Details for: ZOLEDRONIC ACID FOR INJECTION CONCENTRATE
Company: DR REDDY'S LABORATORIES LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02422425 | ZOLEDRONIC ACID FOR INJECTION CONCENTRATE | ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) | 4 MG / 5 ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Zoledronic acid for injection concentrate is used to:
- reduce the abnormal amount of calcium in the blood for example, in the presence of a tumour. This is because 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.
- prevent or delay skeletal complications for example, fractures of the bone and bone pain requiring surgery or radiotherapy, as a result of bone metastases (cancer that has spread from the tumour to the bone) due to different types of tumours.
What it does
Zoledronic acid for injection concentrate is a member of a group of substances called bisphosphonates. These strongly bind to the bone and slow down the rate of bone change. In addition, zoledronic acid for injection concentrate may prevent bone destruction and uncontrolled bone growth associated with the tumour spreading to the bone.
When it should not be used
You should not be given zoledronic acid for injection concentrate if you are:
- pregnant
- breastfeeding
- allergic to zoledronic acid, other bisphosphonates (the group of substances to which zoledronic acid for injection concentrate belongs) or to any other non medicinal ingredients in zoledronic acid for injection concentrate.
- hypocalcaemic (have low calcium levels in your blood)
What the medicinal ingredient is
Zoledronic acid monohydrate
What the non-medicinal ingredients are
Mannitol and Sodium citrate dihydrate and water for injection
What dosage form it comes in
Zoledronic acid for injection is available as a concentrate in vials.
Each vial of zoledronic acid for injection concentrate delivers 4 mg
of zoledronic acid. It is available in cartons containing 1 vial.
Warnings and precautions
Serious Warnings and Precautions
Serious side effects which have been reported with the use of Zoledronic Acid For Injection include:
- osteonecrosis of the jaw (a severe bone disease that affects the jaw)
- deterioration in renal dysfunction. Zoledronic acid for injection concentrate is not recommended in patients with severe kidney impairment.
- hypocalcaemia (low calcium levels in your blood)
If you are being treated with zoledronic acid for injection
concentrate, you should not be treated with another intravenous
form of zoledronic acid or other bisphosphonates (e.g. alendronate,
risedronate, clodronate, etidronate and pamidronate) at the same
time.
Your doctor may request an oral examination (an examination of
your mouth and teetch) before you start treatment and while you are
on treatment with zoledronic acid for injection concentrate. This
may be required since some patients have experienced serious side
effects following dental procedures (such as tooth extraction) while
on zoledronic acid for injection; as well since patients with
unhealed open wounds in the mouth, dental infections or
periodontal disease (disease affecting the surrounding tissues of a
tooth) may be at increased risk of problems with their jaw bones
following dental procedures (such as tooth extraction) while on
treatment with zoledronic acid for injection.
You should avoid invasive dental procedures during your treatment
with zoledronic acid for injection concentrate It is important that
you practice good dental hygiene, routine dental care, and have
regular dental checkups while being treated with zoledronic acid
for injection concentrate. Immediately report any oral symptoms
(any symptoms in your mouth), such as loosening of a tooth, pain,
swelling, or non-healing of sores or discharge (pus or oozing)
during your treatment with zoledronic acid for injection
concentrate.
BEFORE you use zoledronic acid for injection concentrate talk
to your doctor or pharmacist if you:
- Have a kidney problem. Worsening of kidney function, including kidney failure (very rarely with fatal outcome), has been reported with the use of zoledronic acid for injection.
- Have asthma and are also allergic to acetylsalicylic acid (ASA).
- Had or have a heart problem. Cases of irregular heart beat (atrial fibrillation) have been observed with the use of zoledronic acid for injection.
- Have any dental problems or any dental procedures planned in the future.
- Have pain, swelling or numbness of the jaw, a “heavy jaw feeling”, loosening of a tooth, or any other symptoms in your mouth.
