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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 19.03.2022
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Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
Samarium SM 153 Lexidronam is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to diagnose some diseases by studying the function of the body's organs or to treat certain diseases.
Samarium SM 153 Lexidronam is used to help relieve the bone pain that may occur with certain kinds of cancer. The radioactive samarium is taken up in the bone cancer area and gives off radiation that helps provide relief of pain.
Samarium SM 153 Lexidronam is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine or radiation oncology.
The recommended dose of Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) is 1.0 mCi/kg, administered intravenously over a period of one minute through a secure in-dwelling catheter and followed with a saline flush. Dose adjustment in patients at the extremes of weight have not been studied. Caution should be exercised when determining the dose in very thin or very obese patients.
The dose should be measured by a suitable radioactivity calibration system, such as a radioisotope dose calibrator, immediately before administration.
The dose of radioactivity to be administered and the patient should be verified before administering Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam). Patients should not be released until their radioactivity levels and exposure rates comply with federal and local regulations.
The patient should ingest (or receive by i.v. administration) a minimum of 500 mL (2 cups) of fluids prior to injection and should void as often as possible after injection to minimize radiation exposure to the bladder.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should not be used if it is cloudy or if it contains particulate matter.
Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) contains calcium and may be incompatible with solutions that contain molecules that can complex with and form calcium precipitates.
Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) should not be diluted or mixed with other solutions.
Thaw at room temperature before administration and use within 8 hours of thawing.
Radiation Dosimetry: The estimated absorbed radiation doses to an average 70 kg adult patient from an i.v. injection of Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) are shown in Table 7. The dosimetry estimates were based on clinical biodistribution studies using methods developed for radiation dose calculations by the Medical Internal Radiation Dose (MIRD) Committee of the Society of Nuclear Medicine. Radiation exposure is based on a urinary voiding interval of 4.8 hours.
Radiation dose estimates for bone and marrow assume that radioactivity is deposited on bone surfaces, as noted in autoradiograms of biopsy bone samples in 7 patients who received Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam). Although electron emissions from Sm are abundant, with energies up to 810 keV, rapid blood clearance of Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) and low energy and abundant photon emissions generally result in low radiation doses to those parts of the body where the complex does not localize.
When blastic osseous lesions are present, significantly enhanced localization of the radiopharmaceutical will occur, with correspondingly higher doses to the lesions compared with normal bones and other organs..
TABLE 7: RADIATION ABSORBED DOSES
| 70 kg ADULT | ||
| Target Organ | Rad/mCi | mGy/MBq |
| Bone Surfaces | 25.0 | 6.76 |
| Red Marrow | 5.70 | 1.54 |
| Urinary Bladder Wall | 3.60 | 0.097 |
| Kidneys | 0.065 | 0.018 |
| Whole Body | 0.040 | 0.011 |
| Lower large intestine | 0.037 | 0.010 |
| Ovaries | 0.032 | 0.0086 |
| Muscle | 0.028 | 0.0076 |
| Small Intestine | 0.023 | 0.0062 |
| Upper Large Intestine | 0.020 | 0.0054 |
| Testes | 0.020 | 0.0054 |
| Liver | 0.019 | 0.0051 |
| Spleen | 0.018 | 0.0049 |
| Stomach | 0.015 | 0.0041 |
How supplied
Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) is supplied frozen in a single-dose 10 mL glass vial containing 1850
Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) is contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds.
Use: Labeled Indications
Osteoblastic metastatic bone lesion pain: Relief of pain associated with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.
The potential for additive bone marrow toxicity of Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) with chemotherapy or external beam radiation has not been studied. Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) should not be given after either of these treatments until there has been time for adequate marrow recovery..
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What are the possible side effects of Samarium SM 153 Lexidronam?
Adverse events were evaluated in a total of 580 patients who received Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) in clinical trials. Of the 580 patients, there were 472 men and 108 women with a mean age of 66 (range 20 to 87).
Of these patients, 472 (83%) had at least one adverse event. In a subgroup of 399 patients who received Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) 1.0 mCi/kg, there were 23 deaths and 46 serious adverse events. The deaths occurred an average of 67 days (9 to 130) after Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam). Seriou events occurred an average of 46 days (1 - 118) after Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam). Although most of the patient deaths and serious adverse events appear to be related to the underlying disease, the relationship of end stage disease, marrow invasion by cancer cells, previous myelotoxic treatmen and Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) toxicity can not be easily distinguished. In clinical studies, two patients with rapidly progressive prostate cancer developed thrombocytopenia and died 4 weeks after receiving Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam). One of the patients showed evidence of disseminated intravascular coagulation (DIC); the other patient experienced a fatal cerebrovascular accident, with a suspicion of DIC. The relationship of the DIC to the bone marrow suppressive effect of Samarium is not known. Marrow toxicity occurred in 277 (47%) patients.
