In this study we used bisphosphonates in appropriate doses and infusion times, so cr. In particular, the incidence of renal adverse events was low 4. 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. 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. 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. 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. In reproductive toxicity studies in the rat, ibandronate sodium caused. This may be associated with binding to the plasma proteins and its halflife. Studies in rats have shown some reproductive toxicity see section 5. Iv ibandronic acid may be as effective as zoledronic acid in reducing sre in patients with myeloma or metastatic bone disease. No teratogenicity was observed in rats treated with iv doses of 0. Boniva is indicated for the treatment and prevention of.
Tissue damage with inappropriate drug administration. M significantly reduces endothelial cell growth, while ibandronate 2. Have eyes examined and tested by medical personnel. The committee understood that bisphosphonates are usually offered to people with high fracture risk who typically have several risk factors, such as parental. Bisphosphonates are offered to people with the highest risk of osteoporotic fragility fractures. Ibandronic acid as ibandronic sodium monohydrate 1 mg per 1 ml 1 prefilled disposable injection pom. Odanacatib, a cathepsin k inhibitor for the treatment of. The ddds for the bisphosphonates are based on the treatment of osteoporosis if this is an approved indication.
In clinical trials, the two formulations were equally effective in preventing skeletalrelated events and improving quality of life in patients with bone metastases of breast cancer. Hold eyelids apart and flush eyes with plenty of water for at least 15 minutes. The other ingredients are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections. It alters the cycle of bone formation and break down in the body. Safety assessment of etidronic acid and its simple salts as. Either as zoledronic acid 4mg iv 6 monthly or ibandronic acid 50mg tablets one daily from or a period of 3 years. They are used for morbus paget, postmenopausal osteoporosis, and other osteolytic processes.
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. Ibandronic acid should not be used during breastfeeding. Studies in rats have shown reproductive toxicity see section 5. Zoledronic acid accord 4 mg5 ml concentrate for solution for infusion. Both intravenous and oral ibandronic acid were well tolerated with no evidence of renal toxicity. Ibandronic acid bondronat is a potent, newgeneration, nitrogencontaining bisphosphonate, available in both intravenous and oral formulations, which effectively inhibits osteoclastmediated. First aid measures description of first aid measures. There are no adequate data from the use of ibandronic acid in pregnant women. 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. M also significantly reduces capillarylike tube formation and increases apoptosis of endothelial cells. Duration, species, route, dose, end point, target organ.
Zoledronic acid suppresses lung metastases and prolongs overall. Species, route, end point, dose repeated dose toxicity. Ibandronic acid medicinal forms bnf content published by nice. Poorly absorbed mean bioavailability following a 2. Take one 150 mg tablet as ibandronic acid once monthly on the same day each month 2.
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. Ibandronic acid is thought to have less effect on renal function than zoledronic acid. 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. Do not administer boniva injection to patients with severe renal impairment creatinine clearance less than 30 mlmin. Ibandronic acid 150 mg filmcoated tablets summary of. Ibandronate t3d2667 toxin and toxintarget database. Importantly, bone marrow cells from mice treated with a single, clinically relevant dose of zol inhibited breast tumor outgrowth in vivo. Boniva injection is intended for intravenous administration only. In studies in rats using the intravenous route, ibandronic acid decreased fertility at high daily doses see section 5.
The invention relates to a synthetic method of sodium ibandronate, which comprises the following steps. Effects of zoledronic acid and ibandronic acid on renal. This cost may sometimes vary depending on the chemist. Bisphosphonates journal of pain and symptom management. Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer. 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. Ibandronic acid helps by binding to bone, making the bone stronger and reducing the amount of calcium leaving the bone. Renal toxicity associated with ibandronic acid was so low as to be equivalent to placebos. Remain sitting or standing upright for at least 60 minutes after taking the tablet. Brestfeeding it is not known whether ibandronic acid is excreted in human milk. Osteoporosis is a systemic disorder characterized as the depletion of bone mass with structural deterioration of bone tissue.
