Skip to Content

UK Edition. Click here for US version.

ZOLEDRONIC ACID DR. REDDYS 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 Zoledronic acid 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 of the side effects talk to your doctor, nurse or pharmacist. This includes any possible side effects not
listed in this leaflet.
In this leaflet
1. What Zoledronic acid is and what it is used for
2. What you need to know before you use 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

• 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.

1. What Zoledronic acid is and what it is used for
The active substance in Zoledronic acid concentrate 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).

Use in children and adolescents
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
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.

2. What you need to know before you use
Zoledronic acid
Follow carefully all instructions given to you by your
doctor.

Zoledronic acid concentrate contains sodium
This medicine contains less than 1 mmol sodium (23
mg) per dose, i.e. essentially ‘sodium- free’.

Your doctor will carry out blood tests before you start
treatment with Zoledronic acid and will check your
response to treatment at regular intervals.

3. How to use Zoledronic acid


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 in 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.

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.

infusion line.

other medications/substances and should always be given through a separate

intravenously administered substances, Zoledronic acid must not be mixed with

with zoledronic acid.

Since no data are available on the compatibility of Zoledronic acid with other


sodium chloride solution or 5% w/v glucose solution) showed no incompatibility

Studies with glass bottles, several types of infusion bags and infusion lines made

from polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/v

The solution containing Zoledronic acid is given as a single 15-minute


hydrated.

For information on storage conditions see section “How to store Zoledronic acid




3.8 ml for 3.0 mg dose


and following administration of Zoledronic acid to ensure that they are adequately

4.1 ml for 3.3 mg dose


intravenous infusion. The hydration status of patients must be assessed prior to

4.4 ml for 3.5 mg dose


Withdraw the appropriate volume of the liquid concentrate, as follows:

Instructions for preparing reduced doses of Zoledronic acid:

cation-containing solutions such as lactated Ringer’s solution.

Common:
• 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:
• Hypersensitivity reactions.
• Low blood pressure.
• Chest pain.
• Skin reactions (redness and swelling) at the
infusion site, rash, itching.

If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.
5. How to store Zoledronic acid
Your doctor, nurse or pharmacist knows how to store
Zoledronic acid properly (see section 6).
• Keep this medicine out of sight and reach of
children.
• Do not use Zoledronic acid after the expiry date
which is stated on the carton and bottle after EXP.
Storage of the bottle:
• The unopened bottle does not require any special
storage conditions.
Storage after aseptic dilution:
• After aseptic dilution, it is preferable to use the
diluted product immediately. If not used
immediately, the duration and conditions of
storage prior to use are the user’s responsibility.
The total time between dilution, storage in a
refrigerator at 2°C – 8°C and end of
administration must not exceed 24 hours.
6. Contents of the pack and other information
What Zoledronic acid concentrate contains
• The active substance of Zoledronic acid
concentrate is zoledronic acid. One vial with 5 ml
concentrate contains 4 mg zoledronic acid
(anhydrous). One ml concentrate contains
zoledronic acid (as monohydrate) corresponding to
0.8 mg zoledronic acid (anhydrous).
• The other ingredients are: mannitol, sodium
citrate, water for injections.
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, 4, 5
or 10 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, HU17 0LD, United Kingdom
This leaflet was last revised in 08/2012

Keep this medicine out of sight and reach of children.

glucose solution.

Very common:
• Low level of phosphate in the blood.

Very rare:
• Fainting due to low blood pressure.
• Severe bone, joint and/or muscle pain,
occasionally incapacitating.
• Painful redness and/or swelling of the eye.

How to store Zoledronic acid

Do not mix Zoledronic acid concentrate with calcium-containing or other divalent

Tell your doctor about any of the following side
effects as soon as possible:

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.

Do not use Zoledronic acid after the expiry date stated on the pack.

solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v

Uncommon:
• 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.

Rare:
• Slow heart beat.
• Confusion.
• Unusual fracture of the thigh bone particularly in



100 ml of infusion solution. To avoid potential incompatibilities, the infusion

Common:
• Severe kidney impairment (will normally be
determined by your doctor with certain specific
blood tests).
• Low level of calcium in the blood.




The readily prepared Zoledronic acid infusion solution should preferably be used

withdraw the appropriate volume as indicated below and then dilute it further with

Tell your doctor about any of the following side
effects straight away:







cation-free infusion solution. If a lower dose of Zoledronic acid is required, first

The frequency of possible side effects listed below is
defined using the following convention:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from
the available data.





Zoledronic acid concentrate (5.0 ml) with 100 ml of calcium-free or other divalent

Patients whose blood calcium levels are not too high
will also be prescribed calcium and vitamin D
supplements to be taken each day.

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.



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.

immediately. If the solution is not used immediately, storage prior to use is the

How to prepare and administer Zoledronic acid

To prepare an infusion solution containing 4 mg Zoledronic acid, further dilute the

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.

4. Possible side effects



responsibility of the user and should be in a refrigerator at 2°C – 8°C.
The total time between dilution, storage in the refrigerator and end of administration must
not exceed 24 hours.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

Other medicines and Zoledronic acid
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 (a medicine used to treat a certain
type of blood cancer involving the bone) or any
other medicines which may harm your kidneys

The following information is intended for healthcare professionals only:

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.

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.

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