Ibandronic acid accord solution for injection is used to treat osteoporosis a disease that makes bones fragile in women who have been through the menopause and are. Ibandronic acid medicinal forms bnf content published by nice. As this happens, the bone is weakened and calcium is lost from the bone and seeps into the blood, leading to higherthannormal blood levels of calcium. There is no relevant use of ibandronic acid in children below 18 years, and ibandronic acid was not studied in this population see section 5. Ibandronic acid 150 mg filmcoated tablets summary of. Zoledronic acid suppresses lung metastases and prolongs overall. Ibandronic acid as ibandronic sodium monohydrate 1 mg per 1 ml 1 prefilled disposable injection pom. However, both drugs have acceptable sideeffect profiles and the oral formulation is more convenient, and could still be considered if the patient has a strong preference or if difficulties occur with intravenous infusions. Tissue damage with inappropriate drug administration. Take one 150 mg tablet as ibandronic acid once monthly on the same day each month 2. Nov 14, 2019 in reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0. Boniva injection is intended for intravenous administration only. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer. In animals, ibandronic acid inhibits experimentally induced bone resorption caused by ovariectomy, retinoids, tumours or parathyroid hormonerelated protein but does not interfere with osteoclast recruitment.
No significant renal toxicity was seen with iv pamidronate or iv ibandronic acid. The rationale to evaluate this compound in oa is based on the potential role of subchondral bone in both the occurrence and progression of oa and on data derived from animal models of oa. The tablets are supplied in blisters containing 1 or 3 tablets. In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses see section 5. Ibandronic acid ibandronate is a highly potent thirdgeneration bisphosphonate that has been approved for intravenous use since november 2003 for the treatment of bone metastases in breast cancer. In this study we used bisphosphonates in appropriate doses and infusion times, so cr. Bisphosphonates are offered to people with the highest risk of osteoporotic fragility fractures. Safety assessment of etidronic acid and its simple salts.
Do not administer boniva injection to patients with severe renal impairment creatinine clearance less than 30 mlmin. Ibandronic acid accord solution for injection is used to treat osteoporosis a disease that makes bones fragile in women who have been through the menopause and are at risk of developing bone fractures breaks. In particular, the incidence of renal adverse events was low 4. Zoledronic acid alters hematopoiesis and generates breast tumor. The dose of zoledronic acid administered was 4 mg while 2 mg or 4 mg of ibandronic acid was administered.
Bisphosphonates journal of pain and symptom management. Click on the desired brand to find out the drug price or cost of the drug. Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. Ibandronic acid 3mg solution for injection summary of. Ibandronic acid, please wait for 1 hour before you can have your first food and further drinks see 3. Ibandronic acid is a highly potent nitrogencontaining bisphosphonate used for the treatment of osteoporosis target.
Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. Drugs or treatment regimens that minimize the risk of osteoporotic fractures and make the treatment of osteoporosis more convenient and suitable for patients are preferred. Species, route, end point, dose repeated dose toxicity. A randomised, open label, noninferiority phase 3 trial. Longterm ibandronic acid binding to bone tissue can be assumed. For more information on generic medicines, see the question andanswer document. Studies in rats have shown some reproductive toxicity see section 5. Etidronic acid can also be prepared by reaction of an acetic acidacetic anhydride mixture with phosphoric acid. It may also be used to treat hypercalcemia elevated blood calcium levels. Our results suggest that zoledronic acid is preferable to ibandronic acid in preventing skeletalrelated events caused by bone metastases. Ibandronic acid accord is a medicine used to treat certain conditions affecting bones and blood calcium. This is further supported by the potentially lower rates of acutephase reaction and fewer nephrotoxicity concerns with ibandronate compared with those of the more frequently used iv bp zoledronic acid. Bondronat, innibandronic acid european medicines agency. In reproductive studies in rats by the oral route, ibandronic acid decreased fertility.
