Strontium chloride: Difference between revisions

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use this label
{{DrugProjectFormSinglePage
[http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5444c028-3fcd-4b37-82e4-3cce0f53488a]
|authorTag={{RB}}
|genericName=Strontium chloride
|aOrAn=a
|drugClass=metal halide
|indicationType=treatment
|indication=[[bone pain]] in patients with [[Metastasis|painful skeletal metastases]]
|adverseReactions=[[Pain|increased pain]], [[flushing]], [[fatigue]]
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
 
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Indications====
* STRONTIUM CHLORIDE Sr-89 INJECTION, USP is indicated for the relief of [[bone pain]] in patients with [[Metastasis|painful skeletal metastases]].
 
* The presence of bone [[metastases]] should be confirmed prior to therapy.
 
====Dosage====
* The recommended dose of Strontium-89 Chloride is 148 MBq, 4 mCi, administered by slow intravenous injection (1-2 minutes). Alternatively, a dose of 1.5 - 2.2 MBq/kg, 40-60 µCi/kg body weight may be used.
 
* Repeated administrations of Strontium-89 Chloride should be based on an individual patient’s response to therapy, current symptoms, and hematologic status, and are generally not recommended at intervals of less than 90 days.
 
* The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=* Safety and effectiveness in children below the age of 18 years have not been established.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* None
 
<!--Warnings-->
|warnings=* Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised [[bone marrow]] from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. [[Bone marrow suppression|Bone marrow toxicity]] is to be expected following the administration of Strontium-89, particularly [[white blood cells]] and [[platelets]]. The extent of toxicity is variable. It is recommended that the patient’s [[peripheral blood cell counts]] be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium-89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes.
 
 
* In considering repeat administration of Strontium-89 Chloride Injection, the patient’s hematologic response to the initial dose, current [[platelet]] level and other evidence of marrow depletion should be carefully evaluated.
 
 
* Verification of dose and patient identification is necessary prior to administration because Strontium-89 delivers a relatively high dose of radioactivity.
 
 
 
* Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving 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.
 
====Precautions====
 
* Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.
 
 
* Radiopharmaceuticals should only be used 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.
 
 
* STRONTIUM CHLORIDE Sr-89 INJECTION, USP like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.
 
 
* In view of the delayed onset of pain relief, typically 7 to 20 days post injection; administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.
 
 
* A calcium-like [[flushing]] sensation has been observed in patients following a rapid (less than 30 second injection) administration.
 
 
* Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linen and the patient’s environment.
 
 
* Strontium-89 Chloride is excreted primarily by the [[kidneys]]. In patients with [[renal dysfunction]], the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=* A single case of fatal [[septicemia]] following [[leukopenia]] was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.
 
 
* A small number of patients have reported a transient increase in [[bone pain]] at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with [[analgesics]]. A single patient reported [[chills]] and [[fever]] 12 hours after injection without long-term sequelae.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
 
 
 
