Quadramet

What is Quadramet used for?

Quadramet is a prescription medicine that is used to treat bone pain caused by cancer.

Description

QUADRAMET® (samarium sm 153 lexidronam) is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® (samarium sm 153 lexidronam) is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration.

QUADRAMET® (samarium sm 153 lexidronam) does not contain a preservative.

Each milliliter contains 35 mg EDTMP•H₂O, 5.3 mg Ca [as Ca(OH)₂], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.

The structural formula of samarium lexidronam pentasodium is:

The ionic formula is ¹⁵³Sm⁺³ [CH₂N(CH₂PO₃^-2)₂]₂ and the ionic formula weight is 581.1 daltons (pentasodium form, 696).

The pH of the solution is 7.0 to 8.5.

QUADRAMET® (samarium sm 153 lexidronam) is supplied frozen in single-dose glass vials containing 3 mL with 5550 MBq (150 mCi) of samarium-153 at calibration.

Before taking Quadramet, tell your doctor:

• If you are allergic to Quadramet; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed after getting Quadramet for as long as your doctor has told you.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Quadramet with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Quadramet?

• Tell all of your health care providers that you take Quadramet. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• It may take a few weeks to see the full effect.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine is radioactive. You will need to follow what the doctor has told you to lessen being exposed to Quadramet.
• Empty your bladder often for the first 12 hours after getting Quadramet.
• Use the toilet instead of a urinal.
• Use the same toilet each time you use the bathroom in your home. Sit down on the toilet to urinate to keep urine from splashing or spraying. Flush the toilet a few times after each use.
• Clean up any spilled urine right away. Wash your hands well after cleaning up.
• If blood or urine gets onto clothing, wash the clothing by itself. You may also store the clothing for 1 to 2 weeks until the drug goes away.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Quadramet to show that you are NOT pregnant.
• Women must use birth control while taking Quadramet and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking Quadramet and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is Quadramet best taken?

Use Quadramet as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• Drink lots of noncaffeine liquids after using Quadramet unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• This medicine will be given on an as needed basis in a healthcare setting.

What are the side effects of Quadramet that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Feeling very tired or weak.
• A heartbeat that does not feel normal.

What are some other side effects of Quadramet?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or diarrhea.
• More bone pain may rarely happen. Mild pain drugs may help. Call the doctor if this does not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Quadramet?

• If you need to store Quadramet at home, talk with your doctor, nurse, or pharmacist about how to store it.

SRC: NLM .