Pronunciation:

sa-MAR-ee-um Sm 153 lex-ID-roe-nam

Brand Names:

• Quadramet

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Radiopharmaceutical, Antineoplastic

Uses of This Medicine:

Samarium Sm 153 lexidronam injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to find and treat certain diseases or to study the function of the body's organs.

Samarium Sm 153 lexidronam injection is used to help relieve bone pain that may occur with certain kinds of cancer. The radioactive samarium is taken up in the bone cancer area and gives off radiation that helps provide relief from pain.

Samarium Sm 153 lexidronam is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine or radiation oncology.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of samarium Sm 153 lexidronam injection in children younger than 16 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of samarium Sm 153 lexidronam injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bladder control problem (eg, urinary incontinence)—Special precautions will need to be taken to prevent radiation contamination of clothing, bed linens, and the environment.

• Blood problems (eg, bone marrow problems, blood clots) or
• Congestive heart failure, history of or
• Heart rhythm problems (eg, arrhythmia)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A doctor or other health professional will give you this medicine. It is given through a needle placed into a vein.

Drink plenty of fluids before and after receiving this medicine so you will pass more urine. This will help flush the medicine from your body.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects

You will be exposed to radiation when you are given this medicine. Talk with your doctor if you have concerns about this.

This medicine is passed mainly in the urine where radioactivity is present. Follow these guidelines for 12 hours after receiving samarium Sm 153 lexidronam injection, to help reduce the chance of contaminating other persons or the environment with radiation:

• Use a normal toilet, if available, instead of a urinal.
• To prevent contamination of your home environment, flush the toilet several times after using.
• Wipe any spilled urine with a tissue and flush it away.
• Wash your hands after using or cleaning the toilet.
• Wash your clothes and bed linens right away if they become soiled with your urine or blood. Wash them separately from other clothes or store them for 1 to 2 weeks.
• If you cut yourself, wash away any spilled blood.

Samarium Sm 153 lexidronam can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk of developing blood clots (eg, disseminated intravascular coagulation). This is more likely if you have cancer that has spread to other parts of your body. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.

The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

chest pain

chills

cough

dizziness

fainting

fast, slow, or irregular heartbeat

fever

hoarseness

lower back or side pain

painful or difficult urination

pinpoint red spots on the skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

worsening of pain, temporary

Less common

Bloody nose

blurred vision

confusion

cough producing mucus

difficulty breathing

difficulty in speaking

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

double vision

headache

inability to move the arms, legs, or facial muscles

inability to speak

large, flat, blue or purplish patches in the skin

nervousness

pain or swelling in the arms or legs without any injury

pounding in the ears

problems with bleeding or clotting

slow speech

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

Rare

Arm, back, or jaw pain

chest discomfort

decreased urine output

dilated neck veins

extreme weakness or tiredness

irregular breathing

nausea

swelling of the face, fingers, feet, or lower legs

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

loss of strength or energy

muscle pain or weakness

stomach pain

vomiting

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Rare

Loss or thinning of hair

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.