<!--Drug Interactions-->
|drugInteractions=<!--Use in Specific Populations-->
|FDAPregCat=D
|useInPregnancyFDA=* Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving 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.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=Because Strontium acts as a calcium analog, secretion of Strontium-89 Chloride into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride. It is not known whether this drug is excreted in human milk.
|useInPed=* Safety and effectiveness in children below the age of 18 years have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* [[Intravenous]]
|monitoring=* It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox={{chembox2
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 470471352
| Name =
| ImageFile = Strontium chloride hexahydrate.jpg
| ImageSize =
| ImageName = Strontium chloride hexahydrate
| IUPACName = Strontium chloride
| SystematicName = Strontium chembox.png
| OtherNames = Strontium(II) chloride
|Section1={{Chembox Identifiers
| Abbreviations =
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 55440
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = EKE8PS9J6Z
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 36383
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 2219640
| SMILES = [Sr+2].[Cl-].[Cl-]
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/2ClH.Sr/h2*1H;/q;;+2/p-2
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = AHBGXTDRMVNFER-UHFFFAOYSA-L
| InChIKey1 = AHBGXTDRMVNFER-UHFFFAOYSA-L
| CASNo = 10476-85-4
| CASNo_Ref = {{cascite|correct|CAS}}
| CASNo1_Ref = {{cascite|correct|??}}
| CASNo1 = 10025-70-4
| CASNo1_Comment = (hexahydrate)
| EINECS = 233-971-6
| EINECSCASNO =
| PubChem = 61520
| InChI = 1S/2ClH.Sr/h2*1H;/q;;+2/p-2
| RTECS =
  }}
|Section2={{Chembox Properties
| Formula = SrCl<sub>2</sub>
| MolarMass = 158.53&nbsp;g/mol (anhydrous)<br/>266.62&nbsp;g/mol (hexahydrate)
| Appearance = White crystalline solid
| Density = 3.052&nbsp;g/cm<sup>3</sup> (anhydrous, monoclinic form)<br/>2.672&nbsp;g/cm<sup>3</sup> (dihydrate)<br />1.930&nbsp;g/cm<sup>3</sup> (hexahydrate)
| MeltingPtC = 874
| Melting_notes = (anhydrous) <br> 61&nbsp;°C (hexahydrate)
| BoilingPtC = 1250
| Boiling_notes = (anhydrous)
| Solubility = ''anhydrous:'' <br> 53.8&nbsp;g/100&nbsp;mL (20&nbsp;°C) <hr> ''hexahydrate:'' <br> 106&nbsp;g/100&nbsp;mL (0&nbsp;°C) <br> 206&nbsp;g/100&nbsp;mL (40&nbsp;°C)
| SolubleOther = [[ethanol]]: very slightly soluble<br/>[[acetone]]: very slightly soluble <br> [[ammonia]]: insoluble
| Solvent =
| LogP =
| HenryConstant =
| pKa =
| pKb =
| RefractIndex = 1.650 (anhydrous) <br> 1.594 (dihydrate) <br> 1.536 (hexahydrate) <ref>Pradyot Patnaik. ''Handbook of Inorganic Chemicals''. McGraw-Hill, 2002, ISBN 0-07-049439-8</ref>
  }}
|Section3={{Chembox Structure
| CrystalStruct = Deformed [[titanium(IV) oxide|rutile]] structure
| Coordination = octahedral (six-coordinate)
| MolShape =
  }}
|Section4={{Chembox Thermochemistry
| DeltaHf =
| DeltaHc =
| Entropy =
| HeatCapacity = }}
|Section5={{Chembox Pharmacology
| AdminRoutes =
| Bioavail =
| Metabolism =
| HalfLife =
| ProteinBound =
| Excretion =
| Legal_status =
| Legal_US =
| Legal_UK =
| Legal_AU =
| Legal_CA =
| PregCat =
| PregCat_AU =
| PregCat_US =
  }}
|Section7={{Chembox Hazards
| ExternalMSDS =
| EUClass =
| EUIndex = Not listed
| MainHazards = Irritant
| NFPA-H =
| NFPA-F =
| NFPA-R =
| NFPA-O =
| RPhrases =
| SPhrases =
| FlashPt = Non-flammable
| LD50 =
| PEL =
  }}
|Section8={{Chembox Related
| OtherAnions = [[Strontium fluoride]]<br/>[[Strontium bromide]]<br/>[[Strontium iodide]]
| OtherCations = [[Beryllium chloride]]<br/>[[Magnesium chloride]]<br/>[[Calcium chloride]]<br/>[[Barium chloride]]<br/>[[Radium chloride]]
| OtherFunctn =
| Function =
| OtherCpds =
}}
}}
 
 
 
<!--Mechanism of Action-->
|mechAction=
 
<!--Structure-->
|structure=* STRONTIUM CHLORIDE Sr-89 INJECTION, USP is a sterile, non-pyrogenic, aqueous solution of Strontium-89 Chloride for intravenous administration. The solution contains no preservative. Each milliliter contains:
 
 
:* Strontium Chloride 10.9 - 22.6 mg
 
:* Water for Injection q.s. to 1 mL
 
 
* The radioactive concentration is 37 MBq/mL, 1 mCi/mL, and the specific activity is 2.96-6.17 MBq/mg, 80-167 µCi/mg at calibration. The pH of the solution is 4 - 7.5.
 
