Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion EFG

Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion EFG

Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion EFG

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 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 side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

The name of this medicine is Docetaxel Accord. Its common name is docetaxel.
Docetaxel is a substance derived from the needles (leaves) of the yew tree.
Docetaxel belongs to a group of anticancer medicines called taxoids.

Docetaxel Accord 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 may be given either alone or in combination with doxorubicin, trastuzumab, or capecitabine.
• For the treatment of early-stage breast cancer with or without lymph node involvement, docetaxel may be given in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, docetaxel may be given either alone or in combination with cisplatin.
• For the treatment of prostate cancer, docetaxel is given in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, docetaxel is given in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, docetaxel is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using Docetaxel Accord

Do not use Docetaxel Accord:

• if you are allergic (hypersensitive) to docetaxel or to any of the other ingredients of Docetaxel Accord (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 Accord, you will have a blood test to ensure that you have an adequate number of blood cells and sufficient liver function to receive Docetaxel Accord. If your white blood cells are altered, you may develop fever or infections.

Immediately inform your doctor, hospital pharmacist, or nurse if you experience abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in the stool, or fever. These symptoms could be the first signs of severe gastrointestinal toxicity, which may be life-threatening. Your doctor must address this immediately.

Inform your doctor, hospital pharmacist, or nurse if you have vision problems. If you experience visual disturbances, particularly blurred vision, you should have an immediate eye and vision examination.

Inform your doctor, hospital pharmacist, or nurse if you have previously experienced allergic reactions to paclitaxel.

Inform your doctor, hospital pharmacist, or nurse if you have heart problems.

If you develop acute problems or worsening of lung conditions (fever, difficulty breathing, cough), inform your doctor, hospital pharmacist, or nurse immediately. Your doctor may immediately discontinue your treatment.

Your doctor will recommend that you take premedication consisting of an oral corticosteroid such as dexamethasone, starting one day before administration of Docetaxel Accord and continuing for one or two days afterwards, to minimize certain adverse effects that may occur after infusion of Docetaxel Accord, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).

During treatment, you may receive other medications to maintain your blood cell counts.

Docetaxel Accord contains alcohol. Consult your doctor if you have alcohol dependence or liver disorders. See also the section below “Docetaxel Accord contains ethanol (alcohol)”.

Use of Docetaxel Accord with other medicines

Please tell your doctor or hospital pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because Docetaxel Accord or the other medicine may not work as expected, and you may have an increased risk of side effects.

The alcohol content of this medicine may alter the effects of other medicines.

Pregnancy, breast-feeding and fertility

Talk to your doctor before using any medicine.

Docetaxel Accord must not be given during pregnancy unless clearly indicated by your doctor.

You must not become pregnant while being treated with this medicine and should use an effective method of contraception during therapy, as docetaxel may harm the unborn baby. If you become pregnant during treatment, you must inform your doctor immediately.

Breast-feeding must not be undertaken while you are being treated with docetaxel.

If you are a male receiving docetaxel treatment, you are advised not to father a child during treatment and for 6 months after treatment ends. You should also seek advice on sperm preservation before starting treatment, as docetaxel may impair male fertility.

Driving and use of machines

The alcohol content of this medicine may affect your ability to drive and operate machinery.

You may experience adverse effects from this medicine that could impair your ability to drive, use tools, or handle machinery (see section 4 Possible side effects). If this occurs, do not drive or operate any tools or machinery until you have consulted your doctor, nurse, or hospital pharmacist.

Docetaxel Accord contains ethanol (alcohol)

Docetaxel Accord 20 ml/1 ml contains 50% v/v anhydrous ethanol (alcohol), corresponding to 395 mg anhydrous ethanol per vial, equivalent to 10 ml of beer or 4 ml of wine.

Docetaxel Accord 80 ml/4 ml contains 50% v/v anhydrous ethanol (alcohol), corresponding to 1,58 g anhydrous ethanol per vial, equivalent to 40 ml of beer or 17 ml of wine.

Docetaxel Accord 160 ml/8 ml contains 50% v/v anhydrous ethanol (alcohol), corresponding to 3,16 g anhydrous ethanol per vial, equivalent to 80 ml of beer or 33 ml of wine.

This medicine is harmful for individuals suffering from alcoholism.

The alcohol content should be taken into account in pregnant or breastfeeding women, children, and high-risk populations such as patients with liver disease or epilepsy.

The amount of alcohol 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 Accord

Docetaxel Accord will be administered to you by a healthcare professional.

