Quadramet

DRUG 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:

QUADRAMET® (samarium lexidronam pentasodium) Structural Formula Illustration

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.

Physical Characteristics: Samarium-153 is produced in high yield and purity by neutron irradiation of isotopically enriched samarium Sm 152 oxide (152 Sm2O3). It emits both medium-energy beta particles and a gamma photon, and has a physical half-life of 46.3 hours (1.93 days). Samarium-153 has average and maximum beta particle ranges in water of 0.5 mm and 3.0 mm, respectively. The primary radiation emissions of samarium-153 are shown in Table 1.

TABLE 1 - SAMARIUM-153 PRINCIPAL RADIATION EMISSION DATA

  Radiation Energy (keV)* Abundance
Beta 640 30%
Beta 710 50%
Beta 810 20%
Gamma 103 29%
* Maximum energies are listed for the beta emissions, the average beta particle energy is 233 keV.

External Radiation: The specific gamma-ray constant for samarium-153 is 0.46 R/mCi-hr at 1 cm (1.24x10-5 mSv/MBq- hr at 1 Meter). The half-value thickness of lead (Pb) for samarium-153 is approximately 0.10 mm. The use of 1 mm of lead will decrease the external radiation exposure by a factor of approximately 1,000. QUADRAMET® (samarium sm 153 lexidronam) should be stored in a lead-shielded container and frozen until use. Radioactive decay factors to be applied to the stated value for radioactive concentration at calibration are given in Table 2. All radioactivity is calibrated to the reference date and time on the vial.

TABLE 2 - SAMARIUM-153 PHYSICAL DECAY CHART, HALF-LIFE 46.3 HOURS (1.93 DAYS)

Time (hour)* Factor Time (hour)* Factor
-48.0 2.05 +1.0 0.99
-36.0 1.71 +2.0 0.97
-24.0 1.43 +3.0 0.96
-20.0 1.35 +4.0 0.94
-16.0 1.27 +6.0 0.91
-12.0 1.20 +8.0 0.89
-8.0 1.13 +12.0 0.84
-6.0 1.09 +16.0 0.80
-4.0 1.06 +20.0 0.74
-3.0 1.05 +24.0 0.70
-2.0 1.03 +36.0 0.58
-1.0 1.02 +48.0 0.49
*Time = hours before (-) or after (+) calibration

What are the precautions when taking samarium sm 153 lexidronam (Quadramet)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart failure, irregular heartbeat), kidney problems, urinary/bladder problems (e.g., incontinence), decreased bone marrow function, blood disorders (e.g., bleeding problems, low platelet count, blood clotting problems), weakened immune system, low blood calcium levels.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently...

Read All Potential Precautions of Quadramet »


Quadramet Consumer (continued)

SIDE EFFECTS: Diarrhea, dizziness, or a temporary increase in bone pain (pain flare) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection (e.g., fever, chills, persistent sore throat/cough, pain when you urinate).

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy or unusual bleeding/bruising (e.g., bloody nose, bloody/black/tarry stools, bloody/pink urine), unusual weakness/tiredness, pounding/persistent headache, fast/slow/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., heart failure, irregular heartbeat), kidney problems, urinary/bladder problems (e.g., incontinence), decreased bone marrow function, blood disorders (e.g., bleeding problems, low platelet count, blood clotting problems), weakened immune system, low blood calcium levels.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Women should have a negative pregnancy test before treatment. It is recommended that men and women receiving this medication use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) to prevent pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control.

It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.



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