Paclitaxel Accord 6 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paclitaxel Accord 6 mg/ml concentrate for solution for infusion EFG

Read all of 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 have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Paclitaxel belongs to a group of medicines called taxanes, which are used to treat cancer. These agents inhibit the growth of cancer cells.

Paclitaxel Accord is used to treat:

Ovarian cancer

• as first-line treatment (after initial surgery in combination with the platinum-based drug called cisplatin).
• after prior platinum-containing therapy has failed.

Breast cancer

• as first-line treatment for advanced or metastatic cancer (cancer that has spread to other parts of the body). Paclitaxel Accord may be used in combination with an anthracycline (e.g., doxorubicin) or with a medicine called trastuzumab (for patients in whom anthracyclines are not indicated or who have cancer cells with a protein on their surface called HER2; see the trastuzumab package leaflet).
• after initial surgery, following treatment with anthracycline and cyclophosphamide (AC), as adjuvant therapy.
• as second-line treatment for patients who have not responded to standard anthracycline-based therapies or who cannot use such treatments.

Advanced non-small cell lung cancer

• in combination with cisplatin, when surgery, radiotherapy, or both are not indicated.

AIDS-related Kaposi's sarcoma

• after other treatments (e.g., liposomal anthracyclines) have failed.

2. What you need to know before starting Paclitaxel Accord

Do not use Paclitaxel Accord

• if you are allergic (hypersensitive) to paclitaxel or to any of the other ingredients of this medicine (listed in section 6), especially polyoxyethylated castor oil.
• if you are breastfeeding.
• if you have very low levels of white blood cells in your blood. Your doctor will take a blood sample to check this.
• if you have a severe and uncontrolled infection and Paclitaxel Accord is being used to treat Kaposi's sarcoma.

If you are in any of the above situations, talk to your doctor before starting treatment with Paclitaxel Accord.

Paclitaxel Accord is not recommended for use in children and adolescents (under 18 years of age).

Warnings and precautions

Talk to your doctor before starting to use Paclitaxel Accord.

Before starting treatment with Paclitaxel Accord, you will be given other medicines to minimize the risk of allergic reactions.

• if you experience severe allergic reactions (for example, difficulty breathing, shortness of breath, chest tightness, low blood pressure, dizziness, feeling faint, skin reactions such as rash or swelling).

• if you have fever, severe chills, sore throat, or mouth ulcers (signs of bone marrow suppression).

• if you experience numbness or weakness in arms and legs (signs of peripheral neuropathy); a dose reduction of Paclitaxel Accord may be necessary.

• if you have severe liver problems; in this case, the use of Paclitaxel Accord is not recommended.

• if you have cardiac conduction disorders.

• if you develop severe or persistent diarrhea, with fever and stomach pain, during treatment with Paclitaxel Accord or immediately after its administration. You may have inflammation of the colon (pseudomembranous colitis).

• if you have previously received radiation therapy to the chest (as this may increase the risk of pulmonary inflammation).

• if you have mouth sores or redness (signs of mucositis) and are being treated for Kaposi's sarcoma. You may require a lower dose.

Inform your doctor immediately if you are in any of the above situations.

Paclitaxel Accord must always be administered intravenously. Administering Paclitaxel Accord into the arteries may cause inflammation of the arteries, and you could experience pain, swelling, redness, and warmth.

Paclitaxel Accord and other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because paclitaxel or the other medicine may not work as well as expected, or you may be more likely to experience a side effect.

Interaction means that different medicines can affect each other.

Talk to your doctor when using paclitaxel at the same time as any of the following:

• medicines to treat infections (i.e., antibiotics such as erythromycin, rifampicin, etc.; if you are unsure whether the medicine you are taking is an antibiotic, ask your doctor, nurse, or pharmacist)
• medicines used to help stabilize mood, also called antidepressants (e.g., fluoxetine)
• medicines used to treat seizures (epilepsy) (e.g., carbamazepine, phenytoin)
• medicines used to help reduce lipid levels in the blood (e.g., gemfibrozil)
• medicines used for stomach acid or stomach ulcers (e.g., cimetidine)
• medicines used to treat HIV and AIDS (e.g., ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
• the medicine called clopidogrel, used to prevent blood clots.
• a medicine called rifampicin, an antibiotic used for tuberculosis. The dose of paclitaxel may need to be increased.
• vaccines: If you have recently been vaccinated, or if you are planning to get vaccinated, inform your doctor. Using paclitaxel in combination with certain vaccines may lead to serious complications.
• cisplatin (to treat cancer): paclitaxel should be administered before cisplatin. Your kidney function may need to be monitored more frequently.
• doxorubicin (to treat cancer): paclitaxel should be administered 24 hours after doxorubicin to avoid high levels of doxorubicin in your body.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or think you might be pregnant before receiving paclitaxel treatment. If there is a possibility of pregnancy, use an effective and safe method of contraception during treatment.

