QUADRAMET *
Manufacturer Details
DU PONT INC
Compositions:
Samarium SM 153 Lexidronam 1850MBq/ml ( 50 mCi ) at calibration injection in single dose 10 ml vials,
Strength
|
Rate
|
Packing Style
|
1850MBq/ml ( 50 mCi/ml )
|
0.00
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in single dose 10 ml vials
|
List of Related Indications:
- Pain due to osteoblastic metastatic bone lesions
List Of Drugs:
- Samarium SM 153 Lexidronam - @ - Radiopharmaceuticals
Indication Type Description:
Indication:
Pain due to osteoblastic metastatic bone lesions
Adverse Reaction:
Patients with adverse reactions 75%
Cardiovascular- 20% - Arrhythmias 20% Chest pain 2% Hypotension 2%
CNS - 40% Dizziness 1% Paresthesia 6% Spinal cord compression 4%
Dermatologic 18% Rash 2%
GI 45% Abdominal pain 6% Diarrhea 3%
Contra-Indications:
Hypersensitivity
Special Precauions/Warnings-
Bone marrow suppression- Samarium causes bone suppression
use of Samaruim in patients with evidence of compromised bone marrow reserve from
previous therapy or diseases involvment is not recommended.
Hypocalcemia - Caution should be excercised when administering Samarium to patients at risk of develping hypocalcemia
Skeletal - Samarium administration for relief of pain of metastatic bone cancer does not
prevent the development of spinal cord compression. When there is clinical suspicion of
spinal cord compression, appropiate diagnostic and therapeutic measures must be taken
to avoid permanent disability.
Bone marrow suppression- this drug should be used with caution in patients with compromised bone marrow reserves . Samarium cause bone marrow suppression
Incontineance - special precaution such as bladder catherization should be taken with
incontinent patients to minimize the risk of radioactive contamination of clothing
Pregnancy- patient should be adviced about the potential hazard to the fetus.
Women of child bearing age should be advised to avoid becoming pregnant soon after
receiving samiium.
Lactaion- if Samirium is administered formula feedings should be substituted for breastfeeding
Children- safety and efficacy in pediatric patients below the age of 16 years have not been
studied
Monitoring- because of the potential for bone marrow suppression beginning 2 weeks after
samrium administration, blood counts should be monitored for at least 8 weeks or until
recovery of adequate bone marrow function.
Dosages/ Overdosage Etc:
Indication-
Pain due to osteoblastic metastatic bone lesions
Dosage-
Recommended dose -
1mCi /kg administered intravenously over a period of 1 minute through a secure in-dwelling
catheter and followed with saline flush. Dose adjustments in patients at the extremes of weight
have not been studied. Caution should be excercised when determing the dose in very thin
or obese patients
Patient Information:
1. Advice patients that after several hours after administerng samarium radioactivity will be
present in excreted urine. To help protect the patient and others in the surroundings
precautions need to be taken for 12 hours following administration.
2, When possible toiltets should be used rather than a urinal and toilet should be flushed
several times after use.
3. Spilled urine should be cleaned up completly and patients should wash their hands throughly
.
4. If blood or urine gets onto the clothes , the clothing should be washed separately or srored for 1 or 2 weeks to allow for decay of the Sm 153
5. Patient who respond to Samarium might begin to notice the onset of pain relief after 1 week after samarium. Maximum pain relief generally occurs at 3 to 4 weeks after injection of samarium
6. Patients who experience reduction of pain, may be encouraged to decrease their use of opioid analgesics
Pregnancy and lactation:
Pregnancy-
Patient should be adviced about the potential hazard to the fetus.
Women of child bearing age should be advised to avoid becoming pregnant soon after
receiving samiium.
Lactation-
If samirium is adminstered formula feedings should be substituted for breastfeeding
Children-
Safety and efficacy in pediatric patients below the age of 16 years have not been
studied