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DOCETAXEL RATIOPHARM 20 MG/0.5 ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Docetaxel ratiopharm 20 mg/0.5 ml concentrate and solvent for solution for infusion Docetaxel
ratiopharm 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel

Read all of this leaflet carefully before you start taking this medicine because it contains
importantinformation 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 of the side effects talk to your doctor, hospital pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Docetaxel ratiopharm is and what it is used for
2. What you need to know before you use Docetaxel ratiopharm
3. How to use Docetaxel ratiopharm
4. Possible side effects
5. How to store Docetaxel ratiopharm
6. Contents of the pack and other information
1. WHAT DOCETAXEL RATIOPHARM IS AND WHAT IT IS USED FOR
The name of this medicine is Docetaxel ratiopharm. 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 ratiopharm 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 ratiopharm could be administered either alone or
in combination with doxorubicin, or capecitabine.
• For the treatment of early breast cancer with or without lymph node involvement, Docetaxel ratiopharm
could be administered in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, Docetaxel ratiopharm could be administered either alone or in
combination with cisplatin.
• For the treatment of prostate cancer, Docetaxel ratiopharm is administered in combination with
prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, Docetaxel ratiopharm is administered in combination with
cisplatin and 5-fl uorouracil.
• For the treatment of head and neck cancer, Docetaxel ratiopharm is administered in combination with
cisplatin and 5-fl uorouracil.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE/USE DOCETAXEL RATIOPHARM
You must NOT be given Docetaxel ratiopharm if
• you are allergic (hypersensitive) to docetaxel or any other ingredients of Docetaxel ratiopharm.
• the number of white blood cells is too low.
• you have a severe liver disease.

Warnings and precautions
Before each treatment with Docetaxel ratiopharm, you will have blood tests to check that you have
enough blood cells and suffi cient liver function to receive Docetaxel ratiopharm. 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 Docetaxel ratiopharm 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 ratiopharm in
particular allergic reactions and fl uid retention (swelling of the hands, feet, legs or weight gain).
During treatment, you may be given medication to maintain the number of your blood cells.
Other medicines and Docetaxel ratiopharm
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 ratiopharm 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.
Docetaxel ratiopharm 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 ratiopharm 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 Docetaxel ratiopharm.
If you are a man being treated with Docetaxel ratiopharm 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 effect on the ability to drive and use machines have been performed.
Important information about some of the ingredients of Docetaxel ratiopharm
This medicinal product contains alcohol (up to 1.6 g per dose, equivalent to 40 ml beer or 17 ml wine).
Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding
women, 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 medicines.
The amount of alcohol in this medicinal product may impair your ability to drive or use

machines.
3. HOW TO USE DOCETAXEL RATIOPHARM
Docetaxel ratiopharm 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
Docetaxel ratiopharm 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 ratiopharm. 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 hospital pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Docetaxel ratiopharm 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 ratiopharm 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 ratiopharm may be increased when Docetaxel ratiopharm 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; diffi culty 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 ratiopharm 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; infl ammation of the throat and nose; cough
• bleeding from the nose
• sores in the mouth
• stomach upsets including nausea, vomiting and diarrhea, 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 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
• diffi culty or painful swallowing
• haemorrhage
• 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)

• pneumonis (infection of the lungs)
• pulmonary fibroses (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, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme at:
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 DOCETAXEL RATIOPHARM
Keep out of the sight and reach of children.
Docetaxel ratiopharm should not be used after the expiry date shown on the carton and vials.
Do not store above 25°C.
Store in the original package in order to protect from light.
The premix solution should be used immediately after preparation. However the chemical and physical
stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and
8°C or at 25°C. The premix solution is for single use only.
The infusion solution should be used within 4 hours below 25°C.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Docetaxel ratiopharm contains
• The active substance is docetaxel. Each ml of docetaxel solution contains 40 mg of docetaxel
anhydrous. One vial contains 20 mg/0.5 ml or 80 mg/2 ml of docetaxel.
• The other ingredients are citric acid anhydrous, ethanol absolute and polysorbate 80.
The solvent vial contains 9.53% w/w ethanol in water for injections.
What Docetaxel ratiopharm looks like and contents of the pack
Docetaxel ratiopharm concentrate for solution for infusion is a clear, yellow solution. The solvent is a
clear, colourless solution.
Each pack contains
Docetaxel ratiopharm 20 mg/0.5 ml or 80 mg/2 ml
• one single dose vial of concentrate and,
• one single dose vial of solvent

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm,Germany.
Manufacturer:
S.C. SINDAN-PHARMA S.R.L., 11th Ion Mihalache Blvd, 011171, Bucharest 1, Romania.
or
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany.
This leaflet was last revised in:
March 2014.