- Have sores in your mouth. This can lead to osteonecrosis of the
jaw. Your doctor may check if you:
- smoke
- have or have had tooth and/or gum disease
- have dentures that do not fit well
- have other medical conditions at the same time,
Your doctor may tell you to stop taking zoledronic acid for injection concentrate until all sores in your mouth are healed.
After starting treatment with zoledronic acid for injection concentrate
It is important that your doctor checks your progress at regular intervals. He or she may want to take repeated blood tests, especially after starting your treatment with zoledronic acid for injection concentrate.If possible, you should not undergo tooth extraction or any other dental procedures (excluding regular dental cleaning) while you are receiving treatment with zoledronic acid for injection concentrate. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with zoledronic acid for injection concentrate. It is important to maintain good dental hygiene; regularly scheduled dental examinations are recommended.
Tell your doctor if you had or have joint stiffness, aches and pains and difficulty in movement of your thighs, hips, upper arms (in the bones between your shoulders and elbows), lower legs (in the long large bones between your knees and your feet), ribs, backbone, knees, or feet bones (in the five long bones between your ankles and your toes), or pain around your ears. Tell your doctor, as this may be a sign of bone damage due to loss of blood supply to the bone osteonecrosis).
Driving and using machines
Zoledronic acid for injection concentrate may affect your ability to drive a car or to operate machinery. Do not drive a car or operate machinery until you know how zoledronic acid for injection concentrate affects you.Use in Children
Zoledronic acid for injection concentrates should not be used in children.Interactions with this medication
Tell your doctor about any other medicines you are taking or have
recently been taking, including any you have bought without a
prescription. It is particularly important that your doctor knows if
you are also taking aminoglycosides (a type of medicine used to
treat severe infections), calcitonin (a type of medicine used to treat
high calcium levels in the blood and Paget’s disease), loop diuretics
(a type of medicine used to treat high blood pressure or oedema) or
other calcium-lowering medicines, since the combination of these
with bisphosphonates may cause the calcium level in the blood to
become too low. Examples of aminoglycosides include gentamycin
sulfate, tobramycin sulfate and streptomycin sulphate; examples of
loop diuretics include furosemide, torsemide and ethacrinic acid.
It is also important to inform your doctor if you are taking any drugs
that can have an effect on the kidney, since combining these drugs
with zoledronic acid injection concentrate may cause kidney
function to deteriorate. Some examples of these drugs include
aminoglycosides, acetylsalicylic acid (ASA), nonsteroidal anti-inflammatories (e.g. ibuprofen, diclofenac, celecoxib), diuretics
(e.g. hydrochlorothiazide, amiloride, spironolactone and
indapamide) and Angiotensin-Converting Enzyme (ACE)
inhibitors (e.g. enalapril, ramipril, fosinopril).
Tell your doctor if you are taking anti-angiogenic medicines (type
of medicines used to treat cancer, e.g. thalidomide, bortezomid,
lenalidomide, bevacizumab) as part of your cancer treatment
because the combination of these medicines with bisphosphonates
may increase the risk of bone damage in the jaw (osteonecrosis).
Proper use of this medication
Usual Dose
Zoledronic acid for injection concentrate is given by an infusion
into a vein which should last no less than 15 minutes. The dose is
usually 4 mg. If you have a kidney problem, your doctor may give
you a lower dose depending on the severity of your kidney
problem.
If you are being treated for multiple myeloma or bone metastases
of solid tumours, you will be given one infusion of zoledronic acid
for injection concentrate every three to four weeks. If you require
antineoplastic therapy (therapy that blocks the growth of cancer
cells), zoledronic acid for injection concentrate should be
administered either prior to or after this treatment. You will also be
asked to take an oral calcium supplement of 500 mg and a
multivitamin containing at least 400 IU of Vitamin D daily. If you
have a prior history of high levels of calcium in the blood or
develop high levels of calcium in the blood during treatment with
calcium and Vitamin D, you may be advised to discontinue taking
calcium and Vitamin D supplements by your doctor.
