Reclast warnings and precautions also extend to people who have kidney disease, certain allergies, or conditions affecting the thyroid. Reclast is used to treat or prevent osteoporosis caused by menopause, steroid use, or gonadal failure. This prior approval supplemental new drug application provides for changes to the. This medicine is for use when you have a high risk of bone fracture due to osteoporosis. Talk to your doctor if you have any questions about reclast.
Denosumab binds to rankl, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts. Reclast solution for infusion must not be allowed to come in contact with any calcium or other divalent cationcontaining. Zoledronic acid reclast zoledronic acid is a bisphosphonate prescribed to prevent or treat osteoporosis or pagets disease. Zoledronate infusion subsidy scheme zoledronate administration protocol zoledronate infusion protocol date updated. Hypocalcemia following reclast administration is a significant risk in pagets disease. The antibody is produced in genetically engineered mammalian chinese hamster ovary cells. Vanderbilt diabetes and endocrinology vanderbilt health. Highlights of prescribing information hypocalcemia. Medicare and blue crossblue shield of florida both cover. Postdose symptoms decreased in frequency in the zoledronic acid group after the second and third infusion 6. He traveled extensively, and played golf twice a week. Rehydrate patients with hypercalcemia of malignancy prior to administration of zoledronic acid injection and monitor electrolytes during treatment. If refrigerated, allow the infusion to reach room temperature before administration.
Prior authorization protocol reclast zoledronic acid. Alteplase 2mg iv to declot central iv access per infusion solutions protocol as needed for occlusion. We acknowledge receipt of your amendments dated august 15 and 30, 2011. Please send recent lab results containing a serum calcium and serum creatinine level within the last 30 days to allow the. Patients being treated with zometa should not be treated with reclast. Before you receive reclast, drink at least 2 glasses of fluid such as water within a few hours as directed by your doctor. Reclast is the brand name of the prescription drug zoledronic acid, used to treat and prevent osteoporosis a condition in which bones become weak and may break easily it may also be used to.
Reclast solution for infusion must not be allowed to come in contact with any calcium or other divalent cationcontaining solutions, and should be administered as a single intravenous solution through a separate vented infusion line. Reclast is contraindicated in patients with hypocalcemia andor creatinine clearance less than 35 mlmin. The vanderbilt eskind diabetes clinic is one of only three diabetes clinics in the u. Compared to the baseline in 2009 and this year 2016, there has been an 8. Zoledronic acid reclast order form infusion solutions. Yet, 3 days after reclast he began having problems. Consider coadministering 1g paracetamol, as this tends to lessen the severity of acute phase reaction. It takes at least 15 minutes for the yearly infusion. Highlights of prescribing information hypocalcemia may worsen. Zoledronic acid infusion for prevention and treatment of osteoporosis. Read the medication guide and, if available, the patient information leaflet provided by your pharmacist before you start using this product and each time you. Reclast infusion instructions 2 weeks prior to infusion and 2 weeks after infusion 1 increase daily calcium to 1500 mg 2 take at least 2,000 iu of vitamin d daily 10 20 days prior to infusion 1 lab work drawn at dr dahirs office or local pcp office when prearranged through beth, administrative assistant for dr. Your doctor will tell you how often you will receive reclast.
The maximum recommended zoledronic acid dose for the treatment of bone metastases is 4 mg by iv infusion. Bone is a living tissue constantly being remodeled. The day after the infusion i felt slightly tired and achey for 1 day. It is given by injection into a vein common side effects include fever, joint pain, high blood pressure, diarrhea, and feeling tired. We are also one of the top five diabetes clinics nationally for number of patients treated. You may eat normally before receiving your infusion. New zealand data sheet 1 product name aclasta zoledronic acid 5 mg100 ml solution for infusion 2 qualitative and quantitative composition singleuse sterile solution containing 5 mg100 ml zoledronic acid anhydrous, corresponding to 5. If request is for reclast, has a contraindication to or has tried and is intolerant to the generic version of reclast.
