Patient Information Leaflet

Docetaxel Hospira 10 mg/mL Concentrate for Solution for Infusion

docetaxel

Read this leaflet carefully before you start using this medicine, because it contains important information for you

-Keep this leaflet, as you may need to read it again.

-If you are unsure about anything, ask your doctor, pharmacist or nurse.

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

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

2.What you need to know before using Docetaxel Hospira

3.How to use Docetaxel Hospira

4.Possible side effects

5.Storage of Docetaxel Hospira

6.Contents of the pack and additional information

The name of this medication 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 cancer medications 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, stomach cancer, or head and neck cancer:

•This medication may be used alone or in combination with doxorubicin, trastuzumab, or capecitabina for the treatment of advanced breast cancer.

•This medication may be used in combination with doxorubicin and cyclophosphamide for the treatment of early breast cancer with or without lymph node involvement.

•This medication may be used alone or in combination with cisplatin for the treatment of lung cancer.

•This medication is administered in combination with prednisone or prednisolone for the treatment of prostate cancer.

•This medication is administered in combination with cisplatin and 5-fluorouracil for the treatment of metastatic gastric cancer.

•This medication is administered in combination with cisplatin and 5-fluorouracil for the treatment of head and neck cancer.

No useDocetaxel Hospira:

• If you are allergic (hypersensitive) to docetaxel or any of the other components of this medication (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 verify that you have a sufficient number of blood cells and sufficient liver function to receive this medication.In case of white blood cell alterations, you may experience fever or associated infections.

Inform your doctor, pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhea, rectal bleeding, bloody stools, or fever. These symptoms may 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 lung problems (fever, shortness of breath, or cough), inform your doctor, pharmacist, or nurse immediately. Your doctor may interrupt treatment immediately.

Your doctor will recommend taking 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 medication, particularly allergic reactions and fluid retention (swelling of hands, feet, legs, or weight gain).

During treatment, it is possible that other medications will be administered to maintain your blood cell count.

Severe skin problems such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), and generalized acute pustular psoriasis (GPP) have been reported with docetaxel:

• The symptoms of SSJ/TEN 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 symptoms similar to the flu at the same time, such as fever, chills, or muscle pain.
• The symptoms of GPP may include a red, scaly, and generalized rash with inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by 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 medication if you have kidney problems or high blood levels of uric acid.

This medication contains alcohol. Consult your doctor if you suffer from alcohol dependence, epilepsy, or liver insufficiency. See also the section “Docetaxel Hospira contains alcohol (ethanol)” below.

If you have severe fluid retention in the heart, lungs, or stomach, you must be careful with this medication. Your doctor will take this into account.

Other medications and Docetaxel Hospira

Do not use any other medical treatment without first informing your doctor, as interactions between this medication and other medications may occur.

Caution should be exercised when taking this medication in combination with medications such as ciclosporin, ketoconazole, and erythromycin, as significant interactions may occur. An increase in side effects may occur if this medication is used in combination with medications such as ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole (known as potent CYP3A4 inhibitors).Inform your doctor or pharmacist if you are taking or have taken recently any other medication, including those acquired without a prescription. This may make docetaxel or the other medication not have the expected effect, or there may be a greater likelihood of an adverse effect.

The amount of alcohol contained in this medication may alter the effects of other medications.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Docetaxel HospiraSHOULD NOTbe administered during pregnancy unless specifically indicated by your doctor.

You should not become pregnant during treatment and for the 2 months following the end of treatment with this medication. You must use an effective contraceptive method during treatment and for the 2 months following the end of treatment, as this medication may be harmful to the fetus.If you become pregnant during treatment, you must inform your doctor immediately.

You should not breastfeed while receiving treatment with this medication.

If you are a man treated with this medication, you should 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 medication.It is recommended that you inform your doctor about sperm conservation before treatment, as docetaxel may alter male fertility.

Driving and operating machinery

You may experience adverse effects from this medication that may impair your ability to drive, use tools, or operate machinery (see section 4 Possible adverse 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)

Vial of 20 mg/2 mL:

This medication contains 364 mg of alcohol (ethanol) in each 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.

Vial of 80 mg/8 mL:

This medication contains 1455 mg of alcohol (ethanol) in each 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.

Vial of 160 mg/16 mL:

This medication contains 2911 mg of alcohol (ethanol) in each 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.

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

If you have a history of alcohol dependence, consult your doctor or pharmacist before taking this medication.

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

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

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

The amount of alcohol present in this medication may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).

A healthcare professional will administer this medication.

Usual Dose

The dose will depend on yourweight and overall health status. 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 medicationwill be administered through anintravenous infusioninto one of yourveins (intravenous route).The infusion will last approximately one hour during which you will remain in the hospital.

Administration Frequency

You will generally receive the infusion once every 3weeks.

Your doctor may change the dose and administration frequency based on your blood test results, overall health status, and response tothis medication. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling, or fever,and provide your blood test results. This information will allow your doctor to decide if a dose reduction is needed. If you have any questions about using this medication, consult your doctor or pharmacist.

If You Take More Docetaxel Hospira Than You Should

Since this medication is administered in a hospital setting, it is unlikely that you will receive an underdose or overdose. However, inform your doctor if you have any concerns.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

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

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

The severity of docetaxel side effects may increase whenthis medicineis administered in combination with other chemotherapy agents.

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

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

Other more severe reactions may occur.

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

The hospital staff will closely monitor your health during treatment. Inform them immediately if you notice any of these side effects.

