Daunorubicin with cytarabine encap in liposomes parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Parenteral formulations of daunorubicin with cytarabine.
Leukaemia - acute myeloid
Newly diagnosed, therapy-related acute myeloid leukaemia (t-AML), or AML with myelodysplasia-related changes (AML-MRC).
Due to the complexity and specialist nature of dosage regimens for the treatment of malignant disease, specific dosing information on this agent is not included.
Doses may vary significantly if this agent is used as monotherapy or different combinations.
When using this agent, specialist literature, national guidelines, cancer network protocols and Trust chemotherapy protocols should be consulted.
Additional Dosage Information
If a planned dose is missed, the dose should be administered as soon as possible, and the dosing schedule should be adjusted accordingly to maintain an appropriate interval between doses.
Mild hypersensitivity symptoms: Interrupt infusion and monitor vital signs until symptoms resolve. Restart infusion at half the rate of infusion and administer intravenous diphenhydramine and dexamethasone.
Moderate hypersensitivity symptoms: Interrupt treatment and monitor vital signs until symptoms resolve. Resume treatment at the next scheduled dose, at the same dose and infusion rate, and consider premedication with anti-emetics and anti-hyperuricemics.
Severe hypersensitivity symptoms: Permanently discontinue treatment and monitor vital signs until symptoms resolve.
For intravenous infusion only, over a period of 90 minutes.
Children under 18 years
Precautions and Warnings
History of mediastinal radiotherapy
Within 7 months of discontinuing trastuzumab
Renal impairment - creatinine clearance 15-29ml/minute
Severe hepatic impairment
Administration of live vaccines is not recommended
Consider anti-infective prophylaxis in immunocompromised patients
Advise ability to drive/operate machinery may be affected by side effects
Cardiotoxic -Avoid anthracyclines for up to 7 months after last trastuzumab
Consider premedication with hypouricaemic agent
Maintain adequate hydration of patient prior / during treatment
Treatment to be initiated and supervised by a specialist
Different preparations of intravenous daunorubicin are not interchangeable
Consult local policy on the safe use of anti-cancer drugs
Never rechallenge treatment after a severe hypersensitivity reaction
Staff: Not to be handled by pregnant staff
Assess baseline cardiac function prior to treatment
Consider echocardiogram before treatment
Monitor renal and hepatic function before and during treatment
Perform ECG before treatment
Perform full blood count before treatment
Monitor haematological parameters regularly throughout treatment
Monitor patients as drug is cumulative
Monitor patients for signs of tumour lysis syndrome
Monitor uric acid levels
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Antibody response to non-live vaccines may be diminished
Consider the use of anti-emetics before and during therapy
Discontinue if any deterioration in cardiac status occurs
Risk of cardiomyopathy increases with high cumulative dosage
Discontinue if cardiomyopathy occurs
Discontinue if patients show signs of acute copper toxicity
Discontinue permanently if severe hypersensitivity reactions occur
Interrupt treatment if mild hypersensitivity reactions occur
May affect the gastro-intestinal absorption of other drugs
May cause impaired fertility
Male & female: Contraception required during & for 6 months after treatment
Daunorubicin with cytarabine encapsulated in liposomes is not equivalent or interchangeable with other cytarabine or daunorubicin containing products, due to substantial differences in pharmacokinetic properties. The medicinal product name and correct dosage and dosing schedule should be verified prior to administration.
Absolute neutrophil count and platelet count may have an increased time to recovery, and may require additional monitoring.
High cumulative doses of daunorubicin may increase the incidence of adverse cardiac events. Total daunorubicin exposure must be considered, with particular consideration to patients who have received radiation therapy to the mediastinum, as the threshold for potential adverse cardiac events may be lower in these patients.
Pregnancy and Lactation
Daunorubicin and cytarabine encapsulated in liposomes is contraindicated in pregnancy.
At the time of writing there is limited data available on the use of daunorubicin and cytarabine encapsulated in liposomes in pregnant women.
The manufacturer states that, based on animal studies and the drug's mechanism of action, daunorubicin and cytarabine encapsulated in liposomes should not be used in pregnant women unless the potential benefit clearly outweighs the potential risk.
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 ).
Daunorubicin and cytarabine encapsulated in liposomes is contraindicated during breastfeeding.
It is unknown if daunorubicin and cytarabine encapsulated in liposomes is excreted in human breast milk. However due to the potential for serious adverse reactions in the nursing infant it should not be given to women who are breastfeeding.
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
Acute renal insufficiency
Palmar-Plantar Erythrodysaesthesia syndrome
Tumour lysis syndrome
Visual impairment (irreversible)
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: September 2018.
Summary of Product Characteristics: Vyxeos 44mg/100mg powder for concentrate for solution for infusion. Jazz pharmaceuticals UK. Revised August 2018.
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