Version May 2024
Note: Dose adjustments for extremes of weight have not been studied; use caution when determining dose for very thin or obese patients.
Osteoblastic metastatic bone lesion pain: IV: 1 mCi/kg (37 MBq/kg)
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use with caution, patients with renal insufficiency may not tolerate the recommended hydration.
There are no dosage adjustments provided in the manufacturer's labeling. However, a need for dosage adjustment is unlikely since studies have not revealed hepatic excretion.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Hematologic: Thrombocytopenia (69%), leukopenia (59%), anemia (41%)
1% to 10%:
Cardiovascular: Arrhythmias, hypertension, stroke
Central nervous system: Dizziness
Dermatologic: Ecchymosis
Gastrointestinal: Diarrhea
Neuromuscular & skeletal: Bone pain, spinal cord compression
Renal: Hematuria
Respiratory: Bronchitis, epistaxis
Known hypersensitivity to ethylenediaminetetramethylenephosphonic acid (EDTMP), similar phosphonate compounds, or any component of the formulation
Concerns related to adverse effects:
• Bone marrow suppression: May cause myelosuppression (leukopenia, thrombocytopenia, and anemia). White blood cell and platelet nadir usually occur within 3 to 5 weeks, with recovery by 8 weeks; monitor blood counts for at least 8 weeks or until adequate marrow recovery. Consider current hematologic status and history of myelosuppressive response to other myelotoxic agents prior to therapy. Due to potential for additive hematologic toxicity, avoid concurrent chemotherapy and external beam radiation therapy unless benefits outweigh risks.
• Bone pain flare: A transient increase in bone pain (usually mild) occurring within 3 days of administration has been reported in some patients; may be managed with analgesics.
• Disseminated intravascular coagulation (DIC): Active DIC may be a risk factor for severe thrombocytopenia following therapy; deaths have occurred in patients with DIC receiving beta-emitting radiopharmaceuticals.
Disease-related concerns:
• Heart failure: Use with caution in patients with heart failure; recommended hydration to promote urinary excretion may be poorly tolerated and may require additional supportive management.
• Hypocalcemia: Use with caution in patients at risk for developing hypocalcemia (low calcium levels have been reported).
• Incontinence: Incontinent patients may require urinary catheterization to reduce the risk of radioactive contamination of clothes or bed linens.
• Renal insufficiency: Use with caution in patients with renal insufficiency; recommended hydration to promote urinary excretion may be poorly tolerated and may require additional supportive management.
Special populations:
• Weight extremes: Dose adjustments for extremes of weight have not been studied; use caution when determining dose for very thin or obese patients.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Appropriate use: Verify the radioactivity dose to be administered prior to administration. Patients should not be released until their radioactivity levels and exposure rates comply with federal and local regulations. Samarium Sm 153 lexidronam will not prevent and is not indicated for the treatment of spinal cord compression.
• Latex: Vial stopper may contain latex.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous [preservative free]:
Quadramet: 1850 MBq/mL (1 ea [DSC])
No
Solution (Quadramet Intravenous)
1850 mbq/ml (per each): $19,539.46
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer over 1 minute through a secure in-dwelling catheter, followed by a saline flush. Do not dilute or mix with other solutions. Give 500 mL of fluids (IV or orally) prior to administration. To minimize bladder exposure, patients should void as soon as possible after injection. Precautions should be taken for 12 hours following administration. If possible, patients should urinate in a toilet (rather than a urinal); flush the toilet several times after each use. Promptly clean any spilled urine; if blood or urine is on clothing, wash separately or store for 1 to 2 weeks to allow for radioactive decay.
Radiopharmaceutical; use appropriate precautions for handling and disposal.
Osteoblastic metastatic bone lesion pain: Relief of pain associated with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
Women of reproductive potential should have a negative pregnancy test prior to treatment and avoid becoming pregnant during or soon after treatment. Both males and females should use effective contraception following treatment.
Animal reproduction studies have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm.
It is not known if samarium Sm 153 lexidronam is excreted in breast milk; however, based on assumptions and calculations, the patient must be instructed to cease breastfeeding (US Nuclear Regulatory Commission 1977). Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made to discontinue breastfeeding for administration of samarium sm 153 lexidronam; if samarium sm 153 lexidronam is administered, the manufacturer recommends substituting formula for breastfeeding.
CBC with differential and platelets weekly for at least 8 weeks (or until adequate marrow recovery); signs/symptoms of disseminated intravascular coagulation (DIC); signs/symptoms of hypocalcemia (in patients at risk for developing hypocalcemia); fluid status in patients with renal insufficiency or heart failure
Samarium Sm-153 EDTMP has an affinity for bone and concentrates in areas of bone turnover in association with hydroxyapatite. Samarium Sm-153 EDTMP is taken up at the site of the bone metastases to deliver local radiation. In studies, samarium accumulated ~5 times more in osteoblastic lesions than in normal bone.
Onset: Pain relief: 1 week; maximum pain relief occurs at 3 to 4 weeks
Excretion: Urine (34.5% ± 15.5% in the first 6 hours)
Altered kidney function: Approximately one-third of Samarium Sm 153 EDTMP is excreted in the urine; clearance may be reduced in patients with renal impairment.
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