Patient Medication Information: uses, side effects, how to take - Val-Pamidronate Disodium
ABOUT THIS MEDICATION
ABOUT THIS MEDICATION
What the medication is used for:
Pamidronate Disodium is used to treat:
- the increased amount of calcium in the blood (hypercalcemia) in certain conditions
- bone tumors resulting from the spread of tumors at other sites and multiple myeloma (cancer of the cells of the immune system).
- Paget’s disease of bone in patients with symptoms.
What it does:
Pamidronate disodium belongs to a group of medicines called bisphosphonates which strongly bind to the bone and slow down the rate of bone change.
When it should not be used:
You should not be given pamidronate disodium if you have previously had an allergic reaction to pamidronate disodium, to any of its components, or to other bisphosphonates.
What the medicinal ingredient is:
Pamidronate disodium
What the important non-medicinal ingredients are:
Mannitol, Sodium hydroxide, phosphoric acid and water for injection. Sodium hydroxide and phosphoric acid may have been added for pH adjustment.
What dosage forms it comes in:
One vial contains 90 mg of pamidronate disodium in solution. Available in single dose vials of 10 mL.
WARNING AND PRECAUTIONS
ABOUT THIS MEDICATION
PAMIDRONATE DISODIUM MUST NEVER BE GIVEN AS A BOLUS INJECTION SINCE SEVERE LOCAL REACTIONS AND THROMBOPHLEBITIS MAY RESULT FROM HIGH LOCAL CONCENTRATIONS.
PAMIDRONATE DISODIUM SHOULD ALWAYS BE
DILUTED AND ADMINISTERED AS A SLOW INTRAVENOUS INFUSION (see DOSAGE AND ADMINISTRATION). REGARDLESS OF THE VOLUME OF SOLUTION IN WHICH PAMIDRONATE DISODIUM IS DILUTED, SLOW INTRAVENOUS INFUSION IS ABSOLUTELY NECESSARY FOR SAFETY.BEFORE you use PAMIDRONATE DISODIUM talk to your doctor or pharmacist if:
- you have a heart or kidney problem
- you suffer from calcium or vitamin D deficiency (for example owing to your diet or as a result of digestive problems).
- you have any dental problems or any dental treatment/procedure planned in the future (see side effects).
Further Safety Measures
Please consult your doctor if a dental procedure (excluding dental cleaning) is required while you are receiving treatment with pamidronate disodium. If you experience any non healing of dental extraction or infection while taking pamidronate disodium, talk to your doctor. Let your dentist know you are taking pamidronate disodium.
Pregnancy or breast-feeding
You should tell your doctor if you are pregnant, breast-feeding, or planning to become pregnant. Pamidronate disodium should not be given during pregnancy except in special situations and only after a careful discussion with the doctor. Mothers treated with pamidronate disodium should not breastfeed their babies.
Use in children and elderly patients
So far children have not been treated with pamidronate disodium. Until further experience is gained, pamidronate disodium is only recommended for use in adult patients.
If you drive a vehicle or use machinery
Pamidronate disodium may cause some patients to become sleepy or dizzy, especially immediately after 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 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, calcium tablets, or vitamin supplements.
PROPER USE OF THIS MEDICATION
Usual dose:
Pamidronate disodium can be given only by slow infusion into a vein. This is usually 30-90 mg for patients with decreased blood calcium and 90 mg every 3-4 weeks for patients with tumors which have spread to the bone or multiple myeloma. Patients with Paget’s disease of bone usually receive between 30-60 mg in one infusion.
VAL-PAMIDRONATE DISODIUM Page 33 of 32 An infusion may last one or more hours, depending on the dose
given. Your doctor will decide how many infusions you need
and how often you should receive them.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, pamidronate disodium may have, in addition to its beneficial effects, some unwanted effects. The most common side effects are: short-lasting fever and flu-like condition with chills, sometimes together with a feeling of tiredness and general discomfort.
Less common side effects include: short-lasting muscle or joint pain, muscle cramps, redness and swelling at the site of infusion, indigestion, nausea, vomiting, abdominal pain, constipation, diarrhea, loss of appetite, headache, dizziness, sleepiness, tiredness, confusion, agitation, skin rash, itching and eye irritation.
Other side effects not listed above may also occur in some patients. Eye pain, redness, photophobia (light sensitivity), excessive tearing or decreased vision would be reported to your physician as they may indicate more serious eye complications which have been associated with pamidronate disodium.
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 heal 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. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with pamidronate disodium.
This is not a complete list of side effects. For any unexpected effects while taking VAL-PAMIDRONATE DISODIUM, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15 - 25°C. Do not freeze.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
Toll-free telephone: 1-866-234-2345
Toll-free fax: 1-866-678-6789
Email: cadrmp@hc-sc.gc.ca
Regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Valeo Pharma Inc., at:
Toll-free telephone: 1-886-694-0150