Docetaxel Aurobindo

Package leaflet: Information for the patient

Docetaxel Aurobindo 20 mg/ml concentrate for solution for infusion

Please read all of this leaflet carefully before using this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, hospital pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor, hospital pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Docetaxel Aurobindo is and what it is used for
2. What you need to know before using Docetaxel Aurobindo
3. How to use Docetaxel Aurobindo
4. Possible side effects
5. How to store Docetaxel Aurobindo
6. Contents of the pack and other information

1. What Docetaxel Aurobindo is and what it is used for

The name of this medicine is Docetaxel Aurobindo. Its generic name is docetaxel. Docetaxel is a
substance derived from the needle-like leaves of the yew tree.
Docetaxel belongs to a group of anticancer medicines called taxanes.
Docetaxel Aurobindo has been prescribed by your doctor for the treatment of breast cancer, certain
types 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 Aurobindo may be given alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
• For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Aurobindo may be given in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, Docetaxel Aurobindo may be given alone or in combination with cisplatin.
• For the treatment of prostate cancer, Docetaxel Aurobindo is given in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, Docetaxel Aurobindo is given in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, Docetaxel Aurobindo is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using Docetaxel Aurobindo

Do not take Docetaxel Aurobindo:

• if you are allergic (hypersensitive) to docetaxel or to any of the other ingredients of this medicine (listed in section 6);
• if your white blood cell count is too low;
• if you have severe liver disease.

Warnings and precautions
Before each treatment with Docetaxel Aurobindo, you must undergo blood tests to determine whether your blood cells are sufficiently numerous and whether liver function is adequate for receiving Docetaxel Aurobindo. If abnormalities in white blood cells occur, you may also experience fever or infections.
Immediately inform your doctor, hospital pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stools, or fever. These symptoms may be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor will address this immediately.
Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience vision problems, particularly blurred vision, you must immediately have your eyes and vision examined.
Inform your doctor, hospital pharmacist, or nurse if you have had an allergic reaction to a previous treatment with paclitaxel.
Inform your doctor, hospital pharmacist, or nurse if you have heart problems.
If you develop acute lung problems or if pre-existing symptoms worsen (fever, shortness of breath, or cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue treatment.
You will be asked to take a preventive treatment with oral corticosteroids such as dexamethasone one day before administration of Docetaxel Aurobindo and to continue for one or two days afterwards in order to reduce certain adverse effects that may occur following infusion of Docetaxel Aurobindo, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).
During treatment, you may need medicines to maintain your blood cell counts.
Severe skin reactions have been reported with Docetaxel Aurobindo, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP):

• Symptoms of SJS/TEN may include blisters, peeling or bleeding of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also have flu-like symptoms such as fever, chills, or muscle pain at the same time.
• Symptoms of AGEP may include a widespread scaly and red rash with swollen bumps under the skin (including skin folds, trunk, and upper extremities) and blisters accompanied by fever. If you develop severe skin reactions or any of the reactions listed above, contact your doctor or a healthcare professional immediately. Docetaxel Aurobindo contains alcohol. If you have epilepsy or liver problems, consult your doctor or hospital pharmacist before taking this medicine. If you are alcohol-dependent, speak with your doctor or hospital pharmacist before taking this medicine. See also the following section “Docetaxel Aurobindo contains ethanol (alcohol)”.

