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TAXEGIS 80MG CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

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Taxegis

®

20 mg, 80 mg

Concentrate and solvent for solution for infusion
Package leaflet: Information for the user
Taxegis®

20 mg Concentrate and solvent for solution
for infusion
Taxegis® 80 mg Concentrate and solvent for solution
for infusion
Docetaxel
Read all of this leaflet carefully before you start using this
medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, hospital
pharmacist or nurse.
• If you get any side effects talk to your doctor, hospital
pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.
What is in this leaflet:
1. What Taxegis is and what it is used for
2. What you need to know before you use Taxegis
3. How to use Taxegis
4. Possible side effects
5. How to store Taxegis
6. Contents of the pack and other information
1. What Taxegis is and what it is used for
The name of this medicine is Taxegis. Its common name is
docetaxel. Docetaxel is a substance derived from the needles
of yew trees.
Docetaxel belongs to the group of anti-cancer medicines called
taxoids.
Taxegis has been prescribed by your doctor for the treatment
of breast cancer, special forms of lung cancer (non-small cell lung
cancer), prostate cancer, gastric cancer or head and neck
cancer:
• For the treatment of advanced breast cancer, Taxegis could be
administered either alone or in combination with doxorubicin,
or trastuzumab, or capecitabine.
• For the treatment of early breast cancer with or without
lymph node involvement, Taxegis could be administered
in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, Taxegis could be
administered either alone or in combination with cisplatin.
• For the treatment of prostate cancer, Taxegis is administered
in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, Taxegis is
administered in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, Taxegis for infusion
is administered in combination with cisplatin
and 5-fluorouracil.
2. What you need to know before you use Taxegis
Do not use Taxegis
• if you are allergic to docetaxel or any of the other ingredients
of this medicine (listed in section 6.)
• if the number of white blood cells is too low.
• if you have a severe liver disease.
Warnings and precautions
Before each treatment with Taxegis, you will have blood tests
to check that you have enough blood cells and sufficient
liver function to receive Taxegis. In case of white blood cells
disturbances, you may experience associated fever or infections.
You will be asked to take premedication consisting of an oral
corticosteroid such as dexamethasone, one day prior to Taxegis
administration and to continue for one or two days after it
in order to minimise certain undesirable effects which may occur
after the infusion of Taxegis in particular allergic reactions and
fluid retention (swelling of the hands, feet, legs or weight gain).
During treatment, you may be given other medicines to maintain
the number of your blood cells.

Other medicines and Taxegis
Tell your doctor or hospital pharmacist if you are taking, have
recently taken, or might take any other medicine. This is because
Taxegis or the other medicine may not work as well as expected
and you may be more likely to get a side effect.
Pregnancy, breast-feeding and fertility
Ask your doctor for advice before being given any medicine.
Taxegis must 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
during therapy, because Taxegis may be harmful for the unborn
baby. If pregnancy occurs during your treatment, you must
immediately inform your doctor.
You must not breast-feed while you are treated with Taxegis.
If you are a man being treated with Taxegis 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
docetaxel may alter male fertility.
Driving and using machines
No studies on the effects on the ability to drive and use machines
have been performed.
3. How to use Taxegis
Taxegis will be administered to you by a healthcare professional.
Usual dose
The dose will depend on your weight and your general
condition. Your doctor will calculate your body surface area
in square meters (m²) and will determine the dose you should
receive.
Method and route of administration
Taxegis will be given by infusion into one of your veins
(intravenous use). The infusion will last approximately one hour
during which you will be in the hospital.
Frequency of administration
You should usually receive your infusion once 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 Taxegis. In particular, please inform your doctor
in case of diarrhoea, sores in the mouth, feeling of numbness
or pins and needles, fever and give her/him results of your blood
tests. Such information will allow her/him to decide whether
a dose reduction is needed.
If you have any further questions on the use of this medicine,
ask your doctor, or hospital pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Your doctor will discuss these with you and will explain
the potential risks and benefits of your treatment.
The most commonly reported adverse reactions of Taxegis alone
are: decrease in the number of red blood cells or white blood
cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea
and tiredness.
The severity of adverse events of Taxegis may be increased when
Taxegis is given in combination with other chemotherapeutic
agents.
During the infusion at the hospital the following allergic reactions
(may affect more than 1 in 10 people):
• flushing, skin reactions, itching
• chest tightness; difficulty in breathing
• fever or chills
• back pain
• low blood pressure.
More severe reactions may occur.

