Prior authorization protocol reclast zoledronic acid. Advise patients to drink an extra 2 glasses of fluid on day of infusion to ensure good. 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. Zolendronic acid is given as an infusion through a vein in your arm lasting 15 minutes. To make statements that reclast pain begins at a certain time after your treatment is unfounded. Side effects of reclast zoledronic acid injection, warnings. For more information, click here to visit the manufacturers website. Zoledronic acid aclasta for osteoporosis nps medicinewise. In order to help prevent this, you must take calcium and vitamin d, especially during the two weeks after your reclast dose see reclast dosage. Jan 12, 2015 my wife had the iv reclast about 5 months ago. Reclast injection must be administered as an intravenous infusion over no less than 15 minutes. Patients should receive 1500 mg elemental calcium and 800 iu vitamin d daily 2. I am taking nexium daily, which has relieved my gi symptoms.
Forms are updated frequently and may be barcoded for prevention of postmenopausal osteoporosis, also answer the following. This can slow bone loss and may help prevent bone fractures. None zoledronic acid does not inhibit any cyp450 enzymes in vitro. I had a reclast infusion for my bones ten days ago. Reclast zoledronic acid dose, indications, adverse effects. Calcium 1,500mg daily in divided doses for 2 weeks after receiving reclast lidocaine 1% up to 0. Sep 01, 2017 the appropriate hcpcs level ii supply code for reclast is j3489 injection, zoledronic acid, 1 mg. Reclast, for example, was the first osteoporosis drug to be implicated. Bone metastases from solid tumors, multiple myeloma. 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.
Zoledronic acid monohydrate is a white crystalline powder. I looked up some reclast stuff online and found out that some folks have pain for months after their infusion. Alteplase 2mg iv to declot central iv access per infusion solutions protocol as needed for occlusion. Zoledronic acid reclast and zometa is a bisphosphonic acid, which is an inhibitor of. 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. Please attach copy of insurance card with this order check. Zoledronic acid versus risedronate zoledronic acid a single 5 mg infusion was. He is recommending reclast infusion once a year for i think three years and then none. Bmd increases with bisphosphonates are dose dependent and greatest in the first 6. Lab work drawn at dr dahirs office or local pcp office when prearranged. A single dose should not exceed 5 mg and the duration of infusion should be.
The only apparent side effect of reclast is a minor flutype feeling that some patients experience after 48. Reclast may not be recommended for people with moderate or severe kidney disease, as the medication can increase the risk of kidney damage. The intravenousinfusion should be followed by a 10 ml normal saline flush of the intravenous line. Reclast solution for infusion must not be allowed to come in contact with any calcium or other divalent cationcontaining. So i was given an infusion for my bones and now the. Reclast reclast contains the same active ingredient found in zometa. Medication guide reclast reclast zoledronic acid injection. The national osteoporosis foundation has issued guidelines. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use of reclast in patients currently using zometa because the active ingredient in both is zoledronic acid, resulting in significantly increased risk of renal failure not approved if. Reclast zoledronic acid injection 5 mg in a 100 ml. Reclast zoledronic acid is a bisphosphonate used to treat pagets disease, high blood levels of calcium caused by cancer hypercalcemia of malignancy, multiple myeloma a type of bone marrow cancer or cancer that has spread from elsewhere in the body to the bone, to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with.
Common side effects include fever, joint pain, high blood pressure, diarrhea, and. Reclast zoledronic acid injection, solution dailymed. 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. My father had muscle pain, and spasms to begin with. Consider coadministering 1g paracetamol, as this tends to lessen the severity of acute phase reaction. For an initial infusion of reclast lasting 16 minutes or longer, report 96365 intravenous infusion, for therapy, prophylaxis, or diagnosis specify substance or drug. Its molecular formula is c 5 h 10 n 2 o 7 p 2 h 2 o and a molar mass of 290.
