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Aza-anthracenedione cytotoxic Pregnancy: Women of childbearing potential and their partners should be advised to avoid pregnancy; women and men must use effective contraception during and for up to 6 months after treatment. Pregnancy: there are no data from the use of pixantrone in pregnant women and studies in animals have shown reproductive toxicity — Pixuvri is not recommended during pregnancy, nor in women of childbearing potential not using contraception. Breast-feeding: it is unknown whether Pixuvri or its metabolites are excreted in human milk and a risk to the newborn/infant cannot be excluded — breast-feeding should be discontinued during treatment. Fertility: dose-dependent testicular atrophy was detected in dogs after repeated administration at doses as low as 0.1 mg/kg/day (not evaluated in humans); as with other DNA-damaging agents Pixuvri may be associated with fertility impairment, so male patients should use contraceptive methods (preferably barrier) during treatment and for 6 months post-treatment to allow new sperm to mature, and sperm banking should be considered to avoid the risk of long-term infertility.

Pixantrone (Specialist drug)

Brand names: Pixuvri

Pixantrone is an aza-anthracenedione cytotoxic given by intravenous infusion, used as monotherapy for relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: SPECIALIST ONCOLOGY USE — Pixuvri single-agent regimen: the recommended dose is 50 mg/m2 of pixantrone on days 1, 8 and 15 of each 28-day cycle, for up to 6 cycles. The dose must be adjusted before the start of each cycle based on nadir haematologic counts or maximum toxicity from the preceding cycle. The amount in milligrams is determined from the patient's body surface area (BSA), calculated by the institutional standard using a weight measured on day 1 of every cycle. IMPORTANT UNIT NOTE from the SPC: in the EU the recommended dose refers to the BASE of the active substance (pixantrone), and the individual dose must be calculated from the strength of the reconstituted solution containing 5.8 mg/ml pixantrone together with the 50 mg/m2 dose recommendation — in some trials and publications the dose is instead based on the salt form (pixantrone dimaleate).
Route: Intravenous (IV) infusion only — the safety of intrathecal use has not been established. Give as a slow intravenous infusion using an in-line filter over a minimum of 60 minutes, after reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection and further dilution with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml. Pixuvri must be administered by physicians who are familiar with the use of antineoplastic agents and who have the facilities for regular monitoring of clinical, haematological and biochemical parameters during and after treatment.
Frequency: Days 1, 8 and 15 of each 28-day cycle, for up to 6 cycles
Max: 50 mg/m2 per administration on days 1, 8 and 15 of a 28-day cycle, for up to 6 cycles — this is the SPC's recommended dose and the highest figure it gives. The SPC provides no upward dose escalation and no separate ceiling: doses are only ever adjusted DOWNWARD (reduced by 20%) or delayed for haematologic, non-cardiac or cardiac toxicity.
THIS DRAFT REPLACES AN EARLIER HOLD. The previous hold reason (no UK SPC in the bundle) is now STALE — the UK SPC for Pixuvri 29 mg powder for concentrate for solution for infusion (eMC product 3662) has been recovered and matches this page exactly on brand, active substance (pixantrone) and route (IV). INDICATION SCOPE: section 4.1 (therapeutic indications) was NOT fetched into this bundle, so the licensed indication wording is not quoted here; the SPC gives a single recommended monotherapy regimen (section 4.8 describes the safety data as coming from 'all completed single agent studies'). Verify the licensed indication against the SPC before use. DOSE DELAY THRESHOLD: if on day 1 of any cycle the Absolute Neutrophil Count (ANC) is < 1.0 x 10^9/l or the platelet count is < 75 x 10^9/l, delay treatment until ANC recovers to at least 1.0 x 10^9/l and platelets to at least 75 x 10^9/l. HAEMATOLOGIC DOSE MODIFICATION on days 8 and 15 of any cycle — Grade 1-2 (platelets from the lower limit of normal down to 50 x 10^9/l, ANC from the lower limit of normal down to 1.0 x 10^9/l): no change in dose or schedule. Grade 3 (platelets < 50 down to 25 x 10^9/l, ANC < 1.0 down to 0.5 x 10^9/l): delay treatment until recovery to platelets at least 50 x 10^9/l and ANC at least 1.0 x 10^9/l. Grade 4 (platelets < 25 x 10^9/l, ANC < 0.5 x 10^9/l): delay treatment until the same recovery thresholds AND reduce the dose by 20%. NON-HAEMATOLOGIC DOSE MODIFICATION — any grade 3 or 4 drug-related non-cardiac toxicity other than nausea or vomiting: delay treatment until recovery to grade 1 and reduce the dose by 20%. Any grade 3 or 4 NYHA cardiovascular toxicity or persistent LVEF decline: delay treatment and monitor until recovery; consider discontinuation for persistent decline in LVEF of 15% or more of the baseline value. SPECIAL POPULATIONS — Elderly: no specific dose adjustment is required in patients aged 65 years or over. Renal impairment: safety and efficacy not established; patients with serum creatinine greater than 2 x the upper limit of normal were excluded from the randomised studies, so use with caution. Hepatic impairment: safety and efficacy not established; use with caution in mild or moderate liver impairment, and Pixuvri is NOT recommended in severe excretory hepatic impairment (which is also a contraindication). Poor performance status: no information in patients with ECOG greater than 2 — exercise caution. Obesity: caution advised, as data on BSA-based dosing are very limited in this group. SOURCE LIMITS: sections 4.2 posology, 4.3 and 4.6 were captured in full and untruncated; sections 4.4 (warnings) and 4.8 (adverse reactions) were truncated at the source-fetch limit, so those lists below are not complete. Sections 4.1 and 4.5 (interactions) were not fetched. No openFDA or WHO source was present in this bundle.

