Paclitaxel Kabi

Leaflet accompanying the packaging: information for the user

Paclitaxel Kabi, 6 mg/ml, concentrate for solution for infusion

Paclitaxel

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

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You should keep this leaflet, so that you can read it again if you need to.
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In case of any doubts, you should consult a doctor or nurse.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse.
See section 4.

Table of contents of the leaflet

• 1. What is Paclitaxel Kabi and what is it used for
• 2. Important information before using Paclitaxel Kabi
• 3. How to use Paclitaxel Kabi
• 4. Possible side effects
• 5. How to store Paclitaxel Kabi
• 6. Contents of the packaging and other information

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

Paclitaxel Kabi belongs to a group of anticancer medicines called "taxanes". These medicines inhibit the growth of cancer cells.
Paclitaxel Kabi is used to treat the following cancers:

Ovarian cancer:

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as a first-line treatment (after previous surgery, in combination with a platinum-containing medicine, cisplatin);
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when other treatment methods have failed, using traditional platinum-containing medicines.

Breast cancer:

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as a first-line treatment for advanced disease or disease that has spread to other parts of the body (metastases). Paclitaxel Kabi is used in combination with an anthracycline (e.g. doxorubicin) or with trastuzumab (in patients who cannot receive anthracycline treatment and who have HER-2 receptor protein on the surface of their cancer cells, see the patient leaflet for trastuzumab);
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as adjuvant therapy after anthracycline and cyclophosphamide (AC) treatment;
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as a second-line treatment for patients who have not responded to standard anthracycline treatment or for whom anthracycline treatment is not suitable.

Advanced non-small cell lung cancer:

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in combination with cisplatin in patients who are not eligible for surgical or radiotherapy treatment.
Kaposi's sarcoma in AIDS:
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in patients who have not responded to other treatment methods (e.g. liposomal anthracycline formulations).

2. Important information before using Paclitaxel Kabi

When not to use Paclitaxel Kabi:

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if the patient is allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6), particularly to macrogolglycerol ricinoleate (polyoxyethylated castor oil);
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during breastfeeding;
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in patients with reduced white blood cell count (initial neutrophil count <1.5 × 10^9/l or <1.0 × 10^9/l in patients with Kaposi's sarcoma – the doctor will perform a blood test to check if the patient has a sufficient number of blood cells;
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in case of severe and uncontrolled infection, only in patients receiving Paclitaxel Kabi for the treatment of Kaposi's sarcoma.
If the patient has any of the above conditions, they should inform their doctor before starting treatment with Paclitaxel Kabi.
It is not recommended to use Paclitaxel Kabi in children (under 18 years of age).

Warnings and precautions

Before starting treatment with Paclitaxel Kabi, the patient should discuss it with their doctor.
To minimize allergic reactions, before receiving Paclitaxel Kabi, the patient will receive other medicines.
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If the patient experiences allergic reactions (such as difficulty breathing, feeling of suffocation, chest tightness, blood pressure drop, dizziness, feeling of emptiness in the head, skin reactions in the form of rash or swelling).
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If the patient experiences fever, severe chills, sore throat or mouth ulcers (symptoms of bone marrow suppression).
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If the patient experiences numbness, tingling, or weakness in the hands and feet (symptoms of peripheral neuropathy), it may be necessary to reduce the dose of Paclitaxel Kabi.
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If the patient has severe liver function disorders, it is not recommended to use Paclitaxel Kabi.
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If the patient has conduction disorders.
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If the patient experiences severe or persistent diarrhea, accompanied by fever and abdominal pain; the cause may be colitis (pseudomembranous colitis).
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If the patient has previously undergone chest radiation therapy (as this may increase the risk of pneumonia).
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If the patient experiences pain or redness in the mouth (symptoms of mucositis) and is being treated for Kaposi's sarcoma, a smaller dose may be necessary.
Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible leakage during administration.

If any of the above events apply to the patient, they should immediately inform their doctor.

Paclitaxel Kabi should only be administered intravenously. Intrarterial administration of Paclitaxel Kabi may cause arteritis, which can lead to pain, swelling, redness, and burning.

