Prolia patient information pdf

Patient instructions amgen safety net foundation is a nonprofit patient assistance program that helps qualifying. Your doctor will give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with prolia. All patients should receive calcium mg daily and at least 400 iu vitamin d daily see warnings and precautions. This form requires a patients printed name, signature and date of signature in order for the foundation to begin processing the application please proceed to the next page. Prolia denosumab injection side effects, images, uses. It does not include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may. Consumer watchdog petitions fda for black box warning on amgens prolia. 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. You can ask your doctor or pharmacist for information about reclast that is written for health professionals. See what others have said about prolia, including the effectiveness, ease of use and side effects. This leaflet does not take the place of discussions with your doctor. Medication guide prolia prolee a denosumab injection, for subcutaneous use.

This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. Before you or your carer use prolia prefilled syringe with automatic needle guard, read this important information. Discuss the prolia consumer medicine information cmi leaflet with the patient. There is a voluntary patient registry for people who take forteo. Step 3 have your prescribing physician fax the completed application to. This information is not specific medical advice and does not. Clinical information continued required clinical information must be completed in its entirety for all precertification requests. What prolia is and what it is used for what prolia is and how it works prolia contains denosumab, a protein monoclonal antibody that interferes with the action of another protein, in order to treat bone loss and osteoporosis. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture.

In this case, it stops a molecule, called rankl, which normally causes bone turnover. If you receive prolia, you should not receive xgeva. In osteoporosis, some of these struts become thin or. Get educated about medications and treatments that prevent, stop or slow osteoporosis. As a biologic drug, it is manmade and closely resembles proteins, called antibodies, which naturally occur in the body. The patient is not taking any bisphosphonates at this time, nor will they in the future. Please see important safety information on pages 3 and 4. Amgen safety net foundation is a nonprofit prior to. Medication guide prolia proleea denosumab injection. Prolia patient information including how should i take.

Prolia finder you must have javascript enabled to use this website. Patient first name patient last name patient phone patient dob g. Administer prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. Does the patient have a history of osteoporotic noncollision fracture e. Amgen safety net foundation is a nonprofit prior to applying. Amgen safety net foundation is a nonprofit patient assistance program sponsored by amgen that helps qualifying patients access amgen medicines at no cost. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take. Apr 29, 2019 administer prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. Prolia is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture. The patient may continue to take both drugs together. All patients should receive calcium mg daily and at least 400 iu vitamin d daily. Aetna medicare form prolia, xgeva denosumab injectable.

As a biologic drug, it is synthetic and closely resembles naturallyoccurring antibodies in the body. The text only version may be available in large print, braille or audio cd. It is written for patients and gives information about taking or using a medicine. To operate, administer, enroll me in, andor continue my participation in the prolia copay program or any other amgenaffiliated patient support services and activities related to my. Insurance verification and prior authorization form. Talk to your doctor if you have any questions about reclast. This medication guide does not take the place of talking with your doctor about your medical condition or treatment. If a claim is denied for your patient, this sample letter provides a template and guidance on type of. Switching patients from bisphosphonate therapy prolia. Prolia is an injection that will be given to you by a healthcare professional. Consumer watchdog petitions fda for black box warning on. Product information prolia page 1 of 32 prolia product information australian product information prolia denosumab solution for injection 1. The patient is currently on a bisphosphonate, but this drug will be stopped and the requested drug will be started.

Important things you need to know side effects are continued on back. Prolia this information sheet has been produced by the australian rheumatology association to help you understand the medicine that has been prescribed for you. Physician office billing information sheet for prolia cont. Doe, john d xx xx xx doe, john d 5555 any street anytown as 01010 xxx xxxxxxx xx xx xx diagnosis code box 24em85. Physician office billing information sheet for prolia please see important safety information on pages 3 and 4. Treat hypocalcemia, hypovitaminosis d, and other disturbance of. During animal drug testing, tymlos caused some rats to develop a bone cancer called osteosarcoma. For information about how to sign up for this patient registry, call 1866382. If a dose of prolia is missed, administer the injection as soon as the patient is available. Our bones are made up of a thick outer shell and a strong inner mesh, this looks like a honeycomb made up of tiny struts of bone. This is only a brief summary of general information about this medicine. Read the medication guide that comes with prolia before you start taking it and each time you get a refill. Treatment with prolia makes bone stronger and less likely to break.