Paediatric dose

Route: N/A
Frequency: N/A
Max: Not established
UK SPC section 4.2 Paediatric population, verbatim: 'The safety and efficacy of Pixuvri in children aged < 18 years has not yet been established. No data are available.' No paediatric dose is published here and none may be derived from the adult BSA-based regimen. Verify any use under 18 years against a children's formulary and specialist paediatric oncology advice.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to pixantrone dimaleate or to any of the excipients listed in section 6.1
  • Immunisation with live virus vaccines
  • Profound bone marrow suppression
  • Severe abnormal hepatic function

Side effects

  • Most common toxicity — bone marrow suppression, particularly of the neutrophil lineage; with the recommended dose and schedule neutropenia is usually transient, reaching its nadir on days 15-22 following administration on days 1, 8 and 15, with recovery usually occurring by day 28
  • Very common blood and lymphatic — neutropenia, leukopenia, lymphopenia, anaemia, thrombocytopenia
  • Common blood and lymphatic — febrile neutropenia, blood disorder; Uncommon — bone marrow failure, eosinophilia
  • Common infections — neutropenic infection, respiratory tract infection, infection, sepsis
  • Uncommon infections — bronchitis, candidiasis, cellulitis, herpes zoster, meningitis, nail infection, oral fungal infection, oral herpes, pneumonia, salmonella gastroenteritis, septic shock. Infections have been associated with hospitalisation, septic shock and death
  • Cardiac — changes in cardiac function including decreased LVEF or fatal congestive heart failure (CHF) may occur during or after treatment
  • Uncommon neoplasms — neoplasm progression; secondary malignancy including reports of acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS)
  • Uncommon immune — hypersensitivity to the medicinal product
  • Common metabolism — anorexia, hypophosphataemia; Uncommon — hyperuricaemia, hypocalcaemia, hyponatraemia
  • Uncommon psychiatric — anxiety, insomnia, sleep disorder
  • Common nervous system — taste disturbances, paraesthesia, headache, somnolence; Uncommon — dizziness, lethargy
  • Common eye — conjunctivitis
  • Other toxicities such as nausea, vomiting and diarrhoea were generally infrequent, mild, reversible and manageable; effects on hepatic or renal function were minimal
  • NOTE: the section 4.8 adverse-reaction table was truncated in this source capture — this list is not complete; consult the SPC

Monitoring

  • BASELINE before all initial treatment — careful assessment of blood counts, serum total bilirubin, serum total creatinine, and cardiac function measured by left ventricular ejection fraction (LVEF)
  • Blood counts — careful monitoring is required including leukocyte, red blood cell, platelet and absolute neutrophil counts; recombinant haematopoietic growth factors may be used according to institutional or ESMO guidelines
  • Recheck counts on day 1 of every cycle and on days 8 and 15 to apply the dose-modification tables (see notes)
  • Cardiac function — monitor before initiation and during treatment; monitoring of LVEF by MUGA scan or echocardiography is recommended to assess subclinical cardiotoxicity. If cardiac toxicity is demonstrated, re-evaluate the risk versus benefit of continued therapy
  • Careful risk-versus-benefit consideration before treating patients with a baseline LVEF below 45% by MUGA, clinically significant cardiovascular abnormalities (NYHA grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2
  • Body surface area — determine using the institutional standard from a weight measured on day 1 of every cycle
  • Monitor for infection, including pneumonia, cellulitis, bronchitis and sepsis, particularly during neutropenia
  • Remain alert for secondary haematological malignancy (AML, MDS) during and after treatment

Clinical monograph

How it works

It intercalates DNA and inhibits topoisomerase II, forming stable DNA adducts that disrupt replication in dividing tumour cells.

Prescribing in practice

  • Myelosuppression, particularly neutropenia, is the main dose-limiting toxicity and predisposes to serious infection, so blood counts must be monitored and treatment adjusted accordingly.
  • Although designed to reduce cardiac toxicity relative to anthracyclines, cardiac function should still be assessed, especially with prior anthracycline exposure.
  • It can colour the urine bluish and may cause tissue damage on extravasation.

Monitoring

Monitor full blood count before each cycle and cardiac function periodically during treatment.

Counselling the patient

  • Report fever or signs of infection promptly during treatment.
  • Your urine may temporarily turn a blue-green colour, which is harmless.
  • Effective contraception is required during and after treatment.

Evidence & guidelines

NICE and the EU marketing authorisation support pixantrone monotherapy in multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

Reference: NICE TA306; SmPC; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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