Gemcitabine Kabi

Leaflet accompanying the packaging: patient information

Gemcitabine Kabi, 38 mg/ml, concentrate for solution for infusion

Gemcitabine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, nurse, or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What Gemcitabine Kabi is and what it is used for
• 2. Important information before using Gemcitabine Kabi
• 3. How to use Gemcitabine Kabi
• 4. Possible side effects
• 5. How to store Gemcitabine Kabi
• 6. Package contents and other information

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

Gemcitabine Kabi belongs to a group of medicines called cytotoxic medicines. These medicines kill dividing cells, including cancer cells.
Gemcitabine Kabi can be given alone or in combination with other anticancer medicines, depending on the type of cancer.
Gemcitabine Kabi is used to treat the following types of cancer:

• non-small cell lung cancer (NSCLC), alone or in combination with cisplatin,
• pancreatic cancer,
• breast cancer, in combination with paclitaxel,
• ovarian cancer, in combination with carboplatin,
• bladder cancer, in combination with cisplatin.

2. Important information before using Gemcitabine Kabi

When not to use Gemcitabine Kabi:

Warnings and precautions

Before the first infusion, blood samples will be taken from the patient to check kidney and liver function. Before each infusion, blood samples will be taken to check if the patient has enough blood cells to receive Gemcitabine Kabi. Depending on the patient's general condition or if the number of blood cells is too low, the doctor may decide to change the dose or delay treatment. Periodically, blood samples will be taken to check kidney and liver function.
Before starting treatment with Gemcitabine Kabi, the patient should discuss it with their doctor, nurse, or hospital pharmacist.
If the patient has ever experienced severe skin rash or skin exfoliation after using gemcitabine.
If the patient has or has had liver, heart, blood vessel, or kidney disease, they should inform their doctor or pharmacist, as gemcitabine may be contraindicated.
If the patient has recently undergone radiation therapy or is going to undergo radiation therapy, they should inform their doctor, as an early or late radiation reaction may occur after gemcitabine administration.
If the patient has been vaccinated recently, they should inform their doctor, as it may affect the efficacy of gemcitabine.
If the patient experiences symptoms such as pain and dizziness, seizures, vision disturbances, they should inform their doctor, as they may be symptoms of a rare side effect affecting the nervous system, called reversible posterior leukoencephalopathy syndrome.
If the patient experiences difficulty breathing or weakness and paleness of the skin, they should inform their doctor, as it may indicate kidney failure or lung disease.
If the patient experiences generalized edema, shortness of breath, or weight gain, they should inform their doctor, as it may indicate fluid leakage from small blood vessels into tissues.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP), have been reported with gemcitabine. If the patient experiences any symptoms related to these serious skin reactions described in section 4, they should contact their doctor immediately.

Children and adolescents

This medicine should not be used in children under 18 years of age, as there is insufficient data on its safety and efficacy in this age group.

Gemcitabine Kabi and other medicines

The patient should inform their doctor or hospital pharmacist about all medicines they are currently taking or have recently taken, including vaccines and over-the-counter medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or plans to become pregnant, they should inform their doctor. Gemcitabine Kabi should be avoided during pregnancy. The doctor will discuss the potential risk associated with using the medicine during pregnancy with the patient. Women of childbearing age should use effective contraception during gemcitabine treatment and for 6 months after the last dose.

Breastfeeding

If the patient is breastfeeding, they should inform their doctor.
Gemcitabine Kabi should not be used during breastfeeding.

Fertility

Men should be informed not to plan to have children during treatment with Gemcitabine Kabi and for up to 3 months after the end of treatment. It is recommended that men use effective contraception during gemcitabine treatment and for 3 months after the end of treatment. If the patient wants to have children during treatment or within 3 months after the end of treatment, they should consult their doctor or pharmacist. Before starting treatment, the patient may seek advice on sperm preservation.

Driving and using machines

Gemcitabine Kabi may cause drowsiness, especially when combined with alcohol. Patients should not drive or operate machinery until it is established that the medicine does not cause drowsiness.

