Ibandronic Acid Sandoz®
The drug should only be administered intravenously. Accidental intra-arterial administration of the drug or contact with surrounding tissues should be avoided, which can lead to tissue damage.
Use the concentrate for preparing a solution for infusion once.
Usually used in a hospital setting.
Use only clear, freshly prepared solution without foreign particles. From a microbiological point of view, the infusion solution for intravenous administration must be used immediately after preparation. If the drug is not used immediately, then the time and storage conditions of the prepared solution are the responsibility of the medical professional.
The prepared solution can be stored for no more than 24 hours at a temperature of 2 to 8 °C if the dilution is carried out under controlled and validated aseptic conditions.
Should not be mixed with solutions containing calcium. Discard unused solution.
Release of the drug into the environment along with waste must be minimized. Do not dispose of with sewage or household waste.
Established systems for drug disposal must be used.
Standard dosage regimen
Metastatic bone lesions
6 mg IV drip over at least 15 minutes, once every 3 to 4 weeks. The concentrate for preparing a solution for infusion should be diluted in 100 ml of 0.9% sodium chloride solution or 5% dextrose solution.
Hypercalcemia in malignant neoplasms
Therapy with Ibandronic acid Sandoz® is started after adequate rehydration with 0.9% sodium chloride solution. The drug is used only in the form of 1-2 hour intravenous infusions. The concentrate for preparing a solution for infusion is diluted in 500 ml of 0.9% sodium chloride solution or 500 ml of 5% dextrose solution.
The dose of the drug depends on the severity of hypercalcemia, as well as on the type of malignancy. As a rule, patients with osteolytic metastases require lower doses of the drug than patients with the humoral type of hypercalcemia. In most cases, patients with severe hypercalcemia (albumin-corrected serum calcium >3 mmol/L or >12 mg/dL) are given a single dose of 4 mg. Patients with moderate hypercalcemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl) - 2 mg. The maximum single dose used in clinical studies, 6 mg, does not lead to an increase in effect.
In most cases, elevated serum calcium concentrations return to normal within 7 days. The average time for the development of relapse of hypercalcemia (repeated increase in serum albumin-corrected calcium concentration more than 3 mmol/l) was 18-19 days at doses of 2 and 4 mg. The average time for relapse to develop when 6 mg of the drug was administered was 26 days.
A limited number of patients (n=50) received a second infusion to treat hypercalcemia. If there is insufficient effectiveness or if hypercalcemia recurs, repeated administration is possible.
The concentration of albumin-corrected calcium in serum (mmol/l) is calculated using the formula:
serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8.
Serum albumin-corrected calcium concentration in mg/dL is calculated using the formula:
serum calcium (mg/dL) + 0.8 x [4 - albumin (g/dL)].
Purpose of the study. To evaluate the effectiveness of intravenous ibandronic acid on bone mineral density (BMD) in women with osteoporosis.
Material and methods. 30 women with osteoporosis aged 50-80 years (average age 62.7±9.0 years) were examined. The diagnosis of osteoporosis was verified based on the T-criterion in the study areas, according to WHO criteria. The absolute values of BMD of the lumbar spine (L—L!V), proximal femur and femoral neck were determined before treatment and 12 months after it. Ibandronic acid for intravenous administration was administered as a bolus over 30 s at a dose of 3 mg once every 3 months.
To process the measurement results, statistical analysis methods were used (SPSS Statistics 20.0), Wilcoxon and Mann-Whitney tests were used.
Results. Ibandronic acid for intravenous administration has a positive effect on changes in absolute BMD in the lumbar spine and proximal femur, including the femoral neck, causing their increase 12 months after treatment.
Conclusion. Intravenous ibandronic acid is an effective means of increasing BMD in patients with osteoporosis.
Osteoporosis is a chronic progressive disease; it is most common in the female population during menopause [1]. Given the constant increase in the proportion of women over 50 years of age in the general population of European countries, the treatment of osteoporosis and the need for mandatory drug prevention of fractures creates a significant financial burden on the healthcare industry [2]. Currently, the main group of drugs used in the treatment of osteoporosis are oral bisphosphonates, which have proven effective in preventing fractures [3]. However, the prescription of these drugs may be limited due to the presence of contraindications from the gastrointestinal tract or the inability to take them in patients with prescribed bed rest or in the presence of a conflict with other vital drugs. Another significant problem with the use of oral bisphosphonates is low compliance and adherence to treatment. According to studies, after 6 months, every 5th patient violates the prescribed regimen for taking tablet bisphosphonates, and by the end of 1 year, every 2nd patient independently stops oral therapy [4]. Therefore, an alternative is the active introduction of bisphosphonates for intravenous administration into clinical practice.
