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samarium Sm 153 lexidronam

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Overview

What is Quadramet?

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∙HO, 5.3 mg Ca [as Ca(OH)], 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:

The ionic formula is Sm [CHN(CHPO )] 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.



What does Quadramet look like?



What are the available doses of Quadramet?

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What should I talk to my health care provider before I take Quadramet?

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How should I use Quadramet?

QUADRAMET is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

The recommended dose of QUADRAMET 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 QUADRAMET. 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.

QUADRAMET contains calcium and may be incompatible with solutions that contain molecules that can complex with and form calcium precipitates.

QUADRAMET should not be diluted or mixed with other solutions.

Thaw at room temperature before administration and use within 8 hours of thawing.


What interacts with Quadramet?

QUADRAMET is contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds.



What are the warnings of Quadramet?

NSAIDs, including naproxen tablets, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders, or concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding (see PRECAUTIONS; Drug Interactions).

QUADRAMET causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after QUADRAMET, and tended to return to pretreatment levels by 8 weeks. The grade of marrow toxicity is shown in Table 5 below.

Before QUADRAMET is administered, consideration should be given to the patient's current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. Metastatic prostate and other cancers can be associated with disseminated intravascular coagulation (DIC); caution should be exercised in treating cancer patients whose platelet counts are falling or who have other clinical or laboratory findings suggesting DIC. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefits of the treatment outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.

Pregnancy

As with other radiopharmaceutical drugs, QUADRAMET can cause fetal harm when administered to a pregnant woman. Adequate and well controlled studies have not been conducted in animals or pregnant women. Women of child-bearing age should have a negative pregnancy test before administration of QUADRAMET. If this drug is used during pregnancy, or if a patient becomes pregnant after taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant soon after receiving QUADRAMET. Men and women patients should be advised to use an effective method of contraception after the administration of QUADRAMET.

The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex


What are the precautions of Quadramet?

EDTMP is a chelating agent. Although the chelating effects have not been evaluated thoroughly in humans, dogs that received non-radioactive samarium EDTMP (6 times the human dose based on body weight, 3 times based on surface area) developed a variety of electrocardiographic (ECG) changes (with or without the presence of hypocalcemia). The causal relationship between the hypocalcemia and ECG changes has not been studied. Whether QUADRAMET causes electrocardiographic changes or arrhythmias in humans has not been studied. Caution and appropriate monitoring should be given when administering QUADRAMET to patients (See ).

Because concomitant hydration is recommended to promote the urinary excretion of QUADRAMET, appropriate monitoring and consideration of additional supportive treatment should be used in patients with a history of congestive heart failure or renal impairment.

Renal Impairment: Because approximately one third of Samarium Sm-153 EDTMP is excreted in the urine, clearance may be reduced in patients with renal impairment; it is not known if dose adjustment is needed.

This drug should be used with caution in patients with compromised bone marrow reserves. See .

Skeletal

Spinal cord compression frequently occurs in patients with known metastases to the cervical, thoracic or lumbar spine. In clinical studies of QUADRAMET, spinal cord compression was reported in 7% of patients who received placebo and in 8.3% of patients who received 1.0 mCi/kg QUADRAMET. QUADRAMET is not indicated for treatment of spinal cord compression. QUADRAMET administration for pain relief of metastatic bone cancer does not prevent the development of spinal cord compression. When there is a clinical suspicion of spinal cord compression, appropriate diagnostic and therapeutic measures must be taken immediately to avoid permanent disability.

Radiopharmaceutical agents should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

QUADRAMET, like other radioactive drugs, must be handled with care, and appropriate safety measures must be taken to minimize radiation exposure of clinical personnel and others in the patient environment.

Special precautions, such as bladder catheterization, should be taken with incontinent patients to minimize the risk of radioactive contamination of clothing, bed linen, and the patient's environment. Urinary excretion of radioactivity occurs over about 12 hours (with 35% occurring during the first 6 hours). Studies have not been done on the use of QUADRAMET in patients with renal impairment.

INFORMATION FOR PATIENTS

Patients who receive QUADRAMET should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours following administration. Whenever possible, a toilet should be used, rather than a urinal, and the toilet should be flushed several times after each use. Spilled urine should be cleaned up completely and patients should wash their hands thoroughly. If blood or urine gets onto clothing, the clothing should be washed separately, or stored for 1-2 weeks to allow for decay of the Sm-153.

Some patients have reported a transient increase in bone pain shortly after injection (flare reaction). This is usually mild and self-limiting and occurs within 72 hours of injection. Such reactions are usually responsive to analgesics.

Patients who respond to QUADRAMET might begin to notice the onset of pain relief one week after QUADRAMET. Maximal pain relief generally occurs at 3-4 weeks after injection of QUADRAMET. Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.

LABORATORY TESTS

Because of the potential for bone marrow suppression, beginning 2 weeks after QUADRAMET administration, blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.

In a subset of 31 patients who had serum calcium monitored during the first 2 hours after QUADRAMET infusion, a clear pattern of calcium change was not identified. However, 10 (32%) patients had at least one serum calcium level that was below normal (7.16 to 8.28). The extent to which samarium-153-EDTMP is related to this hypocalcemia is not known. Caution should be exercised when administering QUADRAMET to patients at risk for developing hypocalcemia.

DRUG INTERACTIONS

The potential for additive bone marrow toxicity of QUADRAMET with chemotherapy or external beam radiation has not been studied. QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. QUADRAMET should not be given after either of these treatments until there has been time for adequate marrow recovery. (See Section).