Gemcitabine Kabi contains sodium and propylene glycol

The 200 mg vial contains less than 1 mmol of sodium (23 mg) per vial, which means the medicine is considered "sodium-free".
The 1000 mg vial contains 98.36 mg of sodium (a major component of common salt) per vial, which corresponds to 4.92% of the maximum recommended daily intake of sodium in the diet for adults.
The 2000 mg vial contains 196.72 mg of sodium (a major component of common salt) per vial, which corresponds to 9.84% of the maximum recommended daily intake of sodium in the diet for adults.
Propylene glycol in this medicine may cause symptoms similar to those caused by alcohol and may increase the risk of side effects.
The medicine should only be used on the advice of a doctor. The doctor may recommend additional monitoring during treatment with this medicine.

3. How to use Gemcitabine Kabi

The usual dose of Gemcitabine Kabi is 1000 to 1250 mg of the medicine per square meter of body surface area. The body surface area is calculated based on the patient's height and weight. The doctor will determine the appropriate dose based on the patient's body surface area. The dose may be changed or treatment delayed depending on the results of blood tests and the patient's general condition.
The frequency of Gemcitabine Kabi administration depends on the type of cancer being treated.
The hospital pharmacist or doctor will dilute the Gemcitabine Kabi concentrate before administration to the patient.
Gemcitabine Kabi will always be administered after dilution, as an intravenous infusion into one of the patient's veins. The infusion will last about 30 minutes.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gemcitabine Kabi can cause side effects, although not everybody gets them.

In case of any of the following symptoms, the patient should immediately contact their doctor:

• bleeding from the gums, nose, or mouth, or any other bleeding that cannot be stopped, red or pink urine, unexpected bruising on the skin (as the patient may have a low platelet count, which occurs very often),
• feeling tired, feeling weak, shortness of breath, or pale skin (as the patient may have a low hemoglobin level, which occurs very often),
• mild to moderate skin rash (very often) or itching (often), or fever (very often); (allergic reactions),
• temperature of 38°C or higher, sweating, or other signs of infection (as the patient may have a low white blood cell count with fever), known as febrile neutropenia (often),
• mouth pain, redness, swelling, or ulcers (often),
• irregular heart rhythm (arrhythmia) (not very often),
• extreme fatigue and weakness, petechiae, or a tendency to local bleeding on the skin (purpura), severe kidney failure (oliguria or anuria), and signs of infection. These may be symptoms of thrombotic microangiopathy and hemolytic-uremic syndrome, which can be fatal,
• difficulty breathing (often shortly after gemcitabine administration, mild breathing difficulties may occur, which quickly resolve; not very often or rarely, more serious pulmonary complications may occur),
• severe chest pain (myocardial infarction) (rarely),
• severe allergic reactions (anaphylaxis): severe skin rash or hives, swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat, feeling of fainting (anaphylactic reaction) (very rarely),
• generalized edema, shortness of breath, or weight gain may be symptoms of fluid leakage from small blood vessels into tissues (capillary leak syndrome) (very rarely),
• headache with vision disturbances, confusion, seizures, or convulsions (reversible posterior leukoencephalopathy syndrome) (very rarely),
• severe skin rash with itching, exfoliation, or blistering (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rarely),
• red, exfoliating, widespread rash with blisters under the swollen skin (including skin folds, torso, and upper limbs) and blisters with fever - acute generalized exanthematous pustulosis (AGEP - frequency not known).

Other possible side effects of Gemcitabine Kabi:

Very common: may affect more than 1 in 10 people

• low white blood cell count,
• difficulty breathing,
• vomiting,
• nausea,
• hair loss,
• liver function disorders, with abnormal blood test results,
• blood in the urine,
• abnormal urine test results: protein in the urine,
• flu-like symptoms, including fever,
• swelling of the ankles, fingers, feet, and face.

Common: may affect up to 1 in 10 people

• loss of appetite (low appetite),
• headache,
• insomnia,
• drowsiness,
• cough,
• nasal congestion,
• constipation,
• diarrhea,
• itching,
• sweating,
• muscle pain,
• back pain,
• fever,
• weakness,
• chills,
• infections.

