Dosing and uses of Quadramet (samarium sm 153 lexidronam)
Adult dosage forms and strengths
injectable solution
- 50mCi/mL
Metastatic Bone Pain Relief
1 mCi/kg IV
Through secure in-dwelling catheter over 1 minute, followed with saline flush
Patient should ingest (or given by IV) 500 mL fluid & void as often as possible to minimize bladder radiation exposure
Pediatric dosage forms and strengths
< 16 years old: Safety & efficacy not established
Quadramet (samarium sm 153 lexidronam) adverse (side) effects
>10%
Thrombocytopenia (69.3%)
Leukopenia (59.3%)
Hgb decr (40.7%)
Nausea/vomiting (32.7%)
1-10% (undefined)
Arrhythmias
CVA
Ecchymosis
Epistaxis
HTn
Hypotension
Dizziness
Fever
Paresthesia
Pathologic fx
Spinal cord compression
Purpura
Rash
Abdominal pain
Diarrhea
Coagulation d/o
Hematuria
Bronchitis
Chest pain
Pneumonia
Infections
Lymphadenopathy
Oral candidiasis
Pain flare rxn
Myasthenia
Warnings
Contraindications
Hypersensitivity
Cautions
CHF, renal impairment, bone marrow depression
Avoid pregnancy
Causes myelosuppression
Does not prevent spinal cord compression
Pts at risk for hypocalcemia
Pt's urine will be radioactive for several hr, take appropriate precautions
Pregnancy and lactation
Pregnancy category: d
Lactation: discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Quadramet (samarium sm 153 lexidronam)
Metabolism: none
Excretion: urine 20-50%
Mechanism of action
Tetraphosphonate chelating agent that concentrates in bone - precise mechanism unknown
Administration
IV Administration
Over 1 min through in-dwelling catheter
Do not dilute or mix with other solutions
Contains calcium - may form calcium precipitates with chemicals that complex with calcium
Storage
Store frozen at -10°C to -20°C in lead-shielded container
Expires 48 hr after time of calibration (noted on label) or 8 hr after thawing, whichever is earlier