Your doctor will decide how many infusions you need and how
often you should receive them.
If you are being treated for Tumour-Induced Hypercalcaemia
(TIH), you will normally only be given one infusion of zoledronic
acid for injection concentrate. Prior to treatment with zoledronic
acid for injection concentrate, restoring and maintaining adequate
fluid regulation in your body and urine output may help to
eliminate excess calcium from your kidneys.
Overdose
Side effects and what to do about them
Like all medicines, zoledronic acid for injection concentrate may
have, in addition to its beneficial effects, some unwanted effects.
These are usually mild and will probably disappear after a short
time. The most common side effect is short-lasting fever. Patients
may experience a flulike condition including fever, fatigue,
weakness, drowsiness and chills. In some patients, these symptoms
may also be accompanied by bone, joint and/or muscle ache,
arthritis and joint swelling. In most cases, no specific treatment is
required and the symptoms subside after a couple of hours or days.
Other common side effects include gastrointestinal problems such as
nausea, vomiting and thirst as well as swelling of sores inside the
mouth and loss of appetite.
Occasionally, skin reactions (redness and swelling) at the infusion
site may occur. Cases of low blood pressure have also occasionally
been reported; in very rare cases, this resulted in fainting.
Rare cases of rash, itching, chest pain, swelling mainly of the face
and throat, high level of potassium and sodium in the blood, slow
heart beat confusion and a disorder of the kidney function called
Fanconi syndrome have been observed.
Very rare cases of severe bone, joint, and/or muscle pain,
occasionally incapacitating, as well as sleepiness, irregular heart beat
(atrial fibrillation), difficulty breathing with wheezing or coughing,
lung disease, severe allergic reaction and itchy rash have also been
reported.
Reduced levels of calcium in the blood (hypocalcaemia), sometimes
leading to muscle cramps, dry skin or burning sensation, have been
reported in patients treated with zoledronic acid for injection.
Irregular heart beat has also been reported. There have been reports
of abnormal electrical signals of the heart called “prolongation of
the QT interval”, seizures, numbness, spasm and twitching caused
by severely reduced levels of calcium in the blood. In some
instances, the reduced calcium level may be life-threatening and
require hospitalization. If any of these apply to you, tell your
doctor right away.
Blood tests indicating worsening of kidney function (higher levels of
creatinine) including severe kidney failure have been reported with
zoledronic acid for injection; such changes are also known to occur
with other drugs of the bisphosphonate class. Your doctor will carry
out blood tests to monitor your kidney function prior to each dose of
zoledronic acid for injection concentrate. If these tests indicate
worsening of kidney function, your doctor will withhold further
treatment with zoledronic acid for injection concentrate until these
tests have returned to normal.
The level of calcium, phosphate and/or magnesium in the blood may
become too low, but your doctor will monitor this and take
necessary measures.
Other bisphosphonates can cause breathing difficulties in patients
with asthma who are allergic to acetylsalicylic acid (ASA). This has
not been reported with zoledronic acid for injection, in studies done
to date.
Eye pain, redness, photophobia (sensitivity to light), excessive
tearing or decreased vision should be reported to your physician as
they may indicate more serious eye complications which have been
associated with zoledronic acid for injection.
Some patients have reported problems with their jaw bones while
receiving cancer treatments that include zoledronic acid for
injection. Dental hygiene is an important element of your overall
cancer care and is important in possibly decreasing the chances of
this type of problem occurring. Removable dentures should fit
properly and should be removed at night. Please consult with your
doctor if you experience pain in your mouth, teeth or jaw, or if your
gums or mouth heals poorly. Any non-healing of a dental extraction
site or chronic dental infection should be reported and assessed. In
addition, if possible you should not undergo tooth extraction or
other dental procedures (excluding regular dental cleaning) while
on therapy with zoledronic acid for injection concentrate. Please
consult your doctor if a dental procedure (excluding regular dental
cleaning) is required while you are receiving treatment with
zoledronic acid for injection concentrate.
