Medication Guide. In these patients, dental surgery to treat ONJ may exacerbate the condition. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g. prior to initiating treatment with Prolia. 3. Prolia comes as a solution for subcutaneous injection. Adequately supplement patients with calcium and vitamin D while on EVENITY. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. . vertebral, nonvertebral, and
Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. If you have low blood calcium, it may get worse during treatment. [1] You may ask, why would this drug ever be reported using 96401? Patients with or at high risk for osteoporosis should take the lowest possible dosage of vitamin D 3 with the shortest possible interval (eg, 50,000 IU monthly vs 100,000 IU every 2 months . Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Prolia is contraindicated in women who are pregnant and may cause fetal harm. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia. in patients with a history of systemic hypersensitivity to any component of the product. CONNECT WITH AN AMGEN BONE HEALTH FIELD REPRESENTATIVE. In women of reproductive potential, pregnancy. The best places to inject are the top of your thighs and the abdomen. The infusion time must not be less than 15 minutes and the infusion rate should be constant. After your treatment with Prolia is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment: Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Learn
The medicine is also approved to increase bone mass in men receiving androgen deprivation therapy for prostate cancer who are at high . If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. Prolia: 60mg/mL (1mL prefilled syringe or vial) Xgeva: 70mg/mL (120mg/1.7mL vial) Osteoporosis Prolia only Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Reactions have included angioedema, erythema multiforme, and urticaria. 1. Use an effective method of birth control (contraception) during treatment with Prolia and for at least 5 months after your last dose of Prolia. Close, Prolia is indicated for the treatment of postmenopausal women
In
Postmenopausal osteoporosis is a chronic disease that requires ongoing management. 2 DOSAGE AND ADMINISTRATION 2.1 Information Essential to Safe Dosing or Administration - Pregnancy must be ruled out prior to administration of Prolia. For more information about Amgens privacy practices, please visit www.amgen.com/privacy. If your Prolia treatment is stopped, talk to your doctor about other medicine that 2016;22(suppl 4):1-42. malignancies were reported in no patients in the placebo group and 4 (3.3%) patients in the In postmenopausal women with osteoporosis,
4.2 Posology and method of administration Posology You are about to leave the EVENITYProliaHCP.com website and enter a website operated by a third party. In females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start Prolia. Consider discontinuing Prolia if severe symptoms develop. After your treatment with Prolia is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia. The most common side effects of Prolia in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives. Reactions have included anaphylaxis, facial swelling and urticaria. Hypocalcemia: Hypocalcemia may worsen with the use of Prolia, especially in patients with severe renal impairment. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY. *The contraindications vary between the 2 doses, because their . Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated. discontinuing Prolia if severe symptoms develop. High risk of fracture is defined as
Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing. The risk of ONJ may increase with duration of exposure to postmenopausal women at high risk for fracture, defined as a history of
Your risk for having more than . chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid Good oral hygiene practices should be maintained during treatment with Prolia. Adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving Prolia. If you receive Prolia, you should not receive XGEVA. The most common adverse reactions Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY-treated patients. Your low blood calcium must be treated before you receive Prolia. (>5% and more common than placebo) in men with osteoporosis are back pain, arthralgia, Dose/Frequency: Prolia (denosumab) 60mg subcutaneously every 6 months (Administer as subcutaneous injection only to upper arm, upper thigh, or abdomen) Lab Orders: BMP prior to each dose; hold dosing if serum Calcium sub therapeutic. Use of this website and any information contained herein is governed by the Healthgrades User Agreement. osteoporosis, Prolia resulted in significant suppression of bone remodeling as prescriber prior to initiation of Prolia. Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY. consequences, including ONJ, atypical fractures, and delayed fracture healing. Dosage: Evenity is administered more often than Prolia. severe renal impairment, creatinine clearance less than 30 mL/minute) . between the treatment groups. The significance of these findings and the effect of long-term treatment are unknown. In women of reproductive potential, pregnancy, Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia, Dosed every month at 210 mg subcutaneously, for 12 months, using both of the 105 mg/1.17 mL single-use prefilled syringes supplied in each EVENITY, Patients should be adequately supplemented with calcium and vitamin D during treatment. for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Frequency not known. You should take calcium and vitamin D as your doctor tells you to while you receive Prolia. Hypercalcemia of Malignancy Moderate hypercalcemia (ie, corrected serum calcium 12-13.5 mg/dL): 60-90 mg single-dose IV infusion over 2-24 hours Severe hypercalcemia (ie, corrected serum calcium. Treatment To Increase Bone Mass In Men With Osteoporosis. Do not stop, skip or delay taking Prolia without first talking with your doctor. incidence of cataracts was observed. Prolia is contraindicated in women who are pregnant and may cause fetal harm. Due to their efficacy in preserving bone mass and preventing fractures,1 bisphosphonates are commonly prescribed treatments for osteoporosis.2 As with other chronic conditions that are initially asymptomatic,3 failure of osteoporotic patients to follow the treatment prescribed (compliance) for the recommended duration (persistence) has been consistently reported.4, 5, 6 Interruption of Prolia You should take calcium and vitamin D as your doctor tells you to while you receive Prolia. with osteoporosis at high risk for fracture, defined as a history of
evidenced by markers of bone turnover and bone histomorphometry. The most common side effects of Prolia in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat). postmenopausal women at high risk for fracture, defined as a history of