Poorly absorbed mean bioavailability following a 2. Therefore, ibandronic acid teva should not be used during pregnancy. Effects of zoledronic acid and ibandronic acid on renal. This means that ibandronic acid teva is similar to a reference medicine already authorised in the european union eu. Find here online price details of companies selling ibandronic acid. Prescribing and technical information ibandronic acid, 3mg in 3ml solution for injection bonviva. Male and female f344n rats and b6c3f1n mice were administered sodium thioglycolate approximately 99% pure in a vehicle of 95% ethanol.
Nov 29, 2019 ibandronic acid is often prescribed in tablet form, but it is also sometimes prescribed as an injection administered over a short period of time usually ranging from 15 minutes to 2 hours. Zometa zoledronic acid injection, for intravenous use. Ibandronic acid was also well tolerated, with an adverse event profile comparable to that of placebo. Iv ibandronic acid may be as effective as zoledronic acid in reducing sre in patients with myeloma or metastatic bone disease. Breastfeeding it is not known whether ibandronic acid is excreted in human milk.
Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration. Safety assessment of etidronic acid and its simple salts as. No teratogenicity was observed in rats treated with iv doses of 0. Brestfeeding it is not known whether ibandronic acid is excreted in human milk. It was patented in 1986 by boehringer mannheim and approved for medical use in 1996. Outcome the clinical outcomes were the incidence of sre, pfs, os, as well as some ae, such as onj and renal toxicity. Ibandronic acid drug bnf content published by nice.
Fertility there are no data on the effects of ibandronic acid in humans. There are no adequate data from the use of ibandronic acid in pregnant women. Ibandronic acid or ibandronate sodium is a bisphosphonate medication used in the prevention and treatment of osteoporosis and metastasisassociated skeletal fractures in people with cancer. Description ibandronic acid is a group of medicine called bisphosphonates. Research article ferulic acid against cyclophosphamide. Your doctor has recommended that you receive ibandronic acid, which is used in adults and prescribed to you if you have breast cancer that has spread to your bones, or if you have a raised calcium level in your.
Objective randomised controlled trials rcts have given contradictory results about the efficacy and safety of ibandronate in treating metastatic bone disease mbd or multiple myeloma. Either as zoledronic acid 4mg iv 6 monthly or ibandronic acid 50mg tablets one daily from or a period of 3 years. Novel advances in the treatment of osteoporosis british. The main adverse effect seen with oral clodronate and oral ibandronic acid was mild gastrointestinal toxicity. Cn101863919a preparation method of compound sodium. Sep 17, 2012 ibandronic acid bondronat is a potent, newgeneration, nitrogencontaining bisphosphonate, available in both intravenous and oral formulations, which effectively inhibits osteoclastmediated bone resorption.
Ideal sources for wikipedia s health content are defined in the guideline wikipedia. The ddds for the bisphosphonates are based on the treatment of osteoporosis if this is an approved indication. M significantly reduces endothelial cell growth, while ibandronate 2. The reference medicines for ibandronic acid teva are bondronat and bonviva. What ibandronic acid looks like and contents of the pack ibandronic acid 150 mg filmcoated tablets are white filmcoated tablets of oblong shape and scored lc on one side.
Risedronate is a potent bisphosphonate with a wellestablished antiosteoclastic activity effect. Both intravenous and oral ibandronic acid were well tolerated with no evidence of renal toxicity. Among these patients, the incidence of upper gastrointestinal events in the patients treated with bonviva 150 mg once monthly was similar to that in patients treated with ibandronic acid 2. Ibandronic acid accord 6 mg concentrate for solution for infusion one vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid as 6.
