No dose adjustment is necessary in patients with renal impairment. 0000009289 00000 n Below are answers to some commonly asked questions about Xgeva. 0000004267 00000 n 0000007993 00000 n Prolia is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. The recommended injection sites for Prolia include: the upper arm OR the upper thigh OR the abdomen. Denosumab 60 mg (for osteoporosis indications) should not be used in patients with hypocalcaemia, regardless of severity*. Mild side effects in males* using Prolia for osteoporosis include: back pain. The efficacy and safety of Prolia in the treatment to increase bone mass in men with osteoporosis was demonstrated in a 1-year, randomized, double-blind, placebo-controlled trial. Prolia (denosumab) is available as a single-dose prefilled syringe containing 60 mg in a 1 mL solution. 0000020241 00000 n Enrolled men had a baseline BMD T-score between -2.0 and -3.5 at the lumbar spine or femoral neck. Prolia is injected under your skin (subcutaneous). All patients were instructed to take at least 1000 mg of calcium and 800 IU of vitamin D supplementation per day. Prolia significantly reduced the incidence of new vertebral fractures at 3 years (p = 0.0125), as shown in Table 5. Other findings in offspring included absence of axillary, inguinal, mandibular, and mesenteric lymph nodes; abnormal bone growth, reduced bone strength, reduced hematopoiesis, dental dysplasia, and tooth malalignment; and decreased neonatal growth. Tread Lightly When Delaying Denosumab Shots | MedPage Today Treatment with Prolia resulted in a significant reduction in the incidence of nonvertebral fractures (Table 4). Concomitant use of calcimimetic drugs may worsen hypocalcemia risk and serum calcium should be closely monitored. Lumbar spine BMD was higher at 2 years in Prolia-treated patients as compared to placebo-treated patients [-1.0% placebo, +5.6% Prolia; treatment difference 6.7% (95% CI: 6.2, 7.1); p < 0.0001]. Amgen Inc.One Amgen Center DriveThousand Oaks, California 91320-1799. 0000019957 00000 n Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Prolia. Gently slide green safety guard over needle and lock securely in place. There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor. In neonatal rats, inhibition of RANKL (the target of Prolia therapy) with a construct of osteoprotegerin bound to Fc (OPG-Fc) at doses 10 mg/kg was associated with inhibition of bone growth and tooth eruption. Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking Prolia. 0 Denosumab Injection (Prolia) Information - Drugs.com 0000000656 00000 n DO NOT put gray needle cap back on needle. Patients should be transitioned to another antiresorptive agent if Prolia is discontinued. In addition, bone mineral density returns to pretreatment values within 18 months after the last injection [see Clinical Pharmacology (12.2), Clinical Studies (14.1)]. Consider the benefit-risk profile when administering Prolia to patients with severe renal impairment or receiving dialysis. %PDF-1.4 % Make sure to not change your treatment or Xgeva dosage without first talking with your doctor. Treatment of Postmenopausal Women with Osteoporosis. If a patient wishes to start breastfeeding after treatment, advise her to discuss the appropriate timing with her physician [see Contraindications (4), Use in Specific Populations (8.1)]. Well send you a link to a feedback form. joint pain . Denosumab injection (Prolia) is usually given once every 6 months. Prolia is not approved for use in children. It is not known if Prolia passes into your breast milk. ASBMR, AACE, NOF Develop Joint Guidance on COVID-19 Vaccination and Discontinuation of Prolia therapy should be considered based on individual benefit-risk assessment. Brush and floss your teeth regularly. Do not keep Prolia at temperatures above 77F (25C). Women were randomized to receive subcutaneous injections of either placebo (N = 3906) or Prolia 60 mg (N = 3902) once every 6 months. If not used within the 14 days, Prolia should be discarded. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. The treatment differences in BMD at 3 years were 8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck. No evidence of altered pharmacokinetic profile, toxicity profile, or clinical response was associated with binding antibody development. Qualitative assessments showed bone of normal architecture and quality without mineralization defects or bone marrow abnormality. Treatment of Bone Loss in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer or Adjuvant Aromatase Inhibitor Therapy for Breast Cancer. View Labeling Archives, Randomization was stratified by gender within each subpopulation. It will take only 2 minutes to fill in. Xgeva contains the same medicine as Prolia. The genotoxic potential of denosumab has not been evaluated. Advise the patient to adequately supplement with calcium and vitamin D and instruct them on the importance of maintaining serum calcium levels while receiving Prolia [see Warnings and Precautions (5.3), Use in Specific Populations (8.6)]. If a dose of Prolia is missed, administer the injection as soon as the patient is available. In RANKL knockout mice, absence of RANKL (the target of denosumab) also caused fetal lymph node agenesis and led to postnatal impairment of dentition and bone growth. If you have problems caused by some kinds of cancer, your doctor might suggest Xgeva (denosumab) as a treatment option for you. LoginAsk is here to help you access Amgen Prolia Log In quickly and handle each specific case you encounter. The best places to inject are the top of your thighs and the abdomen. Coverage for medication is based on the patient's condition, the appropriateness of the dose and route of administration, bas ed on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and . Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended. DO NOT put the needle cap back on the used syringe. schedule injections every 6 months from the date of the last injection. Although denosumab is ideally suited for use in primary care, it is a second line drug after oral medication (usually bisphosphonates). Martin M, et al. Hypocalcaemia is a known risk with denosumab use, especially in patients with severe renal impairment (creatinine clearance <30 mL/min; estimated glomerular filtration rate [eGFR] 15 29 mL/min/1.73m2) or receiving dialysis. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.3)]. If you and your doctor determine that Xgeva is safe and effective for you, its likely that youll use it long term. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Enrolled patients 50 years of age who were in the glucocorticoid-continuing subpopulation were required to have a baseline BMD T-score of -2.0 at the lumbar spine, total hip, or femoral neck; or a BMD T-score -1.0 at the lumbar spine, total hip, or femoral neck and a history of osteoporotic fracture. Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia. Epidermal and dermal adverse events (such as dermatitis, eczema, and rashes) were reported in 4 patients (3.3%) in the placebo group and 5 patients (4.2%) in the Prolia group. All men were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day. In patients treated with Prolia, 1 (33%) had tetracycline label and 2 (67%) had no tetracycline label present at the 12-month biopsy. Prolia is administered as 1 shot every 6 months1 60 mg subcutaneous injection in the upper arm, upper thigh, or abdomen by a healthcare professional Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia Adequately supplement all patients with calcium and vitamin D The incidence of opportunistic infections was similar to that reported with placebo. The most common adverse reactions reported with Prolia in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. [5] For an upper arm injection, another person will have to administer the shot. The information below describes common dosages that are typically recommended. 0000002386 00000 n Pre-existing hypocalcaemia must be corrected prior to initiating denosumab, and supplementation of calcium and vitamin D is required in all patients receiving 120 mg denosumab unless hypercalcaemia is present. Is There a Connection Between Vitamin D and Joint Pain? Theyre more likely to recommend that you take more calcium and vitamin D supplements. While theres no exact cure for bone metastases, treatment can help reduce symptoms and increase life expectancy. The treatment differences in BMD at 1-year were 4.8% (+0.9% placebo, +5.7% Prolia; (95% CI: 4.0, 5.6); p < 0.0001) at the lumbar spine, 2.0% (+0.3% placebo, +2.4% Prolia) at the total hip, and 2.2% (0.0% placebo, +2.1% Prolia) at femoral neck. How do you bill for Dupixent injection? - urbx.iliensale.com Does medicare cover prolia? - bri.dixiesewing.com In utero denosumab exposure from cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth [see Data]. . Here's what you need to know. CTX levels were below the limit of assay quantitation (0.049 ng/mL) in 39% to 68% of patients 1 to 3 months after dosing of Prolia. Perform pregnancy testing in all females of reproductive potential prior to administration of Prolia. Here are some examples of questions you may want to ask your doctor: Will my doctor change my Xgeva dosage if my calcium levels decrease during treatment? hb```b``d`a``tab@ !V68s 1U[@R\e.R_dkW3m4Pa`Xt@v~F{T6)8UU4TI"!f)zH]4$;%4o[ OHI. Step 3: Immediately Slide Green Safety Guard Over Needle. All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day. This option is only for the duration of the COVID-19 public health emergency. Of the biopsies obtained, 17 (100%) were adequate for qualitative histology. Endocarditis was also reported more frequently in Prolia-treated patients. Adverse reactions reported in 10% of Prolia-treated patients receiving ADT for prostate cancer or adjuvant AI therapy for breast cancer, and more frequently than in the placebo-treated patients were: arthralgia (13.0% placebo vs. 14.3% Prolia) and back pain (10.5% placebo vs. 11.5% Prolia). Of these reports, 1 patient in the placebo group and all 8 patients in the Prolia group had serious events, including one death in the Prolia group. Find out which foods can help. Learn about symptoms, causes, treatment, and outlook. 0000002098 00000 n <]>> In a study of 17 postmenopausal women with osteoporosis, midazolam (2 mg oral) was administered 2 weeks after a single-dose of denosumab (60 mg subcutaneous injection), which approximates the Tmax of denosumab. The primary efficacy variable was percent change in lumbar spine BMD from baseline to month 12. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Evaluate patients with thigh or groin pain to rule out a femoral fracture. If a dose of Prolia is missed, administer the injection as soon as the patient is available. Key takeaways: Prolia (denosumab) is an osteoporosis injection that is a first-choice medication for treating osteoporosis. Presence in Breast Milk, Medline Plus, Drug Products with Same Active Ingredient. Last Update: May 30, 2022. Table 1. Treatment with Prolia significantly increased BMD at all anatomic sites measured at 3 years. As with all therapeutic proteins, there is potential for immunogenicity. It prevents bone-dissolving osteoclast cells from forming. Your carer can also use the outer area of your upper arm. All patients should receive calcium 1000 mg daily and at least. