Paroxysmal nocturnal hemoglobinuria
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Eculizumab (Soliris)
Regimen #1, Hillmen et al. 2006 & Schubert et al. 2008 (TRIUMPH)
Initial therapy
- 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
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 25 to 45 minutes once every 2 weeks
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
- 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
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
- 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
- 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
- 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
- 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