Reclast 5mg100ml iv administered over 30 min x 1 dose. Reclast zoledronate is a good choice for osteoporosis if you arent able to take bisphosphonates by mouth. The infusion protocol for zoledronic acid is briefly outlined in table 1. Reclast drug interactions can occur if it is combined with nsaids and diuretics, among other things. Does reclast bottle, infusion interact with other medications. The iv infusion should be followed by a 10 ml normal saline flush of the intravenous line. Nursing guidelines for administering zoledronic acid to patients with bone metastases. Following the infusion, the manufacturer of reclast recommends a 10 ml normal saline flush of the iv line. Reclast should not be used in patients with severe renal impairment creatinine clearance reclast and zometa is a bisphosphonic acid, which is an inhibitor of osteoclastic bone resorption. Dec 19, 20 reclast put me in bed for between 3 and 4 months with monstrous headaches.
Our free discountrx savings card can help you and your family save money on your prescriptions. Common side effects include fever, joint pain, high blood pressure, diarrhea, and. Patients must be appropriately hydrated prior to administration. For osteoporosis prevention one infusion every 24 months for all other indications one infusion every 12 months. These medications may cause some risk when taken together. All patients with pagets should take 1500 mg of elemental calcium daily in divided doses of two to three times per day and 800 iu of vitamin d daily, particularly in the two weeks following administration. My father had his first and only reclast infusion in sept. Some patients may prefer zoledronic acid to oral therapy for dosing. Administration of zometa 4 mg given as a 5minute intravenous infusion has been shown to result in an increased risk of renal toxicity, as measured by increases in serum creatinine. Zoledronic acid binds to the bone matrix, which decreases osteoclastic activity, prevents bone resorption and skeletal calcium release induced by various stimulatory factors released by tumors.
Dec 24, 2011 my father had his first and only reclast infusion in sept. In patients at high risk of fracture, defined as a recent lowtrauma hip fracture, reclast reduces the incidence of new clinical fractures. Reclast is also used to increase bone mass in men who have osteoporosis, and to treat pagets disease of bone in men and women. Zoledronic acid reclast national osteoporosis foundation.
Reclast zoledronic acid dose, indications, adverse. Reclast and zometa are two different brands of zoledronic acid. Obtain peripheral iv access give sodium chloride 0. Calcium 1,500mg daily in divided doses for 2 weeks after receiving reclast lidocaine 1% up to 0. Reclast fda prescribing information, side effects and uses. Reclast is given as an infusion into a vein by a nurse or a doctor, and the infusion time must not be less than 15 minutes. The doctor considers these changes statistically significant. Sep 01, 2019 reclast injection must be administered as an intravenous infusion over no less than 15 minutes. This medication guide does not take the place of talking with your doctor about your medical condition or treatment. Aarp health insurance plans pdf download medicare replacement pdf download medicare benefits pdf download medicare part b pdf download medicare guidelines for reclast infusion. Zoledronic acid infusion for prevention and treatment of.
Due to risk of clinically significant renal toxicity, do not exceed recommended dose and do not infuse over less than 15 minutes. Reclast injection is available as a sterile solution in bottles for intravenous infusion. A healthcare provider gives zoledronic acid as an intravenous iv dose of 5 mg in a doctors office or other outpatient setting. The total time between removal from storage, dilution, and administration must not exceed 24 hours. Zoledronic acid reclast and zometa is a bisphosphonic acid, which is. Current evidence suggests that a dosing interval of 1. Jan 23, 2009 employ medical assistant to provide iv infusion therapy to patients under her. I am taking nexium daily, which has relieved my gi symptoms. Administering zoledronic acid to patients with bone metastases. Jul 24, 2016 compared to the baseline in 2009 and this year 2016, there has been an 8. Side effects of reclast zoledronic acid injection, warnings. A single dose of reclast should not exceed 5 mg and infusion time should be no less than 15 minutes. Dec 23, 2019 reclast zoledronic acid sometimes called zoledronate is a bisphosphonate medicine that alters bone formation and breakdown in the body. Highlights of prescribing information these highlights do not include all the information needed to use.