The activity of zoledronic acid on neuroblastoma bone. Ibandronic acid was also well tolerated, with an adverse event profile comparable to that of placebo. The most common grade 3 or 4 adverse events were fatigue 97 14% of 697 patients. Other adverse reactions to ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. Ibandronic acid drug information, uses, side effects. Bondronat, innibandronic acid european medicines agency. Zoledronic acid alters hematopoiesis and generates breast tumor. Zometa zoledronic acid injection, for intravenous use.
Renal toxicity may be greater in patients with renal impairment. Safety assessment of etidronic acid and its simple salts. 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. 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. 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.
The bisphosphonate, zoledronic acid reduces experimental. These highlights do not include all the information. The pbac considered there were doubts about the acceptability of the claim of fracture efficacy for ibandronic acid 150 mg based on a. Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those observed with bisphosphonates as a class. For more information on generic medicines, see the questionandanswer document. Ibandronic acid definition of ibandronic acid by medical. Use of ibandronic acid ibandronic acid is a highly potent nitrogencontaining bisphosphonate used for the treatment of osteoporosis. Click on the desired brand to find out the drug price or cost of the drug. Ibandronic acid is therefore a valuable addition to the bisphosphonates used in the treatment of.
Ibandronic acid 150 mg once monthly was shown to be at least as effective as ibandronic acid 2. 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. Longterm efficacy, safety, and patient acceptability of. 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. Ibandronic acid, like most bisphosphonates, is poorly absorbed orally. Public assessment report geneesmiddeleninformatiebank. Ibandronic acid 3mg solution for injection summary of. Here are links to possibly useful sources of information about ibandronic acid. Ibandronic acid ia is a potent bisphosphonate drug used in the prevention and treatment of osteoporosis. The main adverse effect seen with oral clodronate and oral ibandronic acid was mild gastrointestinal toxicity. Novel advances in the treatment of osteoporosis british. No significant renal toxicity was seen with iv pamidronate or iv ibandronic acid. Ibandronic acid, please wait for 1 hour before you can have your first food and further drinks see 3. 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.
The repeated dose toxicity studies consisted of 4week i. Zoledronic acid for injection is indicated for the treatment of patients. 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. Studies in lactating rats have demonstrated the presence of low levels of ibandronic acid in the milk following intravenous administration. Ibandronic acid belongs to a group of medicines called bisphosphonates, which may reverse bone loss by. 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. In reproductive studies in rats by the oral route, ibandronic acid decreased fertility. Therefore, ibandronic acid teva should not be used during pregnancy. 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. Description ibandronic acid is a group of medicine called bisphosphonates.
The reference medicine for ibandronic acid sandoz is bondronat. 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. 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. Fertility there are no data on the effects of ibandronic acid in humans. Alendronatic acid, clodronic acid, etidronic acid, ibandronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid are among the osteolysis inhibitors. The research field is currently very active, and many new discoveries in bisphosphonate bonedisease therapy have been published. It is not known whether ibandronic acid is excreted in human milk.
Tablets should be swallowed whole with plenty of water while sitting or standing. Dualenergy xray absorptiometry dxa is currently the criterion standard for the evaluation of bmd. Pdf zoledronic acid induces cytogenetic toxicity in male germline. 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. Ibandronate sodium 150 mg as ibandronic acid oncemonthly resulted in a mean increase in lumbar spine bmd of 4. Frequency of administration for treatment of tumour induced hypercalcemia, ibandronic acid concentrate for solution for infusion is generally given as a single infusion. A randomised, open label, noninferiority phase 3 trial.
The drug is used to treat high levels of blood calcium caused by malignant tumours whether or not bone secondaries are present. As a precautionary measure, keep away from strong oxidizers 11. May 29, 2012 renal toxicity associated with ibandronic acid was so low as to be equivalent to placebos. Bondria ibandronic acid 150mg 3 tablets cancer womens. Etidronic acid can also be prepared by reaction of an acetic acid acetic anhydride mixture with phosphoric acid. Take ibandronic acid tablets first thing after you get up in the morning. Pharmaceutical benefits scheme pbs ibandronic acid. There are no data on the effects of ibandronic acid in humans. Research article ferulic acid against cyclophosphamide. The reference medicines for ibandronic acid teva are bondronat and bonviva. 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.