 
* PHYSICAL CHARACTERISTIC
 
 
* Strontium-89 decays by beta emission with a physical half-life of 50.5 days. The maximum beta energy is 1.463 MeV (100%). The maximum range of ß- particles from Strontium-89 in tissue is approximately 8 mm.
 
 
* Radioactive decay factors to be applied to the stated value for radioactive concentration at calibration, when calculating injection volumes at the time of administration, are given in Table 1.
 
: [[File:Strontium str.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=* Following [[intravenous]] injection, soluble strontium compounds behave like their calcium analogs, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active [[osteogenesis]]; thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone.
 
 
* Strontium-89 Chloride is retained in metastatic bone lesions much longer than in normal bone, where turnover is about 14 days. In patients with extensive [[Metastasis|skeletal metastases]], well over half of the injected dose is retained in the bones.
 
 
* Excretion pathways are two-thirds urinary and one-third fecal in patients with bone metastases. Urinary excretion is higher in people without bone lesions. Urinary excretion is greatest in the first two days following injection.
 
 
* Strontium-89 is a pure beta emitter and Strontium-89 Chloride selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. (The maximum range in tissue is 8 mm; maximum energy is 1.463 MeV.) Mean absorbed radiation doses are listed under the Radiation Dosimetry section.
 
 
* Clinical trials have examined relief of pain in cancer patients who have received therapy for bone [[metastases]] (external radiation to indexed sites) but in whom persistent pain recurred. In a multi-center Canadian placebo-controlled trial of 126 patients, pain relief occurred in more patients treated with a single injection of Strontium-89 Chloride than in patients treated with an injection of placebo. Results are given in the following tables.
 
 
* Table 2 compares the percentage and number of patients treated with Strontium-89 Chloride Injection or placebo who had reduced pain and no increase in analgesic or radiotherapy re-treatment.
 
: [[File:Strontium PK 1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
* At each visit, treatment success, defined as a reduction in a patient’s pain score without any increase in analgesic intake and without any supplementary [[radiotherapy]] at the index site, was more frequent among patients assigned to Strontium-89 Chloride Injection than to placebo.
 
 
* Table 3 compares the number and percentage of patients treated with Strontium-89 Chloride Injection or placebo as an adjunct to radiotherapy who were pain free without analgesic at the intervals shown.
 
: [[File:Strontium PK 2.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
* The number of patients classified at each visit as treatment successes who were pain free at the index site and required no analgesics was consistently higher in the Strontium-89 group.
 
 
* New pain sites were less frequent in patients treated with Strontium-89.
 
 
* In another clinical trial, pain relief was greater in a group of patients treated with Strontium-89 compared with a group treated with non-radioactive Strontium-88.
 
<!--Nonclinical Toxicology-->
|nonClinToxic======Carcinogenesis, Mutagenesis, Impairment of Fertility=====
 
 
* Data from a repetitive dose animal study suggests that Strontium-89 Chloride is a potential carcinogen. Thirty-three of 40 rats injected with Strontium-89 Chloride in ten consecutive monthly doses of either 250 or 350 µCi/kg developed malignant bone tumors after a latency period of approximately 9 months. No [[neoplasia]] was observed in the control animals. Treatment with Strontium-89 Chloride should be restricted to patients with well documented metastatic bone disease.
 
 
* Adequate studies with Strontium-89 Chloride have not been performed to evaluate mutagenic potential or effects on fertility.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|howSupplied=* STRONTIUM CHLORIDE Sr-89 INJECTION, USP is supplied in a 5 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield-container with a package insert, and two therapeutic agent-warning labels.
|storage=* The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F).
 
