Deepika vegiraju at 08:16, 4 September 2022

2022-09-04T08:16:22Z

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== '''What is {{PAGENAME}}?''' ==

* {{PAGENAME}} is drug used to prevent or treat certain bone problems, especially [[osteoporosis]].
* It is used under the brand name [[Xgeva]] and Prolia to prevent bone problems caused by [[multiple myeloma]] or by solid tumors that have spread to the bone.
* It is also used in certain patients to treat [[giant cell tumor]] of the bone that cannot be removed by surgery, and to treat [[hypercalcemia]] that is caused by cancer and did not get better after treatment with [[bisphosphonates]].
* Denosumab is also used under the brand name [[Prolia]] to increase bone mass in certain patients with [[breast cancer]] or [[prostate cancer]] who have a high risk of breaking bones.
* It is also used to treat osteoporosis in men and [[postmenopausal]] women who have a high risk of breaking bones.

[[File:Denosumab.jpg|alt=A humanized monoclonal antibody and an inhibitor of the RANK LIGAND|thumb|A humanized monoclonal antibody and an inhibitor of the RANK LIGAND]]

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== '''What are the uses of {{PAGENAME}}?''' ==

{{PAGENAME}} 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 with osteoporosis at high risk for fracture
* Treatment of [[glucocorticoid]]-induced osteoporosis in men and women 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]]

== '''How does {{PAGENAME}} work?''' ==

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* It binds to a protein called RANKL, which keeps RANKL from binding to another protein called RANK on the surface of certain bone cells, including bone cancer cells.
* This may help keep bone from breaking down and cancer cells from growing.
* Denosumab may also prevent the loss of calcium from the bones.
* It is a type of [[monoclonal antibody]]. Also called AMG 162.

== '''Who Should Not Use {{PAGENAME}} ?''' ==

* [[Hypocalcemia]]
* [[Pregnancy]]
* Known [[hypersensitivity]] to {{PAGENAME}}

== '''Is {{PAGENAME}} FDA approved?''' ==

* Yes. Prolia was approved in the United States initially in 2020.

== '''How should {{PAGENAME}} be used?''' ==

'''Recommended Dosage: '''
* Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.

'''Multiple Myeloma and Bone Metastasis from Solid Tumors:'''
Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen.

'''Giant Cell Tumor of Bone:'''
* Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy.
* Administer subcutaneously in the upper arm, upper thigh, or abdomen.

'''Hypercalcemia of Malignancy:'''
* Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.

'''Administration:'''
* Xgeva is intended for [[subcutaneous]] route only and should not be administered [[intravenously]], [[intramuscularly]], or [[intradermally]].

== '''What are the dosage forms and brand names of {{PAGENAME}}?''' ==

* Single-dose prefilled syringe containing 60 mg in a 1 mL solution

{{PAGENAME}} is available in fallowing brand namesː
* [[Xgeva]]
* [[Prolia]]

=='''What side effects can this medication cause?'''==

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* 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.

* Male osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, [[arthralgia]], and [[nasopharyngitis]].

* [[Glucocorticoid-induced osteoporosis]]: Most common adverse reactions (> 3% and more common than active-control group) were: back pain, [[hypertension]], [[bronchitis]], and headache.

* 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.

=='''What warnings and special precautions should I follow?''' ==

* [[Hypersensitivity]] including [[anaphylactic]] reactions may occur. Discontinue permanently if a clinically significant reaction occurs.
* [[Hypocalcemia]]: Must be corrected before initiating Prolia. May worsen, especially in patients with renal impairment. Adequately supplement patients with calcium and vitamin D.
* [[Osteonecrosis of the jaw]]: Has been reported with Prolia. Monitor for symptoms.
* Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
* Multiple vertebral fractures have been reported following Prolia discontinuation. Patients should be transitioned to another antiresorptive agent if Prolia is discontinued.
* Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
* Dermatologic reactions: Dermatitis, rashes, and [[eczema]] have been reported. Consider discontinuing Prolia if severe symptoms develop.
* Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
* Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.
* No dose adjustment is necessary in patients with renal impairment. Patients with [[creatinine]] clearance < 30 mL/min or receiving dialysis are at risk for [[hypocalcemia]]. Supplement with calcium and vitamin D, and consider monitoring serum calcium.

== '''What to do in case of emergency/overdose?''' ==

* {{overdose}}

== '''Can {{PAGENAME}} be used in pregnancy?''' ==

* {{PAGENAME}} may cause fetal harm when administered to pregnant women.
* Advise females of reproductive potential to use effective [[contraception]] during therapy, and for at least 5 months after the last dose of Prolia.

=='''Can {{PAGENAME}} be used in children?'''==

* Safety and efficacy not established.

== '''What are the active and inactive ingredients in {{PAGENAME}}?''' ==

'''Active ingredient:''' {{PAGENAME}}

'''Inactive ingredients:
* [[Sorbitol]], [[acetate]], [[polysorbate 20]], [[water for Injection]] (USP), and [[sodium hydroxide]]

== '''Who manufactures and distributes {{PAGENAME}}?''' ==

Prolia is Manufactured by: [[Amgen, Inc.|Amgen Inc.]] One Amgen Center Drive Thousand Oaks, California 91320-1799

== '''What should I know about storage and disposal of this medication?''' ==

* Keep Prolia in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton.
* Do not freeze Prolia.
* When you remove Prolia from the refrigerator, Prolia must be kept at room temperature [up to 77°F (25°C)] in the original carton and must be used within 14 days.
* Do not keep Prolia at temperatures above 77°F (25°C). Warm temperatures will affect how Prolia works.
* Do not shake Prolia.
* Keep Prolia in the original carton to protect from light.
* Keep Prolia and all medicines out of the reach of children.

{{coststubd}}
{{Drugs for treatment of bone diseases}}
{{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems}}
{{Cytokine receptor modulators}}
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[[Category:Amgen]]
[[Category:Monoclonal antibodies]]
[[Category:Osteoporosis drugs]]

Denosumab - Revision history

Deepika vegiraju at 08:16, 4 September 2022