Product Information for the User

Docetaxel Seacross 20 mg/ml Concentrate for Solution for Infusion EFG

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you need advice or more information, consult your doctor, pharmacist, or hospital nurse.
• If you experience any adverse effects, consult your doctor, the hospital pharmacist, or nurse, even if they are not listed in this product information. See section 4.

The name of this medication isDocetaxel Seacross. Its common name is docetaxel. Docetaxel is a substance derived from the needles (leaves) of the yew tree.

Docetaxel belongs to the group of anticancer drugs called taxoids.

Docetaxel has been prescribed by your doctor 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:

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

You should not be givenDocetaxel Seacross:

• if you are allergic (hypersensitive) to docetaxel or to 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, a blood test will be performed to check that you have a sufficient number of blood cells and sufficient liver function to receive this medication. If you have alterations in your white blood cells, you may experience fever or associated infections.

Inform your doctor, hospital 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, hospital pharmacist, or nurse if you have vision problems. If you have vision problems, particularly blurred vision, an eye and vision examination must be performed immediately.

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

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

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

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

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

Severe skin problems have been reported with Docetaxel, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized pustular psoriasis (AGPP) with Docetaxel:

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

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

Docetaxel Seacross contains alcohol. Consult your doctor if you are dependent on alcohol, have epilepsy, or liver disorders. See also the section “Docetaxel Seacross contains ethanol (alcohol)” below.

Use of Docetaxel Seacross with other medications

Please inform your doctor or hospital pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

The reason is that Docetaxel or the other medication may not work as expected and you may have a higher risk of experiencing an adverse effect.

The alcohol content of this medication may alter the effects of other medications.

Pregnancy, breastfeeding, and fertility

Consult your doctor before using any medication.

Docetaxel Seacross should not be administered if you are pregnant, unless clearly indicated by your doctor.

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

Docetaxel Seacross should not be used during breastfeeding.

If you are a man receiving treatment with Docetaxel, you should not father a child and must use an effective contraceptive method during treatment and for 4 months after completing treatment with this medication. It is recommended that you inform about sperm conservation before treatment, as Docetaxel may alter male fertility.

Driving and operating machinery

The alcohol content of this medication may affect your ability to drive and use machines.

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

Docetaxel Seacross contains ethanol (alcohol)

This medication contains50% by volume of ethanol (alcohol), that is 395 mg (0.5 ml) of ethanol per 1 ml of filling volume, equivalent to 10 ml of beer or 4 ml of wine per 1 ml vial, 1.58 g (2 ml) of ethanol per 4 ml of filling volume, equivalent to 40 ml of beer or 17 ml of wine per 4 ml vial, or 3.16 g (4 ml) of ethanol per 8 ml of filling volume, equivalent to 80 ml of beer or 33 ml of wine per 8 ml vial.

This medication is harmful to people who suffer from alcoholism. If you have an addiction to alcohol, consult your doctor or pharmacist before taking this medication.

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

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

The amount of alcohol contained in this medication may affect your ability to drive and use machines due to the fact that it may alter your judgment and reaction time.

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.

Docetaxel will be administered by a healthcare professional.

Usual Dose

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

Form and Route of Administration

Docetaxel will be administered through a vein (intravenous route) via infusion. The infusion will last approximately one hour during which you will be in the hospital.

Administration Frequency

You will receive the treatment, via intravenous infusion, once every 3 weeks.

Your doctor may change the dose and administration frequency based on your blood test results, overall condition, and response to this medication. In particular, inform your doctor if you experience diarrhea, mouth sores, numbness or tingling, fever, and provide your blood test results. This information will allow your doctor to decide if a dose reduction is necessary. If you have any other questions about the use of this medication, ask your doctor or the hospital pharmacist.

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

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

The most frequently reported side effects of docetaxel when administered alone are: a decrease in the number of red or white blood cells, alopecia, nausea, vomiting, mouth sores, diarrhea, and fatigue.

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

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

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

Other more severe reactions may occur.

If you 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 status during treatment. If you notice any of these side effects, report them immediately.

Between docetaxel infusions, 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 patients):

• infections, a decrease in 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
• numbness or tingling or pain in joints or muscles
• headache
• alteration of taste
• inflammation of the eye or excessive tearing
• swelling caused by lymphatic drainage defects
• shortness of breath
• nasal secretion; inflammation of the throat and nose; cough
• nasal bleeding
• mouth sores
• stomach discomfort including nausea, vomiting, and diarrhea, constipation
• abdominal pain
• indigestion
• hair loss (in most cases, your hair will regrow normally). In some cases (unknown frequency), permanent hair loss has been observed
• redness and swelling of the palms of the hands or soles of the feet, which may cause skin detachment (this can also occur in arms, face, or body)
• change in nail color, which may detach
• muscle pain; back or bone pain
• changes or absence of menstrual period
• swelling of hands, feet, legs
• fatigue; or catarrah symptoms
• weight gain or loss
• upper respiratory tract infection.

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

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

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

• inflammation of the colon, small intestine, which could be fatal (unknown frequency); intestinal perforation.