The purpose of this study was to evaluate the effectiveness of intravenous ibandronic acid on bone mineral density (BMD) in women with osteoporosis.
Material and methods
The study included women over 50 years of age with instrumentally verified osteoporosis with or without a history of fractures. Treatment with the drug ibandronic acid for intravenous administration (Bonviva®) was carried out according to the indications for antiresorptive therapy in the metabolic disorders room of the Republican Scientific and Practical Center for Radiation Medicine and Human Ecology (Gomel). Using cubital vein venipuncture, the drug was administered in a stream over 30 s at a dose of 3 mg once every 3 months. Before the therapy, the patients were advised to drink plenty of fluids the day before, as well as daily intake of calcium (at least 1000 mg) and vitamin D (400 to 800 IU) throughout the observation period. Previous use of other antiresorptive drugs was not a criterion for excluding them from the study. The end point for assessing the effectiveness of treatment was the study of the absolute values of BMD of the lumbar spine, proximal femur (POF) and femoral neck (FNC) before the start of therapy and at least 12 months after 4 intravenous injections of ibandronic acid. A reliable criterion for the increase in MIC was exceeding the minimum significant error threshold, which is 1.5%. Instrumental measurement of BMD was performed using dual-energy X-ray absorptiometry (DXA) of the lumbar vertebrae (L,—L|V), FB and SBK (LUNAR Prodigy, (USA) with CORE v 8.5 software). The measurement results are presented in absolute values: in g/cm2 for the lumbar spine and mg/cm2 for the POB.
The diagnosis of osteoporosis was made according to WHO criteria when the T-criterion value in one of the study zones was -2.5 or less. The values of the BMD of the PHB and BBC are presented as the average values of the study on both sides for each patient. In the case of a prosthetic hip joint, measurements were performed on the intact limb [5]. The survey of study participants was carried out using a unified computer program developed at the Republican Scientific and Practical Center for Radiation Medicine and Human Ecology and registered with the NCIS (No. 116 of December 15, 2009, G. N. Romanov, L. S. Starostenko, E. V. Rudenko). The questionnaire included sections about previously suffered low-traumatic fractures, family history of osteoporotic fractures in first-degree relatives aged over SO years, age at menopause, as well as the presence of diseases associated with the development of osteoporosis. The questionnaire took into account information about previous use of calcium supplements in combination with vitamin D and anti-osteoporotic therapy.
Statistical data processing was carried out using the SPSS Statistics 2O.O computer program. Methods of parametric and nonparametric statistics were used for analysis. Data are presented in the format “mean (+95% CI; -95% CI)” or “mean±standard deviation”. To determine the statistical significance of differences in dependent samples, the Wilcoxon test or t-test for paired samples was used; in independent samples, the Mann-Whitney test was used. The dynamics of changes in BMD were assessed by the level of increase in density indicators, expressed as a percentage of the initial level. Changes in indicators over time were defined as statistically significant at P
L I T E R A T U R A 1. Siris E. S. //JAMA.—2001.—Vol. 286,— P. 2815—2822. 2. Melton LJ // J. Bone Miner. Res.—2003.—Vol. 18.— P. 1139—1141. 3. Chesnut S. H. // J. Bone Miner. Res.—2004.—Vol. 19.— P. 1241—1249. 4. Official Internet portal of the International Osteoporosis Foundation // [Electronic resource] / International Osteoporosis Foundation. - Nyon, 2014. - Access mode: https:// www.iofbonehealth.o rg/s ites/defa ult/fil es/PD Fs/s tayin g_ power_2006.pdf. 5. Lewiecki EM // Bone.— 2008.— Vol. 43.— P. 1115—1121. 6. Miller PD // Clin. Exp. Rheumatol.—2008.—Vol. 26.— P. 1125—1133. 7. Miller PD //Bone.—2011.—Vol. 49.— P. 1317—1322. 8. Filleul O., Crompot E., Saussez S. // J. Cancer Res. Clin. Oncol.—2010.—Vol. 136.— P. 1117—1124. 9. Briot K. // Joint Bone Spine. - 2012. - Vol. 79.— P. 304—313. 10. Eriksen EF // J. Bone Miner. Res.—2009.—Vol. 24.— P. 1308—1313.
