Bonviva - instructions for use, analogs, reviews and release forms (150 mg tablets, injections in ampoules for injections in syringes-tubes) drugs for the treatment of osteoporosis in menopause in women, including during pregnancy and lactation

In this article, you can read the instructions for using the drug Bonviva. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Bonviva in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Bonviva with existing structural analogues. Use for the treatment of osteoporosis in menopause in women, including during pregnancy and lactation.

Bonviva - inhibitor of bone resorption and osteoclast activity, highly active nitrogen-containing bisphosphonate.

Ibandronic acid (active ingredient of Bonviva) is a highly active nitrogen-containing bisphosphonate, an inhibitor of bone resorption and osteoclast activity. Ibandronic acid prevents bone destruction caused by blockade of the function of the sexual glands, retinoids, tumors and extracts of tumors.

Ibandronic acid does not impair the mineralization of bone tissue when administered at therapeutic doses for the treatment of osteoporosis and does not affect the process of replenishing the pool of osteoclasts. The selective effect of ibandronic acid on bone tissue is due to its high affinity for hydroxyapatite, which is the mineral matrix of bone.

Ibandronic acid dose-dependent brakes bone resorption and does not have a direct effect on the formation of bone tissue. In menopausal women, it reduces the increased rate of bone tissue renewal to the level of reproductive age, which leads to a general progressive increase in bone mass, a decrease in bone collagen degradation (concentration of deoxypyridinoline and cross-linked C- andN-telopeptides of type 1 collagen) in urine and serum, fracture frequency and increase in bone mineral density (BMD).

High activity and wide therapeutic range provide the possibility of a flexible dosing regimen and intermittent administration of the drug with a long period without treatment at relatively low doses.

Composition

Ibandronate sodium monohydrate + excipients.

Pharmacokinetics

There was no direct relationship between the effectiveness of Bonviv and the concentration of the substance in the blood plasma. The concentration in the blood plasma increases dose-dependently with increasing dose from 0.5 to 6 mg. After entering the systemic circulation, ibandronic acid binds rapidly in the bone tissue or is excreted in the urine. 40-50% of the amount of ibandronic acid, circulating in the blood, penetrates well into the bone tissue and accumulates in it. There is no evidence that ibandronic acid is metabolized. Ibandronic acid does not inhibit the enzymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4 of the cytochrome P450 system. After intravenous administration, 40-50%) of the dose binds in the bones, the rest is excreted unchanged by the kidneys.The concentration of ibandronic acid in the blood decreases rapidly and is 10% of the maximum after 3 hours after intravenous administration.

The pharmacokinetics of ibandronic acid do not depend on sex.

There were no clinically significant interracial differences in the distribution of ibandronic acid in Caucasoid and Mongoloid races. Relatively Negroid race data is not enough.

In patients with impaired renal function, renal clearance of ibandronic acid depends linearly on creatinine clearance (CC). For patients with impaired renal function of mild or moderate severity (CK> 30 mL / min), dose adjustment is not required. In patients with severe renal dysfunction (CK <30 mL / min) who received the drug at a dose of 0.5 mg IV, total, renal and adrenal ibandronic acid clearance was reduced by 67%), 77% and 50%, respectively. However, an increase in systemic concentration did not impair the tolerability of the drug.

Data on the pharmacokinetics of ibandronic acid in patients with impaired liver function are absent. The liver does not play a significant role in the clearance of ibandronic acid, which is not metabolized, but is excreted through the kidneys or by entrapment in bone tissue, so dose correction is not required for patients with impaired liver function.

The studied pharmacokinetic parameters do not depend on age. It should be taken into account the possible decrease in kidney function in elderly patients.

Data on the use of Bonviva in persons under the age of 18 years are absent.

The impact on the risk of fracture of the femoral neck has not been established.

Indications

• treatment of postmenopausal osteoporosis in women with an increased risk of fractures.

The drug reduces the risk of vertebral fracture.

Forms of release

The tablets covered with a cover of 150 mg.

Solution for intravenous administration (injections in ampoules for injections in syringes-tubes).

Instructions for use and treatment regimen

Pills

The drug is administered orally 150 mg (1 tablet) once a month (preferably on the same day of each month), 60 minutes before the first meal on that day, liquid (except water) or other medicines and food additives. Tablets should be swallowed whole, washed down with a glass (180-240 ml) of pure water, in a sitting or standing position. Do not lie down for 60 minutes after taking the drug. Tablets can not be chewed or rassasyvat because of possible ulceration of the upper gastrointestinal tract. Do not use mineral water with a high calcium content.

If you miss a scheduled appointment, you should take 1 pill Bonviva, if before the scheduled admission is more than 7 days, and then take Bonviva once a month in accordance with the schedule. If the next scheduled appointment is less than 7 days, wait until the next scheduled reception, and then continue to receive according to the schedule. Do not take more than 1 pill Bonviva a week.

Older patients do not need a dose adjustment.

Syringe Tubes for Injection

The solution is intended for intravenous administration only. The drug should be administered only by a specialist. Avoid intra-arterial administration of the drug or its entry into surrounding tissues.