Paclitaxel Kabi and other medicines

If the patient is taking paclitaxel with any of the following medicines, they should discuss it with their doctor:
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antibiotics (e.g. erythromycin, rifampicin; if the patient is unsure whether the medicine they are taking is an antibiotic, they should ask their doctor, nurse, or pharmacist), including medicines used to treat fungal infections (e.g. ketoconazole);
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medicines used to stabilize mood, sometimes called antidepressants (e.g. fluoxetine);
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medicines used to treat seizures (e.g. carbamazepine, phenytoin);
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medicines used to reduce fat levels in the blood (e.g. gemfibrozil);
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medicines used to treat heartburn or stomach ulcers (e.g. cimetidine);
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medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine);
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a medicine called clopidogrel, used to prevent blood clots.
The amount of alcohol in this medicine may change the effect of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility If the patient is pregnant or thinks they may be pregnant, they should inform their doctor

before starting treatment with Paclitaxel Kabi. If there is a possibility of becoming pregnant during treatment, effective and safe contraceptive methods should be used. It is not recommended to use Paclitaxel Kabi during pregnancy, unless it is absolutely necessary.
Treated men and women of childbearing age, as well as their partners, must use contraceptive methods for at least 6 months after the end of treatment with paclitaxel. Men should consult their doctor before treatment about storing sperm, due to the possibility of irreversible infertility.
If the patient is breastfeeding, they should inform their doctor.It is not known whether paclitaxel passes into breast milk. Due to the potential harmful effect of the medicine on the infant, breastfeeding should be discontinued during treatment with Paclitaxel Kabi. Breastfeeding should not be resumed until the doctor recommends it.

Driving and using machines

There is no reason why the patient should not be able to drive between treatment cycles. However, it should be remembered that Paclitaxel Kabi contains a certain amount of alcohol and driving immediately after receiving the medicine is not recommended due to its potential effect on the central nervous system. As with any case, the patient should not drive or operate machines if they experience dizziness or a feeling of emptiness in the head.
The amount of alcohol in this medicine may affect the ability to drive and operate machines, as it may affect judgment and reaction time.

Paclitaxel Kabi contains macrogolglycerol ricinoleate and alcohol

The medicine contains macrogolglycerol ricinoleate, which may cause severe allergic reactions.
The patient should inform their doctor if they are allergic to this ingredient of Paclitaxel Kabi.
This medicine contains 393 mg of alcohol (ethanol) per 1 ml, which is equivalent to 39.3% v/v. The amount of alcohol in a 52.5 ml dose of this medicine is equivalent to 515.8 ml of beer or 206.3 ml of wine.
If the patient has epilepsy or liver problems, they should consult their doctor or pharmacist before using the medicine.
If the patient is addicted to alcohol, they should consult their doctor or pharmacist before using this medicine.

3. How to use Paclitaxel Kabi

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To minimize allergic reactions, before starting treatment with Paclitaxel Kabi, the patient will receive other medicines. These medicines may be given in the form of tablets or intravenous infusion, or both.
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Paclitaxel Kabi is administered as an intravenous infusion (into one of the veins), through a filter included in the set. Paclitaxel Kabi is administered by qualified medical personnel.
Qualified medical personnel will prepare the infusion solution before administration. The dose of the medicine will also depend on the results of the patient's blood tests. Depending on the type and severity of the cancer, Paclitaxel Kabi is used as monotherapy or in combination with another anticancer medicine.
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Paclitaxel Kabi should always be administered into one of the veins over 3 or 24 hours. Usually, the medicine is administered every 2 or 3 weeks, unless the doctor recommends otherwise. The doctor will inform the patient about the number of treatment cycles with Paclitaxel Kabi that they need to receive.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately inform their doctor if they experience any symptoms of an allergic reaction,

including one or more of the following symptoms:
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hot flashes;
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skin reactions;
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itching;
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chest tightness;
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shortness of breath or difficulty breathing;
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swelling.
All of these reactions can be a sign of severe side effects.