For more information on generic medicines, see the question andanswer document. Etidronic acid can also be prepared by reaction of an acetic acidacetic anhydride mixture with phosphoric acid. Ibandronate sodium has the full chemical name of 1hydroxy3 methylpentylaminopropylidenebisphosphonic acid, monosodium salt, monohydrate. Ideal sources for wikipedia s health content are defined in the guideline wikipedia. This means that ibandronic acid sandoz is similar to a reference medicine already authorised in the european union eu. Ibandronic acid drug bnf content published by nice. Multiple antiresorptive treatments are available and can be used for the prevention or treatment of osteoporosis. The effectiveness of zoledronic acid and ibandronic acid. Breastfeeding it is not known whether ibandronic acid is excreted in human milk.
Ibandronic acid is a highly potent nitrogencontaining bisphosphonate used for the treatment of osteoporosis target. Get info of suppliers, manufacturers, exporters, traders of ibandronic acid for buying in india. It slows bone loss while increasing bone mass, which may prevent bone fracture. Risedronate is a potent bisphosphonate with a wellestablished antiosteoclastic activity effect. Male and female f344n rats and b6c3f1n mice were administered sodium thioglycolate approximately 99% pure in a vehicle of 95% ethanol. Bondria ibandronic acid 150mg 3 tablets cancer womens, price.
In reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0. If you are prescribed it as an injection, it will be given to you by a doctor or nurse in a hospital clinic. 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. Formation of toxic gases is possible during heating or fire. The action of ibandronate on bone tissue is based partly on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Acute toxicity studies in mice, rats, and dogs revealed toxicities. This means that ibandronic acid teva is similar to a reference medicine already authorised in the european union eu. Ibandronic acid is a nitrogencontaining bisphosphonate with affinity for bone that inhibits osteoclastmediated bone resorption. Longterm ibandronic acid binding to bone tissue can be assumed. The ddds for clodronic acid, pamidronic acid, zoledronic acid, parenteral etidronic acid and parenteral ibandronic acid are based on tumor induced hypercalcemia. Therefore, ibandronate bluefish should not be used during pregnancy. The authors noted that there have been reports of osteonecrosis of the jaw with longterm use of bisphosphonates. Boniva injection is available as a sterile, clear, colorless, readytouse solution in a prefilled syringe that delivers 3.
Each film coated tablet contains ibandronic acid 150 mg as 168. Generic drug ibandronic acid available with manufacturer details. 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. The tablets are supplied in blisters containing 1 or 3 tablets. Immediately wash skin with soap and plenty of water for at least.
Zoledronic acid induces cytogenetic toxicity in male germline cells of swiss albino mice. Our results suggest that zoledronic acid is preferable to ibandronic acid in preventing skeletalrelated events caused by bone metastases. Outcome the clinical outcomes were the incidence of sre, pfs, os, as well as some ae, such as onj and renal toxicity. Ibandronic acid accord is a medicine used to treat certain conditions affecting bones and blood calcium. Ibandronic acid as ibandronic sodium monohydrate 50 mg more. 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. In particular, the incidence of renal adverse events. The medicine is used in preventing further bone deterioration which is associated with cancer. The dose of zoledronic acid administered was 4 mg while 2 mg or 4 mg of ibandronic acid was administered. 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. Nov 14, 2019 in reproductive studies in rats by the intravenous route, ibandronic acid decreased sperm counts at doses of 0. Prescribing and technical information ibandronic acid, 3mg in 3ml solution for injection bonviva. It was patented in 1986 by boehringer mannheim and approved for medical use in 1996. It may also be used to treat hypercalcemia elevated blood calcium levels.