Recommended dose

The dose will depend on your body weight and general 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 Accord will be given as an intravenous infusion into one of your veins. The infusion will last approximately one hour, during which time you will remain in the hospital.

Frequency of administration

The treatment will be administered to you by intravenous infusion once every 3 weeks.

Your doctor may adjust the dose and frequency of administration based on your blood test results, general condition, and response to Docetaxel Accord. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling sensations, fever, and provide your blood test results. This information will help your doctor decide whether a dose reduction is necessary. If you have any further questions about the use of this medicine, ask your doctor or the hospital pharmacist.

4. Possible adverse effects

Like all medicines, Docetaxel can produce adverse effects, although not everyone will experience them.

Your doctor will discuss these with you and explain the possible risks and benefits of your treatment.

The most common adverse effects of Docetaxel when administered alone are: decreased number of red or white blood cells, alopecia, nausea, vomiting, mouth sores, diarrhea, and fatigue.

The severity of Docetaxel's adverse effects may increase when it is administered in combination with other chemotherapeutic agents.

During the infusion at the hospital, the following allergic reactions may occur (may affect more than 1 in 10 patients):

• flushing, skin reactions, itching,
• chest tightness, difficulty breathing,
• fever or chills,
• back pain,
• decreased blood pressure.

Other more serious reactions may also occur.

If you have had an allergic reaction to paclitaxel, you may also experience an allergic reaction to docetaxel, which could be more severe.

Hospital staff will closely monitor your health during treatment. If you notice any of these effects, inform them immediately.

Between one docetaxel infusion and another, the following may occur, and their frequency may vary depending on the combination of medicines you receive:

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

• infections, decreased number of red blood cells (anemia) or white blood cells (important for fighting infections), and platelets,
• fever: if this occurs, you must inform your doctor immediately,
• allergic reactions as described above,
• loss of appetite (anorexia),
• insomnia,
• sensation of numbness, tingling, or pain in joints,
• headache,
• altered taste,
• eye inflammation or excessive tearing,
• swelling caused by defective lymphatic drainage,
• shortness of breath,
• nasal discharge; throat and nose inflammation; cough,
• nosebleeds,
• mouth sores,
• stomach discomfort including nausea, vomiting, diarrhea, constipation,
• abdominal pain,
• indigestion,
• hair loss: in most cases, your hair will grow back normally. 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 lead to skin peeling (this may also occur in arms, face, or body),
• changes in nail color, which may lead to nail loss,
• muscle pain; back or bone pain,
• changes or absence of menstrual periods,
• swelling of hands, feet, legs,
• fatigue; or cold-like symptoms,
• weight gain or weight loss.

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

• oral candidiasis,
• dehydration,
• dizziness,
• impaired hearing,
• low blood pressure, irregular or rapid heartbeat,
• heart failure,
• esophagitis,
• dry mouth,
• difficulty or pain when swallowing,
• bleeding,
• elevated liver enzymes (hence the need for regular blood tests).

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

• fainting,
• skin reactions, phlebitis (vein inflammation), or swelling at the infusion site,
• blood clot formation.

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

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

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

• interstitial lung disease (lung inflammation causing cough and difficulty breathing. Lung inflammation may also occur when docetaxel treatment is used with radiotherapy),
• pneumonia (lung infection),
• pulmonary fibrosis (scarring and thickening in the lungs causing difficulty breathing),
• blurred vision due to retinal inflammation inside the eye (cystoid macular edema),
• decreased levels of sodium, potassium, magnesium, and/or calcium in your blood (electrolyte imbalance),
• ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting). Some of these symptoms may be serious. If this occurs, inform your doctor immediately,
• reactions at the injection site, including at the site of a previous reaction,
• non-Hodgkin's lymphoma (a cancer affecting the immune system) and other cancers may occur in patients treated with docetaxel in combination with certain anticancer treatments.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, hospital pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Docetaxel Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect from light.

Use the vial immediately after opening. If not used immediately, the storage periods and conditions are the responsibility of the user.

From a microbiological standpoint, the product should be diluted under controlled aseptic conditions.

The medicine should be used immediately after being added to the infusion bag. If not used immediately, the storage periods and conditions are the responsibility of the user and normally should not exceed 6 hours below 25°C, including the time of infusion to the patient.

The physical and chemical stability of the infusion solution prepared as recommended has been demonstrated for up to 48 hours when stored between 2 and 8°C in non-PVC bags.

Prepare the infusion solution as recommended. Do not connect the infusion solution to the infusion set for longer than 6 hours when stored at 25°C.

Docetaxel infusion solution is supersaturated and may therefore crystallize over time. If crystals appear, the solution must not be used and should be discarded.

Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the container and other information

What Docetaxel Accord contains

• The active substance is docetaxel. Each ml of concentrate for solution for infusion contains 20 mg of docetaxel.

A 1 ml vial of concentrate contains 20 mg of docetaxel.
A 4 ml vial of concentrate contains 80 mg of docetaxel.
An 8 ml vial of concentrate contains 160 mg of docetaxel.

• The other components are polysorbate 80, anhydrous ethanol (see section 2), and anhydrous citric acid.

What Docetaxel Accord looks like and contents of the pack

Docetaxel Accord concentrate for solution for infusion is a clear, pale yellow to yellowish-brown solution.

Docetaxel Accord 20 mg/1 ml is supplied in a 5 ml clear glass vial with a fluorotec plus rubber stopper, aluminium seal, and an orange flip-off cap.

Docetaxel Accord 80 mg/4 ml is supplied in a 5 ml clear glass vial with a fluorotec plus rubber stopper, aluminium seal, and a red flip-off cap.

Docetaxel Accord 160 mg/8 ml is supplied in a 10 ml clear glass vial with a fluorotec plus rubber stopper, aluminium seal, and a red flip-off cap.

Pack size:

Each pack contains one 1 ml vial of concentrate.
Each pack contains one 4 ml vial of concentrate.
Each pack contains one 8 ml vial of concentrate.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6th floor,
08039 Barcelona,
Spain

Manufacturer

Accord Healthcare Limited
Sage House
319, Pinner Road
North Harrow, Middlesex HA1 4HF
United Kingdom

Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

PREPARATION GUIDE FOR THE USE OF DOCETAXEL ACCORD
CONCENTRATE FOR SOLUTION FOR INFUSION

It is important to carefully read the contents of this guide before preparing the infusion solution of Docetaxel Accord.

Recommendations for safe handling

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling and preparing its solutions. The use of gloves is recommended.

If the Docetaxel Accord concentrate or infusion solution comes into contact with the skin, wash the skin immediately and thoroughly with soap and water. If the concentrate or infusion solution comes into contact with mucous membranes, rinse immediately and thoroughly with water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE this medicine (Docetaxel Accord 20 mg/1 ml concentrate for infusion solution, in a single vial) in combination with other medicines containing docetaxel supplied in 2 vials (concentrate and solvent).

DO NOT USE this medicine (Docetaxel Accord 80 mg/4 ml concentrate for infusion solution, in a single vial) in combination with other medicines containing docetaxel supplied in 2 vials (concentrate and solvent).

DO NOT USE this medicine (Docetaxel Accord 160 mg/8 ml concentrate for infusion solution, in a single vial) in combination with other medicines containing docetaxel supplied in 2 vials (concentrate and solvent).

Docetaxel Accord concentrate for infusion solution does NOT require prior dilution with a solvent and is ready to be added directly to the infusion solution.

• Each vial is for single use only and should be used immediately after opening. If not used immediately, the storage periods and conditions are the responsibility of the user. More than one vial of docetaxel concentrate for infusion solution may be required to achieve the patient's required dose. For example, a 140 mg dose of docetaxel would require 7 ml of docetaxel concentrate for infusion solution.
• Aseptically withdraw the required amount of concentrate for infusion solution using a calibrated syringe with a 21G needle.

The concentration of docetaxel in the Docetaxel Accord vial is 20 mg/ml.

• Then, inject it in a single administration (single injection) into a 250 ml infusion bag containing either 5% glucose solution or 9 mg/ml (0.9%) sodium chloride solution. If a docetaxel dose exceeding 190 mg is required, use a larger volume of infusion fluid to ensure the docetaxel concentration does not exceed 0.74 mg/ml.

• Mix the infusion bag manually by gentle rotation.

• From a microbiological standpoint, dilution should be performed under controlled aseptic conditions and the medicine should be used immediately. If not used immediately, the storage periods and conditions are the responsibility of the user.

Once added to the infusion bag as recommended, the docetaxel infusion solution is stable for 6 hours when stored below 25°C. It must be used within this 6-hour period (including the time for intravenous infusion administration).

Additionally, the physical and chemical stability of the prepared infusion solution, when prepared as recommended, has been demonstrated for up to 48 hours when stored between 2°C and 8°C in non-PVC bags.

The docetaxel infusion solution is supersaturated and may crystallize over time. If crystals appear, the solution must not be used and should be discarded.

• As with all parenteral products, the infusion solution should be inspected visually before use; any solution in which precipitate is observed should be discarded.

Disposal

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations. Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.