Formation of toxic gases is possible during heating or fire. Ibandronic acid bondronat is a potent, newgeneration, nitrogencontaining bisphosphonate, available in both intravenous and oral formulations, which effectively inhibits osteoclastmediated. Ibandronic acid should not be used during breastfeeding. The ddds for clodronic acid, pamidronic acid, zoledronic acid, parenteral etidronic acid and parenteral ibandronic acid are based on tumor induced hypercalcemia. Tablets should be swallowed whole with a glass of water 180 to 240 ml while the patient is sitting or standing in an upright position. It slows bone loss while increasing bone mass, which may prevent bone fracture. Bondria ibandronic acid 150mg 3 tablets cancer womens, price. Dualenergy xray absorptiometry dxa is currently the criterion standard for the evaluation of bmd. Boniva is indicated for the treatment and prevention of. If you are prescribed it as an injection, it will be given to you by a doctor or nurse in a hospital clinic. It is not known whether ibandronic acid is excreted in human milk. The invention relates to a synthetic method of sodium ibandronate, which comprises the following steps.
Ibandronic acid 150 mg filmcoated tablets is available in pack sizes of 1 and 3 filmcoated tablets. There are no data on the effects of ibandronic acid in humans. Get info of suppliers, manufacturers, exporters, traders of ibandronic acid for buying in india. The submission described ibandronic acid 150 mgmonth as being no worse than alendronate 70 mgweek in terms of effectiveness and overall toxicity. Ibandronic acid ia is a potent bisphosphonate drug used in the prevention and treatment of osteoporosis. May 29, 2012 renal toxicity associated with ibandronic acid was so low as to be equivalent to placebos. Etidronic acid can also be prepared by reaction of an acetic acid acetic anhydride mixture with phosphoric acid.
Absorption is impaired by any kind of food or drink other than plain water. Ibandronate t3d2667 toxin and toxintarget database. Therefore, ibandronate bluefish should not be used during pregnancy. Zoledronic acid induces cytogenetic toxicity in male germline cells of swiss albino mice. Ibandronic acid is therefore a valuable addition to the bisphosphonates used in the treatment of. It may also be used to treat hypercalcemia elevated blood calcium levels it was patented in 1986 by boehringer mannheim and approved for medical use in 1996. Take ibandronic acid tablets first thing after you get up in the morning.
In particular, the incidence of renal adverse events. This may be associated with binding to the plasma proteins and its halflife. Generic drug ibandronic acid available with manufacturer details. In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0. Ibandronic acid as ibandronic sodium monohydrate 50 mg more. Ibandronate is, at worst, equivalent in terms of git safety compared with other existing oral bps and, at best, may have lower rates of git toxicity which could make it a more desirable therapy.
Pharmaceutical benefits scheme pbs ibandronic acid. Renal toxicity associated with ibandronic acid was so low as to be equivalent to placebos. Duration, species, route, dose, end point, target organ. The drug is used to treat high levels of blood calcium caused by malignant tumours whether or not bone secondaries are present. Immediately wash skin with soap and plenty of water for at least. Ibandronate sodium has the full chemical name of 1hydroxy3 methylpentylaminopropylidenebisphosphonic acid, monosodium salt, monohydrate.
Use of ibandronic acid ibandronic acid is a highly potent nitrogencontaining bisphosphonate used for the treatment of osteoporosis. Ibandronic acid drug information, uses, side effects. Bondria ibandronic acid 150mg 3 tablets cancer womens. Tablets should be swallowed whole with plenty of water while sitting or standing. Boniva injection is available as a sterile, clear, colorless, readytouse solution in a prefilled syringe that delivers 3. Longterm efficacy, safety, and patient acceptability of. Frequency of administration for treatment of tumour induced hypercalcemia, ibandronic acid concentrate for solution for infusion is generally given as a single infusion. Zoledronic acid for injection is indicated for the treatment of patients.
Importantly, bone marrow cells from mice treated with a single, clinically relevant dose of zol inhibited breast tumor outgrowth in vivo. The effectiveness of zoledronic acid and ibandronic acid. There was no evidence for a direct fetal toxic or teratogenic effect of ibandronic acid in daily orally treated rats and rabbits and there were no adverse effects on the development in f1 offspring in rats. The repeated dose toxicity studies consisted of 4week i.
