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IBANDRONIC ACID 2MG/2ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): IBANDRONIC ACID

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TEVA UK Ref:

231-30-11775-E LEA IBANDRONIC ACID 2mg/ml & 6mg/ml SOL TEVAH
Version:

2

10 March 2016

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.
Children and adolescents
PACKAGE LEAFLET: INFORMATION FOR THE USER Ibandronic acid should not be used in children and
teenagers below age 18 years.
Other medicines and Ibandronic Acid
Ibandronic Acid 2mg/2ml & 6mg/6ml
Please tell your doctor or pharmacist if you are taking
Concentrate for Solution for Infusion
or have recently taken any other medicines, including
Read all of this leaflet carefully before you start using those obtained without a prescription. This is because
this medicine because it contains important
ibandronic acid can affect the way some other
information for you.
medicines work. Also, some other medicines can affect
• Keep this leaflet. You may need to read it again.
the way ibandronic acid works.
• If you have any further questions, ask your doctor or
In particular, tell your doctor or pharmacist if you are
pharmacist.
receiving a type of antibiotic injection called
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not “aminoglycoside” such as gentamicin. This is because
aminoglycosides and ibandronic acid can both lower the
listed in this leaflet.
amount of calcium in your blood.

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. Contents of the pack and other information

1

What Ibandronic Acid is and what it is
used for

Ibandronic Acid concentrate for solution for infusion
contains the active substance ibandronic acid.
Ibandronic acid belongs to a group of medicines called
bisphosphonates.
Ibandronic acid is indicated 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.

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
It is not known if ibandronic acid affects your ability to
drive, use machines or tools. Talk to your doctor first if
you want to drive, use machines or tools.
Ibandronic Acid Concentrate for Solution for Infusion
contains sodium
This medicinal product 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.
• 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 use
Your doctor will work out how much ibandronic acid
Ibandronic acid works by reducing the amount of
you will be given depending on your illness.
calcium that is lost from your bones. This helps to stop
If you have breast cancer that has spread to your bones,
your bones from getting weaker.
then the recommended dose is 3 vials (6 mg) every 3-4
weeks, as an infusion to your vein over at least 15
you need to know before you
2 What
minutes.
receive Ibandronic Acid
If you have a raised calcium level in your blood due to a
tumour then the recommended dose is a single
Do not receive Ibandronic Acid
administration of 1 vial (2 mg) or 2 vials (4 mg),
if you are allergic (hypersensitive) to ibandronic acid or depending on the severity of your illness. The medicine
any of the other ingredients of this medicine that are
should be administered as an infusion to your vein over
listed in Section 6
two hours. A repeated dose may be considered in case
• if you have, or have ever had low levels of calcium of insufficient response or if your illness reappears.
in your blood.
Your doctor may adjust your dose and duration of
intravenous infusion if you have kidney problems.
Do not receive this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or
If you have any further questions on the use of this
pharmacist before having ibandronic acid.
medicine, ask your doctor or pharmacist.
Warnings and precautions
Take special care with Ibandronic Acid
4 Possible side effects
• if you are allergic (hypersensitive) to any other
Like all medicines, this medicine can cause side effects,
bisphosphonates
although not everybody gets them.
• if you have high or low levels of vitamin D or any
other minerals
Talk to a nurse or a doctor straight away if you notice
• if you have kidney problems.
any of the following serious side effects - you may
need urgent medical treatment:
Talk to your doctor of pharmacist before using
• rash, itching, swelling of your face, lips, tongue and
Ibandronic Acid.
throat, with difficulty breathing. You may be having
an allergic reaction to the medicine

TEVA UK Ref:

231-30-11775-E LEA IBANDRONIC ACID 2mg/ml & 6mg/ml SOL TEVAH





problems breathing.
pain or sore in your mouth or jaw
eye pain and inflammation (if prolonged)
talk to your doctor if you have ear pain, discharge
from the ear, and/or an ear infection. These could be
signs of bone damage in the ear.
Other possible side effects
Very common (affects more than 1 in 10 people)
Rise in body temperature.
Common (affects less than 1 in 10 people)
Stomach pain, indigestion, being sick or having
diarrhoea • 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” • Flu-like symptoms (including fever,
chills, bone pain and aching muscles). These symptoms
usually disappear within a couple of hours or days. •
Pain or stiffness in your 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 • 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 • Hair loss • Pain or injury at
the injection site • Weight loss • Kidney cyst.
Rare (affects less than 1 in 1000 people)
Eye pain or inflammation • Unusual fracture of the
thigh bone particularly in patients on long-term
treatment for osteoporosis may occur rarely. Contact
your doctor if you experience pain, weakness or
discomfort in your thigh, hip or groin as this may be an
early indication of a possible fracture of the thigh bone.
Very rare (affects less than 1 in 10000 people)
A condition involving exposed bone in the mouth called
“osteonecrosis of the jaw”.

5

6

2mg/2ml:
One vial with 2 ml concentrate for solution for infusion
contains 2 mg ibandronic acid (as 2.25 mg ibandronic
acid, monosodium salt, monohydrate).
6mg/6ml:
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 Ibandronic Acid Concentrate for Solution for
Infusion 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
2mg/2ml:
1 clear, colourless glass vial
6mg/6ml:
1 or 5 clear, colourless glass vials
The vials are closed with a rubber stopper. Two ml vials
have an orange flip-off cap while 6 ml vials have a
turquoise (greenish blue) flip-off cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturers:
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143
Blaubeuren, Germany
This leaflet was last revised in March 2016
PL 00289/1757
PL 00289/1758

How to store Ibandronic Acid

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.

Method and route of administration
Ibandronic Acid Concentrate for Solution for Infusion should be administered as an intravenous infusion.

1
2

Dosage / Infusion time 1

•50 CLcr<80
•30 CLcr <50
<30

6 mg / 15 minutes
4 mg / 1 hour
2 mg / 1 hour

Infusion Volume 2
100 ml
500 ml
500 ml

Administration every 3 to 4 week
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 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)

=

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

or
Albumin-corrected
= Serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
Serum calcium (mg/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.

10 March 2016

Contents of the pack and other
information

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.

Creatinine Clearance
(ml/min)

2

What Ibandronic Acid Concentrate for Solution for
Infusion contains

The following information is intended for medical or healthcare professionals only

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:

Version:

11775-E

For this purpose the contents of the vial are to be used as follows:
• Hypercalcaemia - added to 500 ml isotonic sodium chloride solution or 500 ml 5% dextrose solution and infused over
1-2 hours.
• Prevention of Skeletal Events - 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
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.

11775-E

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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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