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DOCETAXEL HOSPIRA 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

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Docetaxel Hospira 10 mg/ml
Concentrate for Solution for Infusion
Docetaxel
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Docetaxel Hospira is and what it is used for
2. Before you are given Docetaxel Hospira
3. How Docetaxel Hospira is used
4. Possible side effects
5 How to store Docetaxel Hospira
6. Further information

1. WHAT DOCETAXEL HOSPIRA IS AND WHAT IT IS USED FOR
Docetaxel Hospira is an anti-cancer drug and is used either alone or in combination with
other anti-cancer medicines to treat:
• Early breast cancer with or without lymph node involvement; Docetaxel Hospira is used
in combination with doxorubicin and cyclophosphamide.
• Advanced breast cancer; Docetaxel Hospira is used either alone or in combination
• with doxorubicin, capecitabine or trastuzumab.
• Special forms of lung cancer (non-small cell lung cancer); Docetaxel Hospira is used
either alone or in combination with cisplatin.
• Prostate cancer; Docetaxel Hospira is used in combination with prednisone or
prednisolone.
• Gastric cancer; where the cancer has spread, Docetaxel Hospira is used in combination
with cisplatin and 5-fluorouracil.
• Head and neck cancer; Docetaxel Hospira is used in combination with cisplatin and
5-fluorouracil.

2. BEFORE YOU ARE GIVEN DOCETAXEL HOSPIRA
Do not use Docetaxel Hospira:

• if you are hypersensitive (allergic) to docetaxel or any of the other ingredients
• if you already have a reduced number of white blood cells
• if you have severe liver disease.

Special care will be taken with Docetaxel Hospira:





if the number of white cells in your blood is too low. Your doctor will check this.
if you develop a hypersensitivity (allergic) reaction to this medicine
if you develop reddening or swelling on your hands or feet
if you have severe fluid retention in your heart, lungs or stomach. Your doctor will check
this.
• if you have liver disease
• if you have kidney disease
• to check your heart is working properly if you are to receive this medicine in
combination with trastuzumab.
For breast, non-small cell lung and prostate cancer treatment you will be asked to take an
oral corticosteroid such as dexamethasone before and possibly during your treatment with
Docetaxel Hospira. This will help to reduce some of the undesirable effects associated with
this medicine.
Tell your doctor, hospital pharmacist or nurse if you have vision problems. In case of vision
problems, in particular blurred vision you should immediately have your eyes and vision
examined.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or
cough), please tell your doctor, hospital pharmacist or nurse immediately.
Your doctor may stop your treatment immediately.
Docetaxel Hospira contains alcohol. Discuss with your doctor if you suffer from alcohol
dependency, epilepsy or liver impairment. See also section “Docetaxel Hospira contains
ethanol (alcohol)” below.

Taking other medicines
It is not advisable to use any medical treatment without telling your doctor as there may be
interactions between Docetaxel Hospira and other medicines.
Please tell your doctor if you are taking or have recently taken, any other medicines,
including medicines obtained without a prescription. This is because Docetaxel Hospira
or any other medicine might not work as well as expected and you may be more likely to
experience a side effect.

Pregnancy:
Ask your doctor for advice before being given any medicine.
Docetaxel Hospira should not be administered if you are pregnant unless clearly indicated
by your doctor. You must not become pregnant during treatment with this medicine and
must use an effective method of contraception both during, and for at least three months
after treatment. If pregnancy occurs during your treatment, you must immediately inform
your doctor.
If you are a man being treated with Docetaxel Hospira you are advised not to father a child
during and up to 6 months after treatment and to seek advice on conservation of sperm
prior to treatment because of the possibility of irreversible infertility due to treatment with
docetaxel.

Breast-feeding
You should not breast-feed whilst you are being treated with Docetaxel Hospira.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed
There is no reason why you cannot drive between courses of Docetaxel Hospira except if
you feel dizzy or are unsure of yourself.