The following information is intended for medical or healthcare professionals only:
PREPARATION GUIDE FOR USE WITH DOCETAXEL RATIOPHARM CONCENTRATE
FOR SOLUTION FOR INFUSION AND SOLVENT FOR DOCETAXEL RATIOPHARM
It is important to read the entire contents of this procedure prior to the preparation of either the
Docetaxel ratiopharm premix solution or the Docetaxel ratiopharm infusion solution
FORMULATION
DOCETAXEL RATIOPHARM concentrate for solution for infusion is a clear, yellow solution
containing 40 mg/ml docetaxel (anhydrous).
The solvent for Docetaxel ratiopharm is a clear colourless solution containing 9.53% w/w ethanol in
water for injections.
PRESENTATION
Docetaxel ratiopharm 20 mg/0.5 ml and 80 mg/2 ml is supplied as single dose vials.
Each pack contains:
• one single dose Docetaxel ratiopharm vial of concentrate 20 mg/0.5 ml or 80 mg/2 ml
• one single dose solvent for Docetaxel ratiopharm vial of concentrate 1.5 ml
Docetaxel ratiopharm vials should be stored below 25 °C and protected from light.
Docetaxel ratiopharm should not be used after the expiry date shown on the carton and vials.
Docetaxel ratiopharm 20 mg/0.5 ml concentrate for solution for infusion vial
8 ml clear glass Type I vial with a green flip-off cap. This vial contains 0.5 ml of a 40 mg/ml solution of
docetaxel in citric acid anhydrous, polysorbate 80 and ethanol (fill volume: 24.4mg/0.61 ml). This fill
volume has been established during the development of Docetaxel ratiopharm to compensate for liquid
loss during preparation of the premix due to foaming, adhesion to the walls of the vial and “deadvolume”. This overfill ensures that after dilution with the entire contents of the accompanying solvent for
Docetaxel ratiopharm vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml
docetaxel which corresponds to the labelled amount of 20 mg per vial.
Solvent vial:
8 ml clear glass Type I vial with a transparent grey flip-off cap.
Solvent vial contains 1.5 ml of a 9.53% w/w solution of ethanol in water for injections (fill volume: 1.94
ml). The addition of the entire contents of the solvent vial to the contents of the Docetaxel ratiopharm 20
mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.

Docetaxel ratiopharm 80 mg/2 ml concentrate for solution for infusion vial:
15 ml clear glass Type I vial with a red fl ip off cap. This vial contains 2 ml of a 40 mg/ml solution of
docetaxel in citric acid anhydrous, polysorbate 80 and ethanol (fill volume: 94.4 mg/2.36 ml). This fill
volume has been established during the development of Docetaxel ratiopharm to compensate for liquid
loss during preparation of the premix due to foaming, adhesion to the walls of the vial and “deadvolume”. This overfill ensures that after dilution with the entire contents of the accompanying solvent for
Docetaxel ratiopharm vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml
docetaxel which corresponds to the labelled amount of 80 mg per vial.
Solvent vial:
15 ml clear glass Type I vial with a transparent grey flip-off cap.
Solvent vial contains 6 ml of 9.53% w/w solution of ethanol in water for injections (fi ll volume: 7.3 ml).
The addition of the entire contents of the solvent vial to the contents of the Docetaxel ratiopharm 80 mg
concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
RECOMMENDATIONS FOR THE SAFE HANDLING
Docetaxel ratiopharm is an antineoplastic agent and, as with other potentially toxic compounds, caution
should be exercised when handling it and preparing Docetaxel ratiopharm solutions. The use of gloves is
recommended.
If Docetaxel ratiopharm concentrate, premix solution or infusion solution should come into contact with
skin, wash immediately and thoroughly with soap and water. If Docetaxel ratiopharm concentrate, premix
solution or infusion solution should come into contact with mucous membranes,wash immediately and
thoroughly with water.
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
a) Preparation of the Docetaxel ratiopharm premix solution (10 mg docetaxel/ml)
1. If the vials are stored under refrigeration, allow the required number of Docetaxel ratiopharm boxes to
stand at room temperature (below 25°C) for 5 minutes.
2. Using a syringe fi tted with a needle, aseptically withdraw the entire contents of the solvent for
Docetaxel ratiopharm vial by partially inverting the vial.
3. Inject the entire contents of the syringe into the corresponding Docetaxel ratiopharm vial.
4. Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds. Do
not shake.
5. Allow the premix vial to stand for 5 minutes at room temperature and then check that the solution is
homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in
the formulation).
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
when stored either between 2°C and 8°C or at 25°C. The premix solution is for single use only.
b) Preparation of the infusion solution
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.

2. Inject the required premix 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.
3. Mix the infusion bag or bottle manually using a rocking motion.
The Docetaxel ratiopharm infusion solution should be used within 4 hours and should be aseptically
administered as a 1-hour infusion under room temperature (below 25 C) and normal lighting conditions.
As with all parenteral products, Docetaxel ratiopharm premix solution and infusion solution
should be visually inspected prior to use, solutions containing a precipitate should be discarded.
DISPOSAL
Any unused product or 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.

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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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