BONDRONAT FOR INFUSION 1 MG/ML [SIN11206P]

Product Info

BONDRONAT FOR INFUSION 1 MG/ML

[SIN11206P]

3.1 Therapeutic Indications

• Prevention of skeletal events associated with metastatic bone disease due to breast cancer.

• Treatment of pathologically (abnormally) elevated serum calcium levels (hypercalcemia) as a result of tumours.

3.2 Dosage and Method of Administration

Treatment of Metastatic Bone Disease
The recommended dose for metastatic bone disease is 6 mg IV given every 3–4 weeks. The dose should be infused over at least 15 minutes. For infusion, the contents of the ampoule(s)/vials(s) should be added to 100 ml isotonic sodium chloride solution (or 100 ml 5% dextrose solution).

A shorter (i.e 15 min) infusion time should only be used for patients with normal renal function or mild renal impairment. There are no data available characterizing the use of a shorter infusion time in patients with creatinine clearance below 50ml/min. Prescribers should consult the section Patients with renal impairment for recommendations on dosing and administration in this patient group.

Treatment of hypercalcemia
Bondronat concentrate for infusion is usually administered in a hospital setting. The dose is determined by the doctor considering the following factors.

Prior to treatment with Bondronat the patient should be adequately rehydrated with 0.9% sodium chloride. Consideration should be given to the severity of the hypercalcemia as well as the tumour type. In general patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcemia. In most patients with severe hypercalcemia (albumin-corrected serum calcium* 3 mmol/l or 12 mg/dl) 4 mg will be an adequate single dosage. In patients with moderate hypercalcemia (albumin-corrected serum calcium < 3 mmol/l or < 12 mg/dl) 2 mg is an effective dose. The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.

* Note: Albumin-corrected serum calcium (mmol/l) = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 or Albumin-corrected serum calcium (mg/dl) = serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]

To convert the albumin-corrected serum calcium in mmol/L value to mg/dL, multiply by 4.

In most cases a raised serum calcium level can be reduced to the normal range within 7 days.

The median time to relapse (reincrease of serum albumin corrected serum calcium above 3 mmol/l) was 18 – 19 days for the 2 mg and 4 mg doses. The median time to relapse was 26 days with a dose of 6 mg.

A limited number of patients (n=50) have received a second infusion for hypercalcemia.

Repeated treatment may be considered in case of recurrent hypercalcemia or insufficient efficacy.

Bondronat concentrate for infusion should be administered as an intravenous infusion. For this purpose the contents of the ampoules are to be added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over two hours.

Note

In order to avoid potential incompatibilities, Bondronat concentrate for infusion should only be mixed with isotonic sodium chloride solution or with 5% dextrose solution. Calcium containing solutions should not be mixed with Bondronat concentrate for infusion.

As the inadvertent intra-arterial administration of preparations not expressly recommended for this purpose as well as paravenous administration can lead to tissue damage, care must be taken to ensure that Bondronat concentrate for infusion is administered intravenously.

Patients with renal impairment

Concentrate for solution for infusion in patients with Metastatic Bone Disease:
For patients with mild renal impairment (CLcr ≥50 and <80 mL/min) no dosage adjustment is necessary. For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) or severe renal impairment (CLcr <30 mL/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed.

A 15 minute infusion time has not been studied in cancer patients with CLcr <50 mL/min

3.3 Contraindications

Bondronat is contraindicated in patients with:

• Hypocalcemia (see 3.4 Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• known hypersensitivity to ibandronic acid or to any of its excipients. Caution is to be taken in patients with known hypersensitivity to other bisphosphonates.