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USP DI Vol. II - SAMARIUM SM 153 LEXIDRONAM (Therapeutic)

SAMARIUM SM 153 LEXIDRONAM (Therapeutic)?


Some commonly used brand names are:

In the U.S.?

  • Quadramet

? Not commercially available in Canada.


Category

  • Antineoplastic

Description

SamariumSm 153 lexidronam (sa-MARE-ee-um lex-ID-roe-nam)is a radiopharmaceutical ((ray-dee-oh-far-ma-SOO-ti-kal)).Radiopharmaceuticals are radioactive agents that may be used to diagnose somediseases by studying the function of the body's organs or to treat certaindiseases.

Samarium Sm 153 lexidronam is used to help relieve the bone pain that mayoccur with certain kinds of cancer. The radioactive samarium is taken upin the bone cancer area and gives off radiation that helps provide reliefof pain.

Samarium Sm 153 lexidronam is to be given only by or under the direct supervisionof a doctor with specialized training in nuclear medicine or radiation oncology. It is available in the following dosage form:

    Parenteral
  • Injection (U.S.)


Before Using This Medicine

In deciding to use a medicine, the risks of receiving the medicinemust be weighed against the good it will do. This is a decision you and yourdoctor will make. For samarium Sm 153 lexidronam, the following should beconsidered:

Allergies?Tell yourdoctor if you have ever had any unusual or allergic reaction to bone tumor-seekingmedicines, like samarium Sm 153 lexidronam, or bone-imaging radiopharmaceuticals. Also tell your doctor if you are allergic to any other substances, such asfoods, preservatives, or dyes.

Pregnancy?Studieshave not been done in either humans or animals. However, to avoid exposingthe fetus to radiation, samarium Sm 153 lexidronam is not recommended foruse during pregnancy. Be sure you have discussed this with your doctor.

Breast-feeding?Tellyour doctor if you are breast-feeding or if you intend to breast-feed duringtreatment with this medicine. Because samarium Sm 153 lexidronam may causeserious side effects, breast-feeding is generally not recommended while youare receiving this medicine.

Children?Studieson this medicine have been done only in adult patients, and there is no specificinformation comparing use of samarium Sm 153 lexidronam in children with usein other age groups.

Older adults?SamariumSm 153 lexidronam has been used in older people and has not been shown tocause different side effects or problems in older people than it does in youngeradults.

Other medicines?Althoughcertain medicines should not be used together at all, in other cases two differentmedicines may be used together even if an interaction might occur. In othercases, your doctor may want to change the dose, or other precautions may benecessary. When you are receiving samarium Sm 153 lexidronam, it is especiallyimportant that your doctor know the following:

  • If you have ever receivedradiation therapy or anticancer medicines?Anticancer medicines or radiationtherapy may increase the harmful effects of samarium Sm 153 lexidronam onthe bone marrow
  • Etidronate (e.g., Didronel)?This medicine may prevent samariumSm 153 lexidronam from working properly

Other medical problems?The presence of other medical problems may affect the use of samariumSm 153 lexidronam. Make sure you tell your doctor if you have any other medicalproblems.


Proper Use of This Medicine

Your doctor may have special instructions for youto follow to get ready for your treatment. If you do not understand themor if you have not received such instructions, check with your doctor in advance.

This radiopharmaceutical may accumulate in yourbladder. Therefore, to increase the flow of urine and lessen the amount ofradiation to your bladder your doctor may instruct you to drink plenty ofliquids before receiving samarium Sm 153 lexidronam and urinate often afterwards.

If you have a problem controlling your bladder, tell your doctor beforereceiving samarium Sm 153 lexidronam. Special precautions will need to betaken to prevent radiation contamination of clothing, bed linens, and theenvironment.

Dosing?Thedoses of radiopharmaceuticals will be different for different patients andfor the different types of treatment. The amount of radioactivity of a radiopharmaceuticalis expressed in units called becquerels or curies. The usual adult dose ofsamarium Sm 153 lexidronam is 37 megabecquerels (1 millicurie) per kg (16.8megabecquerels [0.45 millicurie] per pound) of body weight. The dose youreceive depends on your body size. The amount of radiation received fromthis medicine by specific areas of the body to treat a disease is many timeshigher than that from any diagnostic test, such as x-rays and nuclear medicinescans. Repeated doses may be necessary, depending on the kind of diseaseyou have and how your body is responding to treatment.


Precautions After Using This Medicine

It is very important that your doctor check your progressat regular visits to make sure that this medicine is working properlyand to check for unwanted effects. You may need to have blood tests doneregularly.

Follow these guidelines for 12 hours after receivingsamarium Sm 153 lexidronam, to help reduce the chance of contaminating otherpersons or the environment with radiation:

  • Use a normal toilet, if available, instead ofa urinal.
  • Samarium Sm 153 lexidronam is passed mainly inthe urine. To prevent contamination of your home environment, flush the toilettwice after using.
  • Wipe any spilled urine with a tissue and flushit away.
  • Wash your hands after using or cleaning the toilet.
  • Wash your clothes and bed linens immediately,if they become soiled with your urine or blood. Wash them separately fromother clothes.
  • If you cut yourself, wash away any spilled blood.

Samarium Sm 153 lexidronam can temporarily lower the number of white bloodcells in your blood, increasing the chance of getting an infection. It canalso lower the number of platelets, which are necessary for proper blood clotting. If your blood count becomes abnormally low, thereare certain precautions you can take to reduce the risk of infection or bleeding,such as:

  • With abnormally low white blood cell counts:
    • If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
    • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to cleanyour teeth and gums. Check with your medical doctor before having any dentalwork done.
    • Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
  • With abnormally low platelet blood counts:
    • Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
    • Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
    • Avoid contact sports or other situations where bruising or injurycould occur.


Side Effects of This Medicine

Along with its neededeffects, a medicine may cause some unwanted effects. Blood problems, suchas a decrease in the number of white blood cells or platelets, may occur insome patients using samarium Sm 153 lexidronam.

    Check with your doctor immediately if any of the followingside effects occur:

      More common

        Black, tarry stools; blood in urine or stools; cough or hoarseness; fever or chills; lower back or sidepain; painful or difficult urination; pinpoint red spots on skin; unusualbleeding or bruising

      Also, check with your doctor as soon as possible if you notice the followingside effect:

        Less common

          Irregular heartbeat

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

    Less common

      Increase in bone pain (transient); nausea and vomiting

Other side effects not listed above may also occur in some patients.If you notice any other effects, check with your doctor.


Developed: 12/03/98