Docetaxel Hospira contains ethanol (alcohol)
20 mg/2 ml vial
This medicinal product contains 23 vol % ethanol anhydrous (alcohol), i.e. 363 mg per vial,
equivalent to 9 ml beer, 4 ml wine per dose.
80 mg/8 ml vial
This medicinal product contains 23 vol % ethanol anhydrous (alcohol), i.e. 1452 mg per
vial, equivalent to 37 ml beer, 15 ml wine per dose.
160 mg/16 ml vial
This medicinal product contains 23 vol % ethanol anhydrous (alcohol), i.e. 2904 mg per
vial, equivalent to 74 ml beer, 31 ml wine per dose.
Harmful for those suffering from alcoholism.
To be taken into account if you are pregnant or if you are breast-feeding, in children and
high-risk groups such as patients with liver disease, or epilepsy.
The amount of alcohol in this medicinal product may have effects on the central nervous
system (the part of the nervous system that includes the brain and spinal cord).
The amount of alcohol in this medicinal product may alter the effects of other medicines
The amount of alcohol in this medicine may impair your ability to drive or use machines.

3. HOW DOCETAXEL HOSPIRA IS USED
Docetaxel Hospira will be administered to you by a healthcare professional.

For adults only.
Docetaxel Hospira will be prescribed by a specialist in cancer treatment.
The dose depends on your body surface area (calculated by m2), your state of health and
the type of cancer you have. The duration of your treatment will be determined by your
doctor.
This medicine is given by injection into a vein (an intravenous infusion) over a 1 hour
period. Your treatment will be repeated every 3 weeks.
Your doctor may change the dose and frequency of dosing depending on your blood tests,
your general condition and your response to Docetaxel Hospira.

If you are given more Docetaxel Hospira than you should:
As this medicine is given in a hospital, it is unlikely that you will be given too little or too
much, however tell your doctor if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, docetaxel can cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following which occur in
more than 1 in 10 patients:
• flushing
• rash which might be itchy
• chest tightness or difficulty in breathing
• back pain
• fever or chills
• low blood pressure which may make you feel light-headed or faint.
The severity and frequency of side effects may vary depending on whether Docetaxel
Hospira is given alone or in combination with other anti-cancer medicines. Side effects that
might be noticed during your treatment are listed below:

Very common side effects (experienced in more than 1 patient in 10)
• Infection
• Decrease in the number of red and/or white blood cells or platelets (your doctor will
check this)

The following information is intended for medical or healthcare professionals only:
When determining the appropriateness of use in a particular patient, the prescriber should
be familiar with the full SmPC.

SHELF LIFE
Unopened vial: 36 months
After dilution:
After dilution in 0.9% sodium chloride or 5% glucose chemical and physical in-use stability
has been demonstrated for 4 hours when stored below 25°C. From a microbiological point
of view, the infusion preparation should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in
controlled and validated aseptic conditions.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Instructions for Use
To be administered by intravenous infusion. Prior to infusion Docetaxel Hospira should be
diluted under aseptic conditions.
Inspect visually prior to use. Only clear solutions without visible particles should be used.
Contact of Docetaxel Hospira with plasticized PVC equipment or devices used to prepare
solutions for infusion is not recommended. In order to minimise patient exposure to the
plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags
or sets, Docetaxel Hospira should be stored in bottles (glass, polypropylene) or plastic bags
(polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Inject the required volume into a 250 ml infusion bag or bottle containing either:
• Sodium Chloride 9 mg/ml (0.9%)
• Glucose 50 mg/ml (5%)
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion
vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.

