Paclitaxel concentrate for solution for infusion
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Concentrate for solution for infusion containing paclitaxel
Advanced HIV-related Kaposi's sarcoma
Advanced ovarian cancer or residual disease post laparotomy in combination
Metastatic breast cancer in patients whose tumours overexpress HER2
Metastatic breast cancer where anthracycline therapy has failed
Metastatic ovarian cancer unresponsive to platinum-based chemotherapy
Node positive breast carcinoma following anthracycline and cyclophosphamide
Non-small cell lung cancer(adj.)-if surgery/radiography not appropriate
Metastatic ovarian cancer unresponsive to platinum-based chemotherapy.
Primary treatment of ovarian cancer, in combination with cisplatin or carboplatin, in patients with advanced or residual disease after initial laparotomy.
Treatment of non-small cell lung cancer in combination with cisplatin in patients who are not candidates for potentially curative surgery and/or radiation therapy.
The initial treatment of advanced or metastatic breast cancer in combination with anthracycline (if suitable) or trastuzumab, in patients who over-express HER-2 at a 3+ level as determined by immunohistochemistry.
Treatment of node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy. Adjuvant treatment with paclitaxel should be regarded as an alternative to extended AC therapy.
Treatment of metastatic carcinoma of the breast where anthracycline therapy has failed or is not appropriate.
Treatment of advanced AIDS-related Kaposi's sarcoma in patients who have failed prior liposomal anthracycline therapy.
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
Premedication for use with concentrate for solution for infusion
All patients must be premedicated with corticosteroids, antihistamines, and histamine-2 receptor antagonists. Such pre-medication may consist of:
Dexamethasone 20 mg orally approximately 12 and 6 hours prior to paclitaxel infusion (8 to 20 mg for Kaposi's Sarcoma patients)
Diphenhydramine 50 mg intravenously or chlorphenamine 10 mg intravenously 30 to 60 minutes prior to paclitaxel infusion.
Cimetidine 300 mg intravenously or ranitidine 50 mg intravenously 30 to 60 minutes prior to paclitaxel infusion.
AIDS-related Kaposi's sarcoma
Neutrophil count less than 1 x 10 to the power of 9/L and/or platelet count less than 75 x 10 to the power of 9/L: Suspend treatment until neutrophils greater than 1 x 10 to the power of 9/L and platelets greater than 75 x 10 to the power of 9/L
Neutrophil count less than 0.5 x 10 to the power of 9/L for 7 days or longer: Suspend treatment until neutrophils greater than 1 x 10 to the power of 9/L, resume treatment at a 25% dose reduction.
Severe peripheral neuropathy or severe mucositis: Reduce dose by 25%.
All other indications
Neutrophils count less than 1.5 x 10 to the power 9/L and platelet count than 100 x 10 to the power 9/L: Suspend treatment until neutrophils greater than 1.5 x 10 to the power 9/L and platelets greater than 100 x 10 to the power 9/L.
Neutrophil count less than 0.5 x 10 to the power of 9/L for 7 days or longer: Suspend treatment until neutrophils greater than 1.5 x 10 to the power 9/L, resume treatment at a 20% dose reduction.
Severe peripheral neuropathy: Reduce dose by 20%.
For intravenous infusion 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
Baseline neutrophils below 1 x 10 to the power of 9 / L in AIDS patients
Baseline platelet count below 75 x 10 to the power of 9/L in AIDS patients
Severe hepatic impairment
Uncontrolled systemic infection - if treating AIDS-related Kaposi's sarcoma
Precautions and Warnings
History of anthracycline therapy
Monitor cardiac function when a history of exposure to cardiotoxic agents
Advise ability to drive/operate machinery may be affected by side effects
Give pre-treatment counselling and consideration of sperm cryopreservation
Pre-medicate with corticosteroids, antihistamines and H2 antagonists
Prophylactic G-CSF should be considered
Treatment to be initiated and supervised by a specialist
Contains polyethoxylated castor oil (Cremophor EL)
Different formulations are not bioequivalent
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
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Extend monitoring if significant cardiac effects following first dose
Monitor blood counts regularly
Monitor closely patient with pre-existing hepatic impairment
Monitor for hypersensitivity reactions during infusion
Monitor for symptoms of peripheral neuropathy
Monitor patients for signs of adverse cardiovascular effects
Monitor vital signs during initial stage of infusion
Advise patient to report any new or worsening respiratory symptoms
Advise patient to report diarrhoea
Consider dose/ schedule adjustment if neuropathy occurs
Consider pseudomembranous colitis if patient presents with diarrhoea
Reduce dose if severe mucositis occurs
Discontinue if severe hypersensitivity reactions occur
Advise patient not to take St John's wort concurrently
Male & female: Contraception required during & for 6 months after treatment
Breastfeeding: Do not breastfeed & discard milk for 1 week after therapy
Advise patient to wear sun protection on hands and feet
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.
Severe cardiac conduction abnormalities have been reported during paclitaxel therapy. Should significant abnormalities develop during treatment, appropriate therapy should be administered and continuous cardiac monitoring should be performed during additional treatment with paclitaxel.
When used in combination with trastuzumab or doxorubicin, cardiac function should be assessed before treatment including history, physical examination, ECG, echocardiogram and/or MUGA scan. Cardiac function should be monitored throughout treatment (every 3 months). Should cardiac function deteriorate, the clinical benefits of further treatment should be assessed against the potential for producing cardiac damage. If further treatment is administered, monitoring of cardiac function should be more frequent (e.g. every 1 to 2 cycles).
Interstitial pneumonitis has developed in patients treated with paclitaxel and radiotherapy to the lung, irrespective of the chronological order of treatments.
Pregnancy and Lactation
Paclitaxel is contraindicated in pregnancy.
At the time of writing there is limited data on the use of paclitaxel in human pregnancy. Animal studies have shown embryo-foetal toxicity.
The effect of concurrent therapies must also be considered.
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 ).
Paclitaxel is contraindicated during breastfeeding.
It is unknown if paclitaxel is excreted in human breast milk limited data suggests it is, a risk to neonates cannot be excluded. Schaefer recommends breastfeeding is withheld for at least 6 days after the last dose and Lactmed suggest 1 week.
The effect of concurrent therapies must also be considered.
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 myeloid leukaemia
Aspartate aminotransferase increased
Cardiac conduction disturbances
Congestive cardiac failure
Increase in alkaline phosphatase
Increase in creatinine
Injection site reactions
Reduced platelet count
Serum bilirubin increased
Visual field defects
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 2015
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 23 September 2015.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Summary of Product Characteristics: Paclitaxel 6mg/ml concentrate for solution for infusion. Hospira UK Ltd. Revised January 2015.
Summary of Product Characteristics: Paclitaxel 6mg/ml concentrate for solution for infusion. Accord Healthcare Limited. Revised April 2015.
Summary of Product Characteristics: Paclitaxel 6mg/ml concentrate for solution for infusion. Actavis UK Ltd. Revised November 2012.
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
Last revised: 10th May 2010
Last accessed: 23th September 2015.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Paclitaxel Last revised: 10 March 2014
Last accessed: 23 September 2015.
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