Prolia fda prescribing information, side effects and uses. Using denosumab in primary care churchill hospital. Copies of required labs see below for requirement clinical information and patient education. Prolia 60 mg solution for injection patients leaflet. Each pack of prolia contains a reminder card with stickers that can be removed from the box. Initiate first denosumab injection and ensure that the patient understands the plan for followup care blood test in 5 months and repeat injection in 6 months. Denosumab is given as an injection under the skin subcutaneously. If a dose of prolia is missed, the injection should be administered as soon as possible. You must have javascript enabled to use this website. It is important that you do not try to give the injection unless training from your doctor, nurse or pharmacist has been received. Patients treated with prolia should be given the package leaflet and the patient reminder card. Verify that patient s serum calcium level is normal.
The other ingredients are acetic acid, glacial, sodium hydroxide, sorbitol e420, polysorbate 20 and water for injections. Prolia is also used to treat glucocorticoidinduced osteoporosis in men and women at high risk of bone fracture. Your doctor, nurse or pharmacist will show you or your carer how to use prolia. Treatment with prolia makes bone stronger and less likely. This medication guide provides information about the prolia brand of. Read the medication guide that comes with prolia before you start taking it and each time you get a refill. Denosumab brand name prolia is a medicine used to treat osteoporosis. For most patients receiving denosumab injections, the benefits outweigh the potential risk of onj. Auspar prolia denosumab amgen australia pty ltd pm20090039035 date of finalisation 26 october 2010. Afraid to stay on prolia and afraid of rebound fractures if i decide to say no to injection 4.
Atypical lowenergy, or low trauma fractures of the shaft have been reported in patients receiving prolia. Bone is a living tissue and is renewed all the time by a process called bone turnover. Product information prolia page 1 of 32 prolia product information australian product information prolia denosumab solution for injection 1. As a biologic drug, it is synthetic and closely resembles naturallyoccurring antibodies in the body. Prolia solution for injection drug information, side effects.
Instruct patient caregiver on medications and signssymptoms of adverse reaction. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. The most common side effects of prolia in patients receiving certain treatments for prostate or. Fractures are painful and restrict a persons ability to carry out their normal daily tasks. If you have any further questions, ask your doctor or pharmacist. Patients must be adequately supplemented with calcium and vitamin d see section 4. Jan 22, 2020 before you use a prolia prefilled syringe with automatic needle guard, read this important information. The solution may contain trace amounts of translucent to white proteinaceous particles. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.
When denosumab injection prolia is used to treat osteoporosis or bone loss, your doctor or pharmacist will give you the manufacturers patient information sheet medication guide when you begin treatment with denosumab injection and each time you refill your prescription. If you receive prolia, you should not receive xgeva. Qualitative and quantitative composition each 1 ml singleuse prefilled syringe contains 60 mg denosumab. Denosumab is given as a subcutaneous injection under the skin every. New start continued treatment patient information please print physician information please print patient name. Oct 11, 2019 the prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture.
Adequately supplement all patients with calcium and vitamin d. Treat osteoporosis thinning and weakening of bone in women after menopause change of life who. Denosumab prolia is a biologic medication used to prevent fragile bones, also known as osteoporosis, and bone fractures. For the treatment to increase bone mass in men with osteoporosis at high.
This information is provided for general education only. This includes any possible side effects not listed in this leaflet. Prolia official prescribing information for healthcare professionals. Prolia is given as an injection into the tissue just under the skin subcutaneous injection. Prolia this information sheet has been produced by. Prolia denosumab postmenopausal osteoporosis treatment.
Has the patient had 6 or more paid claims for prolia. Please see accompanying prolia full prescribing information, including medication guide. Use the peeloff stickers to mark the next injection date on your calendar andor the reminder card to keep a record of the next injection date. Your prolia is supplied in a prefilled syringe with an automatic needle guard. During prolia treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Talk to your doctor if you have any questions about reclast. Your doctor may decide that it is best for you or a carer to inject prolia. In the us, approximately half of all patients who have had a hip fracture never recover fully. The recommended dose of prolia is 60 mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm. In postmenopausal women with osteoporosis, prolia reduces the incidence of vertebral, nonvertebral, and hip fractures. Denosumab prolia is a biologic medication used to prevent fragile bones, also. Apr 22, 2019 administer prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. Prolia 60 mg solution for injection in prefilled syringe patient information leaflet pil by amgen ltd. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk.
What is the most important information i should know about prolia. Your doctor will give you a patient reminder card, which contains important safety. Please see full prescribing information, including boxed warnings, and medication guide for aranesp. Optional enroll patient in prolong reminder system see end for details. It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider. Osteoporosis is a common condition which causes bones to become fragile and brittle so that they break fracture more easily.
My physician has recommended i stop taking the prolia and just take the calciumvitamin d supplement. Prolia contains the same medicine as xgeva denosumab. See 17 for patient counseling information and medication. Prolia is used to increase bone mass in men with osteoporosis with a high risk of bone fracture, and in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer. The original leaflet can be viewed using the link above. Physician office billing information sheet for prolia contact amgen assist at 18884assist for assistance. You have denosumab as an injection under the skin subcutaneously. Prolia proleea denosumab injection, for subcutaneous use what is the most important information i should know about prolia. Insurance verification and prior authorization form.