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. (, Severe bone, joint, muscle pain may occur. In these patients Prolia also reduced the incidence of vertebral fractures [see Clinical Studies (14.4)]. Dont worry we wont send you spam or share your email address with anyone. What Is the Life Expectancy with Stage 4 Bone Cancer? Thereafter, schedule injections every 6 months from the date of the last injection. ;%xU32,E#=0QyL2L"m Consistent effects on BMD were observed at the lumbar spine in relevant subgroups defined by baseline age, BMD, and baseline history of vertebral fracture. ONJ has been reported in the osteoporosis clinical trial program in patients treated with Prolia [see Warnings and Precautions (5.4)]. You cannot do it to yourself in this location. Prolia Dosage Guide - Drugs.com. Xgeva is approved to treat giant cell tumor of bone in adolescents whose bones have finished growing. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 0000009972 00000 n (, Postmenopausal osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Maternal mammary gland development was normal. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.2)]. Good adherence corresponds to a dosing interval 7 months (defined by MCR 93%), moderate adherence corresponds to an interval of 7 to 10 months (MCR 75%-93%), and poor adherence corresponds to an interval 10 months (MCR 75%). Prolia significantly reduced the incidence of new morphometric vertebral fractures at 1, 2, and 3 years (p < 0.0001), as shown in Table 3. Canberra: Australian Government Department of Health and Ageing, 2010. . (, Suppression of bone turnover: Significant suppression has been demonstrated. If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy [see Adverse Reactions (6.1)]. Side effects should also be reported to Amgen Limited on +44 (0) 1223 436441 or Freephone 1800 535 160. In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia [see Adverse Reactions (6.2)]. Treatment with Prolia results in significant suppression of bone turnover and cessation of Prolia treatment results in increased bone turnover above pretreatment values 9 months after the last dose of Prolia. If you are the carer administering for someone else, put on the gloves and apron provided by the hospital after washing your hands. Prolia is indicated for treatment to increase bone mass in men 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 [see Clinical Studies (14.2)]. Take calcium and vitamin D as directed by your doctor, usually 1000 milligrams of calcium and at least 400 IU of vitamin D daily. See full prescribing information for PROLIA. You can learn more about how we ensure our content is accurate and current by reading our. Prolia significantly reduced the risk of new vertebral fractures at 1, 2 and 3 years (p < 0.0001) (see Table 1). Bone tissue was normal with no evidence of mineralization defects, accumulation of osteoid, or woven bone. When denosumab injection (Xgeva) is used to reduce the risk of fractures from multiple myeloma, or cancer that has spread to the bones, it is usually given once every 4 weeks. DO NOT slide the green safety guard forward over the needle before administering the injection; it will lock in place and prevent injection. The median (range) Tmax values in the serum and seminal fluid samples were 8.0 (7.9 to 21) and 21 (8.0 to 49) days, respectively. These highlights do not include all the information needed to use PROLIA safely and effectively. General information about the safe and effective use of Prolia. Patients received at least 1000 mg calcium and 800 IU vitamin D supplementation daily. Men were randomized to receive SC injections of either placebo (n = 121) or Prolia 60 mg (n = 121) once every 6 months. Also, when do you use 96401? You may report side effects to FDA at 1-800-FDA-1088. This is done by your doctor or a healthcare professional. These are not all the possible side effects of Prolia. 0000002764 00000 n Adequately supplement patients with calcium and vitamin D. (, Osteonecrosis of the jaw: Has been reported with Prolia. 0000009927 00000 n Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. How often do I need to have this treatment? Dosage & Administration 60mg of denosumab (in a 1 ml solution) administered by subcutaneous injection into the thigh, abdomen or back of arm once every 6 months. Warm temperatures will affect how Prolia works. In the clinical study of 7808 postmenopausal women with osteoporosis, the incidence of infections resulting in death was 0.2% in both placebo and Prolia treatment groups. 3 DOSAGE FORMS AND STRENGTHS 1 mL of a 60 mg/mL solution in a single-dose prefilled syringe. 0000018910 00000 n However, the long-term consequences of this degree of suppression of bone remodeling are unknown. Prolia is a RANK ligand (RANKL) inhibitor indicated for: To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The mean baseline lumbar spine BMD T-score was -1.1, and 2.0% of women had a vertebral fracture at baseline. Consistent effects on lumbar spine BMD were observed regardless of gender; race; geographic region; menopausal status; and baseline age, lumbar spine BMD T-score, and glucocorticoid dose within each subpopulation. No, your doctor likely wont change your Xgeva dosage if your calcium levels decrease while youre taking the drug. Although Xgeva and Prolia have the same active ingredient, they have different uses and dosages. When categorized by adherence, the unadjusted annualized percentage BMD change at the lumbar spine was 1.4% for poor adherence, 3.0% for moderate adherence, and 3.9% for good adherence ( P =.002). In ovariectomized monkeys, once-monthly treatment with denosumab suppressed bone turnover and increased bone mineral density (BMD) and strength of cancellous and cortical bone at doses 50-fold higher than the recommended human dose of 60 mg administered once every 6 months, based on body weight (mg/kg).
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