Quadramet

samarium Sm 153 lexidronam

(sa-mar-ee-yum lex-i-droe-nam) ,

Quadramet

(trade name)

Classification

Therapeutic: nonopioid analgesics
Pharmacologic: radiopharmaceuticals
Pregnancy Category: D

Indications

Treatment of bone pain in patients with confirmed osteoblastic skeletal metastases that enhance on radionuclide bone scan.Ankylosing spondylitis, Paget’s disease, rheumatoid arthritis.

Action

Preferentially taken up by bone tumors and metastatic bone lesions, where selective irradiation takes place.

Therapeutic effects

Decreased pain from bony metastases.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Taken up and is selectively retained by metastatic bone lesions.
Metabolism and Excretion: Unbound drug is excreted in urine.
Half-life: 65 min (radioactivity).

Time/action profile (pain relief)

ROUTEONSETPEAKDURATION
IV1–2 wkunknownunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Women with childbearing potential; Diminished bone marrow reserve or other chronic debilitating illness (allow recovery from previous treatments); Patients with a life expectancy <6 mo; Pediatric: Children <16 yr (safety not established).

Adverse Reactions/Side Effects

Cardiovascular

  • arrhythmias
  • hypertension

Hematologic

  • anemia (most frequent)
  • neutropenia (most frequent)
  • thrombocytopenia (most frequent)

Musculoskeletal

  • transient increase in bone pain

Interactions

Drug-Drug interaction

Additive bone marrow toxicity with antineoplastics or previous radiation therapy.

Route/Dosage

Intravenous (Adults) 1 millicuries (mCi)/kg.

Availability

Radioactive Injection: 1850 megabecquerels/mL (50 mCi/mL) in 2 mL fill- and 3 mL fill-vials

Nursing implications

Nursing assessment

  • Assess pain (intensity, location) periodically during therapy. Patient may experience a transient increase in bone pain for 2–3 days beginning 2–3 days after administration. This is normal, and increasing analgesic doses may be required. Pain should begin to diminish after 1–2 wk or longer and may allow for reduction or discontinuation of analgesics. Effects may continue for several months.
  • Lab Test Considerations: Beginning 2 wk after administration of samarium, monitor hematologic parameters (WBC, platelets) weekly for at least 8 wk and until adequate recovery of bone marrow function.

Potential Nursing Diagnoses

Acute pain (Indications)
Deficient knowledge (Patient/Family Teaching)

Implementation

  • Should be administered only in facilities with personnel experienced in the safe use and handling of radiopharmaceuticals.
    • Patient should drink or receive IV a minimum of 500 mL of fluids prior to injection. Instruct patient to void as often as possible following injection to minimize radiation exposure to bladder.
    • Incontinent patients should have urinary catheters placed prior to administration to minimize the risk of radioactive contamination of clothing, linens, and the environment.
  • Intravenous Administration
  • Thaw at room temperature prior to administration; use within 8 hours of thawing or within 48 hours after time of calibration noted on the product label, whichever is earlier.
  • Rate: Administer by slow injection over 1 min. Follow with a saline flush. A flushing sensation may be experienced following a rapid (<30 sec) injection
  • Additive Incompatibility: Do not dilute or mix with other solutions or medications.

Patient/Family Teaching

  • Instruct patient to continue taking pain medication until samarium becomes effective. Analgesic doses may be decreased once the effects of samarium are known.
  • Advise patient that no change in eating or drinking is necessary. Alcohol and caffeine need not be avoided unless advised by health care professional.
  • Samarium is excreted in the urine for several hr after administration. Advise patient to use a normal toilet rather than a urinal if possible and to flush twice after use. Spilled urine or blood from a cut should be wiped up with a tissue and flushed. Good handwashing should be observed, and any linen contaminated with blood or urine should be immediately washed separately from other items and rinsed thoroughly or stored for 1–2 wk to allow for decay of samarium. If any urine collection device is used, the instructions on its use should be followed.
  • Instruct male and female patients to use an effective form of contraception following samarium administration. May be harmful to fetus. Women of childbearing age should have a negative pregnancy test prior to administration of samarium.
  • Instruct patient to notify any health care professional or caregiver of samarium therapy prior to treatment.
  • Advise patient to contact health care professional if the effects of samarium decrease and pain returns.
  • Emphasize the importance of periodic blood tests.

Evaluation/Desired Outcomes

  • Decrease in pain due to bony metastases.

Quadramet

Samarium Sm, Lexidronam Oncology A parenteral radiopharmaceutical for pain relief in metastatic CA to the bone, seen by bone scans. See Bone scan.
References in periodicals archive ?
EUSAPharma (formerly Cytogen) Posts Positive Phase I Report from Trial of Quadramet in Combination with Velcade for the Treatment of Relapsed or Refractory Multiple Myeloma.
Cytogen has also developed Quadramet, a skeletal targeting therapeutic radiopharmaceutical for the relief of bone pain in prostate and other types of cancer, for which the company receives royalties on product sales through Berlex Laboratories, the United States affiliate of Schering AG Germany, which markets the product in the United States.
Currently marketed products include ProstaScint (a monoclonal antibody- based imaging agent used to image the extent and spread of prostate cancer); BrachySeed I-125 and Pd-103 (two uniquely designed, next- generation radioactive seed implants for the treatment of localized prostate cancer); and Quadramet (a skeletal targeting therapeutic radiopharmaceutical marketed for the relief of bone pain in prostate and other types of cancer).
FDA-approved products include ProstaScint (a monoclonal antibody-based imaging agent used to image the extent and spread of prostate cancer); BrachySeed(TM) I-125 and Pd-103 (uniquely designed, next-generation radioactive seed implants for the treatment of localized prostate cancer); and Quadramet (a therapeutic agent marketed for the relief of bone pain in prostate and other types of cancer).
At current levels, quarterly sales trends for QUADRAMET can exhibit short-term variability.
Novel combination regimen of QUADRAMET with the protease inhibitor, bortezomib, well-tolerated with patients receiving up to four doses; preparations underway for follow-up Phase 2 study
The Phase 1 dose escalation study is designed to determine safety and tolerability, as well as response rate, of QUADRAMET in combination with bortezomib (Velcade(R), Millennium Pharmaceuticals, Inc.
A copy of the full prescribing information for CAPHOSOL, QUADRAMET, PROSTASCINT and SOLTAMOX, including Boxed Warnings, warnings, precautions, adverse events and other safety information may be obtained in the U.
QUADRAMET is a skeletal targeting radiopharmaceutical for the treatment of pain arising from cancer that has spread to the bone.
Data presented at ASTRO meeting demonstrate neoadjuvant use of QUADRAMET with hormonal therapy and external beam radiation therapy is well tolerated in patients with high risk disease.
QUADRAMET is indicated for the relief of pain due to metastatic bone disease arising from prostate, breast, multiple myeloma and other types of cancer.
QUADRAMET is approved for the treatment of pain in patients whose cancer has spread to the bone, PROSTASCINTis a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer, and SOLTAMOX is the first liquid hormonal therapy approved in the U.