Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 1,850 MBq/mL
Metastatic Bone Pain Relief
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
< 16 years old: Safety & efficacy not established
Adverse Effects
>10%
Thrombocytopenia (69.3%)
Leukopenia (59.3%)
Anemia (40.7%)
Nausea/vomiting (32.7%)
Frequency Not Defined
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 to drug, similar phosphate compounds, or components of the formulation
Cautions
May cause myelosuppression; recovery may occur after 8 wks; monitor blood counts for at least 8 wks or until adequate marrow recovery; consider current hematologic status and history of myelosuppressive response to other myelotoxic agents prior to therapy; avoid concurrent chemotherapy and external beam radiation therapy unless benefits outweigh risks, due to potential to additive toxicity
Avoid pregnancy
Thrombocytopenia may be a risk factor in patients with disseminated intravascular coagulation
Transient increase in bone pain may occur within 3 days of administration; may manage with analgesics
Use appropriate precautions in handling and disposal of drug product
Incontinent patients may require urinary catherization to reduce radioactive contamination
Does not prevent spinal cord compression
Incontinent patients may require urinary catherization to reduce risk of radioactive contamination of clothes or bed linens
Patients are at risk for hypocalcemia; whether therapy causes electrocardiographic changes or arrhythmias not studied; caution and appropriate monitoring should be given when administering therapy
Patients urine will be radioactive for several hr, take appropriate precautions
Because concomitant hydration recommended to promote urinary excretion of drug, appropriate monitoring and consideration of additional supportive treatment should be used in patients with a history of congestive heart failure or renal insufficiency
Because approximately one third of drug is excreted in urine, clearance may be reduced in patients with renal impairment not known if dose adjustment needed
Pregnancy & 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
Mechanism of Action
Tetraphosphonate chelating agent that concentrates in bone - precise mechanism unknown
Pharmacokinetics
Metabolism: None
Excretion: urine 20-50%
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
Images
Formulary
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