Skip to Content

UK Edition. Click here for US version.

DROBANOS 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL

View full screen / Print PDF » Download PDF ⇩
Transcript
Lek Pharmaceuticals d.d.
DROBANOS

PL 16220/0010

Page 1
15/12/2014

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DROBANOS

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, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1.
What DROBANOS is and what it is used for
2.
What you need to know before you use DROBANOS
3.
How to use DROBANOS
4.
Possible side effects
5.
How to store DROBANOS
6.
Contents of the pack and other information

1. WHAT DROBANOS IS AND WHAT IT IS USED FOR
The name of this medicine is DROBANOS. 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.
DROBANOS 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, DROBANOS 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, DROBANOS could
be administered in combination with doxorubicin and cyclophosphamide.
• for the treatment of lung cancer, DROBANOS could be administered either alone or in combination
with cisplatin.
• for the treatment of prostate cancer, DROBANOS is administered in combination with prednisone or
prednisolone.
• for the treatment of metastatic gastric cancer, DROBANOS is administered in combination with
cisplatin and 5-fluorouracil.
• for the treatment of head and neck cancer, DROBANOS is administered in combination with
cisplatin and 5-fluorouracil.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DROBANOS
Do not use DROBANOS if
• you are allergic to docetaxel or any of the other ingredients of this medicine.
• the number of white blood cells is too low.
PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS



PL 16220/0010

Page 2
15/12/2014

you have a severe liver disease.

Warnings and precautions
Before each treatment with DROBANOS, you will have blood tests to check that you have enough blood
cells and sufficient liver function to receive DROBANOS. In case of white blood cells disturbances, you
may experience associated fever or infections.
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.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone,
one day prior to DROBANOS 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 DROBANOS 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.
DROBANOS contains alcohol. Discuss with your doctor if you suffer from alcohol dependency or liver
impairment. See also section “DROBANOS and ethanol (alcohol)” below.
Other medicines and DROBANOS
Tell your doctor, nurse or hospital pharmacist if you are taking or have recently taken any other
medicine, including medicines obtained without a prescription.
This is because DROBANOS 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.
DROBANOS 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 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 DROBANOS.
If you are a man being treated with DROBANOS 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.

PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS

PL 16220/0010

Page 3
15/12/2014

DROBANOS contains ethanol (alcohol)
This medicinal product contains 75 vol % ethanol (alcohol), i.e. up to 4.7g (6 ml) per 80mg vial,
equivalent to 120ml of beer or 48ml wine per 80mg vial.
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 alter the effects of other medicinal products.
The amount of alcohol in this medicinal product may impair the patient's ability to drive or use machines.
3. HOW TO USE DROBANOS
DROBANOS will be administered to you by a healthcare professional.
Usual dosage
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
DROBANOS will be given by infusion into one of your veins (intravenous use). The infusion will last
approximately 1 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 DROBANOS. 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 product, ask your doctor or 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 Docetaxel alone are: decrease in the number of red
blood cells or white blood cells, loss of hair, nausea, vomiting, sores in the mouth, diarrhoea and
tiredness.
The severity of adverse events of DROBANOS may be increased when DROBANOS 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)
may occur:
• flushing, skin reactions, itching
PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS

PL 16220/0010

Page 4
15/12/2014

• chest tightness; difficulty in breathing
• fever or chills
• back pain
• low blood pressure.
More severe reactions may occur.
The medical staff will monitor your condition closely during treatment. Tell them immediately if you
notice any of these effects.
Between infusions of DROBANOS the following may occur, and the frequency may vary with the
combinations of drugs 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 of 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 colour 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 affect 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
PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS



PL 16220/0010

Page 5
15/12/2014

raised liver enzymes (hence the need for regular blood tests).

Uncommon (may affect 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.
Frequency unknown:
• 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 the sodium in your blood.

Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE DROBANOS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton. The expiry
date refers to the last day of that month.
Do not store above 25°C or below 2C°. Do not freeze.
After first opening, before dilution:
Use the vial immediately after its opening. If not used immediately, in-use storage times and conditions
are the responsibility of the user.
From a microbiological point of view, dilution must take place in controlled and aseptic conditions.
After dilution:
Use the medicine immediately once added into the infusion bag. If not used immediately, in-use storage
times and conditions are the responsibility of the user and should not be longer than 48 hours below 25°C
(including the one hour infusion).
Docetaxel infusion solution is supersaturated, therefore may crystallise over time. If crystals appear, the
solution must no longer be used and shall be discarded.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS

PL 16220/0010

Page 6
15/12/2014

What DROBANOS contains
The active substance is docetaxel.
1 ml concentrate for solution for infusion contains 10 mg docetaxel.
The other ingredients are ethanol anhydrous, citric acid anhydrous, polysorbate 80.
What DROBANOS looks like and contents of the pack
DROBANOS is a clear pale yellow solution.
The medicinal product is supplied in a glass container called vial with a bromobutyl-rubber stopper.
20 mg vial: each vial contains 2 ml concentrate for solution for infusion.
80 mg vial: each vial contains 8 ml concentrate for solution for infusion.
160 mg vial: each vial contains 16 ml concentrate for solution for infusion.

Pack sizes:
1 vial

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Lek Pharmaceuticals d.d.
Verovśkova 57
1526 Ljubljana
Slovenia
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben - Germany
Or
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana - Slovenia
Or
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11, 4866 Unterach - Austria

This leaflet was last revised in 12/2014.

PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS

PL 16220/0010

Page 7
15/12/2014

----------------------------------------------------------------------------------------------------------------------------DROBANOS
The following information is intended for healthcare professionals only:
__________________________________________
Instructions for use
CYTOSTATIC
FORMULATION
DROBANOS is a concentrate for solution for infusion which can directly be used to prepare the infusion
solution. Each vial is for single use and should be used immediately after opening. If not used
immediately, in-use storage times and conditions are the responsibility of the user.
RECOMMENDATIONS FOR THE SAFE HANDLING
DROBANOS is an antineoplastic agent and, as with other potentially toxic compounds, caution should
be exercised when handling it and preparing DROBANOS solutions. The use of gloves is recommended.
If DROBANOS concentrate for solution for infusion or infusion solution should come into contact with
skin, wash immediately and thoroughly with soap and water. If DROBANOS concentrate for solution for
infusion or infusion solution should come into contact with mucous membranes, wash immediately and
thoroughly with water.
PREPARATION FOR THE INFUSION SOLUTION
More than one 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 concentrate for solution for
infusion volume containing 10 mg/ml docetaxel from the appropriate number of vials using graduated
syringes fitted with a needle. For example, a dose of 140 mg docetaxel would require 14 ml docetaxel
concentrate for solution for infusion.
Inject the required concentrate for solution for infusion volume into a 250 ml infusion bag or bottle
containing either 5% glucose solution or 0.9% sodium chloride solution. 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. To prevent multiple piercing of the infusion bag or bottle during the
preparation of the infusion solution, the correct volume of concentrate in accordance with the required
dose must be measured and transferred to the infusion bag or bottle as a single injection only.
Mix the infusion bag or bottle manually using a rocking motion.
From a microbiological point of view, dilution must take place in controlled and aseptic conditions and
the infusion solution should be used immediately. If not used immediately, in-use storage times and
conditions are the responsibility of the user.
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C,
is stable for 48 hours. It should be used within 48 hours (including the one hour infusion IV
administration).
As with all parenteral products, DROBANOS concentrate for solution for infusion and infusion solution
should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Disposal:
PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Lek Pharmaceuticals d.d.
DROBANOS

PL 16220/0010

Page 8
15/12/2014

All materials that have been utilised for dilution and administration should be disposed of according to
standard procedures.

PIL. 16220.0010.006d

V011: PL update to include EMA
recommendations for 11 Sep 2014
EMA/PRAC/537965/2014 PRAC PSUR AR

KP

Expand view ⇕

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.

Hide