The hospital staff will monitor your condition closely during
treatment. Tell them immediately if you notice any of these
effects.
Between infusions of Taxegis the following may occur, and
the frequency may vary with the combinations of medicines that
are received:
Very common (may affect more than 1 in 10 people):
• infections, decrease in the number of red (anaemia), or white
blood cells (which are important in fighting infection)
and platelets
• fever: if this happens you must tell your doctor immediately
• allergic reactions as described above
• loss of appetite (anorexia)
• insomnia
• feeling of numbness or pins and needles or pain in the joints
or muscles
• headache
• alteration in sense of taste
• inflammation of the eye or increased tearing of the eyes
• swelling caused by faulty lymphatic drainage
• shortness of breath
• nasal drainage; inflammation of the throat and nose; cough
• bleeding from the nose
• sores in the mouth
• stomach upsets including nausea, vomiting and diarrhoea,
constipation
• abdominal pain
• indigestion
• hair loss (in most cases normal hair growth should return)
• 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 the arms, face, or body)
• change in the color of your nails, which may detach
• muscle aches and pains; back pain or bone pain
• change or absence of menstrual period
• swelling of the hands, feet, legs
• tiredness; or flu-like symptoms
• weight gain or loss.
Common (may affects up to 1 in 10 people):
• oral candidiasis
• dehydration
• dizziness
• hearing impaired
• decrease in blood pressure; irregular or rapid heart beat
• heart failure
• oesophagitis
• dry mouth
• difficulty or painful swallowing
• haemorrhage
• raised liver enzymes (hence the need for regular blood tests).
Uncommon (may affects up to 1 in 100 people):
• fainting
• at the injection site, skin reactions, phlebitis (inflammation
of the vein) or swelling
• inflammation of the colon, small intestine; intestinal perforation
• blood clots.
If you get any side effects talk to your doctor, hospital pharmacist
or nurse. This includes any possible side effects not listed in this
leaflet.
5. How to store Taxegis
Store below 25°C.
Store in the original package in order to protect from light.
Do not refrigerate or freeze.
Keep this medicine out of the sight and reach of children.
This medicine should not be used after the expiry date shown
on the carton, blister pack and vials. The expiry date refers to the
last day of that month.
Do not use Taxegis if you notice visible signs of deterioration.

300 x 300 mm
1:1
English
EGIS
Pantone Black
Pantone 318 C
Somogyi A. /2013.05.03.

What solvent vial contains
13% (w/v) macrogol 400 in water for injections.
What Taxegis looks like and contents of the pack
Taxegis 20 mg and 80 mg concentrate for solution for infusion is
a clear yellow viscous solution. Solvent for Taxegis infusion is
a clear colourless solution.
Each blister pack contains:
• one single-dose vial of concentrate and,
• one single-dose vial of solvent.
Marketing Authorisation Holder
EGIS PHARMACEUTICALS PLC
H-1106 BUDAPEST, Keresztúri út 30-38.
HUNGARY
Manufacturer
EGIS Pharmaceuticals PLC
H-1165 Budapest, Bökényföldi út 116-120.
Hungary
This medicinal product is authorised in the Member States
of the EEA under the following names:
United Kingdom Taxegis 20 mg Concentrate

and solvent for solution for infusion

Taxegis 80 mg Concentrate

and solvent for solution for infusion
Bulgaria
Taxegis 20 mg/0.5 ml concentrate

and solvent for solution for infusion

Таксегис 20 mg/0.5 ml концентрат

и разтворител за инфузионен разтвор

Taxegis 80 mg/2 ml concentrate

and solvent for solution for infusion

Таксегис 80 mg/2 ml концентрат

и разтворител за инфузионен разтвор
Czech Republic Taxegis 20 mg

Taxegis 80 mg
Hungary
Taxegis 20 mg koncentrátum

és oldószer oldatos infúzióhoz

Taxegis 80 mg koncentrátum

és oldószer oldatos infúzióhoz
Latvia
Taxegis 20 mg un 80 mg koncentrāts

un šķīdinātājs infūziju šķīduma

pagatavošanai
Lithuania
Taxegis 20 mg/80 mg koncentratas

ir tirpiklis infuziniam tirpalui.
Poland
Taxegis
Romania
Taxegis 20 mg/0,5 ml concentrat

şi solvent pentru soluţie perfuzabilă

Taxegis 80 mg/0,5 ml concentrat

şi solvent pentru soluţie perfuzabilă
Slovak Republic Taxegis 20 mg

Taxegis 80 mg
This leaflet was last revised in 10/2012.
PL 03525/0019-0001
PL 03525/0020-0001