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

Very common: may affect more than 1 in 10people

• infection, reduction in the number of red (anemia) or white blood cells (important for fighting infections) and platelets
• fever: if this happens, you must inform your doctor immediately
• allergic reactions as describedabove
• loss of appetite(anorexia)
• insomnia (sleep problems)
• sensation ofnumbness or tingling or pain in the joints
• chest pain
• headache
• alteration of taste
• inflammation of the eye or excessive tearing
• swelling caused by defective lymphatic drainage
• breathing difficulties
• nasal secretion; inflammation of the throat and nose; cough
• nosebleed
• mouth sores
• stomach discomfort 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 may cause skin peeling (this can alsooccurin the arms, face, or body)
• change in nail color, which may cause them to fall off
• muscle or joint pain; back 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.

Common: may affect up to 1 in 10people

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

Uncommon: may affect up to 1 in 100people

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

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

• inflammation of the colon, small intestine, which could be fatal (unknown frequency); 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 blockage causing abdominal pain
• redness of the skin at the site of previous radiation therapy

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

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

Unknown: the frequency cannot be estimated from available data

• problems with your kidneys / decreased renal function (your doctor will check this)
• pulmonary interstitial disease (inflammation of the lungs that causes cough and difficulty breathing, lung inflammation may also occur when docetaxel treatment is used with radiation therapy)
• neumonia (lung infection)
• pulmonary fibrosis (scarring and thickening of the lungs with difficulty breathing)
• blurred vision due to inflammation of the retina (macular cystoid edema)

• decrease in sodium and/ormagnesiumin the blood(electrolyte imbalance disorders)
• ventricular arrhythmia or ventricular tachycardia (manifesting as irregular or rapid heart rhythm, severe shortness of breath, dizziness, or fainting); some of these symptoms may be severe; if this happens, you must 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 may occur in patients receiving treatment with docetaxel in combination with other anticancer treatments
• Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET) (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
• generalized acute pustular psoriasis (PEGA) (red, scaly, and generalized rash with inflamed skin nodules (including skin folds, trunk, and upper limbs) and blisters accompanied by fever)
• tumor lysis syndrome, a severe condition that manifests by changes in blood tests, such as increased levels of uric acid, potassium, phosphate, and decreased levels of calcium; and results in symptoms such as seizures, renal insufficiency (reduced or dark urine) and cardiac arrhythmias. If this happens, you must inform your doctor immediately.
• myositis (inflammation of the muscles - heat, redness, and swelling - that causes muscle pain and weakness).

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

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter 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 above 25 °C.

Store in the original packaging to protect it from light.

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

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

From a microbiological standpoint, the perfusion preparation should be used immediately. If not, the storage times in use and pre-use conditions are the responsibility of the user, and should not normally exceed 24 hours at a temperature of between 2 °C and 8 °C, unless the dilution was performed in controlled and validated aseptic conditions.

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

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Docetaxel Hospira

• The active ingredient 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 Polisorbate 80.

Appearance of the product and contents of the pack

Clear, colourless to pale yellow solution. The medicinal product is supplied in glass containers called vials. One mL of solution contains 10 mg of docetaxel. A vial of 2 mL contains 20 mg of docetaxel, a vial of 8 mL contains 80 mg of docetaxel, and a vial of 16 mL contains 160 mg of docetaxel. The vials may be wrapped in a protective plastic to prevent the risk of spills in the event of vial breakage, known as ONCO-TAIN. The vials are available in single unit packs.

Only some pack sizes may be marketed.

Marketing authorisation holder

Pfizer, S.L.

Avenida de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

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 medicinal product is authorised in the Member States of the European Economic Area 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 à diluer pour perfusion.

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

Last update of this leaflet: December 2023

--------------------------------------------------------------------------------------------------------------------

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

To determine whether the product is appropriate for use in a particular patient, the doctor must be familiar with the entire SmPC.

Shelf life

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 in use for 4 hours when stored at less than 25 °C. From a microbiological point of view, the infusion preparation should be used immediately. If not, the storage times in use and the conditions prior to use are the responsibility of the user, and normally should not exceed 24 hours at a temperature of between 2 °C and 8 °C, unless the dilution has been carried out in controlled and validated aseptic conditions.

Instructions for use, handling and disposal

Instructions for Use:

To administer by intravenous infusion. Prior to its infusion, Docetaxel Hospira must be diluted under aseptic conditions.

Visually inspect before use. Only use transparent solutions without visible particles.

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

Inject the required volume into a 250 mL infusion bag or container 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 as not to exceed a docetaxel concentration of 0.74 mg/mL.

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

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

Special precautions for administration

•DO NOT MIX WITH OTHER MEDICINES

Instructions for Handling

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 properly protected with personal protective equipment, including disposable gloves, eye masks, and long-sleeved coats. The preparation and handling of the solutions should be carried out in a designated area.

Instructions in case of contamination

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

In the event of a spill, properly trained personnel, with appropriate personal protective equipment, should remove as much material as possible using a cytotoxic spill kit or designated absorbent materials. The area should be washed with copious amounts of water. All contaminated waste materials (including sharp objects or cutting tools, containers, absorbent materials, unused solutions, etc.) should be placed in waste bags or rigid, impermeable waste containers, labelled and sealed, and incinerated in accordance with local procedures for the destruction of hazardous waste.

Instructions for Disposal

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

All unused product or waste material should be disposed of in accordance with local requirements.