Pamidronate Disodium Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Breast Cancer, Bone Metastases, Hypercalcemia of Malignancy, Hypercalcemia, Osteolytic Bone Lesions of Multiple Myeloma, Paget's Disease|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||Pamidronate disodium, Mannitol, Phosphoric Acid, Sodium Hydroxide, Water for Injection.|
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 (tumor 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 for Injection or other bisphosphonates;
- are pregnant;
- are breast-feeding.
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
Mannitol, Phosphoric Acid, Sodium Hydroxide, and Water for Injection
What Dosage Forms it Comes In
Pamidronate Disodium for Injection is available as 3 mg/mL, 6 mg/mL, and 9 mg/mL strengths in 10 mL plastic single-dose vials packaged individually.
Vial stoppers do not contain any natural rubber latex.
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 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
- if you have a heart, liver or kidney problem;
- if you suffer from calcium or Vitamin D deficiency (for example owing to your diet or as a result of digestive problems);
- if you have any dental problems or any dental treatment planned in the future;
- had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a
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.
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
- are breast-feeding or intend to breast feed. Mothers treated with Pamidronate Disodium for Injection should not breast-feed their
Use in Children and Elderly Patients
So far children have not been treated with pamidronate disodium for injection. 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 for Injection, 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.
Other Important Information
This medicine has been prescribed for your current medical problem only. Do not give it to other people or use it for any other illnesses.
Interactions With This Medication
Before starting pamidronate disodium 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.
Tumor-induced hypercalcemia: 30-90 mg
Bone tumors or multiple myeloma: 90 mg every 3-4 weeks
Paget’s disease: 30-60 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.
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.
Side Efects and What to do About Them
Patients taking Pamidronate Disodium for Injection may experience side effects, although not everyone gets them.
The most common (more than 1 in 10 patients) side effects are:
- short-lasting fever and flu-like condition with chills, sometimes together with a feeling of tiredness and general discomfort;
- low level of phosphate in
Irregular heart rhythm (atrial fibrillation) has been reported in patients receiving pamidronate disodium for injection. You should report to your doctor if you experience irregular heart beat during treatment with Pamidronate Disodium for Injection.
Less common (affects between 1 and 10 in every 100 patients) side effects include:
- Low level of red blood cells
- Stomach pain
- Sleep disturbances
- Eye irritation
- Skin rash
- High blood pressure
- Changes in blood test results
- Loss of appetite
- Short-lasting muscle or joint pain
- Abdominal pain
- Redness and swelling at the site of infusion
Other side effects not listed above may also occur in some patients. Some of these include: agitation, dizziness, tiredness, muscle cramps, low blood pressure, itching, and abnormal liver function test. Eye pain, redness, photophobia, excessive tearing or decreased vision should be reported to your physician as they may indicate more serious eye complications which have been associated with Pamidronate Disodium for Injection.
Some patients have reported problems with their jaw bones while receiving cancer treatments that include pamidronate disodium. 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 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.
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|
|Spontaneous bleeding and bruising due to low level of blood platelets||✓|
|Low level of lymphocytes, a specific type of white blood cells with important functions in the immune system||✓|
|Tingling or numbness and muscle spasms and twitching, symptoms of low level of calcium||✓|
|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)||✓|
|Hematuria (blood in urine), kidney damage, including deterioration of pre-existing renal disease||✓|
|Low level of white blood cells||✓|
|Heart disease characterized by breathlessness and fluid retention in the body||✓|
|Reactivation of Herpes simplex and Herpes zoster||✓|
|Confusion, visual hallucinations||✓|
This is not a complete list of side effects. For any unexpected effects while taking Pamidronate Disodium for Injection, contact your doctor or pharmacist.
How to Store It
Pamidronate Disodium for Injection should be stored between 15 °C and 30 °C and protected from heat. Store in the original package.
Keep this medicine out of reach and sight of children and pets.
Pamidronate Disodium for Injection should not be used after the expiry date shown on the package label. Remember to take back any unused medicine to your pharmacist.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhpmps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhpmps/medeff/index-eng.php).
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.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.