Docetaxel Hospira 10 mg/ml concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Docetaxel Hospira 10 mg/mL concentrate for solution for infusion

docetaxel

Read the entire 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, pharmacist, or nurse.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The name of this medicine is Docetaxel Hospira. 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.

Your doctor has prescribed Docetaxel Hospira 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, this medicine may be given alone or in combination with doxorubicin, trastuzumab, or capecitabine.
• For the treatment of early breast cancer with or without lymph node involvement, this medicine may be given in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, this medicine may be given alone or in combination with cisplatin.
• For the treatment of prostate cancer, this medicine is given in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, this medicine is given in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, this medicine is given in combination with cisplatin and 5-fluorouracil.

2. What you need to know before using Docetaxel Hospira

Do not use Docetaxel Hospira:

• 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 Hospira, blood tests will be performed to ensure you have sufficient blood cells and adequate liver function to receive this medicine. If you have abnormalities in white blood cells, you may experience fever or associated infections.

Immediately inform your doctor, pharmacist, or nurse if you have abdominal pain or tenderness, diarrhoea, rectal bleeding, blood in stools, or fever. These symptoms could be early signs of severe gastrointestinal toxicity, which may be fatal. Your doctor must address this immediately.

Inform your doctor, pharmacist, or nurse if you have vision problems. In case of visual disturbances, especially blurred vision, an immediate eye and vision examination should be performed.

Inform your doctor, pharmacist, or nurse if you have experienced an allergic reaction to a previous treatment with paclitaxel.

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

If you develop serious or worsening lung problems (fever, shortness of breath, or cough), inform your doctor, pharmacist, or nurse immediately. Your doctor may discontinue your treatment immediately.

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

During treatment, you may be given other medicines to maintain your blood cell counts.

Severe skin reactions have been reported with docetaxel, 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 anywhere (including lips, eyes, mouth, nose, genitals, hands, or feet), with or without rash. You may also have flu-like symptoms at the same time, such as fever, chills, or muscle pain.
• Symptoms of AGEP may include a widespread red, scaly rash with inflamed bumps under the skin (including skin folds, trunk, and upper limbs), blisters, and fever.

If you develop severe skin reactions or any of the reactions mentioned above, contact your doctor or healthcare professional immediately.

Inform your doctor, pharmacist, or nurse before starting this medicine if you have kidney problems or high levels of uric acid in your blood.

This medicine contains alcohol. Consult your doctor if you have alcohol dependence, epilepsy, or liver impairment. See also the section “Docetaxel Hospira contains alcohol (ethanol)” below.

If you have severe fluid retention in the heart, lungs, or stomach, you must take special care with this medicine. Your doctor will take this into account.

Other medicines and Docetaxel Hospira

It is not recommended to use any other medical treatment without first informing your doctor, as drug interactions may occur between this medicine and other medicines.

Caution should be exercised when taking this medicine in combination with drugs such as cyclosporine, ketoconazole, and erythromycin, as significant interactions may occur. There may be an increased risk of side effects if this medicine is used in combination with drugs such as ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole (known as strong CYP3A4 inhibitors). Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This may cause docetaxel or the other medicine to not work as expected, or increase the likelihood of experiencing an adverse effect.

The amount of alcohol present in this medicine may alter the effects of other medicines.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Docetaxel Hospira must NOT be administered during pregnancy unless specifically indicated by your doctor.

You must not become pregnant during treatment and for 2 months after treatment with this medicine has ended. You should use an effective method of contraception during treatment and for 2 months after treatment ends, because this medicine may harm the unborn baby. If you become pregnant during treatment, inform your doctor immediately.

You must not breastfeed while receiving treatment with this medicine.

If you are a male receiving this medicine, you must not father a child and should use an effective method of contraception during treatment and for at least 4 months after treatment ends. It is recommended that you discuss sperm preservation before treatment, as docetaxel may impair male fertility.

Driving and using machines

You may experience adverse effects from this medicine that could affect your ability to drive, use tools, or operate machinery (see section 4 Possible side effects). If this occurs, do not drive or use any tools or machinery before consulting your doctor, nurse, or pharmacist.

Docetaxel Hospira contains alcohol (ethanol)

20 mg/2 mL vial:

This medicine contains 364 mg of alcohol (ethanol) per vial, equivalent to 182 mg/mL (23% v/v). The amount in each vial is equivalent to less than 10 mL of beer or 4 mL of wine.

80 mg/8 mL vial:

This medicine contains 1455 mg of alcohol (ethanol) per vial, equivalent to 182 mg/mL (23% v/v). The amount in each vial is equivalent to less than 37 mL of beer or 15 mL of wine.

