Difference between revisions of "Paroxysmal nocturnal hemoglobinuria"

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'''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].''' 
  
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<big>'''Eculizumab'''</big>
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Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen?  Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].
  
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'''Regimen:'''
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{{TOC limit|limit=2}}
  
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IV  600 mg weekly for 4 doses, followed by 900 mg 1 week later; then 900 mg every 2 weeks as maintenance treatment
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==Eculizumab (Soliris)==
  
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'''Supportive medications''':
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===Regimen #1, Hillmen et al. 2006 & Schubert et al. 2008 (TRIUMPH)===
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====Initial therapy====
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*[[Eculizumab (Soliris)]] 600 mg IV over 25 to 45 minutes once per day on days 1, 8, 15, 22; then [[Eculizumab (Soliris)]] 900 mg IV over 25 to 45 minutes once on day 29
  
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Meningococcal vaccine at least 2 weeks prior to treatment initiation; may revaccinate per current guidelines
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'''5-week course, then proceed to maintenance therapy'''
  
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'''Reference:'''
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====Maintenance therapy====
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''Maintenance therapy starts 2 weeks after the last dose of initial therapy.''
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*[[Eculizumab (Soliris)]] 900 mg IV over 25 to 45 minutes once every 2 weeks
  
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1) Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med 2006;355:1233-1243
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'''20-week course (10 doses during maintenance phase)'''
  
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2) Schubert, J., Hillmen, P., Röth, A., Young, N. S., Elebute, M. O., Szer, J., Gianfaldoni, G., Socié, G., Browne, P., Geller, R., Rother, R. P. and Muus, P. (2008), Eculizumab, a terminal complement   
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Supportive medications:
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inhibitor, improves anaemia in patients with paroxysmal nocturnal haemoglobinuria. British Journal of Haematology, 142: 263–272
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*Patients received Neisseria meningitidis meningococcal vaccination
  
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3) Kelly RJ, Hill A, Arnold LM, et al.(2011) Long term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival. Blood 117(25):6786–6792
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===Regimen #2, Kelly et al. 2011 (ongoing maintenance)===
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====Initial therapy====
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*[[Eculizumab (Soliris)]] 600 mg IV over at least 30 minutes once per day on days 1, 8, 15, 22; then [[Eculizumab (Soliris)]] 900 mg IV over at least 30 minutes once on day 29
  
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4) Hill A, Kelly RJ, Kulasekararaj AG, et al. Eculizumab in paroxysmal nocturnal hemoglobinuria (PNH): a report of all 153 patients treated in the UK. Blood. Vol. 120.(21) 2012. p. 3472
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'''5-week course, then proceed to maintenance therapy'''
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====Maintenance therapy====
 +
''Maintenance therapy starts 2 weeks after the last dose of initial therapy.''
 +
*[[Eculizumab (Soliris)]] 900 mg IV over at least 30 minutes once every 2 weeks
 +
**Patients with return of PNH symptoms, such as red or black urine, abdominal discomfort, or increased LDH before the next dose of eculizumab received higher doses: [[Eculizumab (Soliris)]] 1200 mg IV once every 2 weeks
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'''given indefinitely'''
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Supportive medications:
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*Patients received Neisseria meningitidis meningococcal vaccination
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*Penicillin V 500 mg PO BID as prophylaxis
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**Patients with penicillin allergies instead received: Erythromycin 500 mg PO BID
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===References===
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# Hillmen P, Young NS, Schubert J, Brodsky RA, Socié G, Muus P, Röth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43. [http://www.nejm.org/doi/full/10.1056/NEJMoa061648 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16990386 PubMed]
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# Schubert J, Hillmen P, Röth A, Young NS, Elebute MO, Szer J, Gianfaldoni G, Socié G, Browne P, Geller R, Rother RP, Muus P; TRIUMPH Study Investigators. Eculizumab, a terminal complement inhibitor, improves anaemia in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2008 Jun;142(2):263-72. Epub 2008 May 22. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07183.x/full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18503589 PubMed]
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# Kelly RJ, Hill A, Arnold LM, Brooksbank GL, Richards SJ, Cullen M, Mitchell LD, Cohen DR, Gregory WM, Hillmen P. Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival. Blood. 2011 Jun 23;117(25):6786-92. doi: 10.1182/blood-2011-02-333997. Epub 2011 Apr 1. [http://bloodjournal.hematologylibrary.org/content/117/25/6786.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21460245 PubMed] content property of [http://hemonc.org HemOnc.org]
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# Anita Hill; Richard J Kelly; Austin G Kulasekararaj; Shreyans A Gandhi; Lindsay D Mitchell; Modupe Elebute; Stephen John Richards; Matthew Cullen; Louise M Arnold; Joanna Large; Alexandra Wood; Gemma L Brooksbank; Tracy Downing; Claire McKinley; Dena Cohen; Walter M Gregory; Judith C. W. Marsh; Ghulam J. Mufti; Peter Hillmen. Eculizumab in Paroxysmal Nocturnal Hemoglobinuria (PNH): A Report of All 153 Patients Treated in the UK. 2012 ASH Annual Meeting abstract 3472. [http://abstracts.hematologylibrary.org/cgi/content/abstract/120/21/3472?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=3472&searchid=1&FIRSTINDEX=0&volume=120&issue=21&resourcetype=HWCIT link to abstract]

