| Injection, for subcutaneous use
Initial U.S. Approval: 2010
Prolia (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Prolia is a sterile, preservative-free, clear, colorless to pale yellow solution.
Each 1 mL single-use prefilled syringe of Prolia contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, 0.01% polysorbate 20, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
Each 1 mL single-use vial of Prolia contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
| CLINICAL PHARMACOLOGY
Mechanism of Action
Prolia binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
| INDICATIONS AND USAGE
Prolia is a RANK ligand (RANKL) inhibitor indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for fracture.
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
| WARNINGS AND PRECAUTIONS
| ADVERSE REACTIONS
Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
Bone loss due to hormone ablation for cancer: Most common adverse reactions (= 10% and more common than placebo) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| DOSAGE AND ADMINISTRATION
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.
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.
Preparation and Administration
Latex Allergy: People sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex).
Prior to administration, Prolia may be removed from the refrigerator and brought to room temperature (up to 25°C/77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Prolia in any other way.
Instructions for Prefilled Syringe with Needle Safety Guard
DO NOT slide the green safety guard forward over the needle before administering the injection; it will lock in place and prevent injection.
Activate the green safety guard (slide over the needle) after the injection.
The grey needle cap on the single-use prefilled syringe contains dry natural rubber (a derivative of latex); people sensitive to latex should not handle the cap.
Step 1: Remove Grey Needle Cap
Step 2: Administer Injection
DO NOT put grey needle cap back on needle.
Step 3: Immediately Slide Green Safety Guard Over Needle
With the needle pointing away from you…
Hold the prefilled syringe by the clear plastic finger grip with one hand. Then, with the other hand, grasp the green safety guard by its base and gently slide it towards the needle until the green safety guard locks securely in place and/or you hear a “click.” DO NOT grip the green safety guard too firmly – it will move easily if you hold and slide it gently.
Hold clear finger grip. (image available - package insert)
Gently slide green safety guard over needle and lock securely in place. Do not grip green safety guard too firmly when sliding over needle. (image available - package insert)
Immediately dispose of the syringe and needle cap in the nearest sharps container. DO NOT put the needle cap back on the used syringe.
Instructions for Single-use Vial
| DOSAGE FORMS AND STRENGTHS
Single-use prefilled syringe containing 60 mg in a 1 mL solution.
Single-use vial containing 60 mg in a 1 mL solution.
Prolia is supplied in a single-use prefilled syringe with a safety guard or in a single-use vial. The grey needle cap on the single-use prefilled syringe contains dry natural rubber (a derivative of latex).
60 mg/1 mL in a single-use 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.
| Package Insert data:
Amgen Manufacturing Limited, a subsidiary of Amgen Inc.
1xxxxxx - v3
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - PREFILLED SYRINGE, 60 MG
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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