Posted on December 3rd, 2008 by
Generic Name: Samarium (su-MARE-ee-um) SM-153, Samarium Sm-153 lexidronam injection
Trade Name: Quadramet®
How is this drug used? Samarium 153 is FDA approved for the relief of pain of cancer that has spread to the bone. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Samarium 153 is classified as a radiopharmaceutical. The mechanism by which Samarium 153 relieves the pain from cancer that has spread to the bone is not known. Samarium 153 has an affinity for bone and concentrates in areas of bone turnover, more so than in normal bone. Samarium 153 produces its effects by binding to cancerous areas of the bone and emitting radiation that helps relieve pain at the site.
How is samarium 153 given (administered)? Samarium 153 is administered into a vein (intravenous) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient. Patients may also receive intravenous hydration to promote elimination of samarium 153 from the body. Some patients may have a transient pain reaction after injection.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with samarium 153. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the common (occur in 30% or more of patients) side effects of treatment with samarium 153?
• Low white blood cell levels – increases risk of infection
• Low red blood cell (hemoglobin) levels – increases risk of anemia
• Low platelet levels – increases risk of bleeding
• Nausea and vomiting
• Nervous system disorders (dizziness, numbness/tingling of extremities)
What are the less common (occur in 10% to 29% of patients) side effects of treatment with samarium 153?
• Bleeding (nosebleeds, gastrointestinal bleeding, blood in the urine, etc.)
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What are the possible late side effects of treatment with samarium 153? There is a slight possibility that patients treated with samarium 153 may develop a secondary malignancy. A secondary malignancy is a new and unrelated cancer that occurs in an individual as a result of previous treatment with radiation or chemotherapy. Patients should ask their physician about the possibility of developing a secondary malignancy as a result of their treatment.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, patients should avoid large crowds or persons who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• While patients are being treated with a radioactive substance and for several hours following administration, radioactivity will be present in excreted urine. Precautions against radioactivity need to be in effect for 12 hours following administration.
• A toilet, versus a urinal should be used whenever possible. The toilet should be flushed several times immediately after every use.
• If urine spills outside the toilet, it should be cleaned up immediately and completely. Patients should wash their hands thoroughly.
• If blood or urine gets onto clothing, bed sheets, towels, etc., these items should be washed separately from other items, or stored for 1-2 weeks to allow for decay of the samarium 153.
When should patients notify their physician?
• Difficulty breathing
• Chest pain
• Noticeable differences in heart rate or rhythm
• Numbness or tingling of the extremities
• Paralysis of the extremities
• Fever, chills, cough, sore throat, flu or cold-like symptoms
• Signs of infection – redness, swelling, pus, tenderness, painful urination
• Persistent or severe fatigue
• Unexplained or excessive bleeding (nosebleeds, bruising, black tarry stools, blood in the urine, etc.)
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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