Patient Medication Information: uses, side effects, how to take - Val-Zoledronic Acid
ABOUT THIS MEDICATION
What the medication is used for:
VAL-ZOLEDRONIC ACID 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:
VAL-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, 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 VAL-ZOLEDRONIC ACID if you are:
pregnant
- breast-feeding
allergic to zoledronic acid, other bisphosphonates (the group
of substances to which VAL-ZOLEDRONIC ACID belongs) or to any other nonmedicinal ingredients in VAL-ZOLEDRONIC ACID.
- Hypocalcaemic (have low calcium levels in your blood)
What the medicinal ingredient is:
Zoledronic Acid (as zoledronic acid hemipentahydrate)
What the important nonmedicinal ingredients are:
Mannitol and sodium citrate.
What dosage forms it comes in:
VAL-ZOLEDRONIC ACID is available as a clear colourless concentrate in syringes. Each syringe concentrate delivers 4 mg of zoledronic acid. It is available in cartons containing 1 syringe.
The syringe is NOT for direct injection. CONCENTRATE MUST BE DILUTED PRIOR TO USE
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Serious side effects which have been reported with the use of zoledronic acid include:
- osteonecrosis of the jaw (ONJ)
deterioration in renal function. VAL-ZOLEDRONIC
ACID is not recommended in patients with severe kidney impairment.
- Hypocalcaemia (low calcium in your body)
If you are being treated with VAL-ZOLEDRONIC ACID, 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 VAL-ZOLEDRONIC ACID. This may be required since some patients have experienced serious side effects following dental procedures (such as tooth extraction) while on VAL-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 VAL-ZOLEDRONIC ACID.
You should avoid invasive dental procedures during your treatment with VAL-ZOLEDRONIC ACID. It is important that you practice good dental hygiene, routine dental care, and have regular dental check-ups while being treated with VAL-ZOLEDRONIC 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 VAL-ZOLEDRONIC ACID.
BEFORE you use VAL-ZOLEDRONIC ACID 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 VAL-ZOLEDRONIC ACID;
have asthma and are also allergic to acetylsalicylic acid
(ASA).
had or have a heart problem. Cases of irregular heartbeat
(atrial fibrillation) have been observed with the use of
VAL-ZOLEDRONIC ACID.
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 red blood cell count (anaemia) or if your blood cannot form clots in the normal way.
Your doctor may tell you to stop taking VAL-ZOLEDRONIC ACID until all sores in your mouth are healed.
After starting treatment with VAL-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 VAL-ZOLEDRONIC ACID.
If possible, you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while you are receiving treatment with VAL-ZOLEDRONIC ACID. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with VAL-ZOLEDRONIC 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
VAL-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 zoledronic acid affects you.
Use in Children
VAL-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 medication 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 gentamicin sulfate, tobramycin sulfate and streptomycin sulphate; examples of loop diuretics include furosemide, torsemide and ethacrynic 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 VAL-ZOLEDRONIC ACID may cause kidney function to deteriorate. Some examples of these drugs include aminoglycosides, acetylsalicylic acid (ASA), nonsteroidal anti-inflammatory drugs (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
CONCENTRATE MUST BE DILUTED PRIOR TO USE
Unused solution should be discarded
Usual dose:
VAL-ZOLEDRONIC ACID, after dilution, 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 VAL-ZOLEDRONIC ACID every three to four weeks. If you require antineoplastic therapy (therapy that blocks the growth of cancer cells), VAL-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 hypercalcaemia or develop hypercalcaemia 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 VAL-ZOLEDRONIC ACID. Prior to treatment with zoledronic acid, restoring and maintaining adequate fluid regulation in your body and urine output may help to eliminate excess calcium from your kidneys.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. You may develop serum electrolyte abnormalities and changes in kidney function, including severe kidney impairment.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, VAL-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 heartbeat and confusion have been observed.
Very rare cases of severe bone, joint, and/or muscle pain, occasionally incapacitating, as well as sleepiness, irregular heartbeat (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 heartbeat 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; 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 VAL-ZOLEDRONIC ACID. If these tests indicate worsening of kidney function, your doctor will withhold further treatment with
VAL-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 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 VAL-ZOLEDRONIC ACID. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with VAL-ZOLEDRONIC ACID.
Some patients have reported problems with other bones, other than their jaw bones, while on treatment with VAL-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 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.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| √ | √ | √ | |
| √ √ | √ √ √ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| √ | √ | √ √ √ √ √ √ √ | |
1The 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 VAL-ZOLEDRONIC ACID, contact your doctor or pharmacist.
HOW TO STORE IT
Store VAL-ZOLEDRONIC ACID syringes (concentrate) at room temperature (between 15°C to 30°C).
VAL-ZOLEDRONIC ACID must be kept out of reach and sight of children and pets.
Reporting Suspected 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/drugs-health-products/medeffect-canada.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
Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); by contacting the sponsor: Bausch Health, Canada Inc. or by calling 1-800-361-4261.
Bausch Health, Canada Inc.
2150 St-Elzéar Blvd. West
Laval, Quebec H7L 4A8