Recommended dose
For breast, non-small cell lung, gastric, and head and neck
cancers, premedication consisting of an oral corticosteroid,
such as dexamethasone 16 mg per day (e.g. 8 mg BID)
for 3 days starting 1 day prior to docetaxel administration, unless
contraindicated, can be used.
Prophylactic G-CSF may be used to mitigate the risk
of haematological toxicities.
For prostate cancer, given the concurrent use of prednisone
or prednisolone the recommended premedication regimen is oral
dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before
the docetaxel infusion.
Docetaxel is administered as a one-hour infusion every three weeks.
2. Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Docetaxel must not be used in patients with baseline neutrophil
count of < 1,500 cells/mm3.
Docetaxel must not be used in patients with severe liver
impairment since there is no data available.
Contraindications for other medicinal products also apply, when
combined with docetaxel.
3. Recommendations for the safe handling
Taxegis is an antineoplastic agent and, as with other potentially
toxic compounds, caution should be exercised when handling
it and preparing Taxegis solutions. The use of gloves is
recommended.
If Taxegis concentrate, premix solution or infusion solution
should come into contact with skin, wash immediately and
thoroughly with soap and water. If Taxegis concentrate, premix
solution or infusion solution should come into contact with
mucous membranes, wash immediately and thoroughly with
water.
4. Preparation for the intravenous administration
4.1 Preparation of the Taxegis premix solution
(10 mg docetaxel/ml)
4.1.1 Take out the product vial and the solvent vial from the pack.
The temperature of the product should be about 25°C during
the reconstitution. This can be achieved by any of the below
mentioned means.
4.1.1.A Keep the solvent vial in water bath
at 37°C for 10 minutes.

OR
4.1.1.B Keep the solvent vial in dry bath
at 37°C for 10 minutes.

1. Posology and Method of Administration
The use of docetaxel should be confined to units specialized
in the administration of cytotoxic chemotherapy and it should
only be administered under the supervision of a physician
qualified in the use of anticancer chemotherapy.

4.1.4 Remove the syringe and needle.
Hold the vial horizontally and shake gently
in horizontal position such that minimum
foam is generated Do not shake vigorously
as it will lead to excessive foaming which
can interfere with the mixing process.
Mixing to be done for atleast 45 seconds
and it may be continued in case the solution
is not clear and homogenous.
4.1.5 Allow the premix vial to stand
for 5 minutes at room temperature (below
25°C) and then check that the solution is
clear and homogenous (foaming is normal
even after 5 minutes due to the presence
of polysorbate 80 in the formulation).
4.1.6 Withdraw the solution using a 20 gauge
needle. The premix solution contains
10 mg/ml docetaxel and should be used
immediately after preparation. However the
chemical and physical stability of the premix
solution has been demonstrated for 8 hours
at 2°C to 8°C and at 20°C to 25°C.
4.2 Preparation of the infusion solution
4.2.1 More than one premix vial may be
necessary to obtain the required dose
for the patient. Based on the required dose
for the patient expressed in mg, aseptically
withdraw the corresponding premix volume
containing 10 mg/ml docetaxel from the
appropriate number of premix vials using
graduated syringes fitted with a needle.
For example, a dose of 140 mg docetaxel
would require 14 ml docetaxel premix solution.
4.2.2 Inject the required premix volume into
a 250 ml infusion bag or bottle containing
either Glucose 50 mg/ml (5%) solution for
injection or Sodium chloride 9 mg/ml (0.9 %)
solution for injection. 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.
4.2.3 Mix the infusion bag or bottle
manually using a rocking motion.

OR
4.1.1.C Hold both the vials (solvent and
product vial) in the palm of the hand firmly
and rolling the vials in the hand
for 2 minutes.

POM
The following information is intended for medical
or healthcare professionals only:

4.1.3 Gently inject the entire contents
of the syringe into the corresponding
Taxegis for infusion vial ensuring that
minimum foam is generated. Addition
of solvent to be done slowly and it should
be done on the entire surface of product
i.e. Pouring should not be done at single
point. The contents to be added slowly with
swirling of the product vial so that the entire
product is in contact with the solvent.

4.1.2 Using a syringe fitted with a 20 gauge
needle, aseptically withdraw the 2.0 ml
of the solvent for Taxegis for infusion
20 mg vial by partially inverting the vial.
Using a syringe fitted with a 20 gauge
needle, aseptically withdraw the 7.2 ml
of the solvent for Taxegis for infusion
80 mg vial by partially inverting the vial.

4.2.4 The Taxegis solution should be used
within 24 hours when stored at 2°C to 8°C
and at 20°C to 25° under normal lighting
conditions. The Taxegis solution should be
aseptically administered as a 1-hour infusion.
4.2.5 As with all parenteral products,
Docetaxel premix solution and infusion
solution should be visually inspected prior
to use, solutions containing a precipitate
should be discarded.
A-11

6. Contents of the pack and other information
What Taxegis concentrate vial contains
• The active substance is docetaxel. Each ml of docetaxel
solution contains 40 mg of docetaxel anhydrous. One vial
contains 20 mg or 80 mg docetaxel.
• The other ingredients are polysorbate 80 and citric acid.

5. DISPOSAL
Waste material should be destroyed according to hospital
standard procedures applicable to cytotoxic agents with due
regard to current laws related to the disposal of hazardous waste.

Expand Transcript

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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