Marys Medicine

Hydroxyurea clinical practice guidelines - providers - first choice by select health of south carolina

Tips and guidelines for prescribing hydroxyurea.
Clinical Practice Guidelines • 15mg/kg daily for adult patients with normal kidney function. • 5-10mg/kg daily for adult patients with creatinine clearance (CrCl) <60 mL/min.
• 20mg/kg daily for infants (>9 months) and Baseline laboratory values • Complete blood count (CBC) with differential.
• Reticulocyte count.
• Comprehensive metabolic panel (CMP).
Maintenance therapy • Pregnancy test for females. Provide • If there is toxicity: contraceptive counseling for both males • Stop hydroxyurea.
and females.
• Monitor CBC with differential weekly until • Fetal hemoglobin.
counts recovers.
• Then restart at a dose of 5mg/kg/day Acceptable ranges for therapy initiation lower than the dose given before toxicity • Neutrophils > 2500/mm3.
• Platelets ≥ 95,000/mm3.
• Increase dose by 5mg/kg/day every 8 weeks to a maximum dose of 35mg/kg/day.
• Hemoglobin > 5.3g/dL.
• Once stable dosing is achieved, monitor CBC • Reticulocytes ≥ 95,000/mm3.
with differential and reticulocyte count every 2–3 months.
• Any fetal hemoglobin level is acceptable.
• Do not double doses for missed doses.
Monitor CBC with differential and reticulocyte count every 4 weeks when adjusting dosage. • A 6-month trial on the maximum tolerated dose is required prior to discontinuation for treatment failure.
Target blood counts include: • Discontinue hydroxyurea therapy if the patient • Neutrophils ≥ 2000/mm3.
is pregnant or breastfeeding.
• Platelets > 80,000/mm3.
• Continue therapy during hospitalizations or • Reticulocytes > 80,000/mm3.
• Prescribe folic acid concurrently.
*Hydroxyurea is not approved by the FDA for use in children with sickle cell disease. Use of this medication in children with sickle cell disease is recommended by the NHLBI guidelines published in JAMA cited in reference 1 (on the reverse side). 15. Hankins JS, Ware RE, Rogers ZR, et al, "Long-Term Up of a Randomized Trial Comparing Concurrent 1. Yawn BP, Buchanan GR, et al, "Management of Sickle Hydroxyurea Therapy for Infants With Sickle Cell Single Agent Cisplatin, Cisplatin-Based Combina- Cell Disease; Summary of the 2014 Evidence-Based Anemia: The HUSOFT Extension Study," Blood, 2005, tion Chemotherapy, or Hydroxyurea During Pelvic report by Expert Panel Members," JAMA.2014;312(10): 106(7):2269-75. [PubMed 16172253] Irradiation for Locally Advanced Cervical Cancer: A Hydroxyurea is not approved by the FDA for use in Gynecologic Oncology Group Study," J Clin Oncol, children with sickle cell disease. Use of this medication 2007, 25(19):2804-10. [PubMed 17502627] 2. Alvarez O, Miller ST, Wang WC, et al, "Effect in children with sickle cell disease is recommended of Hydroxyurea Treatment on Renal Function by the NHLBI guidelines published in JAMA cited in 30. Rosenthal MA, Ashley DL and Cher L. "Treatment of Parameters: Results From the Multi-Center Placebo- reference 1. High Risk or Recurrent Meningiomas With Hydroxy- Controlled BABY HUG Clinical Trial for Infants With urea," J Clin Neurosci, 2002, 9(2):156-8. [PubMed Sickle Cell Anemia," Pediatr Blood Cancer, 2012, 16. Harrison CN, Campbell PJ, Buck G, et al, "Hydroxyurea 59(4):668-74. [PubMed 22294512] Compared With Anagrelide in High-Risk Essential 31. Thornburg CD, Dixon N, Burgett S, et al, "A Pilot Study Hydroxyurea is not approved by the FDA for use in Thrombocythemia," N Engl J Med, 2005, 353(1):33-45.
of Hydroxyurea to Prevent Chronic Organ Damage in children with sickle cell disease. Use of this medication [PubMed 16000354] Young Children With Sickle Cell Anemia," Pediatr Blood in children with sickle cell disease is recommended 17. Heeney MM, Whorton MR, Howard TA, et al, "Chemical Cancer, 2009, 52(5):609-15. [PubMed 19061213] by the NHLBI guidelines published in JAMA cited in and Functional Analysis of Hydroxyurea Oral Solu- Hydroxyurea is not approved by the FDA for use in reference 1. tions," J Pediatr Hematol Oncol, 2004, 26(3):179-84.
children with sickle cell disease. Use of this medication 3. Aronoff GR, Bennett WM, Berns JS, et al, Drug [PubMed 15125610] in children with sickle cell disease is recommended Prescribing in Renal Failure: Dosing Guidelines 18. Howard LW and Kennedy LD, "Hydroxyurea in the by the NHLBI guidelines published in JAMA cited in for Adults and Children, 5th ed. Philadelphia, PA: Treatment of Sickle-Cell Anemia," Ann Pharmacother, reference 1. American College of Physicians; 2007, p 100. 1997, 31(11):1393-6. [PubMed 9391697] 32. Thornburg CD, Files BA, Luo Z, et al, "Impact of Hydroxyurea is not approved by the FDA for use in Hydroxyurea on Clinical Events in the BABY HUG Trial," children with sickle cell disease. Use of this medication 19. Kinney TR, Helms RW, O'Branski EE, et al, "Safety Blood, 2012, 120(22):4304-10. [PubMed 22915643] in children with sickle cell disease is recommended of Hydroxyurea in Children With Sickle Cell Anemia: Hydroxyurea is not approved by the FDA for use in by the NHLBI guidelines published in JAMA cited in Results of the HUG-KIDS Study, a Phase I/II Trial," children with sickle cell disease. Use of this medication reference 1. Blood, 1999, 94(5):1550-4.[PubMed 10477679] Hydroxyurea is not approved by the FDA for use in in children with sickle cell disease is recommended 4. Brawley OW, Cornelius LJ, Edwards LR, et al, "National children with sickle cell disease. Use of this medication by the NHLBI guidelines published in JAMA cited in Institutes of Health Consensus Development Confer- in children with sickle cell disease is recommended reference 1. ence Statement: Hydroxyurea Treatment for Sickle by the NHLBI guidelines published in JAMA cited in 33. US Department of Health and Human Services; Cell Disease," Ann Intern Med, 2008, 148(12):932-8.
reference 1. Centers for Disease Control and Prevention; National [PubMed 18458271] 20. Kintzel PE and Dorr RT, "Anticancer Drug Renal Toxicity Institute for Occupational Safety and Health. NIOSH 5. Burnett AK, Milligan D, Prentice AG, et al, "A Compari- and Elimination: Dosing Guidelines for Altered Renal list of antineoplastic and other hazardous drugs in the son of Low-Dose Cytarabine and Hydroxyurea With Function," Cancer Treat Rev, 1995, 21(1):33-64. [PubMed healthcare settings 2014. http://www.cdc.gov/niosh/ or Without All-Trans Retinoic Acid for Acute Myeloid docs/2014-138/pdfs/2014-138.pdf. Updated Septem- Leukemia and High-Risk Myelodysplastic Syndrome in ber 2014. Accessed September 15, 2014.
Patients Not Considered Fit for Intensive Treatment," 21. Klion AD, Bochner BS, Gleich GJ, et al, "Approaches 34. Wang WC, Ware RE, Miller ST, et al, "Hydroxy- Cancer, 2007, 109(6):1114-24. [PubMed 17315155] to the Treatment of Hypereosinophilic Syndromes: A Workshop Summary Report," J Allergy Clin Immunol, carbamide in Very Young Children With Sickle-Cell 6. Döhner H, Estey EH, Amadori S, et al, "Diagnosis and 2006, 117(6):1292-302. [PubMed 16750989] Anaemia: A Multicentre, Randomised, Controlled Trial Management of Acute Myeloid Leukemia in Adults: (BABY HUG)," Lancet, 2011, 377(9778):1663-72. [PubMed Recommendations From an International Expert 22. Kumar B, Saraswat A and Kaur I, "Rediscovering Panel, on Behalf of the European LeukemiaNet," Blood, Hydroxyurea: Its Role in Recalcitrant Psoriasis," Int J Hydroxyurea is not approved by the FDA for use in 2010, 115(3):453-74. [PubMed 19880497] Dermatol, 2001, 40(8):530-4. [PubMed 11703528] children with sickle cell disease. Use of this medication in children with sickle cell disease is recommended 7. Droxia (hydroxyurea) [prescribing information]. 23. Longhurst HJ and Pinching AJ, "Pancreatitis Associated by the NHLBI guidelines published in JAMA cited in Princeton, NJ: Bristol-Myers Squibb; April 2010.
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reference 1. 8. Ferster A, Tahriri P, Vermylen C, et al, "Five Years 35. Wang WC, Wynn LW, Rogers ZR, et al, "A Two-Year of Experience With Hydroxyurea in Children and 24. McGann PT, Flanagan JM, Howard TA, et al, "Genotox- Pilot Trial of Hydroxyurea in Very Young Children With Young Adults With Sickle Cell Disease," Blood, 2001, icity Associated With Hydroxyurea Exposure in Infants Sickle Cell Anemia," J Pediatr, 2001, 139(6):790-6.
