Read all of this leaflet carefully before you start using this medicine. Xgeva is not indicated for the prevention of skeletalrelated events in patients with multiple myeloma see clinical trials 14. Posology supplementation of at least 500mgcalcium and 400iu vitamin d daily is required in all patients, unless hypercalcaemia is presentsee section 4. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter. Information for the patient xgeva 120 mg solution for injection denosumab read all of this leaflet carefully before you start using this medicine because it contains important information for. View important safety information and full prescribing information on. Page 3 full prescribing information 1 indications and usage 1. Adequately supplement patients with calcium and vitamin d 5. Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. Highlights of prescribing information adequately rehydrate. Xgeva is indicated for the prevention of skeletalrelated events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Do not pull the back stopper flange off of the syringe.
Learn about a medicine used to help prevent serious bone problems in patients with multiple myeloma or from solid tumors. Xgeva is indicated for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Zytiga is used to treat men with prostate cancer that has spread to other parts of the body. May 09, 2019 visually inspect xgeva for particulate matter and discoloration prior to administration. Monitor calcium levels, throughout xgeva therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin d as necessary. Information for the patient xgeva 120 mg solution for injection denosumab read all of this leaflet carefully before you start using this medicine because it contains important information for you. If you have any further questions, ask your doctor or pharmacist. You will only feel light resistance when screwing the plunger rod into position. Erbituxcetuximabinjection,for intravenous use initial u. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Prolia denosumab injection, for subcutaneous use initial u. Erbitux can cause serious and fatal infusion reactions. Zytiga abiraterone acetate is a prescription medicine that is used along with prednisone. Patients treated with xgeva should be given the package leaflet and the patient reminder card.
Prescription treatment with zytiga abiraterone acetate. Xgeva product monograph page 4 of 63 pediatrics the safety and efficacy of xgeva have not been studied in pediatric populations other than skeletally mature adolescents aged 17 years with giant. The drug should be used with caution in patients with coronary. Xgeva injection for subcutaneous use prescribing information. This solution is readytouse and may be administered directly to the patient without further preparation.
Visually inspect xgeva for particulate matter and discoloration prior to administration. Page 1 highlights of prescribing information these. Xgeva 3 level of xgeva wasand were previously authorized by hmsacvs and members demonstrate a response to xgeva therapy defined as albumincorrected serum calcium level of xgeva should be administered under the responsibility of a healthcare professional. The infusion time must not be less than 15 minutes given over a constant infusion rate. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. Discontinue permanently if a clinically significant reaction occurs 5. If the next scheduled boniva day is only 1 to 7 days away, wait until the subsequent months scheduled boniva day to take their tablet. Serious bone problem prevention xgeva denosumab injection. Sca and prescribing information for denosumab 120mg injection xgeva.
Denosumab prolia, xgeva related to lcd l33394 a52399. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval. Page 3 of 44 full prescribing information 1 indications and usage 1. Xgeva is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to.
If you have any further questions, ask your doctor, pharmacist, or nurse. Prepare the prefilled syringe by attaching the plunger. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Infusion reactions andcardiopulmonary arrest see full prescribing information for complete boxed warning. Monitor levels more frequently when xgeva is administered with other drugs that can also lower calcium levels. Clinical reasons to avoid iv bisphosphonate therapy renal insufficiency creatinine clearance desmopressin acetate 4 mcgml has infrequently produced changes in blood pressure causing either a slight elev ation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. Highlights of prescribing information procrit epoetin alfa. Shared care arrangement and prescribing information for. Xgeva is indicated for the prevention of skeletalrelated events in patients with bone metastases from solid tumors.
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Xgeva is a sterile, preservativefree, clear, colorless to pale yellow solution. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin d 5. May worsen, especially in patients with renal impairment. Escherichia coli, klebsiella pneumoniae, citrobacter.
For subsequent monthly doses for both of the above scenarios. Xgeva is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for prolia denosumab skip to. Specialty guideline management xgeva denosumab policy. Highlights of prescribing information hypocalcemia. Xgeva denosumab is a human igg2 monoclonal antibody that binds to human rankl. Xgeva is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Use a 27gauge needle to withdraw and inject the entire contents of the vial. Attach the adapter to the powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snaps in place see figure a. Denosumab has an approximate molecular weight of 147 kda and is produced in genetically engineered mammalian chinese hamster ovary cells. Highlights of prescribing information these highlights do not include all the information needed to use reclast safely and effectively. For subsequent monthly doses for both of the above scenarios, instruct patients to return to their original schedule by taking one boniva 150 mg tablet every month on their previous chosen day. Insert the plunger rod into the prefilled syringe containing sterile water, usp, and screw the plunger rod clockwise to tighten. Information for the user prolia 60 mg solution for injection in prefilled syringe denosumab read all of this leaflet carefully before you start using this medicine because it contains.
Highlights of prescribing information these highlights do not include all the information needed to use prolia safely and effectively. Information for the user prolia 60 mg solution for injection in prefilled syringe denosumab read all of this leaflet carefully before you start using this medicine because it contains important information for you. Indications the indications below including fdaapproved indications and compendial uses are considered a covered benefit. Highlights of prescribing information hypocalcemia may worsen.
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