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ZOLEDRONIC ACID IBIGEN 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID HEMIPENTAHYDRATE

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Zoledronic Acid 4 mg/5 ml
concentrate for solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you are given Zoledronic Acid
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If any of the side effects get serious, or if you notice side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.
In this leaflet
1. What Zoledronic Acid is and what it is used for
2. Before you are given Zoledronic Acid
3. How Zoledronic Acid is used
4. Possible side effects
5. How to store Zoledronic Acid
6. Further information

1. WHAT ZOLEDRONIC ACID IS AND WHAT IT
IS USED FOR
The active substance in this medicine is zoledronic
acid, which belongs to a group of substances called
bisphosphonates. Zoledronic acid works by attaching
itself to the bone and slowing down the rate of bone
change. It is used:
• To prevent bone complications, e.g. fractures, in
adult patients with bone metastases (spread of
cancer from primary site to the bone).
• To reduce the amount of calcium in the blood in
cases where it is too high due to the presence of a
tumour in adult patients. Tumours can accelerate
normal bone change in such a way that the release
of calcium from bone is increased. This condition is
known as tumour-induced hypercalcaemia (TIH).
2. BEFORE YOU ARE GIVEN ZOLEDRONIC ACID
• Follow carefully all instructions given to you by
your doctor.
• Your doctor will carry out blood tests before you
start treatment with Zoledronic Acid and will check
your response to treatment at regular intervals.
You should not be given Zoledronic Acid:
• if you are breast-feeding
• if you are allergic (hypersensitive) to zoledronic
acid, another bisphosphonate (the group of
substances to which Zoledronic Acid belongs), or
any of the other ingredients of this medicine (see
section 6, “Further Information”).
Before you are given Zoledronic Acid, tell your doctor:
• if you have or have had any liver problems
• if you have or have had a kidney problem
• if you have or have had pain, swelling or
numbness of the jaw, a feeling of heaviness in the
jaw or loosening of a tooth
• if you are having dental treatment or are due to
undergo dental surgery, tell your dentist that you
are being treated with Zoledronic Acid.
Using other medicines
Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
It is especially important that you tell your doctor if
you are also taking:
• Aminoglycosides (medicines used to treat severe
infections), since the combination of these with
bisphosphonates may cause the calcium level in
the blood to become too low

• Thalidomide or any other medicines which may
harm your kidneys
• Aclasta (a medicine that also contains zoledronic
acid and is used to treat osteoporosis and other
non-cancer diseases of the bone), or any other
bisphosphonate, since the combined effects of
these medicines taken together with Zoledronic
Acid are unknown.
Patients aged 65 years and over
Zoledronic Acid can be given to people aged 65 years
and over. There is no evidence to suggest that any
extra precautions are needed.
Use in children
Zoledronic Acid is not recommended for use in
adolescents and children below the age of 18 years.
Pregnancy and breast-feeding
You should not be given Zoledronic Acid if you are
pregnant. Tell your doctor if you are or think that you
may be pregnant.
You must not be given Zoledronic Acid if you are
breast-feeding.
Ask your doctor for advice before taking any
medicine while you are pregnant or breast-feeding.
Driving and using machines
The effects of Zoledronic Acid on driving, using
machines and performing other tasks that need your
full attention have not been studied. However,
adverse reactions such as dizziness and somnolence
may affect the ability to drive or use machines,
therefore caution should be exercised with the use of
Zoledronic Acid when driving and operating
machinery or performing other tasks that need full
attention.
3. HOW ZOLEDRONIC ACID IS USED
• Zoledronic Acid must only be given by healthcare
professionals trained in administering
bisphosphonates intravenously, i.e. through a vein
• Your doctor will recommend that you drink enough
water before each treatment to help prevent
dehydration
• Carefully follow all the other instructions
given to you by your doctor, nurse or pharmacist.
How much Zoledronic Acid is given
• The usual single dose given is 4 mg
• If you have a kidney problem, your doctor will give
you a lower dose depending on the severity of your
kidney problem.

How Zoledronic Acid is given
• Zoledronic Acid is given as a drip (infusion) into a
vein which should take at least 15 minutes and
should be administered as a single intravenous
solution in a separate infusion line
• Patients whose blood calcium levels are not too
high will also be prescribed calcium and vitamin D
supplements to be taken each day.
How often you will be given Zoledronic Acid
• If you are being treated for the prevention of bone
complications due to bone metastases, you will be
given one infusion of Zoledronic Acid every three
to four weeks
• If you are being treated to reduce the amount of
calcium in your blood, you will normally only be
given one infusion of Zoledronic Acid.
If you are given more Zoledronic Acid than you
should be
If you have received doses higher than those
recommended, you will be carefully monitored by
your doctor. This is because you may develop
abnormal levels of calcium, phosphorus and
magnesium in your blood and/or changes in kidney
function, including severe kidney problems. If your
level of calcium falls too low, you may have to be
given supplemental calcium by infusion.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zoledronic Acid can cause side
effects, although not everybody gets them. The most
common ones are usually mild and will probably
disappear after a short time.
Tell your doctor about any of the following side
effects as soon as possible:
Very common (may affect more than 1 in 10 people):
• Low level of phosphate in the blood.
Common (may affect up to 1 in 10 people):
• Headache and a flu-like syndrome consisting of
fever, fatigue, weakness, drowsiness, chills and
bone, joint and/or muscle ache. In most cases no
specific treatment is required and the symptoms
disappear after a short time (couple of hours or days)
• Gastrointestinal problems such as nausea and
vomiting as well as loss of appetite
• Conjunctivitis
• Blood tests indicating changes in kidney function
(higher levels of creatinine), including severe
kidney problems. Such changes are also known to
occur with other medicines of this kind. In addition,
some cases of kidney disease have been reported
• Low level of red blood cells (anaemia)
• Low level of calcium in the blood.
Uncommon (may affect up to 1 in 100 people):
• Pain in the mouth, teeth and/or jaw, swelling or
sores inside the mouth, numbness or a feeling of
heaviness in the jaw, or loosening of a tooth. These
could be signs of bone damage in the jaw
(osteonecrosis). Tell your doctor and dentist
immediately if you experience such symptoms
• Hypersensitivity reactions
• Low blood pressure
• Chest pain
• Skin reactions (redness and swelling) at the
infusion site, rash, itching
• High blood pressure, shortness of breath,
dizziness, sleep disturbances, tingling or numbness
of the hands or feet, diarrhoea
• Low counts of white blood cells and blood platelets
• Low level of magnesium and potassium in the
blood. Your doctor will monitor this and take any
necessary measures

