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IBANDRONIC ACID ACTAVIS 6 MG CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IBANDRONIC ACID

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Package leaflet: Information for the patient
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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What is and what it is used for
2. What you need to know before you receive
3. How to receive
4. Possible side effects
5. How to store
6. Contents of the pack and other information

1

What is and what it is used for
active substance ibandronic acid.> Ibandronic acid belongs to a group of
medicines called bisphosphonates.
Ibandronic acid is used in adults and prescribed to you if you have breast
cancer that has spread to your bones (called ‘bone metastases’).
• It helps to prevent your bones from breaking (fractures).
• It helps to prevent other bone problems that may need surgery or
radiotherapy.
Ibandronic acid can also be prescribed if you have a raised calcium level in
your blood due to a tumour.
Ibandronic acid works by reducing the amount of calcium that is lost from
your bones. This helps to stop your bones from getting weaker.

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

2

What you need to know before you receive mg6mg >
Do not receive
• if you are allergic to ibandronic acid or any of the other ingredients of
this medicine (listed in Section 6)
• if you have, or have ever had low levels of calcium in your blood
Do not receive this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before having ibandronic acid.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving acid 2 mg6mg >
• if you are allergic to any other bisphosphonates
• if you have high or low levels of vitamin D, calcium or any other
minerals
• if you have kidney problems
• if you have heart problems and the doctor recommended to limit your
daily fluid intake
• if you are having dental treatment or surgery or know that you need some
in the future, tell your dentist that you are being treated
with for cancer
Cases of serious, sometimes fatal allergic reaction have been reported in
patients treated with intravenous ibandronic acid.
If you experience one of the following symptoms, such as shortness of
breath/difficulty breathing, tight feeling in throat, swelling of tongue,
dizziness, feeling of loss of consciousness, redness or swelling of face, body
rash, nausea and vomiting, you should immediately alert your doctor or nurse
(see section 4).
Children and adolescents
Ibandronic acid should not be used in children and adolescents below the age
of 18 years.
Other medicines and
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This is because ibandronic acid can affect

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

the way some other medicines work. Also, some other medicines can affect
the way ibandronic acid works.
In particular, tell your doctor or pharmacist if you are receiving a type of
antibiotic injection called ‘aminoglycoside’ such as gentamicin. This is
because aminoglycosides and ibandronic acid can both lower the amount of
calcium in your blood.
Pregnancy and breast-feeding
Do not receive ibandronic acid if you are pregnant, planning to get pregnant
or if you are breast-feeding. Ask your doctor or pharmacist for advice before
taking any medicines.
Driving and using machines
You can drive and use machines as it’s expected that ibandronic acid has no
or negligible effect on your ability to drive and use machines. Talk to your
doctor first if you want to drive, use machines or tools.
contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial,
i.e. ‘essentially sodium free’.

3

How to receive
Receiving this medicine
- Ibandronic acid is normally given by a doctor or other medical staff who
have experience with the treatment of cancer.
- it is given as an infusion into your vein
Your doctor may do regular blood tests while you are receiving ibandronic
acid. This is to check that you are being given the right amount of this
medicine.
How much to receive
Your doctor will work out how much ibandronic acid you will be given
depending on your illness.
If you have breast cancer that has spread to your bones, then the
recommended dose is 3 vials (6 mg) 1 vial (6mg) every 3-4 weeks, as an
infusion in your vein over at least 15 minutes.
If you have a raised calcium level in your blood due to a tumour then the
recommended dose is a single administration of 1 vial (2 mg) or 2 vials (4
mg) 2mg or 4mg, depending on the severity of your illness. The medicine
should be administered as an infusion in your vein over two hours. A

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

repeated dose may be considered in case of insufficient response or if your
illness reappears.
Your doctor may adjust your dose and duration of intravenous infusion if you
have kidney problems.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4

Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Talk to a nurse or a doctor straight away if you notice any of the
following serious side effects - you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)

persistent eye pain and inflammation

new pain, weakness or discomfort in your thigh, hip or groin. You may
have early signs of a possible unusual fracture of the thigh bone
Very rare (may affect up to 1 in 10,000 people)

pain or sore in your mouth or jaw. You may have early signs of severe
jaw problems (necrosis (dead bone tissue) in the jaw bone)

itching, swelling of your face, lips, tongue and throat, with difficulty
breathing. You may be having a serious, potentially life threatening
allergic reaction (see section 2)
Not known (frequency cannot be estimated from the available data)

asthma attack

Other possible side effects
Common (may affect up to 1 in 10 people)

flu-like symptoms, including fever, shaking and shivering, feeling of
discomfort, fatigue, bone pain and aching muscles and joints. These
symptoms usually disappear within a couple of hours or days. Talk to a

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nurse or doctor if any effects become troublesome or last more than a
couple of days
rise in body temperature
stomach and tummy pain, indigestion, being sick, vomiting or having
diarrhea(loose bowels)
low calcium or phosphate levels in your blood
changes in blood test results such as Gamma GT or creatinine
a heart problem called ‘bundle branch block’
pain in your bone or muscles
headache, feeling dizzy or feeling weak
feeling thirsty, sore throat, changes in taste
swollen legs or feet
aching joints, arthritis, or other joint problems
problems with your parathyroid gland
bruising
infections
a problem with your eyes called ‘cataracts’
skin problems
tooth problems

