DOCETAXEL HOSPIRA 10 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Docetaxel Hospira 10 mg/mL Concentrate for Solution for Infusion

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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Docetaxel Hospira and what is it 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 administered 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 administered in combination with doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, this medicine may be administered alone or in combination with cisplatin.
• For the treatment of prostate cancer, this medicine is administered in combination with prednisone or prednisolone.
• For the treatment of metastatic gastric cancer, this medicine is administered in combination with cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, this medicine is administered in combination with cisplatin and 5-fluorouracil.

2. What you need to know before you use Docetaxel Hospira

Do not useDocetaxel Hospira:

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

Warnings and precautions

Before each treatment with Docetaxel Hospira, you will have blood tests to check that you have a sufficient number of blood cells and sufficient liver function to receive this medicine. In case of altered white blood cell counts, you may experience fever or associated infections.

Inform your doctor, pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhea, rectal bleeding, blood in stools, or fever. These symptoms could be the first signs of severe gastrointestinal toxicity, which can be fatal. Your doctor must address this immediately.

Inform your doctor, pharmacist, or nurse if you have vision problems. In case of vision problems, particularly blurred vision, you must have your eyes and vision examined immediately.

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 severe or worsening problems in your lungs (fever, shortness of breath, or cough), inform your doctor, pharmacist, or nurse immediately. Your doctor may interrupt your treatment immediately.

Your doctor will recommend that you take premedication consisting of an oral corticosteroid such as dexamethasone, one day before the administration of docetaxel and continuing for one or two days after, to minimize certain adverse reactions that may occur after the 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 the number of your blood cells.

Severe skin problems such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported with docetaxel:

• SJS/TEN symptoms may include blisters, peeling, or bleeding on any part of your skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills, or muscle pain.
• AGEP symptoms may include a red, scaly, and widespread rash with bumps under the inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever.

If you develop severe skin reactions or any of the above-mentioned reactions, 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 suffer from alcohol dependence, epilepsy, or liver failure. See also the section “Docetaxel Hospira contains alcohol (ethanol)” below.

If you have severe fluid retention in your heart, lungs, or stomach, you should be careful 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 pharmacological interactions may occur between this medicine and other medicines.

Caution should be exercised when taking this medicine in combination with medicines such as cyclosporine, ketoconazole, and erythromycin, as there is a possibility of significant interactions. An increase in side effects may occur if this medicine is used in combination with medicines such as ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole (known as potent inhibitors of CYP3A4). 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 have the expected effect, or there may be a greater likelihood of experiencing a side effect.

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

Pregnancy, breast-feeding, 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 the end of treatment with this medicine. You must use an effective contraceptive method during treatment and for 2 months after the end of treatment, as this medicine may be harmful to the fetus. If you become pregnant during treatment, you must inform your doctor immediately.

You must not breast-feed while receiving treatment with this medicine.

If you are a man treated with this medicine, you must not father a child and must use an effective contraceptive method during treatment and for at least 4 months after the end of treatment with this medicine. It is recommended that you be informed about sperm preservation before treatment, as docetaxel may alter male fertility.

Driving and using machines

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

Docetaxel Hospira contains alcohol (ethanol)

Vial of 20 mg/2 mL:

This medicine contains 364 mg of alcohol (ethanol) in each vial, which is 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.

Vial of 80 mg/8 mL:

This medicine contains 1455 mg of alcohol (ethanol) in each vial, which is 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.

Vial of 160 mg/16 mL:

This medicine contains 2911 mg of alcohol (ethanol) in each vial, which is 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.

It is unlikely that the amount of alcohol contained in this medicine will have any effect on adults and adolescents, and its effects in children may not be detected. It may have some effects in neonates and young children, such as drowsiness.

If you have a history of alcohol dependence, 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 breast-feeding, 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

This medicine will be administered to you by a healthcare professional.

Usual dose

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

Form and route of administration

This medicine will be administered through an infusion into one of your veins (intravenously). The infusion will last approximately one hour, during which you will remain in the hospital.

Frequency of administration

Generally, you will receive the infusion once every 3 weeks.

Your doctor may change the dose and frequency of administration based on your blood tests, overall health, and response to this medicine. In particular, inform your doctor if you experience diarrhea, mouth ulcers, numbness or tingling, or fever, and provide the results of your blood tests. This information will allow your doctor to decide if a dose reduction is needed. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you use more Docetaxel Hospira than you should

Since this medicine is administered in a hospital, it is unlikely that you will receive an insufficient or excessive dose. Nevertheless, 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 all people suffer from them.

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

The most frequent adverse effects of docetaxel alone are: decrease 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 hospital perfusion, the following allergic reactions may occur (may affect more than 1 in 10 people):

• redness, skin reactions, itching
• chest pressure, difficulty breathing
• fever or chills
• back pain
• low blood pressure

More serious reactions may occur.

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

Hospital staff will closely monitor your health status during treatment. Inform them immediately if you notice any of these effects.

Between one Docetaxel Hospira perfusion and another, the following may occur, and their frequency may vary depending on the combination of medications you receive:

Very frequent: may affect more than 1 in 10 people

• infection, reduction in the number of red or white blood cells in the blood (which are important for fighting infections) and platelets
• fever: if this happens, you should inform your doctor immediately
• allergic reactions like those described above
• loss of appetite (anorexia)
• insomnia (sleep problems)
• feeling of numbness or tingling or pain in the joints
• chest pain
• headache
• taste alteration
• eye inflammation or excessive tearing
• swelling caused by defective lymphatic drainage
• shortness of breath
• nasal secretion; throat and nose inflammation; cough
• nasal bleeding
• mouth sores
• stomach upset including nausea, vomiting, and diarrhea; constipation
• abdominal pain
• indigestion
• hair loss: in most cases, hair growth returns to normal. In some cases (unknown frequency), permanent hair loss has been observed
• redness and swelling of the palms of the hands and soles of the feet, which can cause skin peeling (this can also occur on the arms, face, or body)
• change in nail color, which can fall off
• muscle discomfort or pain; back pain or bone pain
• change or absence of menstruation
• swelling of hands, feet, legs
• fatigue or flu-like symptoms
• weight gain or loss
• upper respiratory tract infection.