Adverse Reactions: The most common adverse reactions (>5% and more common than placebo) are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Concomitant use of calcimimetic drugs may worsen hypocalcemia risk and serum calcium should be closely monitored. (See "Dosages, forms, and administration" below. Postmenopausal osteoporosis is a chronic disease that requires ongoing management. On days 8 and 15 of the first month of treatment, you'll receive another injection of . Any patient who presents with thigh or groin pain should be ). Call your doctor for medical advice about side effects. Data shown are from patients assigned to the denosumab 60 mg every-6-months arm. Read it carefully. In patients who develop serious infections while on Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.3)]. Extensive dental surgery to treat ONJ may exacerbate the condition. Please see Prolia patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, A routine oral exam should be performed by the prescriber prior to initiation of EVENITY. Please see Prolia full Prescribing Information, including Medication Guide. As a subcutaneous injection, Prolia does not undergo first-pass metabolism 2. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Pancreatitis has been reported with Prolia. osteoporosis, serious infections leading to hospitalization were reported more frequently in Geriatric. Medically reviewed by Brittany A. Duke, PharmD, RPh By Patricia Weiser, PharmD Updated on March 14, 2022 It is not the most optimal way to achieve the objective of reducing fracture risk. Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has The information below describes the dosage amount of Prolia that is commonly used or recommended. who have failed or are intolerant to other available osteoporosis therapy. Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. You may need to go to the hospital for treatment. risk factors for fracture; or patients
Therefore, the duration of EVENITY use should be limited to 12 monthly
The most common side effects of Prolia in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat). During EVENITY treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or Discontinuation of EVENITY should be considered based on benefit-risk assessment. For more information about Amgens privacy practices, please visit www.amgen.com/privacy. As with all therapeutic proteins, there is potential for immunogenicity. who have failed or are intolerant to other available osteoporosis therapy. EVENITY is a humanized monoclonal antibody. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections. Read More
The significance of these findings and the effect of long-term treatment are unknown. 4 CONTRAINDICATIONS Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing. Patients receiving Prolia should not receive XGEVA. If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Prolia is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments such as inflammation of your skin (dermatitis), rash, and eczema have been reported. Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Pharmacology, adverse reactions, warnings and side effects. Denosumab is the generic name for the trade name drugs Prolia or Xgeva . The most common side effects of Prolia in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat). Treatment. Tell your doctor right away if you become pregnant while taking Prolia. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g. On the day of the infusion, patients may eat and drink . Prolia is contraindicated in women who are pregnant and may cause fetal harm. chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders. Pharmacist will perform clinical lab monitoring, preferred results within 1430 days of each dose. therapy should be considered, pending a risk/benefit assessment, on an individual basis. Extensive dental surgery to treat ONJ It is created by eHealthMe based on reports of 131,342 people who have side effects when taking Prolia . See More, Prolia is
Hypocalcemia: Hypocalcemia may worsen with the use of Prolia, especially in patients with severe renal impairment. doses. back pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Before or After Meal: As advised by a physician. Concomitant use of calcimimetic drugs may worsen hypocalcemia risk and serum calcium should be closely monitored. osteoporotic fracture, or multiple risk factors for fracture; or patients
guidelines: No drug holiday recommended for Prolia. Please see Prolia full Prescribing Information, including Medication Guide. It it were, that's what the FDA would have approved. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus and urticaria. They may inject Prolia into your abdomen, upper thigh, or upper arm. preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ Not known (frequency cannot be estimated from the available data): talk to your doctor if you have ear pain . The most common side effects of Prolia in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. risk factors for fracture; or patients
an antiresorptive agent should be considered. Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia. Do not stop, skip or delay taking Prolia without first talking with your doctor. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Actual dosing and duration of a particular patients therapy should be based upon the products approved labeling and independent clinical decision of the provider. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. Camacho PM, Petak SM, Binkley N, et al. who have failed or are intolerant to other available osteoporosis therapy. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Pancreatitis has been reported with Prolia. Close, EVENITY is indicated for the treatment of osteoporosis in
In these patients, dental surgery to treat ONJ may exacerbate the condition. If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy. Contraindications: Prolia is contraindicated in patients with hypocalcemia. In postmenopausal women with osteoporosis,
National Osteoporosis Foundation. Mild side effects of Prolia can include:*. Prolia Field Representatives are here to answer any questions you may have or to schedule a visit. All About Prolia's Dosage. and headache. Prolia reduces the incidence
In
EVENITY is indicated for the treatment of osteoporosis in
The most common side effects of Prolia in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat). However, your doctor will determine the best dosage. Hypersensitivity: Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia. It can also be used to help treat bone loss in cancer patients who are receiving treatment for prostate cancer (men) or breast cancer (women). EVENITY should not be initiated in patients who have had a myocardial infarction or, Contraindications: Prolia is contraindicated in patients with hypocalcemia. Breast Cancer Treatmentinduced Bone Loss, Prostate Cancer Treatmentinduced Bone Loss, Starting With Prolia
®, Switching to Prolia
®, All Prolia
® Indications, Without treatment, osteoporotic bones continue to weaken and fracture risk continues to rise, Fracture risk increases following discontinuation of Prolia. The overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia group. Symptoms have included hypotension, dyspnea, throat If osteoporosis therapy remains warranted, continued therapy with
3 DOSAGE FORMS AND STRENGTHS 1 mL of a 60 mg/mL solution in a single-dose prefilled syringe. Dermatologic Adverse Reactions: Epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate with Prolia compared to placebo. expected to remain on glucocorticoids for at least 6 months. More, For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Prolia helps you treat patients at high risk for fracture with 5 indications, Compare the patient experience with Prolia vs alendronate.