Samarium (153Sm) lexidronam

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Samarium (153Sm) lexidronam
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Samarium (153Sm) lexidronam is a that is FDA approved for the {{{indicationType}}} of . Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
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Condition3
  • Dosing Information
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Condition4
  • Dosing Information
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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Samarium (153Sm) lexidronam in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Samarium (153Sm) lexidronam in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Samarium (153Sm) lexidronam in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Samarium (153Sm) lexidronam in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Samarium (153Sm) lexidronam in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Samarium (153Sm) lexidronam in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Samarium (153Sm) lexidronam in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Samarium (153Sm) lexidronam in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Samarium (153Sm) lexidronam during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Samarium (153Sm) lexidronam with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Samarium (153Sm) lexidronam with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Samarium (153Sm) lexidronam with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Samarium (153Sm) lexidronam with respect to specific gender populations.

Race

There is no FDA guidance on the use of Samarium (153Sm) lexidronam with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Samarium (153Sm) lexidronam in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Samarium (153Sm) lexidronam in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Samarium (153Sm) lexidronam in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Samarium (153Sm) lexidronam in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Samarium (153Sm) lexidronam in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Samarium (153Sm) lexidronam in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Samarium (153Sm) lexidronam in the drug label.

Pharmacology

There is limited information regarding Samarium (153Sm) lexidronam Pharmacology in the drug label.

Mechanism of Action

  • The mechanism of action of QUADRAMET® in relieving the pain of bone metastases is not known.

Structure

  • QUADRAMET® is a therapeutic agent consisting of radioactive samarium and a tetraphosphonate chelator, ethylenediaminetetramethylenephosphonic acid (EDTMP). QUADRAMET® is formulated as a sterile, non-pyrogenic, clear, colorless to light amber isotonic solution of samarium-153 lexidronam for intravenous administration. QUADRAMET® does not contain a preservative.
  • Each milliliter contains 35 mg EDTMP•H2O, 5.3 mg Ca [as Ca(OH)2], 14.1 mg Na [as NaOH], equivalent to 44 mg Ca/Na EDTMP (anhydrous calc.), 5-46 µg samarium (specific activity of approximately 1.0-11.0 mCi/µg Sm), and 1850 ± 185 MBq (50 ± 5 mCi) of samarium-153 at calibration.
  • The structural formula of samarium lexidronam pentasodium is:
This image is provided by the National Library of Medicine.
  • The ionic formula is 153Sm+3 [CH2N(CH2PO3-2)2]2 and the ionic formula weight is 581.1 daltons (pentasodium form, 696).
  • The pH of the solution is 7.0 to 8.5.
  • QUADRAMET® is supplied frozen in single-dose glass vials containing 3 mL with 5550 MBq (150 mCi) of samarium-153 at calibration.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Samarium (153Sm) lexidronam in the drug label.

Pharmacokinetics

  • Distribution
  • Human protein binding has not been studied; however, in dog, rat and bovine studies, less than 0.5% of samarium-153 EDTMP is bound to protein. At physiologic pH, >90% of the complex is present as 153Sm[EDTMP]-5, and <10% as 153SmH[EDTMP]-4. The octanol/ water partition coefficient is <10-5.
  • Skeletal Uptake
  • The greater the number of metastatic lesions, the more skeletal uptake of Sm-153 radioactivity. The relationship between skeletal uptake and the size of the metastatic lesions has not been studied. The total skeletal uptake of radioactivity was 65.5%± 15.5% of the injected dose in 453 patients with metastatic lesions from a variety of primary malignancies. In a study of 22 patients with a wide range in the number of metastatic sites, the % of the injected dose (% ID) taken up by bone ranged from 56.3% in a patient with 5 metastatic lesions to 76.7% in a patient with 52 metastatic lesions. If the number of metastatic lesions is fixed, over the range 0.1 to 3.0 mCi/kg, the % ID taken up by bone is the same regardless of the dose.
  • Metabolism
  • The complex formed by samarium and EDTMP is excreted as an intact, single species that consists of one atom of the Sm-153 and one molecule of the EDTMP, as shown by an analysis of urine samples from patients (n=5) administered samarium Sm-153 EDTMP. Metabolic products of samarium Sm-153 EDTMP were not detected in humans.
  • Elimination
  • For QUADRAMET®, calculations of the % ID detected in the whole body, urine and blood were corrected for radionuclide decay. The clearance of activity through the urine is expressed as the cumulated activity excreted. The whole body retention is the simple reciprocal of the cumulated urine activity. (See Skeletal Uptake Section).
  • lood: Clearance of radioactivity from the blood demonstrated biexponential kinetics after intravenous injection in 19 patients (10 men, 9 women) with a variety of primary cancers that were metastatic to bone. Over the first 30 minutes, the radioactivity (mean ± SD) in the blood decreased to 15% (±8%) of the injected dose with a t 1/2 of 5.5 min (±1.1 min). After 30 minutes, the radioactivity cleared from the blood more slowly with a t1/2 of 65.4 min (± 9.6 min). Less than 1% of the dose injected remained in the blood 5 hr after injection.
  • Urine: Samarium Sm-153 EDTMP radioactivity was excreted in the urine after intravenous injection. During the first 6 hours, 34.5% (±15.5%) was excreted. Overall, the greater the number of metastatic lesions, the less radioactivity was excreted.
  • Gender Differences
  • Gender did not affect the samarium Sm-153 EDTMP blood pharmacokinetics, the cumulative % of radioactivity excreted in urine, or the % radioactivity retained in the skeleton when the number of metastatic lesions is taken into account.
  • Special Populations
  • Elderly: The pharmacokinetics of samarium Sm-153 EDTMP did not change with age as seen from comparison of values from people in the age range of 22 to 64 compared to the range 65 to 86 years.
  • Hepatic Insufficiency: Samarium Sm-153 EDTMP scintiscans in 5 patients with metastatic bone disease did not reveal accumulation of activity in the liver or the intestine; this suggests that hepatobiliary excretion did not occur.
  • Renal Insufficiency: Patients with renal insufficiency have not been studied.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Samarium (153Sm) lexidronam in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Samarium (153Sm) lexidronam in the drug label.

How Supplied

Storage

There is limited information regarding Samarium (153Sm) lexidronam Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Samarium (153Sm) lexidronam in the drug label.

Precautions with Alcohol

  • Alcohol-Samarium (153Sm) lexidronam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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  2. ↑ "http://www.ismp.org". External link in |title= (help)


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