97(11):3628-32. [PubMed 11369660] With Sickle Cell Anemia: Results from the BABY-HUG [PubMed 11743503] Hydroxyurea is not approved by the FDA for use in Phase III Clinical Trial," Pediatr Blood Cancer, 2012, Hydroxyurea is not approved by the FDA for use in children with sickle cell disease. Use of this medication 59(2):254-7. [PubMed 22012708] children with sickle cell disease. Use of this medication in children with sickle cell disease is recommended Hydroxyurea is not approved by the FDA for use in in children with sickle cell disease is recommended by the NHLBI guidelines published in JAMA cited in children with sickle cell disease. Use of this medication by the NHLBI guidelines published in JAMA cited in reference 1. in children with sickle cell disease is recommended by the NHLBI guidelines published in JAMA cited in reference 1. 9. Finazzi G and Barbui T, "How I Treat Patients With reference 1. 36. Ware RE, Despotovic JM, Mortier NA, et al, "Pharmaco- Polycythemia Vera," Blood, 2007, 109(12):5104-11.
kinetics, Pharmacodynamics, and Pharmacogenetics [PubMed 17264301] 25. Maier-Redelsperger M, de Montalembert M, Flahault A, et al, "Fetal Hemoglobin and F-Cell Responses to of Hydroxyurea Treatment for Children With Sickle 10. Garden AS, Harris J, Vokes EE, et al, "Preliminary Long-Term Hydroxyurea Treatment in Young Sickle Cell Anemia," Blood, 2011, 118(18):4985-91. [PubMed Results of Radiation Therapy Oncology Group 97-03: Cell Patients. The French Study Group on Sickle Cell A Randomized Phase II Trial of Concurrent Radiation Disease," Blood, 1998, 91(12):4472-9. [PubMed 9616141] Hydroxyurea is not approved by the FDA for use in and Chemotherapy for Advanced Squamous Cell Hydroxyurea is not approved by the FDA for use in children with sickle cell disease. Use of this medication Carcinomas of the Head and Neck," J Clin Oncol, 2004, children with sickle cell disease. Use of this medication in children with sickle cell disease is recommended 22(14):2856-64. [PubMed 15254053] in children with sickle cell disease is recommended by the NHLBI guidelines published in JAMA cited in reference 1. 11. Gisslinger H, Gotic M, Holowiecki J, et al, "Anagrelide by the NHLBI guidelines published in JAMA cited in Compared With Hydroxyurea in WHO-Classified reference 1. 37. Yan JH, Ataga K, Kaul S, et al, "The Influence of Renal Essential Thrombocythemia: The ANAHYDRET Study, A 26. Newton HB, Slivka MA and Stevens C, "Hydroxyurea Function on Hydroxyurea Pharmacokinetics in Adults Randomized Controlled Trial," Blood, 2013, 121(10):1720- Chemotherapy for Unresectable or Residual Menin- With Sickle Cell Disease," J Clin Pharmacol, 2005, 8. [PubMed 23315161] gioma," J Neurooncol, 2000, 49(2):165-70. [PubMed 45(4):434-45. [PubMed 15778424] 12. Griggs JJ, Mangu PB, Anderson H, et al, "Appropriate 38. Zimmerman SA, Schultz WH, Davis JS, et al, "Sustained Chemotherapy Dosing For Obese Adult Patients With 27. Ogbogu PU, Bochner BS, Butterfield JH, et al, "Hype- Long-Term Hematologic Efficacy of Hydroxyurea Cancer: American Society of Clinical Oncology Clinical reosinophilic Syndrome: A Multicenter, Retrospective at Maximum Tolerated Dose in Children With Sickle Practice Guideline," J Clin Oncol, 2012, 30(13):1553-61. Analysis of Clinical Characteristics and Response to Cell Disease," Blood, 2004, 103(6):2039-45. [PubMed [PubMed 22473167] Therapy," J Allergy Clin Immunol, 2009, 124(6):1319-25. Hydroxyurea is not approved by the FDA for use in 13. Grund FM, Armitage JO and Burns P, "Hydroxyurea [PubMed 19910029] children with sickle cell disease. Use of this medication in the Prevention of the Effects of Leukostasis in 28. Restituto P, Mugueta C, Alegre E, et al, "Analytical in children with sickle cell disease is recommended Acute Leukemia," Arch Intern Med, 1977, 137(9):1246-7. Interference of Hydroxyurea in the Determination of by the NHLBI guidelines published in JAMA cited in Urea, Uric Acid, and Lactic Acid," Anal Biochem, 2006, reference 1. 14. Gwilt PR and Tracewell WG, "Pharmacokinetics and 357(1):147-9. [PubMed 16843426] Pharmacodynamics of Hydroxyurea," Clin Pharmacoki- 29. Rose PG, Ali S, Watkins E, et al, "Long-Term Follow- net, 1998, 34(5):347-58. [PubMed 9592619]

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