Paclitaxel should not be used during pregnancy unless clearly necessary. Patients, both men and women, of reproductive age, and/or their partners, should use contraception for at least 6 months after treatment with paclitaxel.

Male patients should seek advice about sperm cryopreservation before starting paclitaxel treatment due to the risk of infertility.

If you are breastfeeding, inform your doctor. Stop breastfeeding if you are receiving Paclitaxel Accord. Do not resume breastfeeding until your doctor tells you to do so.

Driving and using machines

This medicine contains alcohol. Therefore, it may not be advisable to drive immediately after receiving a treatment cycle. Under no circumstances should you drive if you feel dizzy or are not fully alert.

Important information about some of the components of Paclitaxel Accord

Paclitaxel Accord contains macrogolglycerol ricinoleate (50% polyethoxylated castor oil), which may cause severe allergic reactions. If you are allergic to castor oil, consult your doctor before using Paclitaxel Accord.

Paclitaxel Accord contains alcohol

This medicine contains 391 mg of alcohol (ethanol) per ml. The amount of alcohol in this medicine (at the maximum dose of 220 mg/m²) is equivalent to 646 ml of beer or 258 ml of wine.

The amount of alcohol in this medicine may alter the effects of other medicines. Speak with 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 are an alcoholic, consult your doctor or pharmacist before taking this medicine.

3. How to use Paclitaxel Accord

• Before starting treatment with Paclitaxel Accord, you will be given other medicines to minimize the risk of allergic reactions. These medicines may be administered as tablets or intravenous infusion, or both.
• Paclitaxel Accord will be given to you as an intravenous infusion (a slow drip into one of your veins) through an in-line filter. It will be administered by a healthcare professional who will prepare the infusion solution before giving it to you. The dose you receive will also depend on the results of your blood tests. Depending on the type and severity of your cancer, you will receive Paclitaxel Accord either alone or in combination with another antineoplastic agent.
• Paclitaxel Accord must always be administered intravenously over a period of 3 to 24 hours. It is usually given every 2 or 3 weeks, unless your doctor prescribes a different dosing schedule. Your doctor will inform you of the number of treatment cycles with Paclitaxel Accord that you need.

If you have any further questions about the use of this product, ask your doctor.

If you receive more Paclitaxel Accord than you should

There is no known antidote for overdose with Paclitaxel Accord. You will receive treatment for your symptoms.

4. Possible adverse effects

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

If you think you are having an allergic reaction, inform your doctor immediately. You may experience one or more of the following signs:

• Redness (rubor)
• Skin reactions
• Itching (pruritus)
• Chest tightness
• Shortness of breath or difficulty breathing
• Swelling

All of these may be signs of serious adverse effects.

Inform your doctor immediately:

• If you have fever, severe chills, sore throat, or mouth ulcers (signs of bone marrow suppression).
• If you experience numbness or weakness in arms and legs (symptoms of peripheral neuropathy). These neuropathy symptoms may persist for more than 6 months after stopping treatment with paclitaxel.
• If you develop severe or persistent diarrhea, with fever and stomach pain.

Very common adverse effects (may affect more than 1 in 10 people):

• Mild allergic reactions, such as redness (rubor), rash (exanthema), itching (pruritus)
• Infections: mainly upper respiratory tract infections, urinary tract infections
• Shortness of breath
• Sore throat or mouth ulcers, mouth sores, redness, diarrhea, discomfort (nausea, vomiting)
• Hair loss (most cases of hair loss occurred less than one month after starting paclitaxel. When it occurs, hair loss is marked (more than 50%) in most patients)
• Muscle pain, cramps, joint pain
• Fever, severe chills, headache, dizziness, fatigue, paleness, bleeding, bruising more frequently than normal
• Numbness, tingling, or weakness in arms and legs (all symptoms of peripheral neuropathy)*
• Blood tests may show: decreased platelets, white blood cells, or red blood cells, low blood pressure

Common adverse effects (may affect less than 1 in 10 people):

• Mild and transient changes in nails and skin, reactions at injection site (localized inflammation, pain, and redness of the skin)
• Blood tests may show: slowed heart rate, severe elevation of liver enzymes (alkaline phosphatase and AST-SGOT)

Uncommon adverse effects (may affect less than 1 in 100 people):

