Patient Medication Information: uses, side effects, how to take - Pamidronate Disodium for Injection (Sandoz Canada, 3 mg, 6 mg, 9 mg)
ABOUT THIS MEDICATION
What the medication is used for:
Pamidronate Disodium for Injection is used to treat:
high calcium levels in the blood due to cancer
(tumour-induced hypercalcemia)
bone tumours resulting from the spread of
tumours at other sites and multiple myeloma
Paget's disease of bone in patients with
symptoms.
What it does:
Pamidronate Disodium for Injection is a bisphosphonate which strongly binds to the bone and slows down the rate of bone change. This helps to reduce the amount of calcium in the blood and bone loss.
When it should not be used:
You should not be given Pamidronate Disodium for Injection if you are:
allergic to pamidronate disodium or other
bisphosphonates.
- pregnant.
breast-feeding.
If this applies to you, tell your doctor before being given Pamidronate Disodium for Injection. If you think you may be allergic, ask your doctor for advice.
What the medicinal ingredient is:
Pamidronate disodium.
What the important non-medicinal ingredients are:
Mannitol and phosphoric acid.
What dosage forms it comes in:
Pamidronate Disodium for Injection is available as a solution in vials. One vial contains 30 mg, 60 mg or 90 mg of pamidronate disodium. Pamidronate Disodium for Injection is given as an infusion into a vein after appropriate dilution.
WARNINGS AND PRECAUTIONS
Before starting treatment with Pamidronate Disodium for Injection
Be sure that you have discussed Pamidronate Disodium for Injection treatment with your doctor. You may only be given Pamidronate Disodium for Injection after a full medical examination. Your doctor may also request a dental examination with any necessary preventive dentistry carried out prior to treatment with Pamidronate Disodium for Injection. This may be required since some patients have experienced side effects following dental procedures (such as tooth extraction) while on treatment with Pamidronate Disodium for Injection; as well since patients with dental infections or periodontal disease (disease affecting surrounding tissues of a tooth) may be at
Serious Warnings and Precautions
Possible serious side effects with the use of pamidronate disodium include:
- Osteonecrosis of the jaw (a severe bone disease that affects the jaw)
Worsening of kidney function. Pamidronate
Disodium for Injection should not be given to patients with severely reduced kidney function.
Single doses of Pamidronate Disodium for
Injection should not exceed 90 mg and must be given at the recommended infusion rates.
increased risk of problems with their jaw bones following dental procedures (such as tooth extraction) while on treatment with Pamidronate Disodium for Injection (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
BEFORE you use Pamidronate Disodium for Injection talk to your doctor or pharmacist if you:
- have a heart, liver or kidney problem
suffer from calcium or vitamin D deficiency (for
example owing to your diet or as a result of digestive problems).
have any dental problems or any dental
procedures planned in the future.
had or have pain, swelling or numbness of the
jaw or a “heavy jaw feeling” or loosening of a tooth.
- have an eye problem;
- have an ear problem;
have sores in the mouth. This can lead to
osteonecrosis of the jaw. Your doctor may check if you:
o smoke
o have or have had teeth and/or gum disease
o have dentures that do not fit well
o have other relevant medical conditions at the same time such as a low red blood cell count (called anemia) or if your blood cannot form clots in the normal way. Your doctor may tell you to stop taking Pamidronate Disodium for Injection until all sores in your mouth are healed.
During treatment with Pamidronate Disodium for Injection
Ensure sufficient intake of liquids prior to infusions as directed by your doctor as this will help to prevent dehydration.
Your treatment may need to be supplemented with calcium and vitamin D to prevent low calcium levels.
It is important that your doctor checks your progress at regular intervals. Since bisphosphonates (the class of drugs to which Pamidronate Disodium for Injection belongs) may cause damage to the kidneys (worsening of kidney function including kidney failure and death have been reported very rarely with the use of Pamidronate Disodium for Injection), he or she may want to take repeated blood tests, especially after starting your treatment with Pamidronate Disodium for Injection and before each additional dose.
Your doctor may also want to take other repeated blood tests if you have low level of white blood cells, red blood cells and/or platelets.
Tooth Extraction and Other Dental Procedures
If possible, you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while you are receiving treatment with Pamidronate Disodium for Injection. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with Pamidronate Disodium for Injection. It is important to maintain good dental hygiene; regularly scheduled dental examinations are recommended.
Pregnancy or Breast-Feeding
You should tell your doctor if you:
- are pregnant, or planning to become pregnant before you receive Pamidronate Disodium for Injection. Pamidronate Disodium for Injection should not be given during pregnancy.
are breast-feeding, or intend to breast-feed.
Mothers treated with Pamidronate Disodium for Injection should not breast-feed their babies.
Women of Child-bearing Potential
You must use highly effective contraception during treatment.
Use in Children, Adolescents and Elderly Patients
Pamidronate Disodium for Injection has not been adequately studied in children or adolescents. Until further experience is gained, Pamidronate Disodium for Injection is only recommended for use in adult patients.
Elderly patients at the age of 65 years or older may be safely treated with pamidronate disodium, provided that they do not have a serious heart, liver or kidney problem. Ask your doctor if you have any questions about this.
If You Drive a Vehicle or Use Machinery Pamidronate Disodium for Injection may cause some patients to become sleepy or dizzy, especially immediately after the infusion. If this happens you should not drive or use machinery or perform other tasks that need full attention.
