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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 192391-48-3
Drug Levels and Effects
Summary of Use during Lactation
Tositumomab I 131 is no longer marketed in the US. Information in this record refers to the use of tositumomab I 131 as a therapeutic agent. No information is available on the use of tositumomab I 131 during breastfeeding. Because of the potential for serious adverse reactions in nursing infants, the manufacturer and expert opinion recommend not administering the drug in women who wish to continue breastfeeding.[1] If the drug is given, breastfeeding should be discontinued. Parents should limit close contact with their infants and small children after therapeutic tositumomab I 131 administration. Suggested contact times by one group are 30 minutes per day or less of contact at a distance of 2 meters or less for a period of 6 to 23 days.[2] Another group suggests avoiding contact with small children at a distance of 10 cm for an average of 8.1 days (range 3.5 to 12.9 days).[3] Additionally, nursing mothers may have excessive I 131 uptake by the breasts, so they should receive potassium iodide or Lugol's solution before receiving tositumomab I 131 to block uptake by the breasts and thyroid.
Nursing mothers should not work with substances containing I 131 in their workplace.[4]
Drug Levels
After administration of tositumomab I 131, elimination of I 131 is renal. I 131 is a beta and high-energy gamma emitter with a main gamma emission energy of 364 keV and a physical half-life of 8.04 days.[5]
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
References
- 1.
- Goldsmith SJ. Radioimmunotherapy of lymphoma: Bexxar and Zevalin. Semin Nucl Med 2010;40:122-35. [PubMed: 20113680]
- 2.
- Gates VL, Carey JE, Siegel JA, et al. Nonmyeloablative iodine-131 anti-B1 radioimmunotherapy as outpatient therapy. J Nucl Med 1998;39:1230-6. [PubMed: 9669400]
- 3.
- Siegel JA, Kroll S, Regan D, et al. A practical methodology for patient release after tositumomab and (131)I-tositumomab therapy. J Nucl Med 2002;43:354-63. [PubMed: 11884495]
- 4.
- Almén A, Mattsson S. Radiological protection of foetuses and breast-fed children of occupationally exposed women in nuclear medicine - Challenges for hospitals. Phys Med 2017;43:172-7. [PubMed: 28882410]
- 5.
- Dilsizian V, Metter D, Palestro C, Zanzonico P. Advisory Committee on Medical Uses of Isotopes (ACMUI) Sub-Committee on Nursing Mother Guidelines for the Medical Administration of Radioactive Material. Final report submitted: January 31, 2019. 2019. https://www
.nrc.gov/docs /ML1903/ML19038A498.pdf
Substance Identification
Substance Name
Tositumomab I 131
CAS Registry Number
192391-48-3
Drug Class
Breast Feeding
Lactation
Milk, Human
Radiopharmaceuticals
Iodine Radioisotopes
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
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- Iodine-131 Tositumomab: (131)I-anti-B1 antibody, (131)I-tositumomab, anti-CD20 murine monoclonal antibody-I-131, B1, Bexxar, (131)I-anti-B1 antibody, iodine-131 tositumomab, iodine-131 anti-B1 antibody, tositumomab.[BioDrugs. 2003]Iodine-131 Tositumomab: (131)I-anti-B1 antibody, (131)I-tositumomab, anti-CD20 murine monoclonal antibody-I-131, B1, Bexxar, (131)I-anti-B1 antibody, iodine-131 tositumomab, iodine-131 anti-B1 antibody, tositumomab.. BioDrugs. 2003; 17(4):290-5.
- Review Iodine-131 tositumomab (Bexxar): radioimmunoconjugate therapy for indolent and transformed B-cell non-Hodgkin's lymphoma.[Expert Rev Anticancer Ther. 2004]Review Iodine-131 tositumomab (Bexxar): radioimmunoconjugate therapy for indolent and transformed B-cell non-Hodgkin's lymphoma.Friedberg JW, Fisher RI. Expert Rev Anticancer Ther. 2004 Feb; 4(1):18-26.
- Review Sodium Iodide I 131.[Drugs and Lactation Database (...]Review Sodium Iodide I 131.. Drugs and Lactation Database (LactMed®). 2006
- The radioisotope contributes significantly to the activity of radioimmunotherapy.[Clin Cancer Res. 2004]The radioisotope contributes significantly to the activity of radioimmunotherapy.Davis TA, Kaminski MS, Leonard JP, Hsu FJ, Wilkinson M, Zelenetz A, Wahl RL, Kroll S, Coleman M, Goris M, et al. Clin Cancer Res. 2004 Dec 1; 10(23):7792-8.
- Review The role of nuclear medicine in the treatment of non-Hodgkin's lymphoma (NHL).[Leuk Lymphoma. 2003]Review The role of nuclear medicine in the treatment of non-Hodgkin's lymphoma (NHL).Bischof Delaloye A. Leuk Lymphoma. 2003; 44 Suppl 4:S29-36.
- Tositumomab I 131 - Drugs and Lactation Database (LactMed®)Tositumomab I 131 - Drugs and Lactation Database (LactMed®)
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