Some patients have reported problems with other bones, other than
their jaw bones, while on treatment with zoledronic acid for
injection concentrate. Consult your doctor if you had or have aches
and pains and difficulty in movement of your thighs, hips, upper
arms, lower legs, ribs, backbone, knees, or feet bones, or if you
experience pain around your ears.
Unusual fracture of the thigh bone may occur while receiving
treatment with zoledronic acid for injection concentrate. Contact
your doctor if you experience pain, weakness or discomfort in your
thigh, hip or groin as this may be an early sign of a possible fracture
of the thigh bone.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Worsening of kidney function (higher levels of creatinine) | ✔ | ||
| Bone, joint and/or muscle pain, joint stiffness | ✔ | ||
| Conjuctivitis | ✔ | ||
| Uncommon | |||
| Kidney failure (changes in urine color or absence of urine production, changes in kidney function laboratory tests, lower back pain, fatigue, nausea, loss of appetite) | ✔ | ||
| Eye disorders (painful red and/or swollen eye, excessive tearing, light sensitivity, or decreased vision) | ✔ | ||
| Allergic reaction to zoledronic acid for injection (swelling of the face, eyes or tongue, difficulty breathing, hives, rash, sudden onset of low blood pressure) | ✔ | ||
| DizzinessOst eonecrosis of the jaw (numbness or feeling of heaviness in the jaw, poor healing of the gums especially after dental work, loose teeth, exposed bone in mouth, pain in the mouth, teeth or jaw, sores or nonhealing sores in the mouth or discharge (pus or oozing), swelling, dry mouth, swelling, gum infections, or bad breath) | ✔ | ||
| Osteonecrosis of other bones (joint stiffness, aches and pains, and difficulty in movement of the thighs, hips, upper arms, lower legs, ribs, backbone, knees, or feet bones, or pain around the ears) | ✔ | ||
| Unknown1 | |||
| Difficulty breathing with wheezing or coughing | ✔ | ||
| Irregular heart beat (atrial fibrillation) | ✔ | ||
| Sleepiness | ✔ | ||
| Severe allergic reaction | ✔ | ||
| Itchy rash | ✔ | ||
| Thigh pain, weakness or discomfort/ Unusual fracture of the thigh bone | ✔ | ||
| Muscle cramps or twitching, dry skin, burning sensation, or irregular heartbeat | ✔ | ||
| Disorder in kidney function with release of amino acids, phosphate and glucose in urine (acquired Fanconisyndrome) | ✔ | ||
1The frequency with which these side effects may occur cannot
be reliably estimated.
This is not a complete list of side effects. If you have any
unexpected effects after receiving zoledronic acid for injection
concentrate, contact your doctor or pharmacist. H
How to store
Vials (concentrate)
- Store zoledronic acid for injection vials at room temperature (between 15°C – 30°C).
In-use conditions:
Diluted Solutions:
If not administered right after dilution, store diluted solution in the
refrigerator (between 2°C and 8°C) for 24 hours maximum. Prior to
administration, let the refrigerated solution reach room temperature.
The total time between dilution, storage in the refrigerator, and end
of administration must not exceed 24 hours.
Zoledronic acid for injection concentrate must be kept out of reach
and sight of children and pets.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
DIN Owner:
Dr. Reddy’s Laboratories Limited
Bachupally 500 090 - INDIA
Imported By:
Dr. Reddy’s Laboratories Canada Inc.,
Mississauga ON L4W 4Y1 Canada
For more information contact:
1-855-845-1739 or druginfo@drreddys.com
This document plus the full product monograph, prepared for health
professionals can be found by contacting the sponsor Dr. Reddy’s
Laboratories Limited, Bachupally 500 090 - INDIA
This leaflet was prepared by Dr. Reddy’s Laboratories Limited
Last Revised: July 19, 2019