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denosumab

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Overview

What is Prolia?

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.



What does Prolia look like?



What are the available doses of Prolia?

What should I talk to my health care provider before I take Prolia?

How should I use Prolia?

Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined 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

Prolia should be administered by a healthcare professional ()

Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen ()

Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily ()


What interacts with Prolia?

Sorry No Records found


What are the warnings of Prolia?

Sorry No Records found


What are the precautions of Prolia?

Sorry No Records found


What are the side effects of Prolia?

Sorry No records found


What should I look out for while using Prolia?

Prolia is contraindicated in:


What might happen if I take too much Prolia?

There is no experience with overdosage with Prolia.


How should I store and handle Prolia?

Prolia is supplied in a single-use prefilled syringe with a safety guard.  The grey needle cap on the single-use prefilled syringe contains dry natural rubber (a derivative of latex). 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.Prolia is supplied in a single-use prefilled syringe with a safety guard.  The grey needle cap on the single-use prefilled syringe contains dry natural rubber (a derivative of latex). 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.Prolia is supplied in a single-use prefilled syringe with a safety guard.  The grey needle cap on the single-use prefilled syringe contains dry natural rubber (a derivative of latex). 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.Prolia is supplied in a single-use prefilled syringe with a safety guard.  The grey needle cap on the single-use prefilled syringe contains dry natural rubber (a derivative of latex). 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.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology
Prolia is contraindicated in:

Prolia contains the same active ingredient (denosumab) found in Xgeva.  Patients receiving Prolia should not receive Xgeva.

The following serious adverse reactions are discussed below and also elsewhere in the labeling:

The most common adverse reactions reported with Prolia in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions reported with Prolia in men with osteoporosis are back pain, arthralgia, and nasopharyngitis.

The most common (per patient incidence ≥ 10%) adverse reactions reported with Prolia in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain.  Pain in extremity and musculoskeletal pain have also been reported in clinical trials.  

The most common adverse reactions leading to discontinuation of Prolia in patients with postmenopausal osteoporosis are back pain and constipation. 

To report Adverse Reactions with Prolia, please call Amgen Medical Information at 1-800-772-6436, email medinfo@amgen.com, or report the event at  

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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