Received 09.17.14.
Address for correspondence: Romanov Georgy Nikitich.
Gomel State Medical University. 246050, Gomel, st. Lange, 5; sl. tel. (8-0232) 49-19-62. The article was prepared with the participation of Roche Products Limited. Key words:
women, ibandronic acid, bone mineral density, osteoporosis
Author(s):
Romanov G. N., Chernova N. F.
Medical institution: Gomel State Medical University, Republican Scientific and Practical Center for Radiation Medicine and Human Ecology of the Ministry of Health of the Republic of Belarus
Buy Bonviva injection solution 1 mg/ml 3 ml No. 1 in pharmacies
Bonviva Buy Bonviva in pharmacies DOSAGE FORMS solution for intravenous administration 3 mg
MANUFACTURERS Vetter Pharma-Fertigung GmbH and Co.KG packaged by Roche Diagnostics GmbH (Germany)
GROUP Antiosteoporotic agents - biosphosphonates
COMPOSITION Active ingredient: ibandronic acid.
INTERNATIONAL NON-PROPENTED NAME Ibandronic acid
SYNONYMS Bondronate
PHARMACOLOGICAL ACTION Inhibiting bone resorption and osteoclast activity. Regulates the calcium content in the blood and bone tissue, specifically inhibits the increased resorption of bone tissue by osteoclasts. Ibandronic acid inhibits bone resorption in a dose-dependent manner and does not have a direct effect on bone formation. In menopausal women, it reduces the increased rate of bone turnover to the level of reproductive age, which leads to an overall progressive increase in bone mass. Increases bone mass, especially in the spine. Penetrates well into bone tissue and accumulates in it. Excreted mainly by the kidneys.
INDICATIONS FOR USE Humoral tumor hypercalcemia (pseudohyperparathyroidism) in squamous cell cancer of the lungs, kidneys, genitourinary tract and some other malignant neoplasms; hypercalcemia caused by bone destruction in paraproteinemic hemoblastoses, lymphomas or metastatic breast cancer and a number of other solid malignant tumors in the bone; postmenopausal osteoporosis.
CONTRAINDICATIONS Hypersensitivity, increased creatinine levels, prostaglandin bronchial asthma, pregnancy, breastfeeding (cessation of breastfeeding is mandatory).
SIDE EFFECTS : Increased body temperature, flu-like syndrome (fever, chills, myalgia, ossalgia), decreased renal excretion of calcium, hypocalcemia, decreased levels of inorganic phosphorus, dyspeptic disorders, bronchospastic reactions.
INTERACTION Aminoglycosides increase the risk of hypocalcemia. Chemically incompatible with calcium-containing solutions. Products containing calcium and other polyvalent cations (for example, aluminum, magnesium, iron), including milk and solid foods, may interfere with the absorption of the drug and should be consumed no earlier than 60 minutes after oral administration. Calcium supplements, antacids, and medications containing polyvalent cations (eg, aluminum, magnesium, iron) may interfere with the absorption of ibandronic acid and should therefore be taken no earlier than 60 minutes after dosing.
OVERDOSE Symptoms: clinically significant hypocalcemia (convulsions, Trousseau, Chvostek, Weiss, Schlesinger symptoms, prolongation of the QT interval with isoelectric ST interval), renal failure, impaired liver function. Treatment: administration of calcium gluconate, hemodialysis (with a critical change in plasma levels of creatinine and electrolytes).
SPECIAL INSTRUCTIONS During treatment, regular monitoring of the levels of calcium, magnesium, phosphorus and creatinine in the blood serum is necessary.
STORAGE CONDITIONS List B. At a temperature not exceeding 30 degrees C, in a dry place inaccessible to children.
Price, where to buy
You can purchase Ibandronic acid in Russia for an average of 20 rubles.
- Online pharmacies in UkraineUkraine
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1138 UAH. order - Ibandronic acid-Pharmex 1mg/ml 6ml No. 1 concentrate
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Bonviva tablet p/o film 150mg 1 piece
Pharmacological group:
Bone resorption inhibitor – bisphosphonate.
Pharmacodynamics:
Ibandronic acid is a highly active nitrogen-containing bisphosphonate, an inhibitor of bone resorption and osteoclast activity. Ibandronic acid prevents bone destruction caused by gonadal suppression, retinoids, tumors and tumor extracts in vivo. In studies in young (fast-growing) rats, ibandronic acid also inhibited endogenous bone resorption, resulting in increased bone mass compared to control animals.