Treat osteoporosis thinning and weakening of bone in women after menopause. Visit the page to go through the summary of product characteristics and grow your knowledge about prolia, how it works and how it treats. Denosumab prolia is a biologic medication used to prevent fragile bones, also known as osteoporosis, and bone fractures. An nps medicine update article on denosumab is available for consumers. This medication guide provides information about the prolia brand of. If you would like more information, talk with your doctor. During prolia treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.

Prolia fda prescribing information, side effects and uses. Advise the patient to read the fdaapproved patient labeling medication guide. Prolia contains the active substance denosumab, which is a protein. Information for patients denosumab prolia metabolic bone centre. Prolia should be administered by a healthcare professional. The patient is currently on a bisphosphonate, and the requested drug will be added. Bone is a living tissue and is renewed all the time by a process called bone turnover. Osteoporosis patients can be symptomfree until a fracture occurs, but there are several diagnostic methods doctors use to detect its presence. Treat osteoporosis thinning and weakening of bone in women after menopause change of life who. What is the most important information i should know about prolia. Prolia is prescribed to improve your bone density and to reduce your risk of fracture. Prolia is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines such as prednisone for at least six months and are at high risk for fracture. Prolia contains the same medicine as xgeva denosumab. Patient continues to meet the criteria indicated above.

Thereafter, schedule injections every 6 months from the date of the last injection. 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. Medication guide tymlos tim lows abaloparatide injection, for subcutaneous use what is the most important information i should know about tymlos. Prolia proleea denosumab injection, for subcutaneous use what is the most important information i should know about prolia. Also, read the leaflet each time you refill your prescription, just in case anything has changed. Prolia is a medicine that may affect the ability of your body to fight infections serious infections in your skin, lower stomach area abdomen, bladder, or ear may happen if you take prolia inflammation of the inner lining of the heart endocarditis due to an infection also may happen more often in people who take prolia. Prolia standard plan of treatment palmetto infusion services.

Osteoporosis is a common condition which causes bones to become fragile and brittle so that they break fracture more easily. The recommended dose of prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Prolia denosumab postmenopausal osteoporosis treatment. Osteoporosis screening, diagnosis, and treatment guideline. Advise patients that denosumab is also marketed as xgeva, and if taking prolia, they should not receive xgeva see warnings and precautions. Prolia contains denosumab, a protein monoclonal antibody that interferes with the action of another protein, in order to treat bone loss and osteoporosis. Surgery or medicines used in the treatment of men with prostate cancer to stop the production of testosterone can also lead to bone loss. Pdf filed tuesday, public citizen called on the fda to upgrade prolias fracture risk to a boxed warning, the agency. Qualitative and quantitative composition each 1 ml singleuse prefilled syringe contains 60 mg denosumab. Interruption of prolia therapy should be considered, pending a riskbenefit assessment, on an individual basis. If your patient has frequent falls, consider physical therapy referral to develop a personalized plan. Prolia denosumab injection copay card and cost assistance.

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. This information should not be used to decide whether or not to take this medicine or any other medicine. The original leaflet can be viewed using the link above. Below is a text only representation of the patient information leaflet. Amgen safety net foundation is not a state or federally funded program. And absence of unacceptable toxicity from the drug. Prolia is given as an injection into the tissue just under the skin subcutaneous injection. Tell your doctor denosumab prolia is a biologic medication used to prevent fragile bones, also known as osteoporosis, and bone fractures. It does not include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. Visually inspect prolia for particulate matter and discoloration prior to administration whenever solution and container permit.

This program is not open to patients receiving prescription reimbursement under any federal, state, or. Prolia 1 prolia denosumabrch denosu mab consumer medicine information cmi what is in this cmi what prolia is used for before you are given it when you must not be given it before you are given it taking other medicines how it is given instructions for injecting prolia when supplied in a prefilled syringe with an automatic. Fractures are painful and restrict a persons ability to carry out their normal daily tasks. Include patient demographic information and insurance information. Renewal criteria coverage can be renewed based on the following criteria. Medicine update helps consumers to ask the right questions about new medicines, and helps them compare the potential benefits and harms of a new medicine with other medicines.

Prolia denosumab physician information patient information physician name. You must have javascript enabled to use this website. May 01, 2020 the prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have high risk of bone fracture. 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. This medication guide summarizes the most important information about reclast. Jan 22, 2020 the patient information leaflet pil is the leaflet included in the pack with a medicine. You should take calcium and vitamin d as your doctor tells you to while you receive prolia. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Denosumab prolia for postmenopausal osteoporosis nps. Yes no will the patient be using prolia in combination with xgeva.