Unknown frequency(cannot be estimated from available data):

• pulmonary interstitial disease (inflammation of the lungs that produces 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 within the eye (cystoid macular edema)
• decrease in sodium and/or magnesium in your blood (electrolyte imbalance)
• ventricular arrhythmia or ventricular tachycardia (manifesting as irregular or rapid heartbeats, severe shortness of breath, dizziness, or fainting). Some of these symptoms may be severe. If this occurs, inform your doctor immediately
• reactions at the injection site, at the site of a previous reaction
• non-Hodgkin lymphoma (a cancer that affects the immune system) and other types of cancer may occur in patients receiving docetaxel treatment 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 symptoms similar to the flu at the same time, such as fever, chills, or muscle pain
• generalized acute exanthematous pustulosis (PEGA) (red, scaly, and generalized rash with inflamed skin bumps (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, kidney failure (reduced or dark urine) and heart rhythm alterations. If this occurs, you must inform your doctor immediately
• myositis (inflammation of the muscles -heat, redness, and swelling- that produces muscle pain and weakness).

Reporting side effects

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

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

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

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light.

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

From a microbiological standpoint, it should be reconstituted/diluted in controlled, aseptic conditions.

The medication should be used immediately once it has been added to the infusion bag. If not used immediately, storage times and conditions in use are the responsibility of the user and should not normally exceed 8 hours in an infusion bottle or 6 hours in an infusion bag below 25°C, including the infusion time to the patient.

The physical and chemical stability in use of the prepared infusion solution as recommended is demonstrated up to 48 hours if stored between 2°C and 8°C in bags that are not PVC.

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

Do not throw away the medications through the drains. Ask your pharmacist where to dispose of the unused medications. This will help protect the environment.

Composition ofDocetaxel Seacross

• The active ingredient is docetaxel.
• Each ml of concentrate for infusion solution contains 20 mg of docetaxel.
• The other components are polisorbate 80, anhydrous ethanol (see section 2) and citric acid.

Appearance of the product and contents of the pack

Docetaxel Seacross concentrate for infusion solution is a sterile, transparent, viscous, colourless to yellow-brown solution.

The concentrate is supplied in a colourless glass vial of 2 ml with a green flip-off closure.Cada pack contains a vial of 1 ml of concentrate (20 mg of docetaxel).

The concentrate is supplied in a colourless glass vial of 6 ml with an orange flip-off closure.Cada pack contains a vial of 4 ml of concentrate (80 mg of docetaxel).

The concentrate is supplied in a colourless glass vial of 15 ml with a red flip-off closure.Cada pack contains a vial of 8 ml of concentrate (160 mg of docetaxel).

Marketing authorisation holder and responsible person for manufacturing

Seacross Pharma (Europe) Limited

POD 13, The Old Station House

15A Main Street, Blackrock

Dublin, A94 T8P8

Ireland

Last update of the summary of product characteristics:July/2023

Further information is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

GUIDE FOR PREPARATION FOR USE OFDOCETAXEL SEACROSS20 mg/ml CONCENTRATE FOR INFUSION SOLUTION EFG

Please read this guide carefully before preparing the infusion solution of Docetaxel Seacross.

Recommendations for safe handling

Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, it should be handled with caution when manipulating and preparing the solutions. It is recommended to use gloves.

If the Docetaxel concentrate or infusion solution comes into contact with the skin, it should be washed immediately and thoroughly with water and soap. If it enters the mucous membranes, it should be washed immediately and thoroughly with water.

Preparation for intravenous administration

Preparation of the infusion solution

DO NOT USE this medicinal product (Docetaxel Seacross 20 mg/ml concentrate for infusion solution, in a single vial) with other medicinal products containing docetaxel in2vials (concentrate and solvent).

Docetaxel Seacross 20 mg/ml concentrate for infusion solution DOES NOT require a prior dilution with a solvent and is ready to be added to the infusion solution.

• Each vial is for single use and should be used immediately after opening. If not used immediately, the periods of time and conditions of storage in use are the responsibility of the user. It may be necessary to use more than 1 vial of concentrate for infusion solution to obtain the required dose for the patient. For example, for a dose of 140 mg of docetaxel, 7 ml of docetaxel concentrate for infusion solution would be required.
• Extract the required amount of concentrate for infusion solution aseptically using a calibrated syringe with a 21G needle.

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

• Then, inject it once (with a single injection) into a 250 ml infusion bag or bottle, which contains either a 5% glucose solution or a 9 mg/ml sodium chloride solution (0.9%). If a dose greater than 190 mg of docetaxel is required, use a larger volume of infusion solution, in order not to exceed the concentration of 0.74 mg/ml of docetaxel.
• Mix the infusion bag or bottle manually by rotating it.
• From a microbiological point of view, it should be reconstituted/diluted in controlled, aseptic conditions and the infusion solution should be used immediately. If not used immediately, the periods and conditions of storage in use are the responsibility of the user.

Once added to the infusion bag (PP) or infusion bottle (PE) as recommended, the docetaxel infusion solution is stable for 8 hours in the infusion bottle or for 6 hours in the infusion bag if stored below 25°C. It should be used within this 6-8 hour period (including the hour of intravenous administration).

Furthermore, the physical and chemical stability in use of the prepared infusion solution is demonstrated for up to 48 hours if stored between 2°C and 8°C in bags that are not PVC.

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

• As with all parenteral products, the infusion solution should be visually inspected before use; solutions with precipitate should be discarded.

Elimination

The unused medicinal product and all materials that have come into contact with it should be disposed of in accordance with local regulations. Do not dispose of the medicinal product via the sewage system.Ask your pharmacist how to dispose of the medicinal product that is no longer required. This will help protect the environment.