H03833

Component Specification

Requester

Item number:

H03833

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N/A

Country:

UK / Ireland / Malta

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I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
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to the printing stage.
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OI template:
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Mulgrave version:

SVI007
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Dimensions:
118 x 570 mm (20 panels)
Container(s):
vial
Supplier:
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Stock:
40 gsm
Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Pharma code length:
Supplier Code:

Colours
Black:

n/a
n/a
n/a

Signed:
Date:

Version 1
Technician: LH
Date: 17/Feb/16

Version 2
Technician: GEK
Date: 06/Apr/16

Version 3
Technician: GEK
Date: 08/Apr/16

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
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Version 10
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Date: dd/mmm/yy


































Fever
Allergic reactions as described above
Loss of appetite
Inability to sleep
Feeling of numbness or pins and needles
Headache
Reduced sensation to touch
Increased tear formation
Swelling under the skin
Bleeding from the nose
Runny nose, inflammation of the nose and throat
Cough
Chest pain
Change in sense of taste
Shortness of breath/difficulty in breathing
Sores in your mouth (including tongue and/or lips and/or cheeks)
Diarrhoea
Feeling and/or being sick
Constipation
Abdominal pain
Indigestion
Loss of hair
Redness and swelling of the palms of your hands or soles of your feet which may cause
your skin to peel (this may also occur on your arms, face or body)
Change in the colour of your nails, which may detach
Muscle aches or pain
Back pain or bone pain
Change or absence of menstrual period
Swelling of the hands, feet or legs
Feeling of weakness
Tiredness or flu-like symptoms
Weight gain
Weight loss

Common side effects (experienced in 1 to 10 patients in 100 )
















Fungal infection in the mouth
Inflammation of the skin
Dry mouth
Dizziness
Headache
Dehydration
Conjunctivitis
Impaired hearing
Difficulty or pain when swallowing
Irregular heart beat
High or low blood pressure (your doctor will check this)
Heart failure
Heartburn
Bleeding
Raised liver enzymes (your doctor will check this)

Uncommon side effects (experienced in 1 to 10 patients in 1,000)
• Fainting
• Inflammation of the vein
• Inflammation of the colon, small intestine or perforation of the large intestine

Rare side effects (experienced in 1 to 10 patients in 10,000)







Fits or temporary loss of consciousness
Hearing loss
Heart attack
Blood clots
Pneumonia
Inflammation and /or fluid on the lungs which may cause you to cough, with or without
frothy phlegm. Severe cases of lung fibrosis that are sometimes fatal have occurred
• Intestinal blockage causing abdominal pain
• Skin redness at the site of previous radiation therapy

Very rare effects (experienced in less than 1 in 10,000 patients)





Acute myeloid leukaemia. Your doctor will do blood tests to check for this.
Temporary visual disturbances e.g. flashes, flashing lights, reduced vision
Inflammation of the liver
Skin redness and/or blisters or thickened hard skin.

Frequency unknown:









Problems with your kidneys/ decreased kidney function (your doctor will check this)
Interstitial lung disease (inflammation of the lungs causing coughing and
difficulty breathing. Inflammation of the lungs can also develop when docetaxel
therapy is used with radiotherapy)
Pneumonia (infection of the lungs)
Pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Blurred vision due to swelling of the retina within the eye (cystoid macular oedema)
Decrease of sodium in your blood

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom
Yellow Card Scheme
Website at: www.mhra.gov.uk/yellowcard

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website at: www.hpra.ie
e-mail: medsafety@hpra.ie

Malta
ADR Reporting
Website at: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE DOCETAXEL HOSPIRA
Keep out of the sight and reachof children.
Do not use Docetaxel Hospira after the expiry date printed on the carton and label (EXP).
The expiry date refers to the last day of that month.
Store below 25ºC.
Keep the vial in the outer carton in order to protect from light.
After dilution in 0.9% sodium chloride or 5% glucose, chemical and physical in-use stability
has been demonstrated for 4 hours when stored below 25ºC.
From a microbiological point of view, the infusion preparation should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would not normally be longer than 24 hours at 2ºC to 8ºC
unless dilution has taken place in controlled and validated aseptic conditions.

