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Quadramet Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Radioactive + chelating agent.
How Supplied
Single-dose vial (3mL)—1
Manufacturer
Quadramet Indications
Indications
For relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
Quadramet Dosage and Administration
Adult
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.
Children
<16yrs: not established.
Quadramet Contraindications
Not Applicable
Quadramet Boxed Warnings
Not Applicable
Quadramet Warnings/Precautions
Warnings/Precautions
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.
Quadramet Pharmacokinetics
See Literature
Quadramet Interactions
Interactions
Concomitant chemotherapy or external beam radiation may cause additive effects on bone marrow suppression; avoid.
Quadramet Adverse Reactions
Adverse Reactions
Thrombocytopenia, leukopenia, decreased hemoglobin, nausea, vomiting, fever/chills, infection, pain flare reaction, myasthenia, arrhythmias, hematuria; spinal cord compression, agranulocytosis.
Quadramet Clinical Trials
See Literature
Quadramet Note
Not Applicable
Quadramet Patient Counseling
See Literature