In animal models, ibandronic acid has been confirmed to be a potent inhibitor of osteoclast activity and does not impair bone mineralization even when administered at doses more than 5000 times higher than doses for the treatment of osteoporosis.
With long-term use of ibandronic acid in two different dosing regimens (daily or intermittent dosing with an extended period without treatment), new normal bone formation and/or an increase in mechanical strength was observed in studies in rats, dogs and monkeys, even at doses above therapeutic levels. including doses in the toxic range. The effectiveness of Bonviva® in both regimens was confirmed in the clinical study MF4411 - daily administration of 2.5 mg or intermittent administration of 20 mg of the drug over a period of 9-10 weeks without treatment led to a decrease in the incidence of fractures.
In postmenopausal women, oral administration of Bonviva® (both daily and intermittent administration of the drug over a period of 9-10 weeks without treatment) led to biochemical changes characteristic of dose-dependent inhibition of bone resorption, including a decrease in the concentration of biochemical markers of bone collagen breakdown ( deoxypyridinoline and cross-linked C- and N-telopeptides of type I collagen) in urine.
After cessation of treatment, there is a return to the previous, pre-treatment, increased level of bone resorption, characteristic of postmenopausal osteoporosis.
Histological analysis of bone biopsies taken from postmenopausal women in the second and third years of treatment showed the presence of normal bone tissue, as well as the absence of mineralization defects.
In a phase 1 bioequivalence study of 72 postmenopausal women, subjects received oral Bonviva 150 mg every 28 days for a total of 4 doses. This study found that a decrease in serum cross-linked C-telopeptide type I collagen (CTX) concentrations was observed as early as the first 24 hours after the first dose (an average of 28%), and an average maximum decrease in concentration (of 69%). ) was observed after 6 days. After the 3rd and 4th doses, the mean maximum decrease in concentration 6 days after each dose was 74%, and 28 days after the 4th dose, the average decrease in concentration was 56%. When the drug was stopped after the 4th dose, the concentration of biochemical markers showed the cessation of the inhibitory effect of the drug on bone resorption.
Ibandronic acid does not affect the process of replenishment of the osteoclast pool. The selective effect of ibandronic acid on bone tissue is due to its high affinity for hydroxyapatite, which constitutes the mineral matrix of bone.
Ibandronic acid inhibits bone resorption and does not have a direct effect on bone formation. In postmenopausal women, it reduces the increased rate of bone turnover to reproductive age levels, which leads to a progressive increase in bone mass. Daily or intermittent administration of ibandronic acid results in a decrease in bone resorption, as demonstrated by decreased concentrations of biochemical markers of bone turnover in urine and serum, an increase in bone mineral density (BMD), and a decrease in the incidence of fractures.
The high activity and breadth of the therapeutic range provide the possibility of a flexible dosage regimen in relatively low doses and intermittent use of the drug with a long period without treatment.
Efficiency
Bone mineral density (BMD).
In a 2-year, double-blind, multicenter study (BM16549) involving postmenopausal women suffering from osteoporosis (lumbar vertebrae BMD: baseline T-score below -2.5 SD), based on an increase in BMD, it was shown that prescribing Bonviva® at a dose 150 mg once a month is at least as effective as taking the drug at a dose of 2.5 mg daily. Data obtained in the primary analysis after the first year of the study were confirmed in the subsequent analysis after the second year of the study.
In addition, in a prospective analysis, it was proven that Bonviva® at a dosing regimen of 150 mg once a month is superior to Bonviva® 2.5 mg daily in terms of the degree of increase in BMD of the lumbar vertebrae (in the first year of the study, p = 0.002 and in the second year of the study, p less 0.001).
After the first year of the study (primary analysis), 91.3% (p=0.005) of patients receiving Bonviva 150 mg once monthly, compared with 84.0% of patients receiving Bonviva 2.5 mg daily, had an increase in lumbar vertebral BMD or maintaining its original level. At the end of the second year, 93.5% (p=0.004) of patients receiving Bonviva 150 mg once monthly and 86.4% of patients receiving Bonviva 2.5 mg daily had a positive response to therapy.