In controlled studies, 7% of patients receiving 1.0 mCi/kg Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) (as compared to 6% of patients receiving placebo) reported a transient increase in bone pain shortly after injection (flare reaction). This was usually mild, self-limiting, and responded to analgesics.
The most common adverse events observed in controlled clinical studies of Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam), are given in Table 6.
TABLE 6: SELECTED ADVERSE EVENTS REPORTED IN GREATER THAN OR EQUAL TO 1.0 % OF PEOPLE WHO RECEIVED Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) OR PLACEBO IN CONTROLLED CLINICAL TRIALS
| ADVERSE EVENT | Placebo | Samarium SM 153 Lexidronam® 1.0 mCi/kg |
| N = 90 | N = 199 | |
| # Patients with Any Adverse Event | 72 (80%) | 169 (85%) |
| Body As A Whole | 56 (62%) | 100 (50%) |
| Pain Flare Reaction | 5 (5.6%) | 14 (7.0%) |
| Cardiovascular | 19 (21%) | 32 (16%) |
| Arrhythmias | 2 (2.2%) | 10 (5.0%) |
| Chest Pain | 4 (4.4%) | 8 (4.0%) |
| Hypertension | 0 | 6 (3.0%) |
| Hypotension | 2 (2.2%) | 4 (2.0%) |
| Digestive | 44 (49%) | 82 (41%) |
| Abdominal Pain | 7 (7.8%) | 12 (6.0%) |
| Diarrhea | 3 (3.3%) | 12 (6.0%) |
| Nausea &/or Vomiting | 37 (41.1%) | 65 (32.7%) |
| Hematologic & Lymphatic | 12 (13%) | 54 (27%) |
| Coagulation Disorder | 0 | 3 (1.5%) |
| Hemoglobin Decreased | 21 (23.3%) | 81 (40.7%) |
| Leukopenia | 6 (6.7%) | 118(59.3%) |
| Lymphadenopathy | 0 | 4 (2.0%) |
| Thrombocytopenia | 8 (8.9%) | 138(69.3%) |
| Any Bleeding Manifestations* | 8 (8.9%) | 32 (16.1%) |
| Ecchymosis | 1 (1.1%) | 3 (3.0%) |
| Epistaxis | 1 (1.1%) | 4 (2.0%) |
| Hematuria | 3 (3.3%) | 10 (5%) |
| Infection | 10 (11.1%) | 34 (17.1%) |
| Fever and/or Chills | 10 (11.1%) | 17 (8.5%) |
| Infection, Not Specified | 4 (4.4%) | 14 (7.0%) |
Oral Moniliasis | 1 (1.1%) | 4 (2.0%) |
| Pneumonia | 1 (1.1%) | 3 (1.5%) |
| Musculoskeletal | 28 (31%) | 55 (27%) |
| Myasthenia | 8 (8.9%) | 13 (6.5%) |
| Pathologic Fracture | 2 (2.2%) | 5 (2.5%) |
| Nervous | 39 (43%) | 59 (30%) |
| Dizziness | 1 (1.1%) | 8 (4.0%) |
| Paresthesia | 7 (7.8%) | 4 (2.0%) |
| Spinal Cord Compression | 5 (5.5%) | 13 (6.5%) |
| Cerebrovascular Accident/Stroke | 0 | 2 (1.0%) |
| Respiratory | 24 (27%) | 35 (18%) |
| Bronchitis/Cough Increased | 2 (2.2%) | 8 (4.0%) |
| Special Senses | 11 (12%) | 11 (6%) |
| Skin & Appendages | 17 (19%) | 13 (7%) |
| Purpura | 0 | 2 (1%) |
| Rash | 2 (2.2%) | 2 (1%) |
| *Includes hemorrhage (gastrointestinal, ocular) reported in <1%. |
In an additional 200 patients who received Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) in uncontrolled clinical trials, adverse events that were reported at a rate of greater than or equal to 1.0% were similar except for 9 (4.5%) patients who had agranulocytosis. Other selected adverse events that were reported in <1% of the patients who received Samarium SM 153 Lexidronam® (Samarium SM 153 Lexidronam) 1.0 mCi/kg in any clinical trial include: alopecia, angina, congestive heart failure, sinus bradycardia, and vasodilation.