 
* The calibration date (for radioactivity content) and expiration date are quoted on the vial label. The expiration date will be 28 days after calibration. * Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.
|packLabel=====STRONTIUM CHLORIDE SR-89 INJECTION, USP====
: [[File:Strontium PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
====Ingredients and Appearance====
: [[File:Strontium Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
|brandNames=* STRONTIUM CHLORIDE SR-89®<ref>{{Cite web | title = strontium chloride sr-89 | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b74f590-e698-02da-9878-5dc80902dbb4}}</ref>
 
<!--Look-Alike Drug Names-->
|lookAlike=There is limited information regarding the look alike drug names.
|drugShortage=
}}
 
 
 
 
<!--Category-->
 
[[Category:Drug]]

Latest revision as of 17:10, 20 August 2015

Strontium chloride
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Overview

Strontium chloride is a metal halide that is FDA approved for the treatment of bone pain in patients with painful skeletal metastases. Common adverse reactions include increased pain, flushing, fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • The presence of bone metastases should be confirmed prior to therapy.

Dosage

  • The recommended dose of Strontium-89 Chloride is 148 MBq, 4 mCi, administered by slow intravenous injection (1-2 minutes). Alternatively, a dose of 1.5 - 2.2 MBq/kg, 40-60 µCi/kg body weight may be used.
  • Repeated administrations of Strontium-89 Chloride should be based on an individual patient’s response to therapy, current symptoms, and hematologic status, and are generally not recommended at intervals of less than 90 days.
  • The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Strontium chloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Strontium chloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Safety and effectiveness in children below the age of 18 years have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Strontium chloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Strontium chloride in pediatric patients.

Contraindications

  • None

Warnings

  • Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium-89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes.


  • In considering repeat administration of Strontium-89 Chloride Injection, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated.


  • Verification of dose and patient identification is necessary prior to administration because Strontium-89 delivers a relatively high dose of radioactivity.


  • Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving 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.

Precautions

  • Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.


  • Radiopharmaceuticals should only be used 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.


  • STRONTIUM CHLORIDE Sr-89 INJECTION, USP like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.


  • In view of the delayed onset of pain relief, typically 7 to 20 days post injection; administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.


  • A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.


  • Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linen and the patient’s environment.


  • Strontium-89 Chloride is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.

Adverse Reactions

Clinical Trials Experience

  • A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.


  • A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Strontium chloride in the drug label.

Drug Interactions

There is limited information regarding Strontium chloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): D

  • Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving 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.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Strontium chloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Strontium chloride during labor and delivery.

Nursing Mothers

Because Strontium acts as a calcium analog, secretion of Strontium-89 Chloride into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride. It is not known whether this drug is excreted in human milk.

Pediatric Use

  • Safety and effectiveness in children below the age of 18 years have not been established.

Geriatic Use

There is no FDA guidance on the use of Strontium chloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Strontium chloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Strontium chloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Strontium chloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Strontium chloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Strontium chloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Strontium chloride in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

  • It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week.

IV Compatibility

There is limited information regarding IV Compatibility of Strontium chloride in the drug label.

Overdosage

There is limited information regarding Overdose of Strontium chloride in the drug label.

Pharmacology

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Template:Chembox header2 | Strontium chloride
Identifiers
3D model (JSmol)
ChEBI
ChEMBL
ChemSpider
ECHA InfoCard Lua error in Module:Wikidata at line 879: attempt to index field 'wikibase' (a nil value). Lua error in Module:Wikidata at line 879: attempt to index field 'wikibase' (a nil value).
UNII
Properties
SrCl2
Molar mass 158.53 g/mol (anhydrous)
266.62 g/mol (hexahydrate)
Hazards
Related compounds
Template:Chembox header2 | Except where noted otherwise, data are given for
materials in their standard state
(at 25 °C, 100 kPa)
Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Strontium chloride Mechanism of Action in the drug label.

Structure

  • STRONTIUM CHLORIDE Sr-89 INJECTION, USP is a sterile, non-pyrogenic, aqueous solution of Strontium-89 Chloride for intravenous administration. The solution contains no preservative. Each milliliter contains:


  • Strontium Chloride 10.9 - 22.6 mg
  • Water for Injection q.s. to 1 mL


  • The radioactive concentration is 37 MBq/mL, 1 mCi/mL, and the specific activity is 2.96-6.17 MBq/mg, 80-167 µCi/mg at calibration. The pH of the solution is 4 - 7.5.


  • PHYSICAL CHARACTERISTIC


  • Strontium-89 decays by beta emission with a physical half-life of 50.5 days. The maximum beta energy is 1.463 MeV (100%). The maximum range of ß- particles from Strontium-89 in tissue is approximately 8 mm.


