Details for: TARO-ZOLEDRONIC ACID CONCENTRATE
Company: TARO PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02415186 | TARO-ZOLEDRONIC ACID 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
Taro-Zoledronic Acid Concentrate is used to:
1) 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.
2) 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
Taro-Zoledronic Acid 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, Taro-Zoledronic Acid 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 Taro-Zoledronic Acid Concentrate if you are:
- pregnant
- breastfeeding
- allergic to zoledronic acid, other bisphosphonates (the group of substances to which Taro-Zoledronic Acid Concentrate belongs) or to any other non medicinal ingredients in Taro-Zoledronic Acid Concentrate.
- hypocalcaemic (have low calcium levels in your blood)
What the medicinal ingredient is
Zoledronic acid.
What the non-medicinal ingredients are
Mannitol and sodium citrate.
What dosage form it comes in
Taro-Zoledronic Acid Concentrate is available as a clear, colourless concentrate solution in glass vials with a baby blue flip off seal. Each vial of Taro-Zoledronic Acid 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 Taro-Zoledronic Acid Concentrate include:
- osteonecrosis of the jaw (a severe bone disease that affects the jaw)
- deterioration in renal function Taro-Zoledronic Acid Concentrate is not recommended in patients with severe kidney impairment.
- hypocalcaemia (low calcium levels in your blood)
If you are being treated with Taro-Zoledronic Acid 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 teeth) before you start treatment and while
you are on treatment with Taro-Zoledronic Acid Concentrate.
This may be required since some patients have experienced
serious side effects following dental procedures (such as tooth
extraction) while on Taro-Zoledronic Acid Concentrate; 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 Taro-Zoledronic
Acid Concentrate.
You should avoid invasive dental procedures during your
treatment with Taro-Zoledronic Acid Concentrate. It is
important that you practice good dental hygiene, routine
dental care, and have regular dental check- ups while being
treated with Taro-Zoledronic Acid 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 Taro-Zoledronic Acid Concentrate.
BEFORE you use Taro-Zoledronic Acid 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 Taro-Zoledronic Acid Concentrate.
- 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 Taro-Zoledronic Acid Concentrate.
- 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, such as: low blood cell count (anaemia) or if your blood cannot form clots in the normal way
Your doctor may tell you to stop taking Taro-Zoledronic Acid
Concentrate until all sores in your mouth are healed.
After starting treatment with Taro-Zoledronic Acid
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 Taro-Zoledronic Acid
Concentrate.
If possible, you should not undergo tooth extraction or any other
dental procedures (excluding regular dental cleaning) while you
are receiving treatment with Taro-Zoledronic Acid Concentrate.
Please consult your doctor if a dental procedure (excluding
regular dental cleaning) is required while you are receiving
treatment with Taro-Zoledronic Acid 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
Taro-Zoledronic Acid 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 Taro-Zoledronic Acid
Concentrate affects you.
Use in Children
Taro-Zoledronic Acid Concentrate 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 Taro-Zoledronic Acid 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
Taro-Zoledronic Acid Concentrate must be diluted before use as
directed and 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
Taro-Zoledronic Acid Concentrate every three to four weeks. If
you require antineoplastic therapy (therapy that blocks the
growth of cancer cells), Taro-Zoledronic Acid 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 Taro-Zoledronic Acid Concentrate. Prior to treatment with Taro-Zoledronic Acid 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, Taro-Zoledronic Acid 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 flu-like 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. Irregular heart beat has also been reported. There have
been reports of abnormal electrical signal 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; 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 Taro-Zoledronic Acid Concentrate. If these tests indicate
worsening of kidney function, your doctor will withhold further
treatment with Taro-Zoledronic Acid 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, 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.
Some patients have reported problems with their jaw bones
while receiving cancer treatments that include Zoledronic Acid.
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 Taro-Zoledronic
Acid Concentrate. Please consult your doctor if a dental
procedure (excluding regular dental cleaning) is required while
you are receiving treatment with Taro-Zoledronic Acid
Concentrate.
Some patients have reported problems with other bones,
other than their jaw bones, while on treatment with Taro-Zoledronic Acid 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 Taro-Zoledronic Acid 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 talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Worsening of kidney function (higher levels of creatinine) | ✔ | ||
| Bone, joint and/or muscle pain, joint stiffness | ✔ | ||
| Conjunctivitis | ✔ | ||
| 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 Taro-Zoledronic Acid Concentrate (swelling of the face, eyes or tongue, difficulty breathing, hives, rash, sudden onset of low blood pressure) | ✔ | ||
| Dizziness | ✔ | ||
| Osteonecrosis 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, 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 of or discomfort/ Unusual fracture of the thigh bone | ✔ | ||
| Muscle cramps or twitching, dry skin, burning sensation, or irregular heart beat | ✔ | ||
| Disorder in kidney function with release of amino acids, phosphate and glucose in urine (acquired Fanconi syndrome) | ✔ | ||
1
The frequency with which these side effects may occur cannot be
reliably estimated.
This is not a complete list of side effects. For any unexpected
effects while taking Taro-Zoledronic Acid Concentrate, contact
your doctor or pharmacist.
How to store
Vials (concentrate)
- Store Taro-Zoledronic Acid Concentrate vials at room temperature (between 15°C – 30°C).
Taro-Zoledronic Acid Concentrate must be kept out of reach and sight of children and pets.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.taro.ca
or by contacting the sponsor,
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario L6T 1C1
1-800-268-1975
This leaflet was prepared by Taro Pharmaceuticals Inc.
Last revised: January 2, 2019