Samarium sm 153 lexidronam (Intravenous)

Samarium Sm 153 lexidronam injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive substances that can be used to detect and treat specific diseases or to examine how the body's organs work.

Samarium Sm 153 lexidronam injection is used to help relieve bone pain that may happen with certain types of cancer. The radioactive samarium is absorbed in the area affected by bone cancer and releases radiation that helps reduce pain.

Samarium Sm 153 lexidronam should only be given by or under the close supervision of a doctor who has specialized training in nuclear medicine or radiation oncology.

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

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

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

• Use a normal toilet, if available, instead of a urinal.
• To prevent contamination of your home, flush the toilet several times after using it.
• Wipe up 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 happens, 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 doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your 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 using sharp objects such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk of developing blood clots (e.g., 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.

In deciding to use a medicine, you and your doctor will need to consider the risks of the medicine compared to the benefits it may provide. For this medicine, the following points should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine the effects of samarium Sm 153 lexidronam injection in children younger than 16 years. Safety and effectiveness have not been established in this age group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of samarium Sm 153 lexidronam injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might occur. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at the same time as food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Bladder control problems (e.g., urinary incontinence)—Special precautions will be needed to avoid radiation contamination of clothing, bed linens, and the environment.

• Blood problems (e.g., bone marrow issues, blood clots) or
• Congestive heart failure, history of or
• Heart rhythm problems (e.g., arrhythmia)—Use with caution. This may worsen these conditions.

• Kidney disease—Use with caution. The effects may be stronger due to the slower removal of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

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
• Temporary worsening of pain

Less common

• Bloody nose
• Blurred vision
• Confusion
• Cough producing mucus
• Difficulty breathing
• Difficulty speaking
• Dizziness, faintness, or lightheadedness when getting up quickly 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 on 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. Your healthcare professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Quadramet

Available Dosage Forms:

• Solution

Therapeutic Class: Radiopharmaceutical, Antineoplastic

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.