For individuals engaged in sports, the use of medicines containing ethyl alcohol may lead to positive results in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Other medicines and Docetaxel Aurobindo
Inform your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. This is because Docetaxel Aurobindo or other medicines may not work as expected, and you may be more likely to experience adverse effects.
The amount of alcohol in this medicine may alter the effects of other medicines.
Talk to your doctor or hospital pharmacist if you are taking other medicines.
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before this medicine is administered to you.
Pregnancy
Docetaxel Aurobindo MUST NOT be administered during pregnancy unless clearly indicated by your doctor.
You must not become pregnant during treatment with this medicine and should use adequate contraceptive methods during therapy, as Docetaxel Aurobindo may be harmful to the unborn child. If you become pregnant during treatment, inform your doctor immediately.
Breastfeeding
You MUST NOT breastfeed during treatment with Docetaxel Aurobindo.
If you are pregnant or breastfeeding, consult your doctor or hospital pharmacist before taking this medicine.
Fertility
If you are a man being treated with Docetaxel Aurobindo, you are advised not to father a child during treatment and for 6 months after treatment ends, and to consider sperm preservation before starting treatment, as docetaxel may impair male fertility.
Driving and using machines
The amount of alcohol in this medicine may impair your ability to drive or operate machinery.
This is because it may affect your judgment and reaction speed. You may experience adverse effects from this medicine that could impair your ability to drive, use equipment, or operate machinery (see section 4 Possible side effects). If this occurs, do not drive or operate any equipment or machinery until you have discussed it with your doctor, nurse, or hospital pharmacist.
Docetaxel Aurobindo contains ethanol (alcohol)
This medicine contains 400 mg of alcohol (ethanol) in each 1 ml vial, equivalent to 51 vol%. The amount in a vial containing 1 ml of this medicine is equivalent to 10 ml of beer or 4.16 ml of wine.
This medicine contains 1600 mg of alcohol (ethanol) in each 4 ml vial, equivalent to 51 vol%. The amount in a vial containing 4 ml of this medicine is equivalent to 40 ml of beer or 16.67 ml of wine.
This medicine contains 2800 mg of alcohol (ethanol) in each 7 ml vial, equivalent to 51 vol%. The amount in a vial containing 7 ml of this medicine is equivalent to 70 ml of beer or 29.17 ml of wine.
This medicine contains 3200 mg of alcohol (ethanol) in each 8 ml vial, equivalent to 51 vol%. The amount in a vial containing 8 ml of this medicine is equivalent to 80 ml of beer or 33.33 ml of wine.
Harmful for individuals with alcoholism.
To be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
The amount of alcohol contained in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

3. How to use Docetaxel Aurobindo

Docetaxel Aurobindo will be administered to you by a healthcare professional.
Usual dose
The dose will depend on your body weight and general health condition. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.
Method and route of administration
Docetaxel Aurobindo will be administered by intravenous infusion (into a vein). The infusion will last approximately one hour, during which you will remain in the hospital.
Frequency of administration
The infusion is normally given once every 3 weeks.
Your doctor may adjust the dose and frequency of administration based on blood tests, your general condition, and your response to Docetaxel Aurobindo. In particular, inform your doctor if you experience diarrhea, mouth inflammation, numbness or tingling sensations, fever, and show the results of your blood tests. This information will help the doctor decide whether a dose reduction is necessary.
If you have any doubts about how to use this medicine, consult your doctor or hospital pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Your doctor will discuss this with you and explain the potential risks and benefits of your treatment.
The most commonly reported adverse reactions with docetaxel alone are: reduction in the number of red or white blood cells, hair loss, nausea, vomiting, mouth ulcers, diarrhoea, and fatigue.
If Docetaxel Aurobindo is administered to you in combination with other chemotherapeutic agents, the severity of side effects may increase.
During the infusion in hospital, the following allergic reactions may occur (may affect more than 1 in 10 people):

• hot flushes, skin reactions, itching;
• tightness in the chest, difficulty breathing;
• fever or chills;
• back pain;
• low blood pressure.

More severe reactions may also occur.
If you have previously had a hypersensitivity reaction to paclitaxel, you may also develop a hypersensitivity reaction to docetaxel, which could be more severe.
During treatment, your condition will be closely monitored by hospital staff. Inform them immediately if you notice any of these effects.
Between two Docetaxel Aurobindo infusions, the following undesirable effects may occur, and their frequency may vary depending on the concomitant medications you are receiving:

Very common (may affect more than 1 in 10 people):