The patient should immediately inform their doctor if they experience:

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fever, severe chills, sore throat, or mouth ulcers(symptoms of bone marrow suppression);
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numbness or weakness in the hands and feet(symptoms of peripheral neuropathy);
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severe or persistent diarrhea, accompanied by fever and abdominal pain.

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

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mild allergic reactions such as hot flashes, rash, itching;
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infections: mainly of the upper respiratory tract and urinary tract;
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sore throat or mouth ulcers, pain or redness in the mouth, nausea, vomiting;
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hair loss (in most cases, hair loss started before 1 month after the start of paclitaxel treatment. In most of these patients, there was significant hair loss (more than 50%)).
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muscle pain, cramps, joint pain;

• numbness, tingling, or weakness in the hands and feet (symptoms of peripheral neuropathy); may persist for more than 6 months after the end of paclitaxel treatment;
• tests may indicate: decreased platelet count, which can lead to bleeding and increased risk of bruising, decreased white or red blood cell count, and low blood pressure.

Common (may affect up to 1 in 10 people):

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transient, mild changes in the nails and skin disorders, reactions at the injection site (local swelling, pain, redness of the skin);
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tests may indicate: decreased heart rate, significant increase in liver enzyme activity (alkaline phosphatase and aspartate aminotransferase).

Uncommon (may affect up to 1 in 100 people):

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septic shock;
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irregular, rapid heart rhythm (atrial fibrillation, supraventricular tachycardia), cardiac conduction disorders (atrioventricular block, cardiomyopathy), rapid heart rate, heart attack, respiratory failure;
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fatigue, sweating, fainting, severe allergic reactions, vein inflammation, facial swelling, lip swelling, mouth swelling, tongue swelling, or throat swelling;
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back pain, chest pain, pain in the hands and feet, chills, abdominal pain;
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tests may indicate: significant increase in bilirubin levels (jaundice), high blood pressure, blood clots.

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

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decreased white blood cell count with fever and increased risk of infection (febrile neutropenia);
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nerve disorders, including muscle weakness in the arms and legs (motor neuropathy);
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heart failure;
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shortness of breath, pulmonary embolism, pulmonary fibrosis, interstitial pneumonia, dyspnea, pleural effusion;
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intestinal obstruction, intestinal perforation, ischemic colitis, pancreatitis;
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itching, rash, redness of the skin (erythema);
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blood infection (sepsis), peritonitis, pneumonia;
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fever, dehydration, weakness, swelling, and malaise;
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severe allergic reactions that are life-threatening (anaphylactic reactions);
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liver function disorders (liver necrosis, hepatic encephalopathy (in both cases, cases of death have been reported));
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confusional state;
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grand mal seizures, brain nerve damage (autonomic neuropathy affecting involuntary functions of the body, which can cause intestinal obstruction and blood pressure drop), seizures, brain function disorders (encephalopathy), dizziness, headaches, coordination difficulties (ataxia).

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

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irregular, rapid heart rhythm (atrial fibrillation, supraventricular tachycardia);
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sudden disorders of blood cell production (acute myeloid leukemia, myelodysplastic syndrome);
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nerve and/or vision disorders (flashing lights);
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hearing loss or hearing disorders (ototoxicity), tinnitus, dizziness of labyrinthine origin;
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cough;
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blood clots in abdominal and intestinal blood vessels (mesenteric thrombosis), colitis, sometimes with persistent severe diarrhea (pseudomembranous colitis, neutropenic colitis), ascites, esophagitis, constipation;
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severe allergic reactions, including fever, skin redness, joint pain, and/or eye inflammation (Stevens-Johnson syndrome), skin peeling (toxic epidermal necrolysis), redness with irregular red spots (erythema multiforme), skin inflammation with blisters and peeling (exfoliative dermatitis), hives, nail separation from the nail bed (patients during treatment should use a sun-protective cream on their hands and feet);
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loss of appetite (anorexia);
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severe allergic reactions that are life-threatening (anaphylactic shock);
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liver function disorders (liver necrosis, hepatic encephalopathy (in both cases, cases of death have been reported));
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confusional state;
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grand mal seizures, brain nerve damage (autonomic neuropathy affecting involuntary functions of the body, which can cause intestinal obstruction and blood pressure drop), seizures, brain function disorders (encephalopathy), dizziness, headaches, coordination difficulties (ataxia).

