IMPORTANT SAFETY INFORMATION
Contraindications:
QUADRAMET is not for patients who have known allergic reactions to some substances it contains called phosphonates.
Warnings:
Quadramet may cause bone marrow suppression (a decrease in the number of certain blood cells called white blood cells and platelets). These types of blood cells help prevent infections or bleeding. These types of side effects may be serious. Other treatments, such as some cancer treatments, can cause the same problems. Only a doctor can determine if Quadramet will be safe to take while receiving other cancer treatments that have similar effects on these kinds of blood cells.
Caution should be exercised in treating cancer patients whose platelet counts are falling or who have other clinical or laboratory findings that may suggest DIC, a condition in which the clotting elements in blood are consumed or destroyed much faster than normal.
Patients taking Quadramet should have their blood counts monitored for at least 8 weeks, or until their blood counts are returning to normal values.
Quadramet can cause harm to an unborn child when administered to a pregnant woman. Women of childbearing age should have a negative pregnancy test before administration of Quadramet. If Quadramet is used during pregnancy, or if a patient becomes pregnant after taking this drug, the patient should be informed of the potential hazard to the unborn child. Women should be advised to avoid becoming pregnant soon after receiving Quadramet. Due to the radioactive nature of the product, men and women patients should use an effective method of contraception after the administration of Quadramet.
Precautions:
It has not been studied whether Quadramet causes heart problems and therefore caution and appropriate monitoring should be given when administering Quadramet to patients.
Because the taking of fluids is recommended to promote the excretion of Quadramet in urine, appropriate monitoring and consideration of additional supportive treatment should be used in patients with a history of congestive heart failure or renal insufficiency.
Compression of the spinal cord frequently occurs in patients with known metastases to the cervical, thoracic or lumbar spine. Quadramet is not indicated for treatment of spinal cord compression. The administration of Quadramet for pain relief of metastatic bone cancer does not prevent the development of spinal cord compression. When there is a clinical suspicion of spinal cord compression, appropriate diagnostic and therapeutic measures must be taken immediately to avoid permanent disability.
Treatments like Quadramet involving radiation should be used only by physicians who are qualified by training and experience in the safe use and handling of radioactive drugs and whose experience and training have been approved by the appropriate government agency authorized to license the use of radioactive drugs.
Because the treatment involves radiation, there are some steps that a patient will need to take the day of the injection with Quadramet. For several hours following the injection, radioactivity will be present in urine. To help protect the patient and others around the patient, safety measures need to be taken for 12 hours following injection. Whenever possible, a toilet should be used, rather than a urinal, and the toilet should be flushed several times after each use. Spilled urine should be cleaned up completely and a patient should wash his or her hands thoroughly. If blood or urine gets onto clothing, the clothing should be washed separately, or stored for 1-2 weeks before washing to allow for the decay of the radioactive part of the drug.
It is not known whether Quadramet is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Quadramet, a decision should be made whether to continue nursing or to administer the drug. If Quadramet is administered to a nursing mother, formula feedings should be substituted for breast feedings.
The safety and effectiveness of Quadramet in pediatric patients below the age of 16 years have not been established.
Adverse Events:
Commonly observed adverse events for Quadramet are as follows: Bone marrow toxicity occurred in 47% of patients in clinical trials. Non-blood or bone marrow related adverse events that occurred in 5% or more of patients and greater than placebo were pain flare (7%), infection (7%), spinal cord compression (6.5%), diarrhea (6%), heart rhythm problems (5%) and blood in urine (5%).
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