6. FURTHER INFORMATION
What Docetaxel Hospira contains
• T
 he active substance is docetaxel (anhydrous). Each ml of concentrate for solution for
infusion contains 10 mg of docetaxel.
• The other ingredients are citric acid (anhydrous), ethanol anhydrous (see section 2),
Macrogol 300 and Polysorbate 80.
Docetaxel Hospira is a clear colourless to pale yellow solution. The medicine comes in
glass containers called vials. One ml of solution contains docetaxel 10 mg. One 2 ml vial
contains 20 mg docetaxel, one 8 ml vial contains 80 mg docetaxel and one 16 ml vial
contains 160 mg docetaxel. The vials may be wrapped in a protective plastic to reduce
the risk of spillage if the vials break - these are referred to as ONCO-TAIN®. The vials are
available in single packs. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufactuer:
The marketing authorisation holder and manufacturer is Hospira UK Limited,
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
UK
This leaflet was last revised in 04/2016

From a microbiological point of view, the infusion preparation should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the
user and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has
taken place in controlled and validated aseptic conditions.
As with other potentially toxic compounds, caution should be exercised when handling and
preparing docetaxel solutions.

Special precautions for administration
• DO NOT mix with other medicinal products

Instructions for Handling
Local guidelines on safe preparation and handling should be consulted.
Cytotoxic agents should only be prepared and handled by personnel trained in the safe
handling of such preparations. Pregnant personnel should not handle cytotoxic agents.
All personnel involved with handling cytotoxic agents should be adequately protected with
appropriate personal protective equipment, including protective disposable gloves,
eye shield, mask and long-sleeved gown. Preparation and manipulation of solutions should
be performed in a designated handling area.

Instructions for Contamination
In the event of skin contact, thoroughly wash the affected area with soap and water, taking
care not to abrade the skin. A bland cream may be used to treat transient stinging of the
skin. In the event of contact with the eyes, irrigate with copious amounts of water or sodium
chloride 0.9%. Seek medical evaluation.
In the event of spillage, trained personnel wearing appropriate personal protective
equipment should remove the maximum amount of material by use of a cytotoxic drug spill
kit or designated absorbent materials. The area should be rinsed with copious amounts of
water. All contaminated cleaning materials should be disposed of as described below.

Instructions for Disposal
All contaminated waste materials (including sharps, containers, absorbent materials,
unused solutions, etc) should be placed in a designated sealed and labelled impervious
waste disposal bag or rigid waste container, and incinerated in accordance with local
procedures for destruction of hazardous waste.
Any unused product or waste material should be disposed of in accordance with local
requirements.

H03833

Component Specification

Requester

Item number:

H03833

Request number:

N/A

Country:

UK / Ireland / Malta

Inventory code(s):

N/A

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed
to the printing stage.
Previous Item Number: N/A

OI template:
Amalia version:
Mulgrave version:

SVI007
1
n/a

Dimensions:
118 x 570 mm (20 panels)
Container(s):
vial
Supplier:
EU Packing Centre
Stock:
40 gsm
Folded dimensions: 28.5 x 118 mm
Printed both sides: Yes
Perforated:
No
Pharma code:
Pharma code length:
Supplier Code:

Colours
Black:

n/a
n/a
n/a

Signed:
Date:

Version 1
Technician: LH
Date: 17/Feb/16

Version 2
Technician: GEK
Date: 06/Apr/16

Version 3
Technician: GEK
Date: 08/Apr/16

Version 4
Technician: XX
Date: dd/mmm/yy

Version 5
Technician: XX
Date: dd/mmm/yy

Version 6
Technician: XX
Date: dd/mmm/yy

Version 7
Technician: XX
Date: dd/mmm/yy

Version 8
Technician: XX
Date: dd/mmm/yy

Version 9
Technician: XX
Date: dd/mmm/yy

Version 10
Technician: XX
Date: dd/mmm/yy

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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