Frequency not known (cannot be estimated from the available data):

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tumor lysis syndrome;
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fluid accumulation in the macula (macular edema), perception of light phenomena such as flashes (photopsia), deposits in the vitreous body (vitreous floaters);
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vein inflammation;
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skin, blood vessel, and internal organ thickening and hardening (scleroderma);
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systemic lupus erythematosus (butterfly-shaped rash);
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coagulation disorders, cases of disseminated intravascular coagulation (DIC) have been reported; this is a serious condition that can cause excessive bleeding or excessive blood clotting, or both;
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redness and swelling of the palms and soles, which can cause skin peeling.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Paclitaxel Kabi

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store the vials in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the month.
Do not use this medicine if you notice signs of cloudiness or insoluble sediment.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Paclitaxel Kabi contains

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The active substance of the medicine is paclitaxel. Each ml contains 6 mg of paclitaxel.
Each 5 ml vial contains 30 mg of paclitaxel.
Each 16.7 ml vial contains 100 mg of paclitaxel.
Each 25 ml vial contains 150 mg of paclitaxel.
Each 50 ml vial contains 300 mg of paclitaxel.
Each 100 ml vial contains 600 mg of paclitaxel.
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The other ingredients are: ethanol, anhydrous, macrogolglycerol ricinoleate, and anhydrous citric acid (to adjust pH).

What Paclitaxel Kabi looks like and contents of the pack

Concentrate for solution for infusion.
Paclitaxel Kabi is a clear, slightly yellowish solution.
The medicine is available in glass vials with a chlorobutyl rubber stopper coated with Teflon.
Pack sizes:
Packaging contains 1 or 5 glass vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer:

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
Corden Pharma Latina S.p.A.
Via Murillo No. 7
04013 Sermoneta (LT)
Italy
To obtain more detailed information, the patient should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. +48 22 345 67 89

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

Date of last revision of the leaflet:28.06.2021
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Information intended for healthcare professionals only:

Preparation:
As with other anticancer medicines, caution should be exercised when handling paclitaxel. Dilution should be performed by trained personnel in a specially designated area and under aseptic conditions. Appropriate protective gloves should be worn. Precautions should be taken to avoid contact of the medicine with the skin and mucous membranes. In case of skin contact, the area should be washed thoroughly with soap and water. In case of mucous membrane contact, the area should be flushed immediately with water. Localized redness, itching, and swelling have been observed after accidental skin contact. Respiratory distress, chest pain, burning sensation in the throat, and nausea have been observed after inhalation of the solution.
Safety instructions for preparing the infusion solution

• 1. All operations should be performed in a designated room/safety cabinet. Protective gloves and a gown are required. If a separate room/safety cabinet is not available, a mask and protective glasses should be used.
• 2. Pregnant women or women who may become pregnant should not prepare this medicine.
• 3. Open containers, such as vials and bottles, and used needles, syringes, catheters, tubes, and residues of cytostatic medicines, should be considered hazardous waste and disposed of in accordance with local regulations for HAZARDOUS WASTE.
• 4. In case of spillage, the following instructions should be followed: - protective clothing should be worn - broken glass should be collected and placed in a HAZARDOUS WASTE container - contaminated surfaces should be thoroughly rinsed with plenty of cold water - rinsed surfaces should be dried, and materials used for drying should be disposed of in accordance with the recommendations for HAZARDOUS WASTE.
• 5. In case of paclitaxel contact with the skin, the affected area should be rinsed with plenty of water, then washed with soap and water. In case of mucous membrane contact, the area should be flushed immediately with water. If any discomfort occurs, the patient should consult their doctor.
• 6. If paclitaxel gets into the eyes, they should be thoroughly rinsed with plenty of cold water. The patient should immediately consult an ophthalmologist.

Disposal of residues

All unused residues of the medicine and its waste should be disposed of in accordance with local regulations for cytotoxic medicines.