effects including: |
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|What is Prolia? Prolia is a prescription medicine used to: |
| Do not take Prolia if you: |
|Before taking Prolia, tell your doctor about all of your medical conditions, including if you: |
| How will I receive Prolia? |
|What are the possible side effects of Prolia?Prolia may cause serious side effects. |
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|The most common side effects of Prolia in men with osteoporosis are:|
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|The most common side effects of Prolia in patients with glucocorticoid-induced osteoporosis are:|
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|The most common side effects of Prolia in patients receiving certain treatments for prostate or breast cancer are:|
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|Tell your doctor if you have any side effect that bothers you or that does not go away.These are not all the possible side effects of Prolia. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
| How should I store Prolia if I need to pick it up from a pharmacy? |
|General information about the safe and effective use of Prolia. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Prolia for a condition for which it was not prescribed. Do not give Prolia to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about Prolia that is written for health professionals.|
|What are the ingredients in Prolia? Active ingredient: denosumabInactive ingredients: sorbitol, acetate, polysorbate 20, Water for Injection (USP), and sodium hydroxideAmgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-17991xxxxxx – v15 For more information, go to www.Prolia.com or call Amgen at 1-800-772-6436.|
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