He is recommending reclast infusion once a year for i think three years and then none. New treatment, old story as so often happens with new osteoporosis drugs and reclast infusion is a fairly new treatment the truth becomes shrouded as pharmaceutical companies make grabs for money, power, recognition, and more money. Zoledronic acid reclast 5mg100ml iv over at least 15 minutes recommend otc acetaminophen or ibuprofen for minor musclejoint ache or headache. It is available as a generic, but you have to see a doctor to get each dose. It is also approved to increase bone mass in men with osteoporosis and for the prevention of new clinical fractures in patients who have recently had a lowtrauma hip fracture. If above labs have not been done within last 30 days the infusion center will draw on day of infusion. Denosumab binds to rankl, a transmembrane or soluble protein essential for the formation, function, and survival of. The reclast infusion time must not be less than 15 minutes given. Zoledronic acid aclasta for osteoporosis nps medicinewise. Highlights of prescribing information hypocalcemia may. I could literally feel the infusion material moving from the top of my head on downward throughout my whole body over a 34 month period of time.
Ivrclst012017 prescription for geneva woods infusion pharmacy zoledronic acid 5 mg infused intravenously over at least 15 minutes x 1 dose please note. If patients are receiving zometa, they should not receive reclast. Before reclast he was on one prescription medication. Reclast intravenous interactions with other medication. Reclast is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. Reclast put me in bed for between 3 and 4 months with monstrous headaches. Denosumab is a fully human, highly specific, monoclonal antibody to receptor activator of nuclear factor kappab ligand rankl. Reclast, the brand name of the prescription drug zoledronic acid, is an intravenous injection of a bisphosphonate, which is able to slow down the cells that break down the bones, resulting in greater bone mass, effectively reducing the possibility of fractures. You have to go to your doctors office or an infusion center to get each dose by iv infusion. Pamidronate disodium pamidronate disodium injection, solution pamidronate disodium pamidronate disodium injection, powder, lyophilized, for solution for intravenous infusion rx only description pamidronate disodium injection is a bone resorption inhibitor available in 30 mg vials for intravenous administration. This emedtv page lists other medicines that can interact with reclast, describes the problems they can cause, and explains how they can be avoided.
The reclast infusion time must not be less than 15 minutes given over a constant infusion rate. Call your doctor for medical advice about side effects. Zoledronic acid versus risedronate zoledronic acid a single 5 mg infusion was. Reclast zoledronic acid dose, indications, adverse effects. The infusion must be administered by a health care professional. Read the medication guide that comes with reclast before you start taking it and each time you. Dec 17, 2019 our reclast zoledronic acid side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Although the population of individuals with identified osteoporosis is quite large, it is also clear that these conditions are underdiagnosed and undertreated. Drink two 2 glasses of fluids, such as water, within a few hours before receiving reclast to help prevent kidney problems 3.
Reclast is given by infusion into your vein intravenously. Patients must be appropriately hydrated prior to administration of reclast see warnings and precautions 5. Reclast infusion instructions vanderbilt university medical. It is given as a onceyearly infusion for osteoporosis in patients aged 70 years of age or older with a bone mineral density tscore of 2. If infusion reaction occurs, follow infusion reaction protocol in policyprocedure manual discharge instructions to include possible infusion side effects and follow up appointment schedule.
The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Pamidronate disodium pamidronate disodium injection, solution. Zoledronic acid reclast and zometa is a bisphosphonic acid, which is an inhibitor of osteoclastic bone resorption. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, and pagets disease of bone. He had complete blood work done prior to his infusion, and followed all protocol. Unlike other common bisphosphonates that are taken by mouth, reclast bypasses the stomach because it is an infusion into the bloodstream. Our reclast zoledronic acid side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Dec 17, 2019 the ph of the reclast solution for infusion is approximately 6. Drink two 2 glasses of fluids, such as water, within a few hours before receiving reclast to help. Instruct patient to drink two 8ounce glasses of fluid noncaffeinated prior to infusion and eight glasses of fluid daily for at least 2 days after infusion medication orders. On the day of treatment the patient should eat and drink normally, which includes drinking at least 2 glasses of fluid such as water within a few hours prior to the infusion, as directed by their doctor, before receiving reclast.
This can slow bone loss and may help prevent bone fractures. Reclast injection must be administered as an intravenous infusion over no less than 15 minutes. This is not a complete list of side effects and others may occur. Zoledronic acid, also known as zoledronate, is a medication used to treat a number of bone diseases. Pamidronate disodium pamidronate disodium injection.
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