160 mg/16 mL vial:

This medicine contains 2911 mg of alcohol (ethanol) per vial, equivalent to 182 mg/mL (23% v/v). The amount in each vial is equivalent to less than 73 mL of beer or 30 mL of wine.

The amount of alcohol in this medicine is unlikely to have any effect in adults and adolescents, and its effects in children may go unnoticed. However, it may have some effects in neonates and young children, such as drowsiness.

If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

The amount of alcohol contained in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medicine.

The amount of alcohol present 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 Hospira

A healthcare professional will administer this medicine to you.

Usual dose

The dose will depend on your body weight and general health status. Your doctor will calculate your body surface area in square meters (m²) and determine the dose you should receive.

Method and route of administration

This medicine will be administered through 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

You will usually receive the infusion once every 3 weeks.

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

If you use more Docetaxel Hospira than you should

Since this medicine is administered in a hospital setting, it is unlikely that you will receive too little or too much. However, inform your doctor if you have any concerns about this.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

The most common adverse effects of docetaxel are: reduction in the number of red or white blood cells, alopecia (hair loss), nausea, vomiting, mouth ulcers, diarrhea, and fatigue.

The severity of docetaxel's adverse effects may increase when this medicine 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 people):

• flushing, skin reactions, itching
• chest tightness, difficulty breathing
• fever or chills
• back pain
• low 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. Inform them immediately if you notice any of these effects.

Between one Docetaxel Hospira 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 people

• infection, reduction in the number of red blood cells (anemia) or white blood cells (which are 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 (difficulty sleeping)
• sensation of numbness, tingling, or joint pain
• chest pain
• headache
• altered taste
• eye inflammation or excessive tearing
• swelling due to defective lymphatic drainage
• shortness of breath
• nasal discharge; throat and nose inflammation; cough
• nosebleeds
• mouth sores
• stomach discomfort including nausea, vomiting, and diarrhea; 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 and soles of the feet, which may lead to skin peeling (this may also occur in the arms, face, or body)
• discoloration of nails, which may fall out
• muscle discomfort or pain; back pain or bone pain
• changes or absence of menstruation
• swelling of hands, feet, legs
• fatigue or flu-like symptoms
• weight gain or loss
• upper respiratory tract infection

Common: may affect up to 1 in 10 people

• oral candidiasis (fungal infection in the mouth)
• 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)
• increased blood sugar levels (diabetes)
• decreased potassium, calcium, and/or phosphate levels in your blood

Uncommon: may affect up to 1 in 100 people

• fainting
• skin reactions, phlebitis (vein inflammation), or swelling at the infusion site
• blood clot formation
• acute myeloid leukemia and myelodysplastic syndrome (types of blood cancer) may occur in patients treated with docetaxel along with other anticancer treatments

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

• inflammation of the colon or small intestine, which could be fatal (frequency not known); intestinal perforation
• inflammation and/or fluid in the lungs, which may cause cough, with or without frothy sputum. Severe cases of pulmonary fibrosis, sometimes fatal, have been reported
• intestinal obstruction causing abdominal pain
• skin redness in areas previously treated with radiotherapy

Very rare: may affect up to 1 in 10,000 people

• temporary visual disturbances, e.g., flashes of light, flickering lights, reduced vision
• hepatitis (inflammation of the liver)
• redness and/or blisters on the skin or formation of hard areas

Not known: frequency cannot be estimated from available data

• kidney problems / reduced kidney function (your doctor will monitor this)
• 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 inflammation of the eye retina (cystoid macular edema)
• decreased levels of sodium and/or magnesium in the 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
• injection site reactions at the site of a previous reaction
• non-Hodgkin lymphoma (a cancer affecting the immune system) and other types of cancer may occur in patients receiving docetaxel treatment along with other anticancer treatments
• Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blisters, peeling or bleeding on any part of your skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without rash. You may also have flu-like symptoms at the same time, such as fever, chills or muscle pain)
• acute generalized exanthematous pustulosis (AGEP) (widespread red, scaly rash with bumps under inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever)
• tumor lysis syndrome, a serious condition characterized by changes in blood tests, such as increased levels of uric acid, potassium, phosphorus, and decreased calcium levels; leading to symptoms such as seizures, kidney failure (reduced or darkened urine), and heart rhythm disturbances. If this occurs, inform your doctor immediately
• myositis (muscle inflammation—heat, redness, and swelling—causing muscle pain and weakness)

If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor immediately.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Docetaxel Hospira

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

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

Do not store above 25 °C.

Keep in the original packaging to protect from light.