• infections, decreased number of red blood cells (anaemia) or white blood cells (the latter are important in fighting infections), and platelets;
• fever: if this occurs, inform your doctor immediately;
• allergic reactions as described above;
• loss of appetite (anorexia);
• insomnia;
• sensation of numbness, tingling, or pain in joints or muscles;
• headache;
• altered sense of taste;
• eye inflammation or increased eye tearing;
• swelling due to insufficient lymphatic drainage;
• shortness of breath;
• runny nose, throat and nasal inflammation, cough;
• nosebleeds;
• mouth inflammation;
• stomach disorders including nausea, vomiting, diarrhoea, constipation;
• abdominal pain;
• indigestion;
• hair loss (in most cases, hair regrowth returns to normal). In some cases (frequency not known), permanent hair loss has been observed;
• redness and swelling of the palms of the hands or soles of the feet, which may cause skin peeling (this may also occur on arms, face, or body);
• changes in nail colour, which may lead to nail loss;
• muscle pain, back pain, or bone pain;
• changes or absence of menstrual periods;
• swelling of hands, feet, or legs;
• fatigue or flu-like symptoms;
• weight gain or weight loss;
• upper respiratory tract infection.

Common (may affect up to 1 in 10 people):

• oral candidiasis;
• dehydration;
• dizziness;
• hearing disturbances;
• low blood pressure, irregular or rapid heartbeat;
• heart failure;
• oesophagitis;
• dry mouth;
• difficulty or pain when swallowing;
• bleeding;
• increased liver enzymes (requiring regular blood tests);
• increased blood sugar levels (diabetes);
• reduced levels of potassium, calcium, and/or phosphate in the blood.

Uncommon (may affect up to 1 in 100 people):

• fainting;
• at the injection site: skin reactions, phlebitis (vein inflammation), or swelling;
• blood clots;
• acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel, together with certain other anticancer treatments.

Rare (may affect up to 1 in 1,000 people):

• inflammation of the colon or small intestine, which may be fatal (frequency not known); intestinal perforation.

Frequency not known (cannot be estimated from available data):

• interstitial lung disease (lung inflammation that may cause cough and difficulty breathing. Lung inflammation may also develop when docetaxel treatment is given together with radiotherapy);
• pneumonia (lung infections);
• pulmonary fibrosis (scarring and thickening in the lungs causing shortness of breath);
• blurred vision due to swelling of the retina inside the eye (cystoid macular edema);
• low levels of sodium and/or magnesium and/or calcium in the blood (electrolyte imbalance);
• ventricular arrhythmia or ventricular tachycardia (manifesting as rapid or irregular heartbeat, severe shortness of breath, dizziness and/or fainting). Some of these symptoms may be serious. If this occurs, inform a doctor immediately;
• reaction at injection site following a previous reaction;
• non-Hodgkin’s lymphoma (a cancer affecting the immune system) and other tumours may occur in patients treated with docetaxel, together with certain other anticancer treatments;
• Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blisters, skin peeling or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without redness. You may also experience flu-like symptoms such as fever, chills or muscle pain);
• acute generalized exanthematous pustulosis (AGEP) (widespread scaly and red rash with swollen skin bumps (including skin folds, trunk, and upper limbs) and blisters accompanied by fever);
• tumour lysis syndrome, a serious condition revealed by changes in blood tests such as increased levels of uric acid, potassium, and phosphate, and decreased calcium levels; it causes symptoms such as seizures, kidney failure (reduced or darkened urine), and heart rhythm disturbances. If this occurs, inform your doctor immediately;
• myositis (muscle inflammation – with warmth, redness, and swelling – causing muscle pain and weakness).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Docetaxel Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial.
Store below 25°C.
Keep in the original packaging to protect from light.
Do not refrigerate or freeze.
After opening the vial
Each vial is for single use only and must be used immediately after opening. If not used immediately, the
storage times and conditions in use are the responsibility of the user.
After addition to the infusion bag
The diluted solution should be used immediately after preparation. If not used immediately, the storage times
and conditions in use are the responsibility of the user and should normally not exceed 3 days when stored
between 2-8°C protected from light, or 8 hours at room temperature (below 25°C), including the infusion time.
Dispose of all unused medicine and waste materials in accordance with local requirements.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Docetaxel Aurobindo contains

• The active substance is docetaxel. Each ml of docetaxel solution contains 20 mg of anhydrous docetaxel.
• The other components are anhydrous citric acid, povidone, absolute ethanol and polysorbate 80.

