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DOCETAXEL ACCORD 20 MG CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
{Invented name}

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 or your hospital pharmacist.
- 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 hospital pharmacist.
In this leaflet:
1. What Docetaxel for infusion is and what it is used for
2. Before you use Docetaxel for infusion
3. How to use Docetaxel for infusion
4. Possible side-effects
5. How to store Docetaxel for infusion
6. Further information
1. WHAT DOCETAXEL FOR INFUSION IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel for infusion. 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.
Docetaxel for infusion 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, Docetaxel for infusion could be administered
either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
- For the treatment of early breast cancer with lymph node involvement, Docetaxel for
infusion could be administered in combination with doxorubicin and cyclophosphamide.
- For the treatment of lung cancer, Docetaxel for infusion could be administered either alone
or in combination with cisplatin.
- For the treatment of prostate cancer, Docetaxel for infusion is administered in combination
with prednisone or prednisolone.
- For the treatment of metastatic gastric cancer, Docetaxel for infusion is administered in
combination with cisplatin and 5-fluorouracil.
- For the treatment of head and neck cancer, Docetaxel for infusion is administered in
combination with cisplatin and 5-fluorouracil.
2. BEFORE YOU USE DOCETAXEL FOR INFUSION
You must not be given Docetaxel for infusion if
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel for
infusion.
• the number of white blood cells is too low.
• you have a severe liver disease.
Take special care with Docetaxel for infusion
Before each treatment with Docetaxel for infusion, you will have blood tests to check that you
have enough blood cells and sufficient liver function to receive Docetaxel for infusion. 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 Docetaxel for infusion 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 Docetaxel 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.
Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other
medicine, including medicines obtained without a prescription. This is because Docetaxel for
infusion or the other medicine may not work as well as expected and you may be more likely to
get a side effect.
Pregnancy
Ask your doctor for advice before being given any medicine.
Docetaxel for infusion 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 Docetaxel for infusion may be harmful for the
unborn baby. If pregnancy occurs during your treatment, you must immediately inform your
doctor.
If you are a man being treated with Docetaxel for infusion 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.
Breast-feeding
You must not breast-feed while you are treated with Docetaxel for infusion.
Driving and using machines
There is no reason why you cannot drive between courses of Docetaxel for infusion except if
you feel dizzy or are unsure of yourself.
3. HOW TO USE DOCETAXEL FOR INFUSION
Docetaxel for infusion 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
Docetaxel for infusion 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 Docetaxel for infusion. 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 other anticancer medicines, Docetaxel for infusion 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 frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100);
uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10 users in 10,000); very rare
(affects less than 1 user in 10,000); not known (frequency cannot be estimated from the
available data).
The most commonly reported adverse reactions of Docetaxel for infusion 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 Docetaxel for infusion may be increased when Docetaxel for
infusion is given in combination with other chemotherapeutic agents.
During the infusion at the hospital the following allergic reactions (experienced in more than 1
person in 10) may occur:
• 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 Docetaxel for infusion the following may occur, and the frequency may
vary with the combinations of medicines that are received:
Very common (experienced in more than 1 in 10 patients):
• 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
short term 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 (experienced in less than 1 in 10 but more than 1 in 100 patients):
• 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 (experienced in more than 1 in 1,000 but less than 1 in 100 patients):
• 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or hospital pharmacist.
5. HOW TO STORE DOCETAXEL FOR INFUSION
Keep out of the reach and sight of children.
Docetaxel for infusion 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.
Store below 25°C.
Store in the original package in order to protect from light.
Do not refrigerate or freeze.
Do not use Docetaxel for infusion if you notice visible signs of deterioration.

  

6. FURTHER INFORMATION
What Docetaxel for infusion 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.
What solvent vial contains
13% (w/v) macrogol 400 in water for injections.
What Docetaxel for infusion looks like and contents of the pack
Docetaxel 20 mg and 80 mg concentrate for solution for infusion is a clear yellow viscous
solution. Solvent for Docetaxel 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:
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1
4HF, United Kingdom
Manufacturer:
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1
4HF, United Kingdom
Cemelog BRS, H2040 Budaörs, Vasút u. 13., Hungary
This leaflet was last approved in 03/2011.

  

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

Docetaxel for infusion is an antineoplastic agent and, as with other potentially toxic compounds,
caution should be exercised when handling it and preparing Docetaxel for infusion solutions.
The use of gloves is recommended.
If Docetaxel for infusion concentrate, premix solution or infusion solution should come into
contact with skin, wash immediately and thoroughly with soap and water. If Docetaxel for
infusion 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 Docetaxel for infusion 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
25ºC 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 37ºC for 10
minutes.

OR

4.1.1.B Keep the solvent vial in dry bath at 37ºC for 10
minutes.

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.

4.1.2

4.1.3

4.1.4

Using a syringe fitted with a 20 gauge needle,
aseptically withdraw the 2.0 ml of the solvent for
Docetaxel 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
Docetaxel for infusion 80 mg vial by partially inverting
the vial.
Gently inject the entire contents of the syringe into the
corresponding Docetaxel 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.
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
4.2.1

4.2.2

Preparation of the infusion solution
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.
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.

4.2.4

The Docetaxel for infusion solution should be used within
24 hours when stored at 2°C to 8°C and at 20°C to 25°C
under normal lighting conditions. The Docetaxel for
infusion solution should be aseptically administered as a 1hour 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.

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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