- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Concentrate for infusions containing pixantrone (as dimaleate).
Relapsed or refractory B-cell non-Hodgkin's lymphoma - monotherapy
When using this agent, specialist literature, national guidelines, cancer networks protocols and Trust chemotherapy protocols should be consulted.
The recommended dose is 50mg/metre squared of pixantrone on days 1, 8 and 15 of each 28-day cycle for up to 6 cycles.
Dose should be adjusted based on nadir haematological counts and maximum toxicity from the previous cycle. Neutropenia usually reaches its nadir on days 15 to 22 and normally recovers by day 28.
Additional Dosage Information
Dose modifications for haematologic toxicities
On day 1 of any cycle
Platelet count less than 75 x 10 to the power 9/litre and/or absolute neutrophil count (ANC) less than 1.0 x 10 to the power 9/litre: Suspend treatment until platelet count greater than or equal to 75 x 10 to the power 9/litre and ANC greater than or equal to 1.0 x 10 to the power 9/litre.
On days 8 and 15 of any cycle
Platelet count between 25 and 50 x 10 to the power 9/litre and/or absolute neutrophil count (ANC) between 0.5 to 1.0 x 10 to the power 9/litre (Grade 3): Suspend treatment until platelet count greater than or equal to 50 x 10 to the power 9/litre and ANC greater than or equal to 1.0 x 10 to the power 9/litre.
Platelet count less than 25 x 10 to the power 9/litre and ANC count less than 0.5 x 10 to the power 9/litre (Grade 4): Suspend treatment until platelet count greater than or equal to 50 x 10 to the power 9/litre and ANC greater than or equal to 1.0 x 10 to the power 9/litre. Reduce dose by 20%.
Treatment modifications for non-haematologic toxicities
Any grade 3 or 4 drug-related non cardiac toxicity other than nausea or vomiting:
Suspend treatment until recovery to grade 1. Reduce the dose by 20%.
Any grade 3 or 4 New York Heart Association cardiovascular toxicity or persistent Left Ventricular Ejection Fraction (LVEF) decline:
Suspend treatment and monitor until recovery. Consider discontinuation for persistent decline in LVEF of greater than or equal to 15% of baseline value.
For intravenous infusion only, over a minimum of 60 minutes.
Children under 18 years
History of recurrent infection
Neutrophil count below 1.0 x 10 to the power of 9 / L
Platelet count below 50 x 10 to the power of 9/L on day 8 or 15 of cycle
Platelet count below 75 x 10 to the power of 9/L on day 1 of cycle
Severe hepatic impairment
Precautions and Warnings
Females of childbearing potential
History of mediastinal radiotherapy
History of treatment with anthracyclines
Left ventricular ejection fraction value of 45% or less
Performance status of ECOG greater than 2
Predisposition to infection
Restricted sodium intake
Risk factors for cardiovascular disorder
Within 7 months of discontinuing trastuzumab
New York Heart Association class III failure
Renal impairment - serum creatinine above 1.5 times ULN
Serious cardiac arrhythmias
Within 6 months of a myocardial infarction
Administration of live vaccines is not recommended
Sodium content of formulation may be significant
Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
Consider discontinuing if LVEF decreases by 15% or more and persists
Consider premedication with hypouricaemic agent
Evaluate left-ventricular ejection fraction before initiation
Give pre-treatment counselling and consideration of sperm cryopreservation
Maintain adequate hydration of patient prior / during treatment
Treatment to be prescribed under the supervision of a specialist
Consult local policy on the safe use of anti-cancer drugs
If extravasation occurs follow local policy & seek expert help immediately
Staff: Not to be handled by pregnant staff
Monitor cardiac function before and regularly during treatment
Monitor haematological parameters before and during treatment
Monitor renal function prior to initiating treatment
Monitor bilirubin levels before treatment
Monitor patients for development of second primary malignancies
Monitor patients for signs of tumour lysis syndrome
Monitor serum biochemistry regularly
Consider treatment with blood growth factors if severe cytopenias develop
Interrupt therapy if neutrophil count <1.0x10 to the power 9/L
Interrupt treatment and/or reduce dose for any grade 3 toxicity
Interrupt treatment if platelet count <50 x 10 to the power of 9/L
Male & female: Contraception required during & for 6 months after treatment
Advise patient on appropriate sun protection methods
Pregnancy and Lactation
Pixantrone is contraindicated in pregnancy.
At the time of writing there is limited data on the use of pixantrone in pregnant women. Studies in animals have shown reproductive toxicity.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Pixantrone is contraindicated in breastfeeding.
At the time of writing it is unknown whether pixantrone is excreted in human milk, a risk to neonates cannot be excluded.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Alanine aminotransferase increased
Aspartate aminotransferase increased
Blood urea increased
Bone marrow failure
Bundle branch block
Congestive cardiac failure
Gamma glutamyl transferase (GGT) increased
Increase in alkaline phosphatase
Raised neutrophil count
Second primary malignancies
Sensation of warm and/or cold at injection site
Serum creatinine increased
Tumour lysis syndrome
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: November 2018
Summary of Product Characteristics: Pixuvri 29mg powder for concentrate for solution for injection. CTI Life Sciences Ltd. Revised August 2018.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.