Regarding hip BMD values, after the first year of the study, 90.0% (p less than 0.001) of patients receiving Bonviva® 150 mg once a month, and 76.7% of patients receiving Bonviva® 2.5 mg daily, had an increase in BMD or maintaining its original value level. By the end of the second year, 93.4% (p less than 0.001) of patients receiving Bonviva 150 mg once monthly and 78.4% of patients receiving Bonviva 2.5 mg daily had an increase in hip BMD or maintained its baseline level.
Using a more stringent criterion that included global assessment of lumbar vertebrae and hip BMD, at the end of the first year of the study, a positive response was observed in 83.9% (p less than 0.001) of patients receiving Bonviva® 150 mg once a month, and in 65.7 % of patients receiving Bonviva® 2.5 mg daily. By the end of the second year - in 87.1% (p less than 0.001) of patients receiving Bonviva® 150 mg once a month, and in 70.5% of patients receiving Bonviva® 2.5 mg daily.
Biochemical markers of bone resorption
Clinically significant reductions in serum CTX concentrations were obtained after 3, 6, 12 and 24 months of therapy. After a year of treatment with Bonviva 150 mg once a month (primary analysis), the average reduction was 76%, and when taking the drug at a dose of 2.5 mg daily - 67%. By the end of the second year of the study, the average reduction was 68% when taking Bonviva® 150 mg once a month, and 62% when taking Bonviva® at a dose of 2.5 mg daily.
A decrease in CTX concentration of more than 50% compared to the initial value was observed in 83.5% (p = 0.006) of patients receiving Bonviva® 150 mg once a month, and in 73.9% of patients receiving Bonviva® 2.5 mg daily, during the first years of research. By the end of the second year, a positive response to therapy was observed in 78.7% (p = 0.002) of patients receiving Bonviva® 150 mg once a month, and in 65.6% of patients receiving Bonviva® 2.5 mg daily.
Study BM16549 showed that Bonviva 150 mg once monthly and 2.5 mg daily were at least equivalent in reducing fracture risk.
Preclinical safety data
In animal studies, the toxic effect was observed only at drug exposures significantly greater than the maximum drug exposure in humans, and therefore appears to be of little significance for the clinical use of the drug.
No data indicating possible carcinogenic and genotoxic activity have been identified.
Pharmacokinetics:
There was no direct relationship between the effectiveness of ibandronic acid and the concentration of the substance in the blood plasma. Similar effectiveness of ibandronic acid when taken in different dosing regimens (daily or at intervals of several weeks) has been shown in various studies conducted in both human volunteers and animal studies. The total dose received throughout the study period was identical. In rats, the interval between doses of the drug with an intermittent dosing regimen was at least 6 weeks, in dogs - 11 weeks, in monkeys - 30 days and in humans - 9.5 weeks.
Suction
After oral administration, ibandronic acid is rapidly absorbed from the upper gastrointestinal tract. Plasma concentrations increase dose-dependently when the dose is increased to 50 mg and significantly more when the dose is further increased. Time to reach maximum concentration (TCmax) 0.5-2 hours (median - 1 hour) after administration on an empty stomach, absolute bioavailability 0.6%. Concomitant consumption of food or drinks (except pure water) reduces the bioavailability of ibandronic acid by 90%. When taking ibandronic acid 60 minutes before meals, no significant decrease in bioavailability is observed. Ingestion of food or liquid less than 60 minutes after ibandronic acid reduces its bioavailability and the resulting increase in BMD.
Distribution
After entering the systemic circulation, ibandronic acid quickly binds to bone tissue or is excreted in the urine. 40-50% of the amount of the drug circulating in the blood penetrates the bone tissue and accumulates in it. Apparent final volume of distribution 90 l. The binding to plasma proteins at therapeutic concentrations is quite low (about 85%), thus the likelihood of drug-drug interactions due to displacement from binding to plasma proteins is small.
Metabolism
There is no evidence that ibandronic acid is metabolized in animals or humans.
Excretion 40-50% of an orally taken dose absorbed into the bloodstream is bound in the bones, and the rest is excreted unchanged by the kidneys. The unabsorbed drug is excreted unchanged in the feces.
The observed apparent terminal half-life varies widely (10-72 hours) and depends on the drug dose and assay sensitivity. The concentration of the drug in the blood plasma decreases quickly and is 10% of the maximum 3 and 8 hours after intravenous administration and oral administration, respectively.
The overall clearance of ibandronic acid is low, with average values ranging from 84-160 ml/min. Renal clearance (60 ml/min in healthy postmenopausal women) accounts for 50-60% of the total clearance and depends on creatinine clearance. The difference between total and renal clearance reflects the uptake of the substance into bone tissue.
