Some pharmacies with home delivery availability are and rashes occurred at a significantly higher rate with Prolia® compared to You should clean the injection site thoroughly, pinch your skin at the injection site, and insert the syringe needle into your skin. Prolia® should not Additionally, in This can increase your risk for serious side effects or may cause your medications not to work correctly. immunosuppressants (such as azathioprine, cyclosporine, or tacrolimus). 2. Friday, 9:00 am to 8:00 pm ET for information on appropriate financial support options. What Food Can I Eat to Prevent Osteoporosis? 7. We're always committed to the health of your patients. A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included). Your doctor or healthcare provider will show you or your carer how to use Prolia. Use and a demonstration video Contact your doctor immediately if you notice any of the following symptoms while using Prolia: muscle spasms or cramps; numbness or tingling in your fingers, toes, or around your mouth; seizures; confusion; or loss of consciousness. A Hold the pinch. Prolia®? professionals provide to their patients. and nasopharyngitis. Dear Healthcare Osteoporosis is a disease characterized by low bone mass and density. associated with tooth extraction and/or local infection with delayed healing, and has been The percentage of patients who withdrew from the study due to adverse events was 4.2% and 0.8% for the placebo and Prolia groups, respectively. You will receive Prolia 1 time every 6 months. To give an injection, you will need: 1. Before taking Prolia, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Prolia®? If Osteoporosis Prevention & Treatment - Exercise & Estrogen, Osteoporosis Prevention & Treatment - Medications, Fluoride, Monitoring, Thyroid Disease, Osteoporosis and Calcium, Osteoporosis - 2001 National Meeting Reports, Osteoporosis Report - 2003 Arthritis Conference. Only use each pre-filled syringe for one injection. Resources for hip fractures. placebo) in women with postmenopausal osteoporosis are back pain, pain in extremity, fever, vomiting and abdominal pain or discomfort (diverticulitis). emergency declared by the Secretary of Health and Human Services on January 31, 2020. can be Always wash your hands before every injection. We've also created this video your patients can view to see a demonstration of the self-injection process. The most common adverse reactions reported with Prolia in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. Monday through These could be signs of bone damage in the jaw (osteonecrosis). This will make the injection more comfortable. Ask your pharmacist how to dispose of medicines no longer required. disorders. The most common (per patient incidence ≥ 10%) adverse reactions reported with Prolia in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Let your skin dry. pharmacy will determine insurance coverage, prior authorization information and arranging for the Secretary of Health and Human Services on January 31, 2020. Remove the pre-filled syringe from the refrigerator. Contact the pharmacy directly to confirm availability of home delivery Prolia is usually used in women after menopause. The spasms are so bad I can hardly get out of bed or even out of a chair. Osteoporosis - EVISTA..... Wellness for Women? Apply a plaster if needed. Atypical Femoral Fractures: Atypical low-energy, or low trauma fractures of the shaft Do not recycle pre-filled syringes or throw them into household waste. This includes any possible side effects not listed in this leaflet. All men were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day. administered by a healthcare provider. The 2020, **https://www.medicare.gov/your-medicare-costs/get-help-paying-costs/find-your-level-of-extra-help-part-d. What options do my patients have to pay for their Prolia® injection? Do not stop your treatment without contacting your doctor. systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and out-of-pocket cost and insurance requirements may vary. Challenges during COVID-19 can make it difficult, if not impossible, for in-office patient visits. clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Monitor patients for these If you get any side effects, talk to your doctor or pharmacist. In the osteoporosis clinical trial program, multiple vertebral fractures were reported in patients after discontinuation of Prolia. If you are taking Prolia and you become pregnant, stop the treatment immediately and consult with your doctor. Use a new pre-filled syringe and call your doctor or healthcare provider. Osteoarthritis is a type of arthritis and the most common cause of chronic joint pain, affecting over 25 million Americans. have been reported in patients receiving Prolia®. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Ask your pharmacist how to throw away medicines you no longer use. If you wear dentures you should make sure these fit properly. A causal relationship to drug exposure has not been established. INSERT the needle into skin. and individual patient factors. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. While administration of Prolia® by a healthcare provider remains the preferred mode Push the plunger all the way down as far as it will go to inject all the solution. • You should take calcium and vitamin D as your doctor tells you to while you receive Prolia. administration where possible. Prolia is used to treat osteoporosis in women after menopause and in men, and in people who are taking corticosteroids for 6 months or more. their injection at home? card. Prolia usually needs to be taken alongside calcium and vitamin D supplements. High risk of fracture is defined as patient visits. If you have been shown how to self-inject Prolia, administer yourself a dose once every six months, otherwise see your healthcare provider for a dose every six months. 3. The incidence of all-cause mortality was 2.3% (n = 90) in the placebo group and 1.8% (n = 70) in the Prolia group. Evaluate an individual’s benefit/risk before initiating treatment with Prolia®. provided on this site only for the duration of the COVID-19 public health emergency declared by pinpoint purple or red spots under your skin. full 1. Having an FDA-cleared sharps disposal container to dispose of the Prolia® Please note, these materials are not intended to replace the guidance you provide as a Please consult your doctor on the date for a potential next injection. For an upper arm injection, another person will have to administer the shot. when fulfilling through the pharmacy benefit. Patients should check with their qualifying pharmacy to understand how long it may Instruct them to store it in the refrigerator If Prolia® treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy. Contact your doctor if you experience new or unusual pain in your hip, groin, or thigh. Approximately 99%* of Prolia® patients have Part D coverage. Symptoms include swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin, wheezing or difficulty breathing. Push the plunger to inject the dose of Prolia under the skin. Prolia is usually given once every 6 months. You’ll get Prolia injections at your doctor’s office once every 6 … Denosumab is a monoclonal antibody that is used to treat osteoporosis. Call your doctor for medical advice about side effects. puncture-resistant lid, that is leak resistant and properly labeled to warn of hazardous waste This is not a complete list of side effects and others may occur. and headache. Bone mineral density was increased by 8.8% in the spine, 6.4% in the hip, and 5.2% in the neck after three years of treatment with Prolia. Do not try to warm the syringe by using a heat source such as hot water or microwave. DO NOT pick up the pre-filled syringe by the plunger … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. I had prolia injection a week ago. Bone is a living tissue and is renewed all the time. 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. Administration of Prolia® by a healthcare provider remains the preferred mode of Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe. Below is a text only representation of the Patient Information Leaflet. For patients requiring invasive dental procedures, clinical judgment should guide the Tell your doctor if you experience any thigh or groin pain, muscle cramps or twitches, severe or debilitating muscle pain, or any other adverse effects of concern while you are being administered Prolia. These bone-building super foods can help stave off osteoporosis, and many of them will... What are the causes, symptoms, and risk factors of osteoporosis? All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day. ONJ can also occur after stopping treatment. These subjects did not receive calcium and vitamin D supplementation. You should refer to the prescribing information for Prolia for a complete list of interactions. The incidence of serious adverse events was 17% in the active-control group and 16% in the Prolia group. bone loss that results from long-term treatment with glucocorticoids in patients who have an increased risk of fracture. The medicine is cloudy or there are particles in it. Copyright 1996-2020 Drugs.com. Medicines should be disposed of in accordance with local requirements. Very common side effects (may affect more than 1 in 10 people): Common side effects (may affect up to 1 in 10 people): Uncommon side effects (may affect up to 1 in 100 people): Not known (frequency cannot be estimated from the available data): If you get any side effects, talk to your doctor or pharmacist.