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

Active substance(s): ZOLEDRONIC ACID

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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.

Package leaflet: Information for the user

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.

Zoledronic acid 4 mg/5 ml concentrate for solution for infusion
zoledronic acid

You must not be given Zoledronic acid if you are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.

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, nurse or pharmacist.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.

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 medical product contains less than 0.26 mmol sodium (6 mg) per dose, i.e. essentially “sodium-free”.

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 to use Zoledronic acid
4. Possible side effects
5. How to store Zoledronic acid
6. Contents of the pack and other information

3. How to use Zoledronic acid
- 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 recommended 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.

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).

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.
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.

2. What you need to know before you are given Zoledronic acid

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.

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, any other bisphosphonate (the group of substances to which Zoledronic acid belongs), or
any of the other ingredients of this medicine (listed in section 6).

4. Possible side effects

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.

Storage after dilution
- Chemical and physical in-use stability has been demonstrated
for 24 hours at 2°C-8°C after further dilution in 100 ml
physiological saline or 5% w/v glucose solution.

Storage of the original concentrate
- 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.

How to store 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.

- Studies with glass bottles, several types of infusion bags and
infusion lines made from polyvinylchloride, polyethylene and
polypropylene (prefilled with 0.9% w/v sodium chloride solution
or 5% w/v glucose solution) showed no incompatibility with
Zoledronic acid .

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)

- 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.

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

Do not mix Zoledronic acid concentrate with calcium-containing
or other divalent cation-containing solutions such as lactated
Ringer's solution.

- 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.

How to prepare and administer Zoledronic acid

Please see the Summary of Product Characteristics for more
information.

INFORMATION FOR THE HEALTHCARE PROFESSIONALS

The following information is intended for healthcare
professionals only:

Zoledronic acid

Zoledronic acid 4 mg/5 ml concentrate for
solution for infusion

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 containing zoledronic acid (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).

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.

- 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.

Warnings and precautions
Talk to your doctor before you are given Zoledronic acid
- 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 . if you have reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning
sensation, have been reported in patients treated with zoledronic acid. 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
life-threatening. If any of these apply to you, tell your doctor straight away.

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Follow carefully all instructions given to you by your doctor.

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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 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, disturbed sleep, 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
- Watering eyes, eye sensitivity to light
- Sudden coldness with fainting, limpness or collapse
- Difficulty in breathing with wheezing or coughing
- Urticaria.

6. Contents of the pack and other information
What Zoledronic acid contains
- The active substance is zoledronic acid. Each vial contains 4 mg of zoledronic acid (as monohydrate), corresponding to 4.264 mg
zoledronic acid monohydrate.
- The other ingredients are: mannitol (E421), sodium citrate (E331), water for injections.
What Zoledronic acid looks like and contents of the pack
Zoledronic acid concentrate for solution for infusion is a clear, colourless, sterile solution.
Zoledronic acid concentrate 5 ml vial is packed into cartons of 1, 4 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

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).
- Flu-like symptoms including arthritis and joint swelling.
Very rare (may affectup 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.

This medicinal product is authorised in the Member states of the EEA under the following names
Denmark:
Zoledronsyre SUN 4 mg/5 ml koncentrat till infusionsvæske, opløsning
Finland:
Tsoledronihappo SUN 4 mg/5 ml infuusiokonsentraatti, liuosta varten
France:
Acide zolédronique SUN 4 mg/5 ml solution à diluer pour perfusion
Germany:
Zoledronsäure SUN 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
Italy:
Acido Zoledronico SUN 4 mg/5 ml concentrato per soluzione per infusione
The Netherlands:
Zoledroninezuur SUN 4 mg/5 ml concentraat voor oplossing voor infusie
Norway:
Zoledronsyre SUN 4 mg/5 ml konsentrat til infusjonsvæske, oppløsning
Spain:
Ácido zoledrónico SUN 4 mg/5 ml concentrado para solución para perfusión EFG
Sweden:
Zoledronsyra SUN 4 mg/5 ml koncentrat till infusionsvätska, lösning
United Kingdom:
Zoledronic acid SUN 4 mg/5 ml concentrate for solution for infusion
This leaflet was last revised in 06/2014

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 Yellow Card www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zoledronic acid

Do not use this medicine after the expiry date which is stated on the vial and carton box after EXP: The expiry date refers to the last
day of that month.

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

This medicine does not require any special storage conditions.
After dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C after further dilution in 100 ml physiological
saline or 5% w/v glucose solution.
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 at 2-8°C unless dilution has taken place in controlled and validated aseptic conditions. The refrigerated solution
should then be equilibrated to room temperature prior to administration.
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Do not use this medicine if you notice that the visual appearance has changed (only clear solution should be used).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

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 unless dilution has taken place in
controlled and validated aseptic conditions. The refrigerated
solution should then be equilibrated to room temperature prior
to administration.

The diluted Zoledronic acid infusion solution should be used
immediately in order to avoid microbial contamination.

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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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