• Shock due to infections (known as "septic shock")
• Palpitations, cardiac dysfunction (AV block), rapid heartbeat, heart attack, breathing difficulties
• Fatigue, sweating, fainting (syncope), significant allergic reactions, swelling of a vein caused by a blood clot (thrombophlebitis), swelling of the face, lips, mouth, tongue, or throat
• Back pain, chest pain, pain in hands and feet, chills, abdominal pain
• Blood tests may show: marked increase in bilirubin (jaundice), high blood pressure, and blood clots

Rare adverse effects (more than 1 in 10,000 but less than 1 in 1,000 people):

• Decrease in white blood cells, with fever and increased risk of infection (febrile neutropenia)
• Nerve involvement, with sensation of muscle weakness in arms and legs (motor neuropathy)
• Shortness of breath, narrowing and blockage of blood vessels in the lungs that may cause shortness of breath (pulmonary embolism), inflammatory reaction in lung tissue with changes and hardening (pulmonary fibrosis), inflammation of the lungs (interstitial pneumonia), difficulty breathing, lung injury, and fluid around the lungs (pleural effusion)
• Intestinal obstruction, intestinal perforation, inflammation of the colon (ischemic colitis), inflammation of the pancreas (pancreatitis)
• Itching (pruritus), rashes (exanthema), redness of the skin (erythema)
• Blood infection (sepsis), inflammation of the peritoneum (peritonitis)
• Fever (pyrexia), dehydration, weakness (asthenia), fluid accumulation in body tissues (edema), malaise
• Severe and potentially life-threatening hypersensitivity reactions (anaphylactic reactions)
• Blood tests may show: increased blood creatinine, indicating kidney dysfunction
• Heart failure

Very rare adverse effects (may affect less than 1 in 10,000 people):

• Rapid and irregular heart rhythm (atrial fibrillation, supraventricular tachycardia)
• Sudden disorder in blood-forming cells (acute myeloid leukemia, myelodysplastic syndrome)
• Visual disturbances and/or optic nerve disorders (flickering scotoma)
• Hearing loss (ototoxicity), ringing in the ears (tinnitus), vertigo
• Cough
• Blood clot in a blood vessel of the abdomen and intestine (mesenteric thrombosis), inflammation of the colon, sometimes with persistent severe diarrhea (pseudomembranous colitis, neutropenic colitis), fluid retention in the abdomen (ascites), inflammation of the esophagus (esophagitis), constipation
• Severe hypersensitivity reactions, such as fever, skin redness, joint pain and/or eye inflammation (Stevens-Johnson syndrome), localized skin peeling (epidermal necrolysis), red, irregular (exudative) spots (erythema multiforme), skin inflammation with blisters and peeling (exfoliative dermatitis), urticaria, onycholysis (patients undergoing treatment should use sun protection on hands and feet)
• Loss of appetite (anorexia)
• Severe and potentially life-threatening hypersensitivity reactions with shock (anaphylactic reactions)
• Liver function disorders (hepatic necrosis, hepatic encephalopathy [both with reported cases resulting in death])
• Confusion

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Disseminated intravascular coagulation ("DIC") has been reported. This is a serious condition causing excessive bleeding, excessive blood clotting, or both.
• Thickening/hardening of the skin (scleroderma).
• Metabolic complications following cancer treatment (tumor lysis syndrome).
• Eye disorders, such as thickening and inflammation of the macula (macular edema), flashes of light (photopsia), and spots, floaters, and "cobwebs" floating in your field of vision (vitreous floaters), increased tear secretion.
• Inflammation of veins (phlebitis).
• Autoimmune disease with multiple symptoms, such as red, scaly skin patches, joint pain, or fatigue (systemic lupus erythematosus), or rashes and red, thick, often scaly sores that may burn or itch (cutaneous lupus erythematosus).
• Acute inflammatory reaction limited to previously irradiated areas, triggered by administration of systemic agents after radiotherapy (recall phenomenon).
• Excessive sweating (hyperhidrosis).

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Paclitaxel Accord

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

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

Before opening

Do not store above 25 °C. Store the vial in the outer packaging to protect it from light.

Freezing does not have a negative effect on the product.

After opening and prior to dilution (description of conditions)

From a microbiological standpoint, once opened, the product may be stored for a maximum of 28 days at 25 °C.

If other storage periods and conditions are used during medicine handling, the responsibility lies with the user.

After dilution (description of conditions)

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, it should be stored in a refrigerator (between 2 °C and 8 °C) for a maximum of 24 hours, unless the dilution has been carried out under controlled and validated aseptic conditions. For further information on stability after dilution, refer to the section intended for healthcare professionals.

Do not use this medicine if the solution appears cloudy or contains an insoluble precipitate.

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

6. Contents of the pack and other information

Composition of Paclitaxel Accord

The active substance is paclitaxel.