Prolia contains denosumab, a protein monoclonal antibody that interferes with the action of another protein, in order to treat bone loss and osteoporosis. This is to check the amount of calcium in your blood. Prolia is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation. Tell your doctor denosumab prolia is a biologic medication used to prevent fragile bones, also known as osteoporosis, and bone fractures. You have the injection in either the thigh, stomach or upper arm.
Administer prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. Medication guide prolia proleea denosumab injection. If a dose of prolia is missed, the injection should be given as soon as possible. Is the request for more than one 60 mgml injection per 6 months. Patient will not be eligible for prolia therapy until. The prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture. Covid19 updates and resources national osteoporosis. It works by blocking a protein and suppressing the cells that break down bone.
See what others have said about prolia, including the effectiveness, ease of use and side effects. Visually inspect prolia for particulate matter and discoloration prior to administration whenever solution and container permit. See the end of this leaflet for a complete list of ingredients in. Information for patients denosumab prolia sheffield teaching.
Verify last date patient received prolia is 6 months date. As a biologic drug, it is manmade and closely resembles proteins, called antibodies, which naturally occur in the body. Prolia standard plan of treatment palmetto infusion services. Denosumab is an antibody that slows down the natural rate your bones are broken down. Information for the user prolia 60 mg solution for injection in pre. Twoyear treatment with denosumab amg 162 in a randomized phase 2 study of postmenopausal women with low bmd. Prolia proleea denosumab injection, for subcutaneous use.
Mar 26, 2020 prolia is a medication that is used to help treat osteoporosis and increase bone mass in people who have weakened or fragile bones. Physician office billing information sheet for prolia cont. Before you give a prolia injection, make sure you are trained by a health professional to master the technique. These highlights do not include all the information needed to use prolia. Prolia 60 mg solution for injection in prefilled syringe. Product monograph prprolia denosumab 60 mgml solution for injection prefilled syringe professed standard rank ligand inhibitor bone metabolism regulator physicians should become fully familiarized with the efficacysafety profile of prolia and the full content of the product monograph prior to prescribing the drug. To get the most benefit from your treatment, it is important to use prolia for as long as your doctor prescribes it for you. The excess mortality rate of a hip fracture is estimated to be 20%. Each 1 ml prefilled syringe contains 60 mg of denosumab 60 mgml. Please see prolia full prescribing information and medication guide. Thereafter, injections should be scheduled every 6 months from the date of the last injection. I certify that the above information is accurate and will be made available for audit, if requested. Prolia is a medication that is used to help treat osteoporosis and increase bone mass in people who have weakened or fragile bones.
Interruption of prolia therapy should be considered, pending a riskbenefit assessment, on an individual basis. Please see important safety information on pages 3 and 4. Prolia important safety information coding and billing. Denosumab is given as an injection just under the skin. Contents of the pack and other information what prolia contains the active substance is denosumab. Your doctor or nurse will take a blood test before each treatment. If a dose of prolia is missed, administer the injection as soon as the patient is available. Before you or your carer use prolia prefilled syringe with automatic needle guard, read this important information. Medication guide prolia pro leea denosumab injection, for subcutaneous use. By completing and faxing this form, you represent that your patient is aware of the disclosure of their personal health information to amgen and its agents for. Injections should be scheduled 6 months from the date of the last injection. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. These highlights do not include all the information needed to use.
Please see indications and important safety information on page 2, and the accompanying prolia full prescribing information, including medication guide. Administer 60 mg every 6 months as a subcutaneous injection in the. Prolia finder you must have javascript enabled to use this website. Patient name id number health insurer name andor group number provider name national provider id number contact information collect product and billing information. Due to the unprecedented healthcare crisis caused by the respiratory illness brought on by the novel coronavirus covid19, congress and the centers for medicare and medicaid services. Denosumab is an osteoporosis medication prescribed to help strengthen your bones and reduce your risk of breaking a bone. Information for patients information for patients denosumab prolia metabolic bone centre. Prolia is also used to increase bone mass in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer. All patients should receive calcium mg daily and at least 400 iu vitamin d daily see warnings and precautions 5. Prolia is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body. Feb 21, 2019 prolia is used to increase bone mass in men with osteoporosis with a high risk of bone fracture, and in women and men with a high risk of bone fracture caused by receiving treatments for certain types of cancer. The typical injection dosage is one syringe every 6 months. There is a voluntary patient registry for people who take forteo.
Forteo medication guide food and drug administration. Insurance information fill out entirely and fax copy of patients insurance card both sides. Treat hypocalcemia, hypovitaminosis d, and other disturbance of. 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. Detailed information on this medicinal product is available on the website of the. Ensure patients are aware that they should report symptoms of hypocalcaemia a. Include patient demographic information and insurance information. Thereafter, schedule injections every 6 months from the date of the last injection. Add prescription to patient record and book next blood test in 5 months and injection in 6 months. Bmp prior to scheduling injection and fax results along with patient weight to op therapy.