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Samarium Sm 153 Lexidronam

Medically reviewed by Drugs.com. Last updated on Jun 24, 2020.

Pronunciation

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

Index Terms

  • 153Sm-Lexidronam
  • Samarium-153 Lexidronam

Dosage Forms

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

Solution, Intravenous [preservative free]:

Quadramet: 1850 MBq/mL (1 ea)

Brand Names: U.S.

  • Quadramet

Pharmacologic Category

  • Radiopharmaceutical

Pharmacology

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.

Excretion

Excretion: Urine (34.5% ± 15.5% in the first 6 hours)

Onset of Action

Pain relief: 1 week; maximum pain relief occurs at 3 to 4 weeks

Special Populations: Renal Function Impairment

Approximately one-third of Samarium Sm 153 EDTMP is excreted in the urine; clearance may be reduced in patients with renal impairment.

Use: Labeled Indications

Osteoblastic metastatic bone lesion pain: Relief of pain associated with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

Contraindications

Known hypersensitivity to ethylenediaminetetramethylenephosphonic acid (EDTMP), similar phosphonate compounds, or any component of the formulation

Dosing: Adult

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)

Reconstitution

Radiopharmaceutical; use appropriate precautions for handling and disposal. Wear gloves and use adequate shielding for handling and administration. Measure the appropriate dose using a suitable radioactivity calibration system immediately prior to administration. Do not dilute or mix with other solutions. Thaw at room temperature prior to administration.

Administration

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.

Storage

Store frozen at -10°C to -20°C (14°F to -4°F) in a lead-shielded container. Product expires within 56 hours of calibration or within 8 hours of thawing, whichever occurs earlier.

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). 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.

Monitoring Parameters

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

Reproductive Considerations

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.

Pregnancy Risk Factor

D

Pregnancy Considerations

Animal reproduction studies have not been conducted. All radiopharmaceuticals have the potential to cause fetal harm.

Patient Education

What is this drug used for?

• It is used to treat bone pain caused by cancer.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Diarrhea

• Increased bone pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any bleeding that is very bad or that will not stop

• Severe loss of strength and energy

• Abnormal heartbeat

• Burning or numbness feeling

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.