Patients must receive adequate hydration prior to the administration of reclast. Medication guide zoledronic acid injection what is the. Information for the user aclasta 5 mg solution for infusion. Mention any dental procedures surgery, implants or any procedures with oral or iv contrast ct, mri planned or scheduled for 1 month prior to or 1 month after infusion to dr dahir, or. Reclast zoledronic acid is a bisphosphonate used to treat pagets disease, high blood levels of calcium caused by cancer hypercalcemia of malignancy, multiple myeloma a type of bone marrow cancer or cancer that has spread from elsewhere in the body to the bone, to treat or prevent osteoporosis in postmenopausal women, and to increase bone mass in men with osteoporosis. A single dose of reclast zoledronic acid injection should not exceed 5 mg and the duration of infusion should be no less than. The optimal duration of use has not been determined. Medicationrelated osteonecrosis of the jaws from once per. Now she needs to get 2 teeth extracted, and i am not sure it is safe, or that a dentist would even do. In the event of a hypersensitivity reaction during the infusion of this medication, we will implement the reaction protocol. The medicare advantage policy guideline documents are generally used to support. If above labs have not been done within last 30 days the infusion center will draw on day of infusion. Calcium 1,500mg daily in divided doses for 2 weeks after receiving reclast.
The maximum recommended zoledronic acid dose for the treatment of bone metastases is 4 mg by iv infusion, infused over no. Reclast infusion instructions vanderbilt university medical. Fracture risk reduction vs control, hip fx, an external file that holds a. The safety and efficacy of reclast for the treatment of osteoporosis is based on clinical data of three years duration. She hears the doctors diagnosis of osteoporosis as if it. You may eat normally before receiving your infusion.
The availability of a onceayear zoledronic acid infusion heralds a new era in the. Reclast reclast zoledronic acid injection read the medication guide that comes with reclast before you start taking it and each time you get a refill. Information on submitting spl files using elist may be found in the guidance for industry. Question, answer and discussion format created by a distinguished. Suzuki, dds, phd, mba o steonecrosis of the jaws is a commonly reported side effect with patients prescribed oral antiresorptive medications formerly known as bisphosphonates to. Affected cytochrome p450 isoenzymes and drug transporters. Pagets disease reclast 5mg once yearly or as determined note. Dec 19, 20 reclast put me in bed for between 3 and 4 months with monstrous headaches. Drink two 2 glasses of fluids, such as water, within a few hours before receiving reclast to help prevent kidney problems 3. The ph of the reclast solution for infusion is approximately 6. Patients must be off oral bisphosphonates fosamax, boniva, etc.
Obtain peripheral iv access give sodium chloride 0. Reclast fda prescribing information, side effects and uses. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, and pagets disease of bone. Reclast side effects include any and all of the other problems of osteoporosis drugs, including osteonecrosis of the jaw and nontraumatic fractures, but because reclast is given as a once yearly intravenous infusion, it can cause some unique side effects that can only occur when drugs are given via an intravenous dosage like the reclast infusion is. Reclast zoledronic acid is a prescription drug used to treat osteoporosis in men, postmenopausal women, and pagets disease. 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. Zolendronic acid is used to treat or prevent osteoporosis. Reclasts firsts the negative side effects of reclast are, in many ways, the same negative side effects you can expect from any osteoporosis drug, although with a few rather frightening variations.
Applicable codes the following lists of codes is provided for reference purposes only and may not be all inclusive. Prescription acetaminophen tylenol 680 mg po once 8060 minutes prior to dose of zoledronic acid reclast. Reclast injection is considered medically necessary for the treatment of. Jul 24, 2016 compared to the baseline in 2009 and this year 2016, there has been an 8. The vancomycin i took for my cdiff in april seems to have worked. Zoledronic acid clearance was independent of dose but dependent upon the patients creatinine clearance. Administering zoledronic acid to patients with bone metastases.
