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Samarium Sm 153 Lexidronam

Pronunciation

(sa MAR ee um es em won fif tee three lex ID roe nam)

Index Terms

  • 153Sm-Lexidronam

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Quadramet: 1850 MBq/mL (3 mL)

Brand Names: U.S.

  • Quadramet

Pharmacologic Category

  • Radiopharmaceutical

Use: Labeled Indications

Relief of pain associated with osteoblastic metastatic bone lesions that demonstrate increased localization on radionuclide bone scans

Contraindications

Known hypersensitivity to ethylenediaminetetramethylenephosphonic acid (EDTMP) or similar phosphonate compounds

Dosage

IV: Adults: 1 mCi/kg (37 MBq/kg)

Dosage adjustment in renal impairment: No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Dosage adjustment in hepatic impairment: No dosage adjustment provided in manufacturer’s labeling. However, dosage adjustment unlikely since studies have not revealed hepatic excretion.

Administration

For IVadministration (over 1 minute). Give 500 mL of fluids (IV or orally) prior to administration. To minimize bladder exposure, patients should void frequently after injection.

Radiopharmaceutical; use appropriate precautions for handling and disposal.

Storage

Store frozen at -20°C to -10°C (-4°F to 14°F) in a lead-shielded container.

Adverse Reactions

>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

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: May cause myelosuppression (leukopenia, thrombocytopenia, and anemia); consider current hematologic status and history of myelosuppressive response to other myelotoxic agents prior to therapy. Evaluate the risk:benefit when combining with other myelotoxic therapies. Avoid myelosuppressive therapies for 4-8 weeks before and for 12 weeks after samarium Sm 153 lexidronam.

• Disseminated intravascular coagulation (DIC): Active DIC may be a risk factor for severe thrombocytopenia following therapy; deaths have occurred in patients with DIC receiving β-emitting radiopharmaceuticals.

Disease-related concerns:

• Incontinence: Incontinent patients may require urinary catheterization to reduce the risk of radioactive contamination of clothes or bed linens.

Special populations:

• Pregnancy: May cause fetal harm if administered during pregnancy.

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: Spinal cord compression (SCC): Not indicated for the treatment of SCC; SCC has been reported in patients receiving samarium Sm 153 lexidronam.

Pregnancy Risk Factor

D

Pregnancy Considerations

Animal studies have not been conducted. There are no adequate and well-controlled studies in pregnant women. Radiopharmaceuticals have the potential to cause fetal harm. Women of childbearing potential should avoid becoming pregnant during or soon after treatment. Both males and females should use effective contraception following treatment.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anemia, leukopenia, thrombocytopenia, dizziness, diarrhea, or considerable osteodynia (rare). Have patient report immediately to prescriber signs of infection, ecchymosis, hemorrhaging, or severe asthenia (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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