Details for: JAMP-ZOLEDRONIC ACID
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02482525 | JAMP-ZOLEDRONIC ACID | 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
JAMP-ZOLEDRONIC ACID 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
JAMP-ZOLEDRONIC ACID 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, JAMP-ZOLEDRONIC ACID 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 JAMP-ZOLEDRONIC ACID if you are:
What the medicinal ingredient is
Zoledronic acid.
What the non-medicinal ingredients are
Mannitol and sodium citrate.
What dosage form it comes in
AMP-ZOLEDRONIC ACID is available as a concentrate in vials. Each vial of JAMP-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
JAMP-ZOLEDRONIC ACID include:
If you are being treated with JAMP-ZOLEDRONIC ACID, you
should not be treated with another intravenous form of zoledronic
acid (i.e. ACLASTA®) 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 JAMP-ZOLEDRONIC ACID. This may be
required since some patients have experienced serious side effects
following dental procedures (such as tooth extraction) while on
JAMP-ZOLEDRONIC ACID; 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 JAMP-ZOLEDRONIC ACID.
You should avoid invasive dental procedures during your
treatment with JAMP-ZOLEDRONIC ACID. It is important that
you practice good dental hygiene, routine dental care, and have
regular dental check- ups while being treated with JAMPZOLEDRONIC ACID. 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 JAMP-ZOLEDRONIC ACID.
BEFORE you use JAMP-ZOLEDRONIC ACID talk to your
doctor or pharmacist 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 red blood cell count (anaemia) or if your blood cannot form clots in the normal way.
After starting treatment with JAMP-ZOLEDRONIC ACID
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 JAMP-ZOLEDRONIC ACID.
If possible, you should not undergo tooth extraction or any other dental procedures (excluding regular dental cleaning) while you are receiving treatment with JAMP-ZOLEDRONIC ACID. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with JAMPZOLEDRONIC ACID. 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
JAMP-ZOLEDRONIC ACID may affect your ability to drive a car or to operate machinery. Do not drive a car or operate machinery until you know how JAMP-ZOLEDRONIC ACID affects you.
Use in Children
JAMP-ZOLEDRONIC ACID 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 JAMP-ZOLEDRONIC ACID may cause kidney
function to deteriorate. Some examples of these drugs include
aminoglycosides, acetylsalicylic acid (ASA), nonsteroidal antiinflammatories (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:
JAMP-ZOLEDRONIC ACID 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 JAMPZOLEDRONIC ACID every three to four weeks. If you
require
antineoplastic therapy (therapy that blocks the growth of cancer
cells), JAMP-ZOLEDRONIC ACID 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 JAMPZOLEDRONIC ACID. Prior to treatment with JAMPZOLEDRONIC
ACID,
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, JAMP-ZOLEDRONIC ACID 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 JAMPZOLEDRONIC ACID. 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 JAMP-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 JAMP-ZOLEDRONIC ACID. If these tests indicate
worsening of kidney function, your doctor will withhold further
treatment with JAMP-ZOLEDRONIC ACID 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 JAMP-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 JAMP-ZOLEDRONIC ACID.
Some patients have reported problems with their jaw bones while
receiving cancer treatments that include JAMP-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 JAMP-ZOLEDRONIC ACID.
Please consult your doctor if a dental procedure (excluding
regular dental cleaning) is required while you are receiving
treatment with JAMP-ZOLEDRONIC ACID.
Some patients have reported problems with other bones, other than
their jaw bones, while on treatment with JAMP-ZOLEDRONIC
ACID. 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 JAMP-ZOLEDRONIC ACID. 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 or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency help |
|---|---|---|---|
| Common | |||
| Worsening of kidney function (higher levels of creatinine) | ✔ | ||
| Bone, joint and/or muscle pain, joint stiffness | ✔ | ||
| Conjunctivitis | ✔ | ||
| Uncommon | |||
| Kidney failure (changes in urine colour 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 JAMPZOLEDRONIC ACID (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, 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 | ✔ | ||
| 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 heart beat | ✔ | ||
| Disorder in kidney function with release of amino acids, phosphate and glucose in urine (acquired Fanconi syndrome) | ✔ | ||
This is not a complete list of side effects. If you have any unexpected effects after receiving JAMP-ZOLEDRONIC ACID, contact your doctor or pharmacist.
How to store
Vials (concentrate)
JAMP-ZOLEDRONIC ACID 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/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.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
For more information, please contact your healthcare professionals
or pharmacist first, or Angita Pharma Corporation at: 1-866-399-
9091.
The information in this document is current as of the last revision
date shown below. For the most current information please visit our
website or contact us directly.
This leaflet was prepared by
Jamp Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Preparation: November 7, 2018