Not very common: may affect up to 1 in 100 people

• interstitial lung disease (pulmonary fibrosis),
• bronchospasm (wheezing),
• abnormal chest X-ray (pulmonary fibrosis),
• heart failure,
• kidney failure,
• severe liver damage, including liver failure,
• stroke.

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

• low blood pressure,
• exfoliation, ulcers, or blisters,
• skin necrosis and blisters,
• reactions at the injection site,
• acute respiratory distress syndrome in adults (severe pneumonia causing breathing difficulties),
• skin rash (similar to sunburn) that may occur on skin that has been previously irradiated (radiation recall),
• fluid in the lungs,
• pulmonary fibrosis associated with radiation therapy (symptoms of radiation-induced lung injury),
• gangrene of the fingers or toes,
• symptoms of peripheral vasculitis (inflammation of blood vessels).

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

• increased platelet count,
• ischemic colitis (inflammation of the colon caused by reduced blood flow),
• low hemoglobin level, low white blood cell count, and low platelet count will be detected in blood tests.
• thrombotic microangiopathy: blood clots forming in small blood vessels.

Frequency not known: frequency cannot be estimated from the available data

• sepsis: when bacteria and their toxins circulate in the blood and start damaging organs,
• pseudovasculitis: redness of the skin with swelling.

In case of any of the above side effects, the patient should immediately inform their doctor.
If the patient experiences any side effects, they should consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gemcitabine Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Do not store in a refrigerator. Do not freeze.
Shelf life after dilution (infusion solution):
Physical and chemical stability has been demonstrated after dilution in 0.9% sodium chloride solution, at concentrations between 0.1 mg/ml and 5 mg/ml, for 7 days at temperatures between 2°C and 8°C or at 25°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.
The medicine is for single use only. Any unused solution should be disposed of.
Do not use this medicine if the solution is discolored or contains visible particles.
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. Package contents and other information

What Gemcitabine Kabi contains

The active substance of the medicine is gemcitabine.
One ml of the concentrate for solution for infusion contains 38 mg of gemcitabine (as hydrochloride).
Each vial contains 200 mg of gemcitabine (as hydrochloride).
Each vial contains 1000 mg of gemcitabine (as hydrochloride).
Each vial contains 2000 mg of gemcitabine (as hydrochloride).
The other ingredients are propylene glycol, macrogol 400, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Gemcitabine Kabi looks like and contents of the pack

This medicine is a concentrate for solution for infusion.
Gemcitabine Kabi is a clear, colorless to slightly yellowish solution, free from visible particles.
Each pack contains 1 vial of: 5.26 ml, 26.3 ml, or 52.6 ml of the concentrate.
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
For 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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:22.05.2024
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Information intended for healthcare professionals only:

Preparation

During the preparation and disposal of the infusion solution, standard safety precautions for handling cytotoxic medicines should be followed. Women who are pregnant should not prepare the medicine. The preparation of the infusion solution should be performed in a protective cabinet using protective clothing and gloves. If a protective cabinet is not available, a mask and protective glasses should also be used.
In case of eye contact, the medicine may cause severe irritation. The eyes should be rinsed immediately with water. If irritation persists, the patient should consult a doctor.
In case of spillage of the solution on the skin, the skin should be rinsed thoroughly with water.

Dilution instructions

The only recommended diluent for diluting Gemcitabine Kabi, 38 mg/ml, concentrate for solution for infusion is 9 mg/ml (0.9%) sodium chloride solution for injection (without preservatives).
The total amount of gemcitabine in the form of a concentrate for solution for infusion required to be administered to an individual patient should be diluted in at least 500 ml of sterile 9 mg/ml (0.9%) sodium chloride solution for injection to achieve clinically relevant concentrations.
Given the recommended dose (from 1000 to 1250 mg/m²) and body surface area (between 1 m² and 2 m²), concentrations between 2 mg/ml and 5 mg/ml are achieved.
The following dilution instructions should be strictly followed to avoid side effects.

• 1. During the dilution of gemcitabine for intravenous infusion, aseptic methods should be used.
• 2. The medicine should be inspected for particulate matter and discoloration prior to administration. If particulate matter is present, the medicine should not be administered.

Any unused medicine or waste material should be disposed of in accordance with local regulations.