Description of the appearance of Docetaxel Aurobindo and contents of the pack
Docetaxel Aurobindo concentrate for solution for infusion is a clear, pale yellow solution.
Docetaxel Aurobindo is available in a clear glass vial with a rubber stopper and an aluminium cap with a polypropylene disc. The vial is packaged with or without a protective plastic overwrap.
Packs:
1 single-dose vial of 1 ml
1 single-dose vial of 4 ml
1 single-dose vial of 7 ml
1 single-dose vial of 8 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta
Manufacturer
Generis Farmacêutica, S.A.
Rua João de Deus, no 19, Venda Nova,
2700-487 Amadora, Portugal
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia BBG 3000, Malta
This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Docetaxel AB 20 mg/ml concentrate for solution for infusion
Germany Docetaxel Aurobindo 20 mg/ml concentrate for the preparation of an infusion solution
Italy Docetaxel Aurobindo
Luxembourg Docetaxel AB 20 mg/ml solution to be diluted for perfusion
Netherlands Docetaxel Aurobindo 20 mg/ml concentrate for solution for intravenous infusion
Portugal Docetaxel Aurovitas
Spain Docetaxel Aurovitas 20 mg/ml concentrate for solution for perfusion

The following information is intended for healthcare professionals only:
Docetaxel Aurobindo 20 mg/ml concentrate for solution for infusion

Instructions for use

Docetaxel Aurobindo is an antineoplastic agent and, like other potentially toxic compounds, care must be taken during handling and preparation of Docetaxel Aurobindo solutions.
Cytotoxic agents should only be prepared for administration by personnel trained in the safe handling of such preparations. Pregnant personnel must not handle cytotoxic agents. Before starting, refer to local guidelines regarding cytotoxic substances. The use of gloves is recommended. If concentrated Docetaxel Aurobindo or infusion solution comes into contact with the skin, wash immediately and thoroughly with water and soap. If concentrated Docetaxel Aurobindo or infusion solution comes into contact with mucous membranes, rinse immediately and thoroughly with water. In case of spillage, the maximum amount of material should be removed by trained personnel wearing personal protective equipment, using a cytotoxic drug spill kit or specific absorbent materials. The area should be rinsed with a large amount of water. All contaminated cleaning materials must be disposed of in accordance with current local regulations.
Preparation of infusion solution
To obtain the required dose for the patient, more than one vial of Docetaxel Aurobindo 20 mg/ml concentrate for infusion solution may be needed. Based on the required patient dose expressed in mg, aseptically withdraw the corresponding volume of docetaxel 20 mg/ml from an appropriate number of vials using a graduated syringe with a needle. For example, for a dose of 140 mg of docetaxel, 7 ml of Docetaxel Aurobindo 20 mg/ml concentrate for infusion solution should be withdrawn.
For docetaxel doses below 192 mg, inject the required volume of Docetaxel Aurobindo 20 mg/ml concentrate for infusion solution into a 250 ml infusion bag or bottle containing 250 ml of glucose 50 mg/ml (5%) infusion solution or sodium chloride 9 mg/ml (0.9%) infusion solution. For doses exceeding 192 mg of docetaxel, more than 250 ml of infusion solution is required, as the maximum concentration of docetaxel is 0.74 mg per ml of infusion solution.
Manually mix the infusion bag or bottle with an oscillating motion. The diluted solution must be used within 8 hours and administered aseptically as a 1-hour infusion at room temperature under normal lighting conditions.
As with all parenteral medicinal products, this medicine should be inspected visually before use and solutions containing precipitates should be discarded.
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with current local regulations.
Storage after opening
Each vial is for single use only and should be used immediately after opening. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
Storage after dilution
From a microbiological standpoint, reconstitution/dilution must be performed under controlled and aseptic conditions, and the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.
Once added as recommended into an infusion bag, the docetaxel infusion solution, when stored below 25°C in non-PVC bags, is stable for 8 hours. It must be used within 8 hours (including the 1-hour time required for intravenous infusion).
Furthermore, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated for up to 3 days when stored between +2°C and 8°C, protected from light.
The docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must no longer be used and must be discarded.
Disposal
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with current local regulations.