Use the vial immediately after opening. If not used immediately, the duration and conditions of in-use storage are the responsibility of the user.

After dilution in sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose, chemical and physical in-use stability has been demonstrated for 4 hours when stored at less than 25 °C.

From a microbiological standpoint, the infusion preparation should be used immediately. If not, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2 °C to 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.

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

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Contents of the container and other information

Composition of Docetaxel Hospira

• The active substance is docetaxel. Each mL of concentrate for solution for infusion contains 10 mg of docetaxel.
• The other components are citric acid, anhydrous ethanol (see section 2 “Docetaxel Hospira contains alcohol (ethanol)”), Macrogol 300 and Polysorbate 80.

Appearance of the product and contents of the container

Clear solution, colourless to pale yellow. The medicine comes in glass containers called vials. One mL of solution contains 10 mg of docetaxel. A 2 mL vial contains 20 mg of docetaxel, an 8 mL vial contains 80 mg of docetaxel, and a 16 mL vial contains 160 mg of docetaxel. The vials may be wrapped in protective plastic to prevent spillage in case of breakage, known as ONCO-TAIN®. Vials are available in single-unit packs.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Pfizer, S.L.

Avenida de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Avara Liscate Pharmaceutical Services S.p.A.

Via Fosse Ardeatine, 2

(Liscate (Milan)) - 20060

Italy

Pfizer Service Company BV

Hermeslaan 11

1932 Zaventem

Belgium

This medicinal product is authorised in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Greece, Ireland, Malta, Slovakia, Sweden, United Kingdom (Northern Ireland): Docetaxel Hospira

France: DOCETAXEL HOSPIRA 10 mg/mL, solution to be diluted for infusion.

Spain: Docetaxel Hospira 10mg/mL concentrate for solution for infusion

Date of the most recent revision of this leaflet: December 2023

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The following information is intended for healthcare professionals only.

To determine whether the product is suitable for use in a particular patient, the physician should be familiar with the full Summary of Product Characteristics.

Shelf life

Unopened vial: 36 months

After dilution:

After dilution in sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose, chemical and physical in-use stability has been demonstrated for 4 hours when stored at less than 25 °C. From a microbiological standpoint, the infusion preparation should be used immediately. If not, in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2 °C to 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.

Instructions for use, handling and disposal

Instructions for Use:

For intravenous infusion. Prior to infusion, Docetaxel Hospira must be diluted under aseptic conditions.

Visually inspect before use. Only use solutions that are clear and free from visible particles.

Contact between docetaxel and plasticised PVC equipment or devices used for preparing infusion solutions is not recommended. To minimize patient exposure to DEHP (di-2-ethylhexyl phthalate), which may leach from PVC infusion bags or sets, docetaxel solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-coated administration sets.

Inject the required volume into a 250 mL infusion bag or bottle containing:

• Sodium chloride 9 mg/mL (0.9%) solution for injection
• Glucose 50 mg/mL (5%)

If a docetaxel dose greater than 200 mg is required, use a larger volume of infusion vehicle so that the concentration of docetaxel does not exceed 0.74 mg/mL.

From a microbiological standpoint, the infusion preparation should be used immediately. If not, in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

As with other potentially toxic compounds, precautions should be taken during handling and preparation of docetaxel solutions.

Special precautions for administration

• DO NOT mix with other medicines

Handling instructions

Local guidelines for safe preparation and handling should be consulted.

Only personnel properly trained in the safe handling of cytotoxic agents should prepare and handle these preparations. Pregnant personnel should not handle cytotoxic agents.

All personnel handling cytotoxic agents must be adequately protected with personal protective equipment, including disposable protective gloves, eye protection, and long-sleeved gowns. Preparation and handling of solutions must be performed in a designated area.

Instructions in case of contamination

In case of skin contact, wash the affected area thoroughly with water and soap, taking care not to cause abrasions to the skin. A mild cream may be used to treat transient skin irritation. In case of eye contact, rinse thoroughly with large amounts of water or 0.9% sodium chloride. Seek medical advice.

In case of spillage, trained personnel wearing appropriate personal protective equipment should remove as much material as possible using a cytotoxic drug spill kit or designated absorbent materials. The area should be washed with copious amounts of water. All contaminated cleaning materials must be disposed of as described below.

Disposal instructions

All contaminated waste materials (including sharps or cutting instruments, containers, absorbent materials, unused solutions, etc.) must be placed in labelled, sealed, impermeable waste bags or rigid waste containers and incinerated in accordance with local procedures for the destruction of hazardous waste.

Any unused product or waste material must be disposed of in accordance with local requirements.