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AstraZeneca

Iasibon
ibandronic acid

Package leaflet: Information for the patient


Iasibon 1 mg concentrate for solution for infusion

ibandronic acid


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What Iasibon looks like and contents of the pack

Iasibon is a colourless, clear solution. Iasibon 1 mg is supplied as pack containing 1 ampoule (2 mL type I glass ampoule).


Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Pharmathen S.A. Dervenakion 6

Pallini 15351

Attiki Greece


Manufacturer Pharmathen S.A. Dervenakion 6

Pallini 15351 Attiki

Greece


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.


België/Belgique/Belgien

Pharmathen S.A.

Tél/Tel: +30 210 66 04 300

Lietuva

Pharmathen S.A.

Tel: +30 210 66 04 300


България

Alvogen Pharma Bulgaria Ltd

Teл.: + 359 2 441 7136

Luxembourg/Luxemburg

Pharmathen S.A.

Tél/Tel: +30 210 66 04 300


Česká republika

Pharmathen S.A.

Tel: +30 210 66 04 300

Magyarország

Pharmathen S.A.

Tel.: +30 210 66 04 300


Danmark

Pharmathen S.A.

Tlf: +30 210 66 04 300

Malta

Pharmathen S.A.

Tel: +30 210 66 04 300

Deutschland

Pharmathen S.A.

Tel: +30 210 66 04 300

Nederland

Pharmathen S.A.

Tel: +30 210 66 04 300


Eesti (Estonia)

Pharmathen S.A.

Tel: +30 210 66 04 300

Norge

Pharmathen S.A.

Tlf: +30 210 66 04 300


Ελλάδα

INNOVIS PHARMA AEBE

Τηλ: +30 210 6664805-806

Österreich

Pharmathen S.A.

Tel: +30 210 66 04 300


España

Pharmathen S.A.

Tel: +30 210 66 04 300

Polska

Pharmathen S.A.

Tel.: +30 210 66 04 300


France

Pharmathen S.A.

Tél: +30 210 66 04 300

Portugal

Pharmathen S.A.

Tel: +30 210 66 04 300


Hrvatska

Pharmathen S.A.

Tel: +30 210 66 04 300

România

Alvogen Romania SRL Tel: +(40) 21 351 0286


Ireland

Pharmathen S.A.

Tel: +30 210 66 04 300

Slovenija

Pharmathen S.A.

Tel: +30 210 66 04 300


Ísland

Alvogen ehf.

Sími: +354 522 2900

Slovenská republika

Pharmathen S.A.

Tel: +30 210 66 04 300


Italia

Pharmathen S.A.

Tel: +30 210 66 04 300

Suomi/Finland

Pharmathen S.A.

Puh/Tel: +30 210 66 04 300


Κύπρος

The Star Medicines Importers Co. Ltd

Τηλ: +357 25371056

Sverige

Pharmathen S.A.

Tel: +30 210 66 04 300


Latvija

Pharmathen S.A.

Tel: +30 210 66 04 300

United Kingdom (Northern Ireland)

Pharmathen S.A.

Tel: +30 210 66 04 300


This leaflet was last revised in


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The following information is intended for healthcare professionals only


Dose: Prevention of skeletal events in patients with breast cancer and bone metastases

The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks. The dose should be infused over at least 15 minutes.


Patients with renal impairment

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:


image

Creatinine Clearance

(mL/min) Dosage Infusion Volume


image

50 CLcr <80 6 mg (6 mL of concentrate for


1 and Time 2

solution for infusion) 100 mL over 15 minutes

≥30 CLcr <50

4 mg (4 mL of concentrate for

solution for infusion) 500 mL over 1 hour

<30

2 mg (2 mL of concentrate for

image

solution for infusion) 500 mL over 1 hour

  1. 0.9% sodium chloride solution or 5% glucose solution

  2. Administration every 3 to 4 week


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


Dose: Treatment of tumour-induced hypercalcaemia

Iasibon is usually administered in a hospital setting. The dose is determined by the doctor considering the following factors.


Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/mL (0.9%) sodium chloride. Consideration should be given to the severity of the hypercalcaemia as well as the tumour type. In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥3 mmol/L or ≥12 mg/dL) 4 mg is an adequate single dosage. In patients with moderate hypercalcaemia (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 concentrations are calculated as follows:


Albumin-corrected Serum calcium (mmol/L)


Albumin-corrected Serum calcium (mg/dL)

= Serum calcium (mmol/L) - [0.02 x albumin (g/L)] + 0.8


or

= 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 (re-increase 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.


Method and route of administration

Iasibon concentrate for solution for infusion should be administered as an intravenous infusion.


For this purpose the contents of the vial are to be used as follows:


Note:

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


Diluted solutions are for single use. Only clear solutions without particles should be used.


It is recommended that the product once diluted be used immediately (see point 5 of this leaflet “How to store Iasibon”).


Iasibon concentrate for solution for infusion should be administered as an intravenous infusion.

Care must be taken not to administer Iasibon concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.


Frequency of administration

For treatment of tumour induced hypercalcaemia, Iasibon concentrate for solution for infusion is generally given as a single infusion.


For the prevention of skeletal events in patients with breast cancer and bone metastases, the Iasibon infusion is repeated at 3-4 week intervals.


Duration of treatment

A limited number of patients (50 patients) have received a second infusion for hypercalcaemia. Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.


For patients with breast cancer and bone metastases, Iasibon infusion should be administered every 3-4 weeks. In clinical trials, therapy has continued for up to 96 weeks.


Overdose

Up to now there is no experience of acute poisoning with Iasibon concentrate for solution for infusion. Since both the kidney and the liver were found to be target organs for toxicity in preclinical studies with high doses, kidney and liver function should be monitored.


Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.