Generic Name and Formulations:
Ethylenediaminetetramethylenephosphonic acid (EDTMP) 35mg, Ca 5.3mg, Na 14.1mg (equivalent to Ca/Na EDTMP 44mg), samarium 5–46mcg, 1850 +/- 185MBq of samarium-153; per mL; soln for IV inj; preservative-free.
Lantheus Medical Imaging
Indications for QUADRAMET:
For relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
Ingest a minimum of 500mL of fluids prior to injection and void as often as possible after injection. 1mCi/kg IV over a period of 1 minute through a secure in-dwelling catheter and followed with a saline flush. Radiation dosimetry: see full labeling.
<16yrs: not established.
Should be administered by personnel familiar with radioactive drugs. Compromised bone marrow reserve: not recommended. Cancer patients whose platelet counts are falling or who have findings suggesting disseminated intravascular coagulation. CHF. Renal impairment. Hypocalcemia. Maintain adequate hydration. Thin or obese patients. Monitor blood counts weekly for at least 8 weeks, or until recovery of adequate bone marrow function. Incontinent patients; perform bladder catheterization to minimize radioactive contamination of patients environment. Blood or urine on clothing: wash separately or store for 1–2 weeks to allow for radioactive decay. Latex allergy. Pregnancy (Cat.D); should have negative pregnancy tests before administration; use effective contraception after administration. Nursing mothers: not recommended.
Concomitant chemotherapy or external beam radiation may cause additive effects on bone marrow suppression; avoid.
Radioactive + chelating agent.
Thrombocytopenia, leukopenia, decreased hemoglobin, nausea, vomiting, fever/chills, infection, pain flare reaction, myasthenia, arrhythmias, hematuria; spinal cord compression, agranulocytosis.
Single-dose vial (3mL)—1