Before administration, it is necessary to inspect the solution for any foreign matter or discoloration.

Use needles complete with syringes. The syringe tube is intended for single administration only.

Standard dosing regimen

The drug is administered in a dose of 3 mg intravenously bolus (for 15-30 seconds) 1 every 3 months. In addition, calcium and vitamin D preparations should be recommended.

In case of missed scheduled injection, it is necessary to inject as soon as possible. Further, the drug should be continued every 3 months after the last injection.

You can not prescribe the drug more than once in 3 months.

During treatment, kidney function, serum calcium, phosphorus and magnesium should be monitored.

Older patients do not need a dose adjustment.

Side effect

• loss of appetite;
• dyspepsia (nausea, abdominal pain);
• flatulence;
• diarrhea, constipation;
• gastritis;
• gastroenteritis;
• esophagitis;
• arthralgia;
• myalgia;
• pain in the limbs;
• osteoarthritis;
• back pain;
• musculoskeletal pain;
• pain in the bones;
• atypical susceptible and diaphyseal fractures of the femur (typical for the bisphosphonate class);
• headache;
• dizziness;
• insomnia;
• depression;
• rash;
• angioedema;
• hives;
• swelling of the face;
• inflammatory diseases of the eyes;
• influenza-like syndrome;
• fever;
• chills;
• fatigue;
• weakness;
• nasopharyngitis;
• cystitis;
• urinary tract infection;
• bronchitis;
• upper respiratory tract infection;
• arterial hypertension;
• hypercholesterolemia;
• phlebitis;
• thrombophlebitis;
• asthenia;
• hypersensitivity reactions.

Contraindications

• hypocalcemia (before the use of Bonviva, as with the appointment of all bisphosphonates used to treat osteoporosis, hypocalcemia should be eliminated);
• severe renal dysfunction (serum creatinine greater than 200 μmol / L (2.3 mg / dL) or KC less than 30 mL / min);
• pregnancy;
• lactation period;
• children's age (safety and efficacy in persons under 18 years of age is not established);
• increased sensitivity to ibandronic acid and other components of the drug.

Application in pregnancy and lactation

The experience of clinical use of Bonviva during pregnancy is absent.

Pre-clinical studies showed no signs of direct embryotoxic or teratogenic effects. The adverse effects of ibandronic acid in studies of reproductive toxicity in animals were the same as in all bisphosphonates: a decrease in the number of embryos, a malfunction in the delivery process, an increase in the incidence of visceral abnormalities (constriction of the ureteropelvic segment).

It is not known whether ibandronic acid is excreted in human breast milk.

It is excreted in milk from animals.After 24 hours, the concentration of ibandronic acid in blood plasma and milk is the same and corresponds to 5% of the maximum.

Use in children

Safety and effectiveness in children and adolescents under 18 years are not established.

Application in elderly patients

Older patients do not need a dose adjustment.

special instructions

Osteoporosis can be confirmed by detecting a low BMD (T index <-2 SD [Standard deviation - standard deviation]), fracture (including history) or low bone mineral density (T index <-2.5 SD) in the absence confirmed fracture.

Prior to the use of Bonviva, hypocalcemia and other metabolic disorders of bone tissue and electrolyte balance should be corrected. Patients should consume sufficient amounts of calcium and vitamin D. If the patient does not receive calcium and vitamin D with food, then they should additionally be taken as food supplements.

Before each injection should determine the content of serum creatinine.

Patients with concomitant diseases receiving nephrotoxic therapy who may have impaired renal function should be carefully observed.

When bisphosphonates were used in patients with cancer, osteonecrosis of the jaw was observed, most often associated with tooth extraction and / or local infection (in particular, osteomyelitis). Osteonecrosis of the jaw developed mainly on the background of intravenous application of bisphosphonates, which was often accompanied by chemotherapy and the use of glucocorticosteroids (SCS).

Osteonecrosis of the jaw was also noted against the background of taking oral bisphosphonates for the treatment of osteoporosis.

In the presence of such attendant risk factors as oncological disease, radiation or chemotherapy, reception of GCS, as well as insufficient oral hygiene, it is recommended that a dental examination and appropriate preventive treatment be performed before the appointment of bisphosphonates.

During treatment with bisphosphonates, it is necessary to avoid invasive dental procedures.

Surgical dental intervention against the background of bisphosphonate therapy can enhance the manifestations of the osteonecrosis of the jaw. It is unknown whether the risk of osteonecrosis reduces the elimination of bisphosphonates.The decision to conduct treatment should be taken for each patient individually after assessing the risk / benefit ratio.

When taking bisphosphonates, incl. and the drug Bonviva, there may be a severe pain syndrome: pain in the joints, bones and muscles. The pains arose both in a day and a few months after the beginning of the drug, most patients were allowed after the cessation of therapy, in some of them the symptoms resumed after the re-appointment of the same or another drug.