Pharmacokinetics in special groups of patients
The pharmacokinetics of ibandronic acid does not depend on gender.
There were no clinically significant interracial differences in the distribution of ibandronic acid in individuals of the Caucasian and Mongoloid races. There is not enough data regarding the Negroid race.
Patients with impaired renal function
In patients with impaired renal function, the renal clearance of ibandronic acid is linearly dependent on creatinine clearance (CC). For patients with mild or moderate renal impairment (CC>30 ml/min), no dose adjustment is required, according to the results of study BM16549, where the majority of patients had impaired renal function. In patients with severe renal impairment (CK
Patients with liver dysfunction
There are no data on the pharmacokinetics of ibandronic acid in patients with impaired liver function. The liver does not play a significant role in the clearance of ibandronic acid, which is not metabolized but is excreted through the kidneys and by binding to bone tissue. Therefore, for patients with impaired liver function, no dose adjustment is required. Since at therapeutic concentrations ibandronic acid binds weakly to plasma proteins (85%), it is likely that hypoproteinemia in severe liver disease does not lead to a clinically significant increase in the concentration of the free substance in the blood.
Elderly age
The studied pharmacokinetic parameters do not depend on age (multivariate analysis). The possible decrease in renal function in elderly patients should be taken into account (see subsection "Patients with impaired renal function").
Children
There are no data on the use of Bonviva® in persons under 18 years of age.
Pharmacodynamics and pharmacokinetics
After taking the tablet, the acid is quickly absorbed into the body in the upper parts of the digestive tract and reaches its maximum concentration after 0.5-2 hours if taken on an empty stomach. If you take food or drinks at the same time (not including clean water), bioavailability is reduced by 90 percent. Eating food or drinks half an hour after taking acid reduces bioavailability by 30 percent. Eating food or drinks one hour after taking the acid does not affect bioavailability. If you take acid two hours after eating, bioavailability decreases to 75 percent.
When ibandronic acid enters the systemic circulation, it binds to bone tissue at a high rate or is excreted in the urine. It is 87 percent bound to plasma proteins at therapeutic concentrations. Metabolization data are not available.
On average, from 40 to 50 percent of the acid that circulates in the blood penetrates the bone tissue, where accumulation occurs, the rest is excreted unchanged by the kidneys.
Instructions for use (Method and dosage)
Used orally or intravenously. The treatment regimen and dose depend on the clinical situation and indications. The tablets should not be taken with water containing large amounts of calcium. As a rule, the tablets are taken one hour before the first meal and liquid (not including water) of the day. The tablet must be swallowed whole in a standing or sitting position with a glass of clean water. After taking the pill, you should not lie down for an hour. Also, tablets containing acid should not be sucked or chewed, as ulceration of the upper gastrointestinal tract may occur.
It is used intravenously only in hospital settings. Before use, the contents of the ampoule are diluted with the required amount of a five percent dextrose or isotonic sodium chloride .
pharmachologic effect
It is a nitrogen-containing bisphosphonate and an inhibitor of bone resorption. Does not affect bone formation. The selective effect is determined by the high affinity for hydroxyapatite , which makes up the mineral bone matrix. It has a dose-dependent inhibitory effect on tumor osteolysis, reduces the growth of existing ones and prevents the development of new bone metastases.
In postmenopausal women, it reduces the excessive rate of bone tissue turnover, due to which bone mass progressively increases.
Helps prevent bone destruction, which is caused by tumors, retinoids and cessation of gonadal function.
Side effects
When taking ibandronic acid, you may experience:
- short-term decrease in the level of calcium in the blood serum (with intravenous administration), hypersensitivity, thrombophlebitis , phlebitis , reactions at the injection site, hypercholesterolemia , arterial hypertension, upper respiratory tract infections, bronchitis, urinary tract infections, cystitis , nasopharyngitis ;
- asthenia , weakness , flu-like syndrome;
- inflammatory eye diseases;
- osteonecrosis of the jaw, diaphyseal and atypical subtrochanteric fractures of the femur, musculoskeletal pain, back pain, osteoarthritis , pain in the extremities, myalgia , arthralgia ;
- urticaria , facial swelling, angioedema ;
- rash;
- insomnia , dizziness , headache ;
- duodenitis , vomiting , dysphagia , esophagitis , gastroenteritis , gastritis , constipation , diarrhea , flatulence , dyspepsia .