Revision as of 06:25, 21 October 2013

Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer.

Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.


Eculizumab (Soliris)

Regimen #1, Hillmen et al. 2006 & Schubert et al. 2008 (TRIUMPH)

Initial therapy

5-week course, then proceed to maintenance therapy

Maintenance therapy

Maintenance therapy starts 2 weeks after the last dose of initial therapy.

20-week course (10 doses during maintenance phase)

Supportive medications:

  • Patients received Neisseria meningitidis meningococcal vaccination

Regimen #2, Kelly et al. 2011 (ongoing maintenance)

Initial therapy

5-week course, then proceed to maintenance therapy

Maintenance therapy

Maintenance therapy starts 2 weeks after the last dose of initial therapy.

  • Eculizumab (Soliris) 900 mg IV over at least 30 minutes once every 2 weeks
    • Patients with return of PNH symptoms, such as red or black urine, abdominal discomfort, or increased LDH before the next dose of eculizumab received higher doses: Eculizumab (Soliris) 1200 mg IV once every 2 weeks

given indefinitely

Supportive medications:

  • Patients received Neisseria meningitidis meningococcal vaccination
  • Penicillin V 500 mg PO BID as prophylaxis
    • Patients with penicillin allergies instead received: Erythromycin 500 mg PO BID

References

  1. Hillmen P, Young NS, Schubert J, Brodsky RA, Socié G, Muus P, Röth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43. link to original article contains verified protocol PubMed
  2. Schubert J, Hillmen P, Röth A, Young NS, Elebute MO, Szer J, Gianfaldoni G, Socié G, Browne P, Geller R, Rother RP, Muus P; TRIUMPH Study Investigators. Eculizumab, a terminal complement inhibitor, improves anaemia in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2008 Jun;142(2):263-72. Epub 2008 May 22. link to original article contains verified protocol PubMed
  3. Kelly RJ, Hill A, Arnold LM, Brooksbank GL, Richards SJ, Cullen M, Mitchell LD, Cohen DR, Gregory WM, Hillmen P. Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival. Blood. 2011 Jun 23;117(25):6786-92. doi: 10.1182/blood-2011-02-333997. Epub 2011 Apr 1. link to original article contains verified protocol PubMed content property of HemOnc.org
  4. Anita Hill; Richard J Kelly; Austin G Kulasekararaj; Shreyans A Gandhi; Lindsay D Mitchell; Modupe Elebute; Stephen John Richards; Matthew Cullen; Louise M Arnold; Joanna Large; Alexandra Wood; Gemma L Brooksbank; Tracy Downing; Claire McKinley; Dena Cohen; Walter M Gregory; Judith C. W. Marsh; Ghulam J. Mufti; Peter Hillmen. Eculizumab in Paroxysmal Nocturnal Hemoglobinuria (PNH): A Report of All 153 Patients Treated in the UK. 2012 ASH Annual Meeting abstract 3472. link to abstract
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