Atypical susceptible and diaphyseal fractures of the femur are marked against the background of bisphosphonate administration, primarily in patients receiving long-term treatment for osteoporosis. Causal link is not established. Fractures of this type were also noted in patients with osteoporosis who did not receive bisphosphonate therapy. Transverse and short oblique fractures can be localized along the entire length of the femur from a small spit to an epicondylitis elevation. The occurrence of atypical fractures occurs spontaneously or as a result of minor injuries. For weeks or months before the completion of the completed fracture of the hip, patients experience pain in the thigh orIn the groin, which is often accompanied by radiographic signs of a stress fracture. Due to the fact that atypical fractures are often bilateral, it is necessary to monitor the condition of another femur in patients with diaphyseal fracture of the femur. Poor healing of atypical fractures was noted. If a suspected atypical fracture is suspected and the results of the survey are obtained, consideration should be given to discontinuing bisphosphonate therapy, based on an assessment of the benefit / risk ratio in each case.

Patients should be informed of the need to report any pain in the thigh or in the groin during therapy with bisphosphonates. If these symptoms are present, a check should be performed to identify incomplete hip fracture.

The use of oral bisphosphonates can lead to local irritation of the mucosa of the upper gastrointestinal tract. In connection with the possible irritant effect of the drug and the worsening of the current underlying gastrointestinal disease, caution should be exercised in prescribing Bonviva to patients with active pathological processes localized in the upper gastrointestinal tract (for example,established Barrett's esophagus, dysphagia, other diseases of the esophagus, gastritis, duodenitis or ulcers).

In patients receiving oral bisphosphonates, cases of adverse events such as esophagitis, ulcers or erosion of the esophagus, occasionally accompanied by bleeding or the development of strictures or perforations of the esophagus, are described. In some cases, adverse events were severe and required hospitalization. Probably, the risk of developing severe adverse events on the side of the esophagus is higher in patients who do not follow the dosing regimen and / or continue to take oral bisphosphonates after the appearance of symptoms indicative of esophageal irritation. Patients should carefully read the recommendations for taking the drug and carefully observe them.

Doctors should be especially attentive to any signs or symptoms indicating possible reactions from the esophagus, and patients should be warned about the need to stop taking Bonviva and consult a doctor if they have dysphagia, pain when swallowing or behind the sternum, the appearance or increased heartburn.

When using oral bisphosphonates (post-registration observation), individual cases of stomach and duodenal ulcer development, sometimes severe and complicated, are described, although in clinical studies there was no increase in the risk of these diseases.

Impact on the ability to drive vehicles and manage mechanisms

Studies on the effect of the use of Bonviv on the ability to drive and other mechanisms have not been conducted. The drug causes undesirable phenomena that can affect the ability to drive vehicles and mechanisms.

Instruction for disposal of the drug

Destruction of syringes / needles

When using and destroying syringes and other medical devices containing needles, the following rules should be strictly observed:

• Do not reuse syringes and needles;
• all used needles and syringes should be placed in containers (disposable containers resistant to piercing);
• Keep the container out of the reach of children.
• It should be avoided to dispose of the containers for needles together with household waste;
• Dispose of containers filled with syringes / needles according to local requirements or as instructed by the doctor.

Patients should be provided with pierce-resistant containers for the disposal of syringes and needles at home.

Destruction of unused medicinal product or after expiry date

The presence of drugs in the environment should be minimized. Do not dispose of Bonviva with sewage or with household waste. If possible, it is necessary to use special systems for the disposal of medicinal products.

Drug Interactions

Bonviva does not affect the activity of the main isoenzymes of the cytochrome P450 system. In therapeutic concentrations, ibandronic acid weakly binds to blood plasma proteins, and therefore it is unlikely that it will displace other drugs from the binding sites with proteins. Ibandronic acid is excreted only by the kidneys and is not subjected to any biotransformation. Apparently, the route of excretion of ibandronic acid does not include any transport systems involved in the excretion of other drugs.

Foods and nutritional supplements with calcium, antacids and oral medicines containing calcium and other polyvalent cations (for example, aluminum, magnesium, iron), incl. milk and solid food, may interfere with the absorption of the drug, so they should be consumed no earlier than 60 minutes after ingestion of Bonviva.

Bonviva solution for intravenous administration is incompatible with calcium-containing solutions and other solutions for intravenous administration.

Analogues of the drug Bonviva

Structural analogs for the active substance:

• Bondronate.

Analogues on the curative effect (agents for the treatment of osteoporosis):

• Additive of calcium;
• Aquadetry;
• Aklast;
• Andriol;
• Arthromax;
• Bivalos;
• Bora Bora;
• Wang Alpha;
• Calcium vectrum;
• Veprena;
• Calcemin;
• Calcemin Advance;
• Calcium D3 Nycomed;
• Calcium D3 Nicomed Forte;
• Xidifon;
• Lysite (L-Lysine);
• Methandrostenolone;
• Ossin;
• Ostalon;
• Osteogenon;
• Osteoka solution;
• Osteoppan;
• Osteotriol;
• Osteohin;
• Retabolil;
• Tilcotyl;
• Tobitil;
• Tridin;
• Forosa;
• Forste;
• Fosavans;
• Fosamax;
• Ergocalciferol;
• Ethal.

Similar medicines:

Other medicines: