IBANDRONIC ACID SANDOZ 6 MG CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: SODIUM IBANDRONATE MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibandronic acid Sandoz 2 mg concentrate for solution for infusion
Ibandronic acid Sandoz 6 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.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, nurse or pharmacist.
 If you get any effects, talk to your doctor, nurse or pharmacist. This includes any possible
side effects not listed in this leaflet.

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 contains the active substance ibandronic acid. This belongs to the 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.
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 receive Ibandronic acid
 if you are allergic (hypersensitive) 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 nurse
before having Ibandronic acid.
Warnings and precautions
Talk to your doctor or nurse before receiving Ibandronic acid
 if you are allergic (hypersensitive) to any other bisphosphonates
 if you have high or low levels of vitamin D or any other minerals

if you have kidney problems.
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
Ibandronic acid should not be used in children and teenagers below age 18 years.

Other medicines and Ibandronic acid
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines,
including medicines obtained without a prescription.. 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 any medicine.
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule (vial for 6 mg), 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 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 mg (3 vials of 2 mg & 1
vial of 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 (1 vial of 2 mg) or 4 mg (2 vials of 2 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:
rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having
an allergic reaction to the medicine
problems breathing.
pain or sore in your mouth or jaw
eye pain and inflammation (if prolonged).

Other possible side effects

Very common (may affect more than 1 in 10 people)























rise in body temperature.
Common (may affect 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 (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”
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 (may affect 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 (may affect less than 1 in 10000 people)
a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any side effects not
listed in this leaflet.

5.

HOW TO STORE IBANDRONIC ACID
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use Ibandronic acid 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. .
Chemical and physical in-use stability on dilution in sodium chloride solution (0.9%) and dextrose
solution (5%) solutions has been demonstrated for 48 hours in a refrigerator (2°C - 8°C).
From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours in a refrigerator (2°C - 8°C), unless dilution has taken
place in controlled and validated aseptic conditions.

Do not use Ibandronic acid if you notice that the solution is not clear or contains particles.
Unused solution should be discarded.

6.

FURTHER INFORMATION
What Ibandronic acid contains
Ibandronic acid Sandoz 2 mg concentrate for solution for infusion:
The active substance is ibandronic acid. One ampoule with 2 ml concentrate for solution for infusion
contains 2 mg ibandronic acid (as 2.25 mg ibandronic acid, monosodium salt, monohydrate).
Ibandronic acid Sandoz 6 mg concentrate for solution for infusion:
The active substance is ibandronic acid. One vial with 6 ml concentrate for solution for infusion
contains 6 mg ibandronic acid (as 6,75 mg ibandronic acid, monosodium salt, monohydrate).


The other ingredients are citric acid, monohydrate, sodium chloride, sodium hydroxide for pH
adjustment, hydrochloric acid for pH adjustment, water for injections.

What Ibandronic acid looks like and contents of the pack
Ibandronic acid is a colourless, clear solution.
Ibandronic acid Sandoz 2 mg concentrate for solution for infusion is supplied as packs containing 1, 3,
5 and 10 ampoules (2 ml type I glass ampoule).
Ibandronic acid Sandoz 6 mg concentrate for solution for infusion:
1 vial with 6 ml concentrate for solution for infusion (type I glass vial) closed with bromobutyl rubber
stoppers and sealed with aluminium caps provided with polyethylene flip cap.
Pack sizes:
1, 3, 5 and 10 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation
Sandoz Ltd
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
United Kingdom
Manufacturer
Sirton Pharmaceuticals S.P.A., Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italy or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or

LEK Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia

This leaflet was last revised in 03/2012.

------------------------------------------------------------------------------------------------------------------------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
(ml/min)
≥50

6 mg / 15 minutes

100 ml

6 mg / 1 hour

500 ml

<30
2

Infusion Volume 2

30 CLcr <50

1

Dosage / Infusion time 1

2 mg / 1 hour

500 ml

Administration every 3 to 4 week
0.9% sodium chloride solution or 5% dextrose 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)

=

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:



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.

Expand view ⇕

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.

Hide
(web1)