Bondronat - Instructions For Use, Indications, Doses

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Bondronat

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Terms and conditions of storage

Bondronate - an inhibitor of bone resorption, reduces the incidence of skeletal complications in malignant diseases.

Release form and composition

Dosage forms:

• concentrate for the preparation of solution for infusion: colorless transparent liquid (2 or 6 ml in a bottle, in a cardboard box 1 bottle);
• coated tablets: almost white or white, oblong in shape, engraved on one side "L2", on the other - "IT" (7 pcs. in a blister, in a cardboard box 4 blisters; 28 pcs. in a bottle, in a cardboard box 1 bottle).

1 ml of concentrate contains:

• active substance: sodium ibandronate monohydrate - 1.125 mg, which is equivalent to 1 mg of ibandronic acid;
• auxiliary components: 99% acetic acid, sodium acetate, sodium chloride, water for injection.

1 tablet contains:

• active substance: sodium ibandronate monohydrate - 56.25 mg, which is equivalent to 50 mg of ibandronic acid;
• auxiliary components: stearic acid, lactose monohydrate, colloidal anhydrous silica gel, povidone (K 25), crospovidone, microcrystalline cellulose;
• shell composition: opadry 00A28646 [titanium dioxide (E 171), hypromellose, talc].

Indications for use

• hypercalcemia in patients with malignant neoplasms;
• metastatic bone disease - to reduce pain, reduce the risk of pathological fractures and hypercalcemia, in order to reduce the need for radiation therapy in case of the threat of fractures and pain syndrome.

Contraindications

• age up to 18 years;
• During pregnancy and breastfeeding;
• individual hypersensitivity to the components of the drug.

Bondronate should be prescribed with caution in patients with severe renal impairment [creatinine clearance (CC) less than 30 ml / min], hypersensitivity to other bisphosphonates.

In addition, it is recommended to prescribe pills with caution with concomitant therapy with non-steroidal anti-inflammatory drugs (NSAIDs).

Method of administration and dosage

Concentrate for solution for infusion

The ready-made solution of the concentrate is intended for intravenous (IV) drip administration in a hospital setting.

To prepare the infusion solution, the concentrate can be mixed with 5% dextrose solution or 0.9% sodium chloride solution.

Recommended dosage regimen:

• metastatic lesions of bones in breast cancer: 6 mg 1 time in 3-4 weeks. The drug is mixed with 100 ml of 0.9% sodium chloride solution or 5% dextrose solution and injected over 15 minutes. A 15-minute infusion can be performed only with normal renal function or mild impairment (CC greater than 50 ml / min). In patients with CC less than 50 ml / min, the safety and effectiveness of this procedure have not been established;
• hypercalcemia in malignant neoplasms: severe form (with albumin-corrected serum calcium 12 mg / dl or more or 3 mmol / l and more) - 4 mg once; moderate (with albumin-corrected serum calcium less than 12 mg / dl or 3 mmol / l) - 2 mg. For intravenous infusion, the concentrate is dissolved in 500 ml of 0.9% sodium chloride solution or 5% dextrose solution for 60–120 minutes. Bondronate is used after adequate hydration with 0.9% sodium chloride solution. A single dose should not exceed 6 mg, it does not increase the therapeutic effect. Re-introduction is possible in the absence of a sufficient effect after the first injection or in case of recurrence of hypercalcemia.

With varying degrees of severity of renal dysfunction, an increase in the systemic concentration of the drug does not impair its tolerance in patients. However, in patients with breast cancer with metastatic bone lesions, correction of the duration of infusion and the volume of 0.9% sodium chloride solution or 5% dextrose solution is required.

Recommended dosage, taking into account CC for patients with breast cancer with metastatic bone lesions:

• CC more than 50 ml / min: 6 mg of the concentrate is dissolved in 100 ml of 0.9% sodium chloride solution or 5% dextrose solution, the duration of the infusion is 15 minutes;
• CC 30-50 ml / min: 6 mg, infusion using 500 ml of 0.9% sodium chloride solution or 5% dextrose solution for 60 minutes;
• CC less than 30 ml / min: 2 mg, infusion using 500 ml of 0.9% sodium chloride solution or 5% dextrose solution for 60 minutes.

The infusion is carried out once every 3-4 weeks.

No dose adjustment is required in elderly patients and with impaired liver function.

