Radium chloride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Radium chloride is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Common adverse reactions include nausea, diarrhea, vomiting, and peripheral edema.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Radium chloride FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Radium chloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Radium chloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Radium chloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Radium chloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Radium chloride in pediatric patients.
Contraindications
- Xofigo is contraindicated in pregnancy.
- Xofigo can cause fetal harm when administered to a pregnant woman based on its mechanism of action.
- Xofigo is not indicated for use in women.
- Xofigo is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus
Warnings
Bone Marrow Suppression
- In the randomized trial, 2% of patients on the Xofigo arm experienced bone marrow failure or ongoing pancytopenia compared to no patients treated with placebo. There were two deaths due to bone marrow failure and for 7 of 13 patients treated with Xofigo, bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients on the Xofigo arm and 2% on the placebo arm permanently discontinued therapy due to bone marrow suppression.
- In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) were similar for patients treated with Xofigo and placebo. Myelosuppression; notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia; has been reported in patients treated with Xofigo. In the randomized trial, complete blood counts (CBCs) were obtained every 4 weeks prior to each dose and the nadir CBCs and times of recovery were not well characterized. In a separate single-dose phase 1 study of Xofigo, neutrophil and platelet count nadirs occurred 2 to 3 weeks after Xofigo administration at doses that were up to 1 to 5 times the recommended dose, and most patients recovered approximately 6 to 8 weeks after administration.
- Hematologic evaluation of patients must be performed at baseline and prior to every dose of Xofigo. Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL. Before subsequent administrations of Xofigo, the ANC should be ≥ 1 x 109/L and the platelet count ≥ 50 x 109/L. If there is no recovery to these values within 6 to 8 weeks after the last administration of Xofigo, despite receiving supportive care, further treatment with Xofigo should be discontinued. Patients with evidence of compromised bone marrow reserve should be monitored closely and provided with supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.
- The safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use with chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.
Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- In the randomized clinical trial in patients with metastatic castration-resistant prostate cancer with bone metastases, 600 patients received intravenous injections of 50 kBq/kg (1.35 microcurie/kg) of Xofigo and best standard of care and 301 patients received placebo and best standard of care once every 4 weeks for up to 6 injections. Prior to randomization, 58% and 57% of patients had received docetaxel in the Xofigo and placebo arms, respectively. The median duration of treatment was 20 weeks (6 cycles) for Xofigo and 18 weeks (5 cycles) for placebo.
- The most common adverse reactions (≥ 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema (Table 3). Grade 3 and 4 adverse events were reported among 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in Xofigo-treated patients (≥ 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.
- Treatment discontinuations due to adverse events occurred in 17% of patients who received Xofigo and 21% of patients who received placebo. The most common hematologic laboratory abnormalities leading to discontinuation for Xofigo were anemia (2%) and thrombocytopenia (2%).
Table 3 shows adverse reactions occurring in ≥ 2% of patients and for which the incidence for Xofigo exceeds the incidence for placebo.
Laboratory Abnormalities
Table 4 shows hematologic laboratory abnormalities occurring in > 10% of patients and for which the incidence for Xofigo exceeds the incidence for placebo.
Postmarketing Experience
There is limited information regarding Radium chloride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Radium chloride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Radium chloride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Radium chloride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Radium chloride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Radium chloride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Radium chloride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Radium chloride in geriatric settings.
Gender
There is no FDA guidance on the use of Radium chloride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Radium chloride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Radium chloride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Radium chloride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Radium chloride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Radium chloride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Radium chloride Administration in the drug label.
Monitoring
There is limited information regarding Radium chloride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Radium chloride and IV administrations.
Overdosage
There is limited information regarding Radium chloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Radium chloride Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Radium chloride Mechanism of Action in the drug label.
Structure
There is limited information regarding Radium chloride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Radium chloride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Radium chloride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Radium chloride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Radium chloride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Radium chloride How Supplied in the drug label.
Storage
There is limited information regarding Radium chloride Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Radium chloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Radium chloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Radium chloride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Radium chloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Radium chloride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Radium chloride Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Template:Chembox new Radium chloride, RaCl2, was the first radium compound to be prepared in a pure state and was the basis of Marie Curie's original separation of radium from barium.[1] The first preparation of radium metal was by the electrolysis of a solution of radium chloride using a mercury cathode.
Preparation
Radium chloride crystallises from solution as the dihydrate. It may be dehydrated by heating to 100 °C in air for one hour followed by 5½ hours at 520 °C under argon.[2] If the presence of other anions is suspected, the dehydration may be effectuated by fusion under hydrogen chloride.[3]
Properties
Radium chloride is a white solid with a blue-green luminescence, especially when heated. It is less soluble in water than other alkaline earth metal chlorides, a fact which is used in the first stages of the separation of radium from barium by fractional crystallization. It is only sparingly soluble in azeotropic hydrochloric acid and virtually insoluble in concentrated hydrochloric acid.[4]
Gaseous radium chloride exists as RaCl2 molecules, as with other alkaline earth metal halides. The gas shows strong absorptions in the visible spectrum at 676.3 nm and 649.8 nm (red): the dissociation energy of the radium–chlorine bond is estimated as 2.9 eV,[5] and its length as 292 pm.[6]
Uses
Radium chloride is still used for the initial stages of the separation of radium from barium during the extraction of radium from pitchblende. The large quantities of material involved (tonnes of ore for milligrams of radium) favour this less costly (but less efficient) method over those based on radium bromide or radium chromate (used for the later stages of the separation).
Sources
- Gmelins Handbuch der anorganischen Chemie (8. Aufl.), Berlin:Verlag Chemie, 1928, pp. 60–61.
- Gmelin Handbuch der anorganischen Chemie (8. Aufl. 2. Erg.-Bd.), Berlin:Springer, 1977, pp. 362–64.
References
- ↑ Curie, M.; Debierne, A. (1910). C. R. Hebd. Acad. Sci. Paris 151:523–25.
- ↑ Weigel, F.; Trinkl, A. (1968). Radiochim. Acta 9:36–41.
- ↑ Hönigschmid, O.; Sachtleben, R. (1934). Z. Anorg. Allg. Chem. 221:65–82.
- ↑ Erbacher, O. (1930). Ber. Dtsch. Chem. Ges. 63:141–56.
- ↑ Lagerqvist, A. (1953). Arkiv Fisik 6:141–42.
- ↑ Karapet'yants, M. Kh.; Ch'ing, Ling-T'ing (1960). Zh. Strukt. Khim. 1:277–85; J. Struct. Chem. (USSR) 1:255–63.