Paclitaxel powder for solution for infusion
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder for solution for infusion formulations of paclitaxel.
Fallopian tube cancer
Primary peritoneal cancer
Relapsed platinum sensitive high grade serous epithelial ovarian cancer
Treatment of first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in adult patients in combination with carboplatin.
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
250mg per metre squared body suface area (BSA) every 3 weeks for 6 cycles.
Patients with Hepatic Impairment
Moderate and severe hepatic impairment
Dose reduction of 20% is recommended
Additional Dosage Information
1st dose reduction: 200mg per metre squared BSA
2nd dose reduction: 175mg per metre squared BSA
For intravenous infusion only after dilution.
Children under 18 years
Neutrophil count below 1.5 x 10 to the power of 9 / L at baseline
Platelet count below 100 x 10 to the power of 9 / L at baseline
Serum bilirubin above 5 times upper limit of normal
Serum transaminases above 10 times upper limit of normal
Severe renal impairment
Precautions and Warnings
Patients over 75 years
Restricted sodium intake
Moderate hepatic impairment
Monitor cardiac function when a history of exposure to cardiotoxic agents
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Anti-diarrhoeals may be required during treatment
Pre-medicate with corticosteroids, antihistamines and H2 antagonists
Prophylactic G-CSF should be considered
Different formulations are not bioequivalent
Accidental contact of soln with skin/mucous membranes-rinse well with water
Consult local policy on the safe use of anti-cancer drugs
Dilute and use as an infusion
If extravasation occurs follow local policy & seek expert help immediately
Never rechallenge treatment after a severe hypersensitivity reaction
Paclitaxel to be administered before cisplatin when used in combination
Reducing the infusion rate may minimise severity of infusion reactions
Staff: Not to be handled by pregnant staff
Monitor blood counts regularly
Monitor for hypersensitivity reactions during infusion
Advise patient that alopecia may occur
Advise patients at risk of neutropenia to report any signs of infection
Consider dose/ schedule adjustment if neuropathy occurs
Consider the use of anti-emetics before and during therapy
Discontinue if grade 4 toxicity occurs
Discontinue if severe hypersensitivity reactions occur
Interrupt therapy if platelet count less than 100 x 10 to the power of 9/L
Suspend treatment and reduce dose if febrile neutropenia occurs
Female: Contraception required during and for 6 months after treatment
Advise patient to report signs / symptoms of infusion related reactions
This paclitaxel should not be substituted for or with the albumin bound nanoparticle formulation of paclitaxel.
When paclitaxel is used in combination therapy, it should be administered before cisplatin.
Infusion site reactions are very common, especially on the first infusion. These reactions may be improved by slowing the rate of infusion. In patients who experience severe pain or other infusion reactions should be considered for central venous catheter.
Pregnancy and Lactation
Paclitaxel is contraindiacted during pregnancy.
The manufacturer recommends that paclitaxel should not be used in pregnancy unless the clinical condition requires treatment. There is limited data in the use of paclitaxel in pregnant women, however, paclitaxel is expected to cause serious birth defects. Animal studies have shown foetal toxicities.
Paclitaxel is contraindicated during breastfeeding.
The manufacturer recommends that breastfeeding must be discontinued during paclitaxel treatment. Paclitaxel is excreted in human milk and may have serious adverse reactions in breastfed infants.
Cellulitis (injection site)
Infusion site reaction
Intravascular coagulation (disseminated)
Peripheral motor neuropathy
Peripheral sensory neuropathy
Respiratory tract infection
Upper abdominal pain
Urinary tract infections
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: July 2022
Summary of Product Characteristics: Apealea 60mg powder for solution for infusion. Inceptua. Revised December 2021.
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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.