Frequent: may affect up to 1 in 10 people

• oral candidiasis (fungal infection in the mouth)
• dehydration
• dizziness
• impaired hearing
• decrease in blood pressure, irregular or rapid heartbeats
• heart failure
• esophagitis
• dry mouth
• difficulty or pain when swallowing
• bleeding
• elevation of liver enzymes (hence the need for regular blood tests)
• increase in blood sugar levels (diabetes)
• decrease in potassium, calcium, and/or phosphate in the blood.

Infrequent: may affect up to 1 in 100 people

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

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

• colon, small intestine inflammation, which could be fatal (unknown frequency); intestinal perforation
• lung inflammation and/or fluid, which can cause cough, with or without foamy sputum. Serious cases of pulmonary fibrosis have occurred, sometimes fatal
• intestinal blockage that causes abdominal pain
• skin redness in the area of previous radiotherapy

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

• temporary visual disturbances, e.g., flashes, intermittent lights, reduced vision
• liver inflammation
• redness and/or blisters on the skin or formation of hardness.

Unknown: frequency cannot be estimated from available data

• kidney problems / decreased renal function (your doctor will check)
• interstitial lung disease (inflammation of the lungs that causes cough and difficulty breathing, lung inflammation can also occur when docetaxel treatment is used with radiotherapy)
• pneumonia (lung infection)
• pulmonary fibrosis (scarring and thickening in the lungs with difficulty breathing)
• blurred vision due to inflammation of the ocular retina (cystoid macular edema)

• decrease in sodium and/or magnesium levels in the blood (electrolyte imbalance disorders)
• ventricular arrhythmia or ventricular tachycardia (which manifests as an irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting); some of these symptoms can be severe; if this happens, you should inform your doctor immediately.
• reactions at the injection site in the area of a previous reaction
• non-Hodgkin lymphoma (a cancer that affects the immune system) and other types of cancer can occur in patients receiving treatment with docetaxel along with other anticancer treatments.
• Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) (blisters, peeling, or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without a rash. You may also have flu-like symptoms at the same time, such as fever, chills, or muscle pain)
• acute generalized exanthematous pustulosis (AGEP) (red, scaly, and widespread rash with bumps under the inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever.
• tumor lysis syndrome, a serious condition that manifests as changes in blood tests, such as increased uric acid, potassium, phosphorus, and decreased calcium levels; and results in symptoms such as seizures, kidney failure (reduced or darkened urine), and heart rhythm disturbances. If this happens, you should inform your doctor immediately.
• myositis (inflammation of the muscles - heat, redness, and swelling - that causes muscle pain and weakness).

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

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Docetaxel Hospira

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Keep in the original packaging to protect it from light.

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

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

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

The docetaxel perfusion solution is supersaturated, so it may crystallize over time. If crystals appear, the solution should no longer be used and should be discarded.

Medicines should not be thrown down the drain. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Docetaxel Hospira

• The active ingredient is docetaxel. Each mL of concentrate for solution for perfusion 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 Package Contents

Clear solution from colorless to light 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 a protective plastic to prevent the risk of spills in case of vial breakage, known as ONCO-TAIN®. The vials are available in single-unit packaging.

Only some package 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

Hoge Wei 10

1930 Zaventem,

Belgium

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

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

France: DOCETAXEL HOSPIRA 10 mg/mL, solution à diluer pour perfusion.

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

Date of the last revision of this prospectus: December 2023

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The following information is intended only for doctors or healthcare professionals.

To determine if the product is suitable for use in a particular patient, the doctor must be familiar with the entire Summary of Product Characteristics.

Validity Period

Unopened vial: 36 months

After dilution:

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

Instructions for Use, Handling, and Disposal

Instructions for Use:

For intravenous perfusion administration. Prior to its perfusion, Docetaxel Hospira must be diluted under aseptic conditions.

Inspect visually before use. Only use clear solutions without visible particles.

It is not recommended to contact docetaxel with PVC-coated equipment or devices used for the preparation of perfusion solutions. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be released from PVC bags or perfusion equipment, docetaxel solutions should be stored in glass or polypropylene containers or polypropylene or polyolefin plastic bags and administered through polyethylene-coated equipment.

Inject the required volume into a 250 mL perfusion 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 perfusion vehicle, so as not to exceed a concentration of 0.74 mg/mL of docetaxel.

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

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

Special Precautions for Administration

• DO NOT mix with other medicines

Handling Instructions

Local guidelines should be consulted for safe preparation and handling.

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

All personnel involved in the handling of cytotoxic agents should be adequately protected with personal protective equipment, including disposable protective gloves, eye masks, and long-sleeved gowns. Preparation and handling of the solutions should be carried out 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 skin abrasions. A mild cream can be used to treat transient skin burning. In case of eye contact, rinse with plenty of water or 0.9% sodium chloride. Seek medical advice.

In case of spillage, trained personnel, with 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 should be disposed of as described below.

Disposal Instructions

All contaminated waste materials (including sharp or cutting elements, containers, absorbent materials, unused solutions, etc.) should be placed in labeled and sealed 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 should be disposed of in accordance with local requirements.