  • Radioactive decay factors to be applied to the stated value for radioactive concentration at calibration, when calculating injection volumes at the time of administration, are given in Table 1.
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Pharmacodynamics

There is limited information regarding Pharmacodynamics of Strontium chloride in the drug label.

Pharmacokinetics

  • Following intravenous injection, soluble strontium compounds behave like their calcium analogs, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active osteogenesis; thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone.


  • Strontium-89 Chloride is retained in metastatic bone lesions much longer than in normal bone, where turnover is about 14 days. In patients with extensive skeletal metastases, well over half of the injected dose is retained in the bones.


  • Excretion pathways are two-thirds urinary and one-third fecal in patients with bone metastases. Urinary excretion is higher in people without bone lesions. Urinary excretion is greatest in the first two days following injection.


  • Strontium-89 is a pure beta emitter and Strontium-89 Chloride selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. (The maximum range in tissue is 8 mm; maximum energy is 1.463 MeV.) Mean absorbed radiation doses are listed under the Radiation Dosimetry section.


  • Clinical trials have examined relief of pain in cancer patients who have received therapy for bone metastases (external radiation to indexed sites) but in whom persistent pain recurred. In a multi-center Canadian placebo-controlled trial of 126 patients, pain relief occurred in more patients treated with a single injection of Strontium-89 Chloride than in patients treated with an injection of placebo. Results are given in the following tables.


  • Table 2 compares the percentage and number of patients treated with Strontium-89 Chloride Injection or placebo who had reduced pain and no increase in analgesic or radiotherapy re-treatment.
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  • At each visit, treatment success, defined as a reduction in a patient’s pain score without any increase in analgesic intake and without any supplementary radiotherapy at the index site, was more frequent among patients assigned to Strontium-89 Chloride Injection than to placebo.


  • Table 3 compares the number and percentage of patients treated with Strontium-89 Chloride Injection or placebo as an adjunct to radiotherapy who were pain free without analgesic at the intervals shown.
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  • The number of patients classified at each visit as treatment successes who were pain free at the index site and required no analgesics was consistently higher in the Strontium-89 group.


  • New pain sites were less frequent in patients treated with Strontium-89.


  • In another clinical trial, pain relief was greater in a group of patients treated with Strontium-89 compared with a group treated with non-radioactive Strontium-88.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Data from a repetitive dose animal study suggests that Strontium-89 Chloride is a potential carcinogen. Thirty-three of 40 rats injected with Strontium-89 Chloride in ten consecutive monthly doses of either 250 or 350 µCi/kg developed malignant bone tumors after a latency period of approximately 9 months. No neoplasia was observed in the control animals. Treatment with Strontium-89 Chloride should be restricted to patients with well documented metastatic bone disease.


  • Adequate studies with Strontium-89 Chloride have not been performed to evaluate mutagenic potential or effects on fertility.

Clinical Studies

There is limited information regarding Clinical Studies of Strontium chloride in the drug label.

How Supplied

  • STRONTIUM CHLORIDE Sr-89 INJECTION, USP is supplied in a 5 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield-container with a package insert, and two therapeutic agent-warning labels.

Storage

  • The vial and its contents should be stored inside its transportation container at room temperature (15-25°C, 59-77°F).


  • The calibration date (for radioactivity content) and expiration date are quoted on the vial label. The expiration date will be 28 days after calibration. * Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.

Images

Drug Images

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Package and Label Display Panel

STRONTIUM CHLORIDE SR-89 INJECTION, USP

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Ingredients and Appearance

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Strontium chloride in the drug label.

Precautions with Alcohol

  • Alcohol-Strontium chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • STRONTIUM CHLORIDE SR-89®[2]

Look-Alike Drug Names

There is limited information regarding the look alike drug names.

Drug Shortage Status

Price

References

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

  1. ↑ Pradyot Patnaik. Handbook of Inorganic Chemicals. McGraw-Hill, 2002, ISBN 0-07-049439-8
  2. ↑ "strontium chloride sr-89".
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