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denosumab

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Overview

What is XGEVA?

Xgeva (denosumab) is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.

Xgeva is a sterile, preservative-free, clear, colorless to pale yellow solution.

Each single-dose vial of Xgeva contains 120 mg denosumab, acetate (18 mM), polysorbate 20 (0.01%), sorbitol (4.6%), Water for Injection (USP), and sodium hydroxide to a pH of 5.2.



What does XGEVA look like?



What are the available doses of XGEVA?

Injection: 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.

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

How should I use XGEVA?

Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.


What interacts with XGEVA?

Sorry No Records found


What are the warnings of XGEVA?

Sorry No Records found


What are the precautions of XGEVA?

Sorry No Records found


What are the side effects of XGEVA?

Sorry No records found


What should I look out for while using XGEVA?

Hypocalcemia ()

Known clinically significant hypersensitivity to Xgeva ()


What might happen if I take too much XGEVA?

There is no experience with overdosage of Xgeva.


How should I store and handle XGEVA?

ArrayXgeva is supplied in a single-dose vial.Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton.  Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days.  Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label.Protect Xgeva from direct light and heat.Avoid vigorous shaking of Xgeva.Xgeva is supplied in a single-dose vial.Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton.  Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days.  Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label.Protect Xgeva from direct light and heat.Avoid vigorous shaking of Xgeva.Xgeva is supplied in a single-dose vial.Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton.  Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days.  Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label.Protect Xgeva from direct light and heat.Avoid vigorous shaking of Xgeva.Xgeva is supplied in a single-dose vial.Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton.  Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days.  Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label.Protect Xgeva from direct light and heat.Avoid vigorous shaking of Xgeva.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Xgeva binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption, thereby modulating calcium release from bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth. Xgeva prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors, and osteoclast-like giant cells.

Non-Clinical Toxicology
Hypocalcemia ()

Known clinically significant hypersensitivity to Xgeva ()

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and action of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.

The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.









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

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

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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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