Quadramet (Intravenous)

Samarium Sm 153 lexidronam injection is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that can be used to find and treat certain diseases or to study 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 of bone cancer and emits radiation that helps reduce 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.

It is very important that your doctor checks 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 receive this medicine. Talk with your doctor if you have concerns about this.

This medicine is mainly passed 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 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 your 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 (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 need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Appropriate studies have not been done on how samarium Sm 153 lexidronam injection affects children younger than 16 years. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any problems specific to older adults that would limit the use of samarium Sm 153 lexidronam injection in the elderly.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if interactions could occur. In these situations, your doctor may need to 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 taken near mealtime or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Bladder control problem (e.g., urinary incontinence)—Special precautions will be necessary to prevent 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. These conditions may worsen.

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may also cause some unwanted effects. Not everyone will experience these side effects, but if they do happen, you may need medical help.

Contact your doctor or nurse right away if you notice any of the following side effects:

More common

• Black, tarry stools
• Bleeding gums
• Blood in 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 that produces mucus
• Difficulty breathing
• Difficulty speaking
• Dizziness, faintness, or lightheadedness when standing up quickly from lying or sitting
• Double vision
• Headache
• Inability to move arms, legs, or facial muscles
• Inability to speak
• Large, flat, blue or purplish patches on the skin
• Nervousness
• Pain or swelling in arms or legs without 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 require medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have suggestions to help prevent or lessen some of these side effects. Contact your health care professional if any of the following side effects continue, are bothersome, or if you have 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 sensations

Rare

• Loss or thinning of hair

Other side effects not listed may also happen in some patients. If you notice any other effects, consult 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.