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WYOST is a brand name for Denosumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: WYOST (denosumab injection) is indicated for: • reducing the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours. • treatment of adults and skeletally mature…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations All patients, except those with hypercalcemia, should receive at least 500 mg calcium daily and at least 400 IU vitamin D daily. 3 Pediatrics) Multiple Myeloma and Bone Metastasis from Solid Tumours The recommended dose of Wyost is 120 mg administered as a single subcutaneous injection once every 4 weeks.
Giant Cell Tumour of Bone The recommended dose of Wyost is 120 mg administered as a subcutaneous injection once every 4 weeks with a loading dose of 120 mg on days 8 and 15 of the first month of therapy. Hypercalcemia of Malignancy Refractory to Intravenous Bisphosphonate The recommended dose of Wyost is 120 mg administered as a subcutaneous injection once every 4 weeks with a loading dose of 120 mg on days 8 and 15 of the first month of therapy.
4 Administration Prior to administration, Wyost may be removed from the refrigerator and brought to room temperature (up to 25oC) by standing in the original carton. This generally takes 15 to 30 minutes. Do not warm Wyost in any other way (see 11 STORAGE, STABILITY AND DISPOSAL).
Visually inspect Wyost for particulate matter and discolouration prior to administration. Wyost is a clear, colourless to slightly yellowish or slightly brownish. Do not use if the solution is cloudy or if the solution contains visible particles or foreign particulate matter.
Use a 27-gauge needle to withdraw and inject the entire contents of the vial. The vial is filled to ensure a deliverable dose of 120 mg. Do not re-enter the vial. Discard vial and any liquid remaining in the vial. Wyost is intended for use under the guidance and supervision of physicians who have fully familiarized themselves with the efficacy/safety profile of Wyost.
After an initial training in proper subcutaneous injection technique, patients may self-inject Wyost if a physician determines that is appropriate and with medical follow-up as necessary. WYOST (denosumab injection) Page 6 of 52 Wyost is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.
Administer Wyost via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. 5 Missed Dose If a dose of Wyost is missed, administer the injection as soon as the patient is available. Thereafter, injections should be scheduled every 4 weeks from the date of the last injection.
1 Dosing Considerations All patients, except those with hypercalcemia, should receive at least 500 mg calcium daily and at least 400 IU vitamin D daily. 3 Pediatrics) Multiple Myeloma and Bone Metastasis from Solid Tumours The recommended dose of Wyost is 120 mg administered as a single subcutaneous injection once every 4 weeks.
Giant Cell Tumour of Bone The recommended dose of Wyost is 120 mg administered as a subcutaneous injection once every 4 weeks with a loading dose of 120 mg on days 8 and 15 of the first month of therapy. Hypercalcemia of Malignancy Refractory to Intravenous Bisphosphonate The recommended dose of Wyost is 120 mg administered as a subcutaneous injection once every 4 weeks with a loading dose of 120 mg on days 8 and 15 of the first month of therapy.
4 Administration Prior to administration, Wyost may be removed from the refrigerator and brought to room temperature (up to 25oC) by standing in the original carton. This generally takes 15 to 30 minutes. Do not warm Wyost in any other way (see 11 STORAGE, STABILITY AND DISPOSAL).
Visually inspect Wyost for particulate matter and discolouration prior to administration. Wyost is a clear, colourless to slightly yellowish or slightly brownish. Do not use if the solution is cloudy or if the solution contains visible particles or foreign particulate matter.
Use a 27-gauge needle to withdraw and inject the entire contents of the vial. The vial is filled to ensure a deliverable dose of 120 mg. Do not re-enter the vial. Discard vial and any liquid remaining in the vial. Wyost is intended for use under the guidance and supervision of physicians who have fully familiarized themselves with the efficacy/safety profile of Wyost.
After an initial training in proper subcutaneous injection technique, patients may self-inject Wyost if a physician determines that is appropriate and with medical follow-up as necessary. WYOST (denosumab injection) Page 6 of 52 Wyost is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.
5 Post-Market Adverse Reactions). • Pre-existing hypocalcemia must be corrected prior to initiating therapy with Wyost (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia). WYOST (denosumab injection) Page 5 of 52 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Osteonecrosis of the jaw (ONJ) (see 7 WARNINGS AND PRECAUTIONS, Other, and
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 5 Post-Market Adverse Reactions).
• Pre-existing hypocalcemia must be corrected prior to initiating therapy with Wyost (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypocalcemia). WYOST (denosumab injection) Page 5 of 52
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Denosumab in Canada.
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Administer Wyost via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. 5 Missed Dose If a dose of Wyost is missed, administer the injection as soon as the patient is available. Thereafter, injections should be scheduled every 4 weeks from the date of the last injection.
5 OVERDOSAGE There is no experience with overdosage of denosumab. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, health professionals should record both the brand name and the non-proprietary (active ingredient) name as well as other product- specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
2. 2. Wyost is supplied in a carton containing 1 vial. Description Wyost is a genetically engineered human IgG2 kappa type monoclonal antibody directed against the transmembrane or soluble receptor activator of nuclear factor kappa-B ligand (RANKL).
The mode of action of Wyost is to bind to RANKL and consequently inhibit bone resorption by preventing RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors, and osteoclast-like giant cells. 7 mL solution in a single-use vial Acetic acid, hydrochloric acid, polysorbate 20, sodium hydroxide, sorbitol, water for injection WYOST (denosumab injection) Page 7 of 52 mammalian cell expression system.
Wyost is isolated by a primary separation and a series of purification steps, typical for monoclonal antibodies, including chromatography steps as well as virus removal and inactivation steps. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Patients being treated with Wyost should not be treated concomitantly with other denosumab-containing medicinal products. 4 Drug-Drug Interactions). Carcinogenesis and Mutagenesis Please see 16 NON-CLINICAL TOXICOLOGY. 1%). These cases were predominantly cellulitis.
7%). Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. Endocrine and Metabolism Hypocalcemia Denosumab can cause severe symptomatic hypocalcemia and fatal cases have been reported.
Signs and symptoms of severe hypocalcemia may include, for example, altered mental status, tetany, seizures and QTc prolongation. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Wyost. Monitor calcium […]