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. Treatment and prevention of postmenopausal osteoporosis treatment to increase bone mass in men with osteoporosis treatment and prevention of glucocorticoidinduced osteoporosis. Current evidence suggests that a dosing interval of 1. Reclast solution for infusion must not be allowed to come in contact with any. Zoledronic acid monohydrate is highly soluble in 0. Medication guide zoledronic acid injection what is the most. Reclast injection is available as a sterile solution in bottles for intravenous infusion. A patient that is already receiving zometa should not be treated with reclast. Zoledronic acid reclast order form infusion solutions. The doctor considers these changes statistically significant. However, it is possible that not all of the warnings or precautions were discussed in this article.
Reclast information, side effects, warnings and recalls. Zoledronic acid, also known as zoledronate, is a medication used to treat a number of bone diseases. This medicine is for use when you have a high risk of bone fracture due to osteoporosis. The 0 to 24 hour renal clearance of zoledronic acid was 3. Dosage of reclast is not greater than 5 mg given by intravenous injection once per year.
Compared to the baseline in 2009 and this year 2016, there has been an 8. Highlights of prescribing information may worsen during. Annual infusion of reclast works well american bone health. Reclast is used to treat or prevent osteoporosis caused by menopause, steroid use, or gonadal failure. Now she needs to get 2 teeth extracted, and i am not sure it is safe, or that a dentist would even do it. Dec 23, 2019 reclast zoledronic acid sometimes called zoledronate is a bisphosphonate medicine that alters bone formation and breakdown in the body. May 08, 2020 the ph of the reclast solution for infusion is approximately 6. Reclast zoledronic acid sometimes called zoledronate is a bisphosphonate medicine that alters bone formation and breakdown in the body. Aclasta contains the active substance zoledronic acid. The humble osteoporosis patient gets lost in the proverbial shuffle. Bone is a living tissue constantly being remodeled. It is given by injection into a vein common side effects include fever, joint pain, high blood pressure, diarrhea, and feeling tired. Patients must be appropriately hydrated prior to administration of reclast seewarnings and precautions 5. Researchers compared the results of reclast versus actonel in 833 patients over a years time.
Intravenous bisphosphonates medical policy pdf blue cross. Reclast iv pain how long does it last osteoporosis. The severe bone pain came about a week or more after his infusion. You should drink 2 glasses of fluid at least one hour before receiving your infusion. Increase supplements and continue 1 week after infusion. Unlike other common bisphosphonates that are taken by mouth, reclast bypasses the stomach because it is an infusion into the bloodstream. The reclast infusion time must not be less than 15 minutes given over a constant infusion rate. 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. Patients taking actonel showed a bone mineral density bmd increase of 2. The total cost of reclast infusion depends on if insurance is involved, the clinic, the dose, the length of the infusion treatment, the doctor and inclusions in the bill. 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.
The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. Reclast zoledronic acid dose, indications, adverse. Osteoporosis is a disease which causes bones to become thin. Medicationrelated osteonecrosis of the jaws from once per year intravenous zoledronic acid reclast. This medication guide does not take the place of talking with your doctor about your medical condition or treatment.
Postdose symptoms decreased in frequency in the zoledronic acid group after the second and third infusion 6. Prior authorization approval criteria fallon health. The day after the infusion i felt slightly tired and achey for 1 day. There are currently no generic alternatives to reclast. Reclast, for example, was the first osteoporosis drug to be implicated in the formation of osteonecrosis of the jaw onj. The infusion protocol for zoledronic acid is briefly outlined in table 1. Side effects, drug interactions, dosage, and pregnancy and breastfeeding safety information are provided. Zoledronate infusion subsidy scheme zoledronate administration protocol zoledronate infusion protocol date updated. Final thoughts there are a number of situations in which reclast should not be taken, as well as several precautions and warnings people should be aware of before starting the medication. The maximum recommended zoledronic acid dose for the treatment of bone metastases is.
Above criteria are not met patient has any contraindications to the use of zoledronic acid. Zoledronic acid reclast zoledronic acid is a bisphosphonate prescribed to prevent or treat osteoporosis or pagets disease. 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. A designated nurse practitioner will evaluate your patient. Reclast zoledronic acid is an expensive drug used to treat pagets disease and osteoporosis in women. 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.
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