Film-coated tablets

The tablets are taken orally, in a sitting or standing position, swallowing whole, washed down with clean plain water (180-240 ml) 30 minutes before breakfast, or taking any liquid other than water, or other medicines and dietary supplements (BAA) to food. After taking the pill, the patient should not take a horizontal position for 60 minutes. The use of calcium-fortified mineral water is contraindicated.

Recommended dosage: 50 mg once a day, daily.

Correction of the dosage regimen for impaired renal function:

• CC from 50 to 80 ml / min: usual dose;
• CC from 30 to 50 ml / min: 50 mg 1 time in two days;
• CC less than 30 ml / min: 50 mg once a week.

If liver function is impaired and in elderly patients, dose adjustment is not required.

The safety of using the tablets in patients unable to sit or stand for 60 minutes has not been established.

Side effects

The use of Bondronat can cause undesirable effects on the part of laboratory parameters: often - hypophosphatemia (does not require therapeutic intervention), a decrease in the excretion of calcium by the kidneys; sometimes - hypocalcemia; very rarely - osteonecrosis of the jaw.

In addition, the side effects of the drug, characteristic separately for each of the dosage forms:

• concentrate: fever, headache, asthenia; sometimes - hypersensitivity reactions, flu-like syndrome (ossalgia, fever, chills, myalgia); rarely - diarrhea, dyspepsia, with aspirin bronchial asthma - bronchospasm;
• tablets: often - dyspepsia, hypocalcemia.

special instructions

Before starting treatment with Bondronate, the patient should undergo therapy aimed at eliminating hypocalcemia and other disorders of electrolyte balance and bone metabolism. Patients are prescribed a sufficient intake of calcium and vitamin D, including in the form of dietary supplements.

The concentrate solution should not be used for intra-arterial administration or allowed to get into the surrounding tissues.

Treatment should be carried out under regular close monitoring of renal function, serum calcium, magnesium and phosphorus levels.

When administered intravenously, overhydration should not be allowed in patients predisposed to the development of heart failure.

Due to the high risk of oropharyngeal ulceration, chewing or dissolving tablets is strictly prohibited.

Taking the tablets should be done in strict accordance with the recommended rules, this will reduce the risk of developing disorders of swallowing, esophagitis, and ulceration of the esophagus and stomach. Symptoms of damage to the esophagus include heartburn, pain when swallowing, the appearance or intensification of dysphagia, chest pain. When these conditions appear, you must stop taking the pills and consult a doctor.

The use of Bondronat is associated with the risk of developing osteonecrosis of the jaw. Cases of osteonecrosis of the jaw are more common with oncological pathologies during dental procedures, less often with postmenopausal osteoporosis or other diseases. Risk factors include diagnosed cancer, concomitant chemotherapy and radiation therapy, corticosteroid treatment, gum disease, anemia, coagulopathy, and infections. With intravenous administration of the drug, the risk of developing osteonecrosis of the jaw is greater than with oral administration.

If surgical dental intervention is necessary against the background of the use of the drug, the decision on the possibility of therapy should be made by the attending physician for each patient individually after the ratio of the potential risk to the expected benefit.

The development of signs of flu-like syndrome (fever, chills, ossalgia, myalgia) with IV administration of Bondronat usually does not require specific treatment, the symptoms disappear after a few hours or days on their own.

The effect on the patient's ability to drive vehicles and mechanisms has not been established.

Drug interactions

Ibandronic acid weakly binds to blood plasma proteins, does not biotransform, except for the kidneys, its excretion route does not include transport systems involved in the excretion of other drugs, therefore the probability of Bondronat interaction is insignificant.

The drug does not affect the action of the main isoenzymes of the cytochrome P _{450 system}.

There is no interaction with tamoxifen, estrogen preparations.

In order not to disrupt the absorption of the drug, you should take food, including milk and other drinks besides ordinary water, no earlier than 30 minutes after taking the tablets.

NSAIDs and bisphosphonates can irritate the gastrointestinal mucosa.

The drug solution should not be mixed with calcium-containing solutions.

With the simultaneous administration of ranitidine, the bioavailability of ibandronic acid when administered by infusion increases by 20%.

When combined with H ₂ -histamine receptor blockers or other drugs that increase gastric acidity, dose adjustment is not required.

Terms and conditions of storage

Keep out of the reach of children.

Store in a dry place at temperatures up to 30 ° C.

The shelf life is 5 years.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!