• Irregular heart rhythm (atrial fibrillation) has been
seen in patients receiving zoledronic acid for
postmenopausal osteoporosis. It is currently
unclear whether zoledronic acid causes this
irregular heart rhythm but you should report it to
your doctor if you experience such symptoms after
you have received this medicine
• Severe allergic reaction: shortness of breath,
swelling mainly of the face and throat
• Sleepiness
• Weeping of the eye, eye sensitivity to light
• Sudden coldness with fainting, limpness or
collapse
• Difficulty in breathing with wheezing or coughing
• Urticaria (‘nettle rash’).
Rare (may affect up to 1 in 1,000 people):
• Slow heartbeat
• Confusion
• Unusual fracture of the thigh bone particularly in
patients on long-term treatment for osteoporosis.
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 up to 1 in 10,000 people):
• Fainting due to low blood pressure
• Severe bone, joint and/or muscle pain,
occasionally incapacitating
• Painful redness and/or swelling of the eye.
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor, nurse or pharmacist.
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10 a.m.
to 2 p.m. Mondays to Fridays) or fill in a paper form
available from your local pharmacy.

INTERLINEA 12 pt

PACKAGE LEAFLET: INFORMATION FOR THE USER

5. HOW TO STORE ZOLEDRONIC ACID
Your doctor, nurse or pharmacist knows how to store
Zoledronic Acid properly (see section 6).
6. FURTHER INFORMATION
What Zoledronic Acid contains
• The active substance is zoledronic acid.
• One vial contains 4 mg zoledronic acid
corresponding to 4.66 mg zoledronic acid
hemipentahydrate.
• The other ingredients are mannitol, sodium citrate,
water for injection.
What Zoledronic Acid looks like and contents of the
pack
Zoledronic Acid is supplied as a liquid concentrate in
a vial. One vial contains 4 mg of zoledronic acid. Each
pack contains the vial with concentrate.
Zoledronic Acid is supplied as packs containing 1 vial.
Marketing Authorisation Holder
Ibigen S.r.l.
Via Fossignano, 2 - 04011 – Aprilia (LT) - Italy
Manufacturer
Istituto Biochimico Italiano S.p.A.
Via Fossignano, 2 - 04011 – Aprilia (LT) - Italy
Date of last revision 02/2013

How to prepare and administer Zoledronic Acid

Instructions for preparing reduced doses of

To prepare an infusion solution containing

Zoledronic Acid:

4 mg Zoledronic Acid, further dilute the Zoledronic

Withdraw the appropriate volume of the liquid

Acid concentrate (5.0 ml) with 100 ml of calcium-free

concentrate, as follows:

or other divalent cation-free infusion solution. If a

- 4.4 ml for 3.5 mg dose

lower dose of Zoledronic acid is required, first

- 4.1 ml for 3.3 mg dose

a single 15-minute intravenous infusion.

withdraw the appropriate volume as indicated below

- 3.8 ml for 3.0 mg dose

The hydration status of patients must be assessed

and then dilute it further with 100 ml of infusion
solution. To avoid potential incompatibilities, the

prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2°C
– 8°C, unless dilution has taken place in controlled
and validated aseptic conditions.
• The solution containing Zoledronic Acid is given as

• Studies with glass bottles, several types of infusion

w/v sodium chloride or 5% w/v glucose solution.

and discolouration should be used.
preparation of the infusion.
• From a microbiological point of view, the product

containing solutions such as lactated Ringer’s

should preferably be used immediately. If not used

solution.

immediately, in-use storage times and conditions

be mixed with other medications/substances and
should always be given through a separate
infusion line.

• Keep Zoledronic Acid out of the reach and sight of

Acid to ensure that they are adequately hydrated.

discarded. Only clear solution free from particles

calcium-containing or other divalent cation

administered substances, Zoledronic Acid must not

How to store Zoledronic Acid

• For single use only. Any unused solution should be

Do not mix Zoledronic Acid concentrate with

Zoledronic Acid with other intravenously

prior to and following administration of Zoledronic

infusion solution used for dilution must be either 0.9%

• Aseptic techniques must be followed during the

• Since no data are available on the compatibility of

bags and infusion lines made from
polyvinylchloride, polyethylene and polypropylene
(prefilled with 0.9% w/v sodium chloride solution or

children.
• Do not use Zoledronic Acid after the expiry date
stated on the pack.
• After dilution: The diluted solution for infusion

5% w/v glucose solution) showed no

should be used immediately. If not used

incompatibility with Zoledronic Acid.

immediately, in-use storage times and conditions
prior to use are the responsibility of the user.

INTERLINEA 15 pt

INTERLINEA 15 pt

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

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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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