INTERACTIONS WITH THIS MEDICATION
Before starting Pamidronate Disodium for Injection treatment, talk to your doctor about any other medicines that you are using or intend to use. It is especially important that your doctor knows if you are being treated with another bisphosphonate, calcitonin, thalidomide, or vitamin supplements.
PROPER USE OF THIS MEDICATION
Pamidronate Disodium for Injection can be given only by slow infusion into a vein. The dose will be decided by your doctor.
Usual dose:
Tumour-induced hypercalcemia: 30 to 90
mg
Bone tumours or multiple myeloma: 90 mg
every 3 to 4 weeks
- Paget’s disease: 30 to 60 mg in one infusion
An infusion may last one or more hours, depending on the dose given and the condition of your kidney. You may receive additional saline solution for re-hydration.
Overdose:
SIDE EFFECTS AND WHAT TO DO ABOUT
THEM
Like all medicines, patients treated with Pamidronate Disodium for Injection may experience side effects. Very common side effects:
These side effects may affect more than 1 in 10 patients.
short-lasting fever and flu-like conditions with
chills, sometimes together with a feeling of tiredness and general discomfort.
- Low level of calcium and phosphate in the blood.
- Tiredness, lack of energy.
If any of these affects you severely, tell your doctor.
Common side effects:
These side effects may affect between 1 and 10 in every 100 patients.
- Low level of red blood cells
- Low level of white blood cells
- Low level of platelets (cells in the blood that help stop bleeding)
- Headache
- Sleep disturbances
- Eye irritation
- High blood pressure
- Irregular heart rhythm (atrial fibrillation)
- Vomiting
- Loss of appetite
- Abdominal pain
- Diarrhea
- Constipation
- Stomach pain
- Sickness (nausea)
- Skin rash
- Generalised pain
- Low levels of potassium and magnesium in the blood
Short-lasting muscle or joint pain
If any of these affects you severely, tell your doctor.
Uncommon side effects:
These side effects may affect between 1 and 10 in every 1000 patients.
- Agitation
- Muscle cramps
- Low blood pressure
- Itching
- Abnormal liver function test
- Problems with jaw bones (osteonecrosis of the jaw)
If any of these affects you severely, tell your doctor.
The following side effects have been reported in some patients taking Pamidronate Disodium for Injection:
Painful red eye and/or swollen eye, painful eyeball, photophobia, excessive tearing or decreased vision. You should report these to your doctor as they may indicate more serious complications.
In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Problems with jaw bones (osteonecrosis of the jaw). Dental hygiene is an important element of your overall patient 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 assessed. If you notice any other effects, tell your doctor immediately. In addition, if possible, you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while on therapy with Pamidronate Disodium for Injection. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with Pamidronate Disodium for Injection (see WARNINGS and PRECAUTIONS: Tooth Extraction and Other Dental Procedures).
Some side effects could be serious and might need immediate medical attention.
| 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 seek immedia te emergen cy medical attention | ||
Only if severe | In all cases | |||
| Common | Low level of blood platelets which, if severe, may cause spontaneous bleeding and bruising | ✓ | ||
Low level of white blood cells which, if severe, may cause fever, mouth ulcers, infections of the throat, ears, skin, or lungs (pneumonia) | ✓ | |||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom/effect Tingling or numbness and muscle spasms and twitching, symptoms of low level of calcium Irregular heart rhythm (atrial fibrillation) | Talk with your doctor or pharmacist | Stop taking drug and seek immedia te emergen cy medical attention | ||
| Only if severe | In all cases | |||
| ✓ | ||||
| ✓ | ||||
Uncomm on
| Severe allergic reaction which causes difficulty in breathing, swollen lips and tongue or a sudden fall in blood pressure | ✓ | ||
| 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, swelling or gum infections, bad breath) | ✓ | ||
| Osteonecrosis of the external auditory canal (chronic ear infections, ear pain, discharge from the ear) | ✓ | ||
| Seizures | ✓ | ||
| Pseudotumor cerebri (moderate to severe headaches, ringing in ears, nausea, vomiting, dizziness, blurred or dim vision, brief | ✓ |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom/effect episodes of blindness, double vision, seeing light flashes, neck, shoulder or back pain) 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) Kidney damage, including deterioration of pre-existing renal disease | Talk with your doctor or pharmacist | Stop taking drug and seek immedia te emergen cy medical attention | ||
Only if severe | In all cases | |||
| ✓ | ||||
| ✓ | ||||
| Rare | Protein in urine | ✓ | ||
| Very rare | Anaphylactic shock | ✓ | ||
| Blood in urine | ✓ | |||
Heart disease characterized by breathlessness and fluid retention in the body | ✓ | |||
| Reactivation of Herpes simplex and Herpes zoster | ✓ | |||
| Confusion, visual hallucinations | ✓ | |||
| High level of sodium and potassium in the blood | ✓ | |||
| Unknown | Painful eyeball and/or swollen eyes | ✓ | ||
This is not a complete list of side effects. If you have any unexpected side effects after receiving Pamidronate Disodium for Injection, contact your
doctor or pharmacist.
HOW TO STORE IT
Store between 15 and 30°C. Protect from heat. Keep out of the reach of children.
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/drugs-health-
products/medeffect-canada/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
If you want more information about Pamidronate Disodium for Injection:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.sandoz.ca ,or by calling 1-800-361-3062.