Uncommon (affects less than 1 in 100 people)
• shaking or shivering
• your body temperature getting too low (‘hypothermia’)
• a condition affecting the blood vessels in your brain called
‘cerebrovascular disorder’
• heart and circulatory problems (including palpitations, heart attack,
hypertension and varicose veins)
• changes in your blood cells (‘anaemia’)
• a high level of alkaline phosphatase in your blood
• fluid build up and swelling (‘lymphoedema’)
• fluid in your lungs
• stomach problems such as ‘gastroenteritis’ or ‘gastritis’
• gallstones
• being unable to pass water (urine), cystitis (bladder inflammation)
• migraine
• pain in your nerves, damaged nerve root
• deafness
• increased sensitivity of sound, taste or touch or changes in smell

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Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL














difficulty swallowing
mouth ulcers, swollen lips (‘cheilitis’), oral thrush
itching or tingling skin around your mouth
pelvic pain, discharge, itching or pain in the vagina
a skin growth called a ‘benign skin neoplasm’
memory loss
sleep problems, feeling anxious, emotional instability, or mood swings
skin rash
hair loss
pain or injury at the injection site
weight loss
kidney cyst.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.

5

How to store
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
After dilution the infusion solution is stable for 24 hours at 2-8 °C (in a
refrigerator).
Do not use this medicine after the expiry date which is stated on the folding
box and on the label after EXP. The expiry date refers to the last day of that
month.
Do not use this medicine if you notice that the solution is not clear or
contains particles.
Unused solution should be discarded.

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

6

Contents of the pack and other information
What contains
One vial with 2 ml concentrate for solution for infusion contains 2 mg
ibandronic acid (as 2.25 mg ibandronic acid, monosodium salt,
monohydrate).
One vial with 6 ml of a concentrate for solution for infusion contains 6 mg
ibandronic acid (as 6.75 mg ibandronic acid, monosodium salt,
monohydrate).
One ml concentrate for solution for infusion contains 1 mg ibandronic acid
(as 1.13 mg ibandronic acid, monosodium salt, monohydrate).
The other ingredients are sodium chloride, sodium hydroxide (E524) (for pH
adjustment), acetic acid, glacial (E260), sodium acetate trihydrate and water
for injections.
What looks like and contents of the pack
Ibandronic acid concentrate for solution for infusion is a clear and colourless
solution.
It is available in packs of
1, 3, 5 or 10 clear, colourless glass vials
The vials are closed with a rubber stopper.
2 ml vials have an orange flip-off cap
6 ml vials have a turquoise (greenish blue) flip-off cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
<[To be completed nationally]>
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
Manufacturers:
Synthon BV, Microweg 22, 6545CM Nijmegen, The Netherlands

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Synthon Hispania SL, Castelló 1, Polígono Las Salinas, 08830 Sant Boi de
Llobregat, Spain

To be completed nationally
under the following names:>
<{Name of the Member State}> <{Name of the medicinal product}>
<{Name of the Member State}> <{Name of the medicinal product}>
<…>
This leaflet was last revised in September 2014

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Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

--------------------------------------------------------------------------------------------The following information is intended for medical or healthcare
professionals only
Dosage: 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:
Creatinine Clearance
Dosage / Infusion time 1
Infusion Volume 2
(ml/min)
≥50 CLcr<80
6 mg / 15 minutes
100 ml
≥30 CLcr <50
4 mg / 1 hour
500 ml
<30
2 mg / 1 hour
500 ml
1
Administration every 3 to 4 week
2
0.9% sodium chloride solution or 5% glucose solution
A 15 minute infusion time has not been studied in cancer patients with CLCr
<50 mL/min.
Dosage: Tumour-induced Hypercalcaemia
Ibandronic acid is usually administered in a hospital setting. The dose is
determined by the doctor considering the following factors.
Prior to treatment with ibandronic acid 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 will be 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.

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

* Note albumin-corrected serum calcium concentrations are calculated as
follows:
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) + 0.8 x [4 - albumin
Serum calcium (mg/dl)
(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.
Method and route of administration
Ibandronic acid 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:
• Treatment of tumour induced hypercalcaemia - added to 500 ml isotonic
sodium chloride solution or 500 ml 5% dextrose solution and infused over
2 hours.
• Prevention of Skeletal Events in patients with breast cancer and bone
metastases - added to 100 ml isotonic sodium chloride solution or 100 ml
5% dextrose solution and infused over at least 15 minutes. See also
dosage section above for patients with renal impairment.
Note:
In order to avoid potential incompatibilities, ibandronic acid concentrate for
solution for infusion should only be mixed with isotonic sodium chloride
solution or with 5% dextrose solution. Calcium containing solutions should
not be mixed with ibandronic acid 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 ”).

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

Ibandronic acid concentrate for solution for infusion should be administered
as an intravenous infusion. Care must be taken not to administer ibandronic
acid 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 hypercalcemia, ibandronic acid 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 ibandronic acid 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, ibandronic acid 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 ibandronic acid
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.

Issue date: 03-08-12

Document: M131_03.IBE.sod.mhy.csi.001.06.core.WD

Author: PL

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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