First aid measures description of first aid measures. Research article ferulic acid against cyclophosphamideinduced heart toxicity in mice by inhibiting nf b pathway yafansong, 1 chunyanzhang, 1 congxiawang, 1 lingzhao, 1 zhengwang, 2 zhijundai, 3 shuailin, 3 huafengkang, 3 andxiaobinma 3 department of cardiology, e second al iated hospital, medical school of xi an jiaotong university, xi an, china. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. Ibandronic acid 150 mg once monthly was shown to be at least as effective as ibandronic acid 2. Remain sitting or standing upright for at least 60 minutes after taking the tablet.
Odanacatib, a cathepsin k inhibitor for the treatment of. Here are links to possibly useful sources of information about ibandronic acid. Zoledronic acid accord 4 mg5 ml concentrate for solution for infusion. Renal toxicity may be greater in patients with renal impairment. The medicine is used in preventing further bone deterioration which is associated with cancer. This cost may sometimes vary depending on the chemist. The research field is currently very active, and many new discoveries in bisphosphonate bonedisease therapy have been published.
They are used for morbus paget, postmenopausal osteoporosis, and other osteolytic processes. Ibandronic acid is a nitrogencontaining bisphosphonate with affinity for bone that inhibits osteoclastmediated bone resorption. Ibandronic acid is thought to have less effect on renal function than zoledronic acid. Nitrogencontaining bisphosphonates such as pamidronate, alendronate, risedronate, ibandronate and zoledronate appear to act as analogues of isoprenoid diphosphate lipids, thereby inhibiting farnesyl pyrophosphate fpp synthase, an enzyme in the. The action of ibandronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. There was no evidence for a direct foetal toxic or teratogenic effect of ibandronic acid in orally treated rats 30 mgkgday and rabbits 20 mgkgday. Alendronatic acid, clodronic acid, etidronic acid, ibandronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid are among the osteolysis inhibitors. These highlights do not include all the information.
Ibandronic acid helps by binding to bone, making the bone stronger and reducing the amount of calcium leaving the bone. For more information on generic medicines, see the questionandanswer document. Oral ibandronic acid was assessed in 435 women with bony metastases randomised to take 20 mg, 50 mg or a placebo daily for up to 96 weeks. The activity of zoledronic acid on neuroblastoma bone. Acute toxicity studies in mice, rats, and dogs revealed toxicities. Studies in rats have shown reproductive toxicity see section 5.
Multiple antiresorptive treatments are available and can be used for the prevention or treatment of osteoporosis. How to take ibandronic acid tablets pregnancy and breast feeding ibandronic acid tablets are for use only by postmenopausal women and must not be taken by women who could still have a baby. The committee understood that bisphosphonates are usually offered to people with high fracture risk who typically have several risk factors, such as parental. The reference medicine for ibandronic acid sandoz is bondronat. This means that ibandronic acid sandoz is similar to a reference medicine already authorised in the european union eu.
M also significantly reduces capillarylike tube formation and increases apoptosis of endothelial cells. Ibandronic acid definition of ibandronic acid by medical. It alters the cycle of bone formation and break down in the body. The authors noted that there have been reports of osteonecrosis of the jaw with longterm use of bisphosphonates. Ibandronate sodium 150 mg as ibandronic acid oncemonthly resulted in a mean increase in lumbar spine bmd of 4. The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections. Ibandronic acid belongs to a group of medicines called bisphosphonates, which may reverse bone loss by.
The bisphosphonate, zoledronic acid reduces experimental. As a precautionary measure, keep away from strong oxidizers 11. In reproductive toxicity studies in the rat, ibandronate sodium caused. The pbac considered there were doubts about the acceptability of the claim of fracture efficacy for ibandronic acid 150 mg based on a. When administered with adequate calcium and vitamin d replacement, antiresorptive treatments improve bone mineral density bmd, reduce bone turnover, and reduce both vertebral and nonvertebral osteoporotic fractures when administered orally daily, weekly.