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IBANDRONATE SIGA 2 MG CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE

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B. PACKAGE LEAFLET

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Package leaflet: Information for the patient
[Ibandronic Acid] 1mg/1ml Concentrate for Solution for Infusion
[Ibandronic Acid] 2mg/2ml Concentrate for Solution for Infusion
[Ibandronic Acid] 6mg/6ml 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 or your pharmacist.

If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What [Ibandronic Acid] is and what it is used for
2.
What you need to know before you receive [Ibandronic Acid]
3.
How to receive [Ibandronic Acid]
4.
Possible side effects
5.
How to store [Ibandronic Acid]
6.
Content of the pack and other information

1.

What [Ibandronic Acid] is and what it is used for

[Ibandronic Acid] contains the active substance ibandronic acid. This belongs to the 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 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.

2.

What you need to know before you receive [Ibandronic Acid]

Do not use [Ibandronic Acid]:

if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are 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 applies to you. If you are not sure, talk to your doctor or
pharmacist before having [Ibandronic acid].
Warnings and precautions:

if you are allergic to any other bisphosphonates

if you have high or low levels of vitamin D, calcium or any other minerals

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if you have kidney problems
If you have heart problems and the doctor recommended to limit your daily fluid intake

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before receiving
[Ibandronic acid].
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 [Ibandronic acid].
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 no be used in children and adolescents below age 18 years.
Other medicines and [Ibandronic acid]:
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 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 this medicine.
Driving and using machines:
You can drive and use machines as it’s expected that [Ibandronic Acid] has no or negligible effect your
ability to drive and use machines or tools. Talk to your doctor first if you want to drive, use machines or
tools.
[Ibandronic Acid] contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free’.

3. How to receive [Ibandronic Acid]
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, than the recommended dose is 6 ampoules (6
mg)every 3-4 weeks, as an infusion to your vein over at least 15 minutes.
If you have a raised calcium level in your blood due to a tumour than the recommended dose is a single
administration of 2 ampoules (2 mg) or 4 ampoules (4 mg), depending on the severity of your illness.

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If you have breast cancer that has spread to your bones, than the recommended dose is 3 ampoules (6 mg)
every 3-4 weeks, as an infusion to your vein over at least 15 minutes.
If you have a raised calcium level in your blood due to a tumour than the recommended dose is a single
administration of 1 ampoules (2 mg) or 2 ampoules (4 mg), depending on the severity of your illness.
If you have breast cancer that has spread to your bones, than the recommended dose is 1 vial (6 mg) every
3-4 weeks, as an infusion to your vein over at least 15 minutes.
If you have a raised calcium level in your blood due to a tumour than the recommended dose is a single
administration of 2 mg or 4 mg, depending on the severity of your illness.
The medicine should be administered as an infusion to your vein over two hours. A 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:
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 nurse or doctor if any effects become troublesome or last more than a couple of days.
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)
Other possible side effects
Common (may affect up to 1 in 10 people)

rise in body temperature.

stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)

low calcium or phosphate levels in your blood

changes in blood test results such as Gamma GT or creatinine

a heart rhythm 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

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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 (may affect 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” .(stroke
or brain bleeding)

heart and circulatory problems (including palpitations, heart attack, hypertension (high blood
pressure) 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

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

injury or pain at the injection site

weight loss

kidney cyst (fluid-filled sac in the kidney)
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 national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How to store [Ibandronic acid]



Keep this medicine out of the sight and reach of children.
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.

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6.

After dilution the infusion solution is stable for 24 hours at 2-8 oC (in a refrigerator).
Do not use this medicine if you notice that the solution is not clear or contains particles.

Content of the pack and other information

What [Ibandronic Acid] contains

The active substance is ibandronic acid.
One ampoule with 1ml concentrate for solution for infusion contains 1mg ibandronic acid (as sodium
monohydrate).
One ampoule with 2ml concentrate for solution for infusion contains 2mg ibandronic acid (as sodium
monohydrate).
One ampoule with 6ml concentrate for solution for infusion contains 6mg ibandronic acid (as sodium
monohydrate).


The other ingredients are sodium chloride, glacial acetic acid, sodium acetate trihydrate and water
for injections.

What [Ibandronic Acid] looks like and contents of the pack
[Ibandronic Acid] is a colourless, clear solution.
[Ibandronic Acid] 1ml is supplied as pack containing 1 ampoule (2ml type I transparent glass ampoule ).
[Ibandronic Acid] 2ml is supplied as pack containing 1 ampoule (4ml type I transparent glass ampoule ).
[Ibandronic Acid] 6ml is supplied as pack containing 1, 5 and 10 vials (9ml type I clear glass vial) sealed
with a bromobutyl rubber stopper and aluminium flip 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}>
Manufacturer
Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki Hellas
Pharmathen International S.A., Dervenakion 4, Pallini 15351, Attiki Hellas
The medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in {MM/YYYY}
--------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only
Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases

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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 (CLc r≥ 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 recommendations should be followed:
Creatine Clearance (mL/min)
Dosage/Infusion time1
≥ 50 CLcr<80
6mg/ 15 minutes
≥30 CLcr<50
4mg/ 1 hour
<30
2mg/ 1 hour
1
Administration every 3 to 4 week
2
0.9% sodium chloride solution or 5% glucose solution

Infusion Volume2
100 ml
500ml
500ml

A 15 minute infusion time has not been studied in cancer patients with CLcr <50 mL/min.
Dosage: Treatment of Tumour-induced Hypercalcemia
[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.
* Note albumin-corrected serum calcium concentrations are calculated as follows:
Albumin-corrected serum
calcium (mmol/l)
Albumin-corrected serum
calcium (mg/dl)

=
Or
=

Serum calcium (mmol/l) –
[0.02 x albumin (g/l)] + 0.8
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.
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:


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.

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Treatment of tumour-induced hypercalcaemia - added to 500 ml isotonic sodium chloride solution
or 500 ml 5% dextrose solution and infused over 2 hours.

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 [Ibandronic Acid]”).
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
[Ibandronic Acid] concentrate for solution for infusion is administered intravenously.
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.

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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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