Bonefos is a bone resorption inhibitor used in bone metastases.
Release form and composition
The drug is produced in the form of capsules and coated tablets for oral administration, as well as a concentrate from which a solution is prepared for intravenous administration.
The composition of the capsules Bonefos includes:
- 400 mg disodium clodronate anhydrous;
- Excipients: colloidal silicon dioxide, calcium stearate, lactose monohydrate;
- The composition of the shell: titanium dioxide, gelatin, ferric oxide red and oxide yellow.
Capsules are sold in 10 pcs. in blisters and 100 pcs. in plastic bottles.
The composition of the tablets Bonefos includes:
- 800 mg disodium clodronate anhydrous;
- Auxiliary components: microcrystalline silicized cellulose, stearic acid, croscarmellose sodium and magnesium stearate;
- The composition of the shell: opadray YI-7000, including titanium dioxide, macrogol 400 and hypromellose.
Implemented tablets of 10 pcs. in blister packs packed in cartons.
1 ml of Bonefos solution contains:
- 60 mg of disodium clodronate anhydrous (in one ampoule - 300 mg);
- Auxiliary components: sodium hydroxide and injection water.
A solution of 5 ml in glass ampoules, in 5 pcs. in the cardboard inserts packed into cardboard boxes.
Indications for use
As indicated in the instructions for Bonefos, this drug is intended for the treatment of:
- Osteolytic metastases of malignant tumors in the bones;
- Myeloma (multiple myeloma);
- Hypercalcemia due to malignant tumors.
According to the annotations to the drug, the use of Bonefos contraindicated:
- During pregnancy;
- Breastfeeding women;
- Simultaneously with bisphosphonates;
- In severe renal failure, when the CC is less than 10 ml per minute (at the terminal stage);
- In case of hypersensitivity to disodium clodronate anhydrous, other bisphosphonates or any auxiliary component of the drug.
Prescribe the drug, but with extreme caution, patients who have impaired renal function.
Dosing and Administration
Oral dosage forms are taken orally in the morning on an empty stomach, washed down with plenty of water. In this case, the tablets can be divided into two parts, and the capsules should be swallowed whole.
The daily dosage of the drug, as a rule, is 1600 mg, taken once a day. If Bonefos is shown in a higher dose, it is divided into two doses, while in the morning it is recommended to take a larger portion, and a smaller one should be drunk between meals, 2 hours after breakfast, or 1 hour before lunch.
It is forbidden to take the drug at the same time with food, milk or drugs, which include calcium or other divalent cations, since they interfere with the absorption of clodronic acid.
Bonefos solution is administered intravenously, diluting the concentrate with 500 ml of 5% dextrose solution or 0.9% sodium chloride solution.
Before prescribing the drug and during the period of treatment with this medication, the patient should drink large amounts of liquid. In addition, control of renal function and serum calcium concentration is necessary.
When osteolytic bone changes due to malignant tumors, in the absence of hypercalcemia, the doctor determines individually the dose of Bonefos in each case. The initial daily dosage is typically 1600 mg. Depending on the clinical indications, it can be increased, up to a maximum of 3200 mg.
With hypercalcemia due to malignant neoplasms, Bonefos is administered at 300 mg drip for at least two hours. The duration of treatment is determined by the normalization of the concentration of calcium in the serum, but should not exceed 7 days. It is also possible the option of a single injection of the solution in the amount of 1500 mg for four hours. If necessary, repeat the infusion or transfer the patient to a tablet form of the drug.
If, for some reason, intravenous administration of the medication is not possible for a patient with hypercalcemia, Bonefos is prescribed in the form of tablets in a daily dose of 2400-3200 mg daily. Taking into account the individual reaction to the treatment and the rate of decrease of calcium in the blood, the dosage is gradually reduced to 1600 mg.
The most common adverse event observed with the use of Bonefos is diarrhea. It manifests itself usually in a mild form and most often when prescribing the drug in high doses.
In addition, according to the instructions to Bonefos, during the period of treatment are possible:
- Often (1/100 prescriptions): asymptomatic hypocalcemia, nausea, vomiting, increased transaminases in the normal range;
- Rarely (1/10 000 prescriptions): hypocalcemia, an increase in the concentration of parathyroid hormone and alkaline phosphatase in serum, an increase in transaminases by 2 times, hypersensitivity reactions.
As part of the post-marketing use of Bonephos, the following adverse reactions have been reported:
- Impaired respiratory function, bronchospasm (in patients with hypersensitivity to acetylsalicylic acid, in people with asthma);
- Impaired renal function, severe renal failure;
- Severe pain in bones, joints, muscles.
The structural analogue of Bonfos is Clobir.
According to the mechanism of action, the following drugs can be considered analogs of Bonefos: Aklast, Actonel, Alendronat, Aredia, Blaztera, Bonviva, Bondronat, Veroklast, Zoleriks, Zometa, Xidiphon, Lindron, Ostalon, Ostealen, Ostearpar, Pomegara, Rezoklastin FS, Strongos, Tevon, Ostealen, Ostepar, Pomegara, Resoklastin FS, Strongos, Tevlan, Testalon, Ostearpar, Pomegara, Resoklastin FS, Strongos, Tevolon, Ostealen, Ostepar, Pomegara, Resoklastin FS, Strongos, Tevon , FOSAMAX and others.
Terms and conditions of storage
Bonefos is a prescription drug. According to the manufacturer’s recommendations, it should be stored in a place protected from sunlight, at temperatures up to 25 ºС. If these conditions are met, the shelf life of tablets and capsules is 5 years, the concentrate is 3 years, and the solution prepared from it can be stored for 24 hours at a temperature of 2-8 ° C.