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Patient handout

DVT in paroxysmal nocturnal hemoglobinuria (PNH)

PRODUCTION

1. Your condition

This handout is for dvt in paroxysmal nocturnal hemoglobinuria (pnh). Your care team identified this based on: unilateral leg swelling in patient with dark / cola-colored morning urine, episodic abdominal pain, dysphagia, erectile dysfunction, or fatigue out of proportion — consider pnh.

Other reasons your team may use this plan: budd-chiari, portal, mesenteric, splenic, or cerebral venous sinus thrombosis as index event — flow cytometry for pnh clones is mandatory regardless of cbc; cbc with cytopenias plus elevated ldh 5-10× normal, low haptoglobin, indirect hyperbilirubinemia, urine hemosiderin — classic pnh biochemical profile; patient with known aplastic anemia or low-risk mds who develops new venous thrombosis — repeat pnh flow cytometry; pnh clones evolve in 30-50% of aplastic anemia.

2. Your medications

Take these medications exactly as prescribed. Do not stop or change a dose without talking to your provider.

MedicationStarting doseHowWhenWhat it does
apixaban10 mg BID × 7 d → 5 mg BID full-dose; 2.5 mg BID extended-phase after first 6 mo if continuing indefinitePOBID × ≥3 months minimum, indefinite for any thrombotic event in PNH per expert consensusAMPLIFY (Agnelli NEJM 2013 PMID 23808982) — apixaban first-line for VTE; AMPLIFY-EXT supports 2.5 mg BID extended-phase; expert consensus accepts DOAC for PNH VTE layered on complement inhibition
rivaroxaban15 mg BID × 21 d → 20 mg daily; 10 mg daily extended-phase after first 6 mo if continuing indefinitePOBID then daily ≥3 months, indefinite per criteriaEINSTEIN-DVT (Bauersachs NEJM 2010 PMID 21128814)
edoxaban60 mg PO daily (30 mg if CrCl 15-50, weight ≤60 kg, or with strong P-gp inhibitor) after 5-10 d LMWH bridgePOdaily × ≥3 months, indefinite per criteriaHokusai-VTE (Büller NEJM 2013 PMID 23991958)
warfarin5 mg daily; INR target 2-3POdaily ≥3 months, indefinite per criteriaTRAPS (Pengo Blood 2018 PMID 30002145) — warfarin > rivaroxaban in triple-positive APS; preferred when DOAC clearance unpredictable
enoxaparin1 mg/kg SC BID; reduce to 1 mg/kg daily if CrCl <30SCBIDASH 2020 (PMID 33007077); ASH 2018 pregnancy (PMID 30482767) — LMWH first-line in pregnancy and as bridge during workup
eculizumab600 mg IV weekly × 4 weeks → 900 mg IV q14d maintenanceIVweekly × 4 then q14d indefiniteTRIUMPH (Hillmen NEJM 2006 PMID 16990386); Hillmen Blood 2007 (PMID 17716988) — eculizumab reduces thromboembolic events ~85% in PNH; foundational therapy
ravulizumab2400-3000 mg IV loading weight-based then maintenance q8wIVq8wLee Blood 2019 / Kulasekararaj — ravulizumab non-inferior to eculizumab with less breakthrough hemolysis and longer dosing interval
pegcetacoplan1080 mg SC twice weeklySCtwice weeklyPEGASUS (Hillmen NEJM 2021 PMID 33730455) — pegcetacoplan superior to eculizumab in patients with persistent anemia; addresses extravascular hemolysis on C5 inhibitor
meningococcal-acwy-conjugate-vaccine0.5 mL IM single dose with booster q5yIM≥2 weeks before C5 inhibitor; booster q5yCDC ACIP and FDA REMS — Neisseria meningitidis infection risk dramatically increased on C5 inhibitor; vaccination ≥2 weeks before therapy mandatory
meningococcal-b-vaccine0.5 mL IM 2-dose seriesIM0 + 6 months ≥2 weeks before C5 inhibitorCDC ACIP — serogroup B coverage required in addition to ACWY conjugate for complement-deficient patients
ciprofloxacin500 mg PO daily as prophylaxis if vaccination cannot precede C5 inhibitor by 2 weeksPOdaily until 2 weeks post-vaccinationBridge prophylaxis until meningococcal vaccine immunity develops; expert consensus

Plan: PNH VTE — acute AC + complement inhibition + meningococcal vaccination + transplant consideration (TRIUMPH; PEGASUS; ASH 2020; ACCP 2021)

3. When to call your provider

Contact your care team if any of the following happen:

  • New VTE despite AC + complement inhibitor → reassess adherence + breakthrough hemolysis + consider pegcetacoplan
  • Pregnancy → switch to LMWH + continue eculizumab
  • Transformation suspicion → urgent bone marrow + transplant evaluation
  • Major bleed → reverse, hold, reassess indefinite indication

4. When to seek emergency care

Call 911 or go to the nearest emergency room right away if you have:

  • Patient on eculizumab or ravulizumab missed scheduled meningococcal booster (5-year interval) or initiated C5 inhibitor without ACWY plus serogroup B vaccination — high-risk window for invasive Neisseria meningitidis infection(life-threatening)
  • Persistent or rising LDH and falling haptoglobin on stable eculizumab or ravulizumab dosing plus new thrombotic event — suggests pharmacokinetic breakthrough or extravascular hemolysis from C3 fragment opsonization
  • PNH with severe aplastic-anemia overlap (ANC < 500, platelets < 20, retic < 60 × 10⁹/L) plus thrombosis — transplant evaluation indicated; complement inhibition alone insufficient
  • Splanchnic vein thrombosis (Budd-Chiari, portal, mesenteric, splenic) or cerebral venous sinus thrombosis as index event — flow cytometry mandatory; PNH diagnosis triggers indefinite AC plus complement inhibition plus vaccination(life-threatening)

5. Follow-up

Long-term hematology + thrombosis clinic co-management; annual bone marrow if disease progression suspected; pregnancy planning (eculizumab safe; LMWH preferred over DOAC / warfarin for thrombosis); transplant evaluation if severe aplastic anemia; PNH transformation to MDS / AML surveillance; cardiovascular risk factor optimisation; education on breakthrough hemolysis recognition and meningococcal infection symptoms (fever / headache / petechiae / neck stiffness → ED immediately)

6. Sources

Guideline: TRIUMPH eculizumab in PNH + PEGASUS pegcetacoplan + Schrezenmeier international PNH registry + ASH 2018 thrombophilia + ACCP/CHEST 2021

  1. pubmed.ncbi.nlm.nih.gov/16990386
  2. pubmed.ncbi.nlm.nih.gov/17716988
  3. pubmed.ncbi.nlm.nih.gov/33730455