Skip to Content

UK Edition. Click here for US version.

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

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Zoledronic acid 4 mg/5 ml concentrate for solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you are given 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.
What is in this leaflet
1. What Zoledronic acid is and what it is used for
2. What you need to know before you are given Zoledronic acid
3. How Zoledronic acid is used
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other information
1. What Zoledronic acid is and what it is used for
The active substance in Zoledronic acid 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 adult patients where it is too high due to
the presence of a tumour. 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. What you need to know 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 to zoledronic acid, another bisphosphonate (the group of substances to
which Zoledronic acid belongs), or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Before you are given Zoledronic acid, tell your doctor:
 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.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps,
dry skin, burning sensation, have been reported in patients treated with Zometa. Irregular heart
beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as
secondary to severe hypocalcaemia. In some instances the hypocalcaemia may be lifethreatening. If any of these apply to you, tell your doctor straight away.
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.
Children and adolescents
Zoledronic acid is not recommended for use in adolescents and children below the age of 18
years.
Other medicines and Zoledronic acid
Tell your doctor if you are taking, have recently taken or might take any other medicines. 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 (a medicine used to treat a certain type of blood cancer involving the bone) or
any other medicines which may harm your kidneys.
 Other medicines that also contain zoledronic acid and are 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.
 Anti-angiogenic medicines (used to treat cancer), since the combination of these with
zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw
(ONJ).
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

There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic acid.
You should therefore be careful when driving, using machinery or performing other tasks that
need full attention.
Zoledronic acid contains sodium
This medicine contains less than 1 mmol sodium (as sodium citrate anhydrous) per dose of
Zoledronic acid, being essentially sodium free.
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, pharmacist or nurse.

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 often Zoledronic acid is given
 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.
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.
If you are given more Zoledronic acid than you should be
If you have received doses higher than those recommended, you must be carefully monitored by
your doctor. This is because you may develop serum electrolyte abnormalities (e.g. abnormal
levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including
severe kidney impairment. 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, this medicine 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 serious side effects straight away:
Common (may affect up to 1 in 10 people):
 Severe kidney impairment (will normally be determined by your doctor with certain specific
blood tests).
 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.
 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 zoledronic acid.
 Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Very rare (may affect up to 1 in 10,000 people):
 As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary
to hypocalcaemia), seizures, numbness and tetany (secondary to hypocalcaemia).
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 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 reactions such as nausea and vomiting as well as loss of appetite.
 Conjunctivitis.
 Low level of red blood cells (anaemia).
Uncommon (may affect up to 1 in 100 people):
 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.
Sleepiness.
Tearing of the eye, eye sensitivity to light.
Sudden coldness with fainting, limpness or collapse.
Difficulty in breathing with wheezing or coughing.
Urticaria.

Rare (may affect up to 1 in 1,000 people):
 Slow heart beat.
 Confusion.
 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.
 Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
5.

How to store Zoledronic acid

Your doctor, pharmacist or nurse knows how to store Zoledronic acid properly (see section 6).
6. Contents of the pack and other information
What Zoledronic acid contains
 The active substance of Zoledronic acid is zoledronic acid. One vial contains 4 mg
zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
 The other ingredients are: Sodium citrate (E331), mannitol (E421) and water for injections.
What Zoledronic acid looks like and contents of the pack
Zoledronic acid is clear, colourless solution filled into colourless glass vial with rubber stopper
and aluminium seal.
It is available in packs containing 1, 4 or 10 vials. Each vial contains 5 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
Manufacturer
Agila Specialties Polska Sp.z.o.o.
10, Daniszewska Str
03-230 Warsaw
Poland
The leaflet was last revised in September 2014
-----------------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or healthcare professionals only
How to prepare and administer Zoledronic acid To prepare an infusion solution containing 4
mg zoledronic acid, further dilute the Zoledronic acid concentrate (5.0 ml) with 100 ml of
calcium-free or other divalent cation-free infusion solution. If a lower dose of Zoledronic acid is
required, first withdraw the appropriate volume as indicated below and then dilute it further with
100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for
dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Do not mix Zoledronic acid concentrate with calcium-containing or other divalent cationcontaining solutions such as lactated Ringer’s solution.
Instructions for preparing reduced doses of Zoledronic acid:
Withdraw the appropriate volume of the liquid concentrate, as follows:
 4.4 ml for 3.5 mg dose
 4.1 ml for 3.3 mg dose
 3.8 ml for 3.0 mg dose


For single use only. Any unused solution should be discarded. Only clear solution free from
particles and discolouration should be used. Aseptic techniques must be followed during the
preparation of the infusion.



From a microbiological point of view, the diluted solution for infusion 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 at 2°C – 8°C.
The refrigerated solution should then be equilibrated to room temperature prior to
administration.



The solution containing zoledronic acid is given as a single 15-minute intravenous infusion
in a separate infusion line. The hydration status of patients must be assessed prior to and
following administration of Zoledronic acid to ensure that they are adequately hydrated.



Studies with several types of infusion lines made from polyvinylchloride, polyethylene and
polypropylene showed no incompatibility with Zoledronic acid.



Since no data are available on the compatibility of Zoledronic acid with other intravenously
administered substances, Zoledronic acid must not be mixed with other
medications/substances and should always be given through a separate infusion line.

How to store Zoledronic acid
 Keep Zoledronic acid out of the sight and reach of children.
 Do not use Zoledronic acid after the expiry date stated on the pack.
 The unopened vial does not require any specific storage conditions.
 The diluted Zoledronic acid infusion solution should be used immediately in order to avoid
microbial contamination.

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