Bonefos® [Clodronic acid]

Brand Bayer Pharma AG

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Clinical Pharmacology

Bonefos has the effect of normalizing the calcium content in the bone tissue, inhibiting bone resorption

Indications

Hypercalcemia due to malignant tumors;
osteolytic metastases of malignant tumors and myeloma (multiple myeloma);
prevention of development of bone metastases of primary breast cancer

Composition

1 tablet contains 800 mg clodronate disodium.

Clodronic acid is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Bonefos	Bayer Pharma AG	Germany	pills
Bonefos	Bayer Pharma AG	Germany	capsules
Bonefos	Bayer Pharma AG	Germany	ampoules

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Dosage and Administration

For oral use. Tab. 800 mg for ease of administration can be pre-divided into 2 parts, which should be taken at the same time, but not crushed or dissolved. The dose of Bonefos 1600 mg is preferable to take once in the morning on an empty stomach, drinking a glass of water, after which you should refrain from eating food and other drugs for 2 hours (except for ordinary water). Dose Bonefos more than 1600 mg is prescribed in 2 doses: the first - as recommended above, the second - between meals, 2 hours after or 1 hour before eating, drinking or taking other drugs.

With hypercalcemia, 2400–3200 mg / day in 2 divided doses with a gradual decrease to a maintenance dose of 1600 mg / day; with osteolytic bone changes due to malignant tumors without hypercalcemia - an initial dose of 1600 mg / day, if necessary - up to 3600 mg / day (not more); in patients with signs of renal failure - no more than 1600 mg.

Adverse reactions

From the side of electrolyte balance: asymptomatic hypocalcemia is possible, very rarely - hypocalcemia accompanied by clinical manifestations.
On the part of the gastrointestinal tract: sometimes - nausea, vomiting, diarrhea.
On the part of the endocrine system: it is possible to increase the level of parathyroid hormone in the blood serum, usually accompanied by a decrease in the level of calcium in the serum.
On the part of the liver: an increase in the activity of aminotransferases is possible.
On the part of the kidneys: rarely - an increase in serum creatinine and proteinuria; acute renal failure, which may develop after a quick injection of the drug.
On the part of the skin: occasionally there are skin reactions, according to the clinical picture, corresponding to hypersensitivity reactions.
On the part of the respiratory system: in patients with bronchial asthma, with a hypersensitivity to acetylsalicylic acid in history, possible violations of respiratory function.

Contraindications

Hypersensitivity to clodronic acid, other bisphosphonates, or any components that make up the preparation;
pregnancy;
breastfeeding period;
concomitant therapy with other bisphosphonates;
children's age (there is no clinical experience).

Drug interactions

There is evidence of a relationship between clodronate intake and renal impairment with simultaneous administration of NSAIDs, most commonly diclofenac.
Due to the high probability of hypocalcemia, caution should be exercised in the appointment of clodronate along with aminoglycosides.
It was reported that the simultaneous reception of estramustine phosphate together with clodronate leads to an increase in the concentration of estramustine phosphate in the serum up to 80%.
Clodronate forms poorly soluble complexes with divalent cations, therefore the simultaneous use of food or drugs containing divalent cations, for example, antacid preparations or iron preparations, leads to a significant decrease in the bioavailability of clodronic acid.
Pharmaceutical Interaction
Compatibility of the concentrate for the infusion solution with other drugs or solutions for injection has not been studied. Drug Bonefos should be diluted and administered only in accordance with the recommendations indicated.

Special instructions

Bonefos should not be taken with milk, food, or with preparations containing calcium or other divalent cations, since they all interfere with the absorption of clodronate. The prepared solution for infusion should be used within 12 hours.

Overdosage

Symptoms: with the on / in the introduction of clodronic acid in high doses, an increase in serum creatinine and renal dysfunction was reported.
Treatment: symptomatic therapy. It is necessary to ensure that the patient receives a sufficient amount of fluid, as well as monitor kidney function and the content of calcium in the blood serum.