Each ml of concentrate for solution for infusion contains 6 mg of paclitaxel.

Each vial contains 5, 16.7, 25, 50 or 100 ml (equivalent to 30, 100, 150, 300 or 600 mg of paclitaxel, respectively).

The other components are polyoxyethylated castor oil 35 (macrogol glycerol ricinoleate 35) and anhydrous ethanol.

Appearance of the product and contents of the pack

Paclitaxel Accord is a clear, colourless or slightly yellowish solution free from visible particles.

It is available in vials containing 5 ml, 16.7 ml, 25 ml, 50 ml or 100 ml of concentrate for solution for infusion.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Date of the most recent review of this summary: December 2025.

Updated and detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) at https://www.aemps.gob.es/.

This information is intended for healthcare professionals only

Preparation of infusion solutions

• The containers and infusion equipment used with Paclitaxel Accord must not contain DEHP. This minimizes patient exposure to DEHP [di-(2-ethylhexyl)phthalate], which may leach from PVC present in containers or equipment. The use of filter models (e.g., IVEX-2) incorporating a short plastic PVC inlet and/or outlet tubing does not result in significant leaching of DEHP.
• Exercise caution when handling Paclitaxel Accord, as with all other antineoplastic agents. Always wear appropriate protective gloves when handling vials containing paclitaxel. Dilution must be performed under aseptic conditions by trained personnel in a designated area. In case of skin contact, wash the affected area thoroughly with water and soap. In case of contact with mucous membranes, rinse thoroughly with abundant water.
• "Chemo-Dispensing Pin" devices or similar should not be used, as they may cause the vial stopper to dislodge, compromising the sterility integrity.

Step 1: Dilute the concentrate

Prior to administration, Paclitaxel Accord must be diluted using one of the following:

• 0.9% sodium chloride infusion solution
• 5% dextrose infusion solution
• 0.5% dextrose and 0.9% sodium chloride infusion solution
• Compound sodium chloride infusion solution with 5% dextrose

The final paclitaxel concentration for infusion must be between 0.3 mg/mL and 1.2 mg/mL.

DEHP-free containers and infusion equipment must be used.

Once diluted, the solutions may appear cloudy, which is attributed to the formulation vehicle and does not clear upon filtration. No significant loss of potency has been observed after simulated administration of the solution through a drip set with an in-line filter.

Step 2: Administer the infusion

Administer corticosteroids, antihistamines, and H2 antagonists to all patients prior to Paclitaxel Accord administration.

Do not re-administer Paclitaxel Accord until the neutrophil count is ≥ 1,500/mm³ (≥ 1,000/mm³ for patients with Kaposi's sarcoma) and the platelet count is ≥ 100,000/mm³ (≥ 75,000/mm³ for patients with Kaposi's sarcoma).

Avoid precipitation of the infusion solution:

• Use immediately after dilution
• Do not shake, vibrate, or agitate excessively
• Thoroughly rinse infusion equipment before use
• Regularly check the appearance of the solution and discontinue infusion if precipitation is observed

Chemical and physical stability of the diluted solution has been demonstrated for 7 days at 5°C and 25°C when diluted in 5% dextrose solution, and for 14 days when diluted in 0.9% sodium chloride solution. From a microbiological standpoint, the diluted product should be used immediately or stored at 2°C to 8°C for a maximum of 24 hours.

Paclitaxel Accord must be administered through an appropriate in-line filter with a microporous membrane of ≤ 0.2 micrometers. Infusion bags and administration sets free of DEHP must be used. The use of filter models incorporating a short plastic inlet and/or outlet tubing does not result in significant leaching of DEHP.

Step 3: Disposal

Unused products or waste materials derived from them must be disposed of in accordance with local regulations for handling cytotoxic compounds.

Dosage:

The recommended doses for intravenous infusion of Paclitaxel Accord are as follows:

Do not re-administer Paclitaxel Accord until the neutrophil count is ≥ 1,500/mm³ (≥ 1,000/mm³ for patients with Kaposi's sarcoma) and the platelet count is ≥ 100,000/mm³ (≥ 75,000/mm³ for patients with Kaposi's sarcoma).

Patients who experience severe neutropenia (neutrophil count < 500/mm³ for one week or longer) or severe peripheral neuropathy should have their dose reduced by 20% in subsequent cycles (25% for patients with Kaposi's sarcoma) (see the Summary of Product Characteristics).

There are insufficient data to recommend dose adjustments in patients with mild to moderate hepatic dysfunction. Patients with severe hepatic impairment should not be treated with Paclitaxel Accord (see the Summary of Product Characteristics).

Paclitaxel Accord is not recommended for use in children and adolescents under 18 years of age due to lack of safety and efficacy data.