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Carcinogenesis in humans given EDTMP, in QUADRAMET, is not likely. Osteosarcomas occurred in a 2-year toxicity/carcinogenicity study of EDTMP administered by gastric intubation to Sprague-Dawley rats, in male rats at 50 mg/kg/day and in male and female rats at 150 mg/kg/day (the dosage was increased to 333 mg/kg/day on day 329 of treatment). Osteosarcomas were not reported in a published chronic dietary study of up to 130 weeks of EDTMP in Fisher 344 rats, at dietary doses up to 100 mg/kg/day (not the maximum tolerated dose). However, at study termination in female Fisher 344 rats, this dose was associated with statistically significantly higher rate of pancreatic islet-cell adenomas and carcinomas.

The results of the following genotoxicity assays with non-radioactive samarium- EDTMP were negative: Salmonella reverse mutation (AMES) assay, unscheduled DNA synthesis in rat liver primary cell culture, chromosomal aberration assay in rat lymphocytes, CHO/HGPRT forward mutation assay, and mouse bone marrow micronucleus test.

Studies have not been performed to assess the effect of QUADRAMET on fertility.

PREGNANCY

See Section.

NURSING MOTHERS

It is not known whether QUADRAMET is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from QUADRAMET, a decision should be made whether to continue nursing or to administer the drug. If QUADRAMET is administered, formula feedings should be substituted for breast feedings.

PEDIATRIC USE

Safety and effectiveness in pediatric patients below the age of 16 years have not been established.


What are the side effects of Quadramet?

Sorry No records found


What should I look out for while using Quadramet?

QUADRAMET is contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds.

QUADRAMET causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after QUADRAMET, and tended to return to pretreatment levels by 8 weeks. The grade of marrow toxicity is shown in Table 5 below.

Before QUADRAMET is administered, consideration should be given to the patient's current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. Metastatic prostate and other cancers can be associated with disseminated intravascular coagulation (DIC); caution should be exercised in treating cancer patients whose platelet counts are falling or who have other clinical or laboratory findings suggesting DIC. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefits of the treatment outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.


What might happen if I take too much Quadramet?

Overdosage with QUADRAMET has not been reported. An antidote for QUADRAMET overdosage is not known. The anticipated complications of overdosage would likely be secondary to bone marrow suppression from the radioactivity of Sm, or secondary to hypocalcemia and cardiac arrhythmias related to the EDTMP.


How should I store and handle Quadramet?

QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.QUADRAMET is supplied frozen in a single-dose 10 mL glass vial containing 1850 ± 185 MBq/mL (50 ± 5 mCi/mL) of samarium-153, at calibration.QUADRAMET is available in the following size:The vial is shipped in a lead shield; a package insert is included.The drug product expires 56 hours after the time of calibration noted on the label, or 8 hours after thawing, whichever is earlier.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 Sm[EDTMP], and

Non-Clinical Toxicology
QUADRAMET is contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds.

QUADRAMET causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after QUADRAMET, and tended to return to pretreatment levels by 8 weeks. The grade of marrow toxicity is shown in Table 5 below.

Before QUADRAMET is administered, consideration should be given to the patient's current clinical and hematologic status and bone marrow response history to treatment with myelotoxic agents. Metastatic prostate and other cancers can be associated with disseminated intravascular coagulation (DIC); caution should be exercised in treating cancer patients whose platelet counts are falling or who have other clinical or laboratory findings suggesting DIC. Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks. Use of QUADRAMET in patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement is not recommended unless the potential benefits of the treatment outweigh the risks. Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function.

The potential for additive bone marrow toxicity of QUADRAMET with chemotherapy or external beam radiation has not been studied. QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. QUADRAMET should not be given after either of these treatments until there has been time for adequate marrow recovery. (See Section).

EDTMP is a chelating agent. Although the chelating effects have not been evaluated thoroughly in humans, dogs that received non-radioactive samarium EDTMP (6 times the human dose based on body weight, 3 times based on surface area) developed a variety of electrocardiographic (ECG) changes (with or without the presence of hypocalcemia). The causal relationship between the hypocalcemia and ECG changes has not been studied. Whether QUADRAMET causes electrocardiographic changes or arrhythmias in humans has not been studied. Caution and appropriate monitoring should be given when administering QUADRAMET to patients (See ).

Because concomitant hydration is recommended to promote the urinary excretion of QUADRAMET, appropriate monitoring and consideration of additional supportive treatment should be used in patients with a history of congestive heart failure or renal impairment.

Renal Impairment: Because approximately one third of Samarium Sm-153 EDTMP is excreted in the urine, clearance may be reduced in patients with renal impairment; it is not known if dose adjustment is needed.

This drug should be used with caution in patients with compromised bone marrow reserves. See .

Adverse events were evaluated in a total of 580 patients who received QUADRAMET 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 (81%) had at least one adverse event. In a subgroup of 399 patients who received QUADRAMET 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 QUADRAMET. Serious events occurred an average of 46 days (1 - 118) after QUADRAMET. 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 treatment and QUADRAMET toxicity can not be easily distinguished. In clinical studies, two patients with rapidly progressive prostate cancer developed thrombocytopenia and died 4 weeks after receiving QUADRAMET. 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 (48%) patients (See section).

In controlled studies, 7% of patients receiving 1.0 mCi/kg QUADRAMET (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 QUADRAMET, are given in Table 6.

In an additional 200 patients who received QUADRAMET 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
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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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