Gemcitabine Accord

Leaflet accompanying the packaging: information for the user

Gemcitabine Accord, 200 mg, powder for solution for infusion

Gemcitabine Accord, 1 g, powder for solution for infusion

Gemcitabine Accord, 2 g, powder for solution for infusion

Gemcitabine

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

• Keep this leaflet, you may need to read it again.
• In case of further doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

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

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

Gemcitabine Accord belongs to a group of cytotoxic medicines that work by destroying dividing cells, including cancer cells.
Gemcitabine Accord can be used alone or in combination with other anticancer medicines, depending on the type of cancer.
Gemcitabine Accord is used to treat the following types of cancer:

• as monotherapy or in combination with cisplatin in the treatment of non-small cell lung cancer (NSCLC),
• in the treatment of pancreatic cancer,
• in combination with paclitaxel in the treatment of breast cancer,
• in combination with carboplatin in the treatment of ovarian cancer,
• in combination with cisplatin in the treatment of bladder cancer.

2. Important information before using Gemcitabine Accord

When not to use Gemcitabine Accord

• if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6),
• if you are breastfeeding.

Warnings and precautions

Before the first infusion, medical staff will take blood samples from you to assess whether your kidney and liver function is sufficient. Before each infusion, medical staff will take blood samples from you to assess whether there are enough cells in your blood to administer Gemcitabine Accord. Depending on your overall condition and in case of excessive reduction in blood cell count, your doctor may change the dose or postpone the administration of the medicine. Periodically, blood samples will be taken from you to assess kidney and liver function.

Tell your doctor:

• if you have ever had a severe skin rash or blistering or peeling of the skin after taking gemcitabine,
• if you have or have had liver, heart, vascular or kidney disease, as gemcitabine may be contraindicated,
• if you have been or are going to be exposed to radiation therapy, as early or late radiation reaction may occur with gemcitabine,
• if you have been recently vaccinated, as this may affect the action of gemcitabine,
• if you experience difficulty breathing or weakness and pallor (may be signs of kidney or lung failure).
• if you experience generalized edema, shortness of breath or weight gain, as these may be signs of fluid leakage from small blood vessels to tissues, a serious condition called capillary leak syndrome.
• if you experience headache with vision disturbances, confusion, seizures or changes in vision, you should contact your doctor immediately. These may be symptoms of a very rare adverse reaction affecting the nervous system, called reversible posterior encephalopathy.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP) have been reported with gemcitabine. If you experience any of the symptoms related to these severe skin reactions described in section 4, you should contact your doctor immediately.

Children and adolescents

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

Gemcitabine Accord and other medicines

Tell your doctor or hospital pharmacist about all the medicines you are taking or have recently taken, including vaccines and medicines obtained without a prescription.

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should avoid taking Gemcitabine Accord during pregnancy. Your doctor will inform you about the risks associated with taking Gemcitabine Accord during pregnancy. Women of childbearing age must use effective contraception during treatment with Gemcitabine Accord and for 6 months after the last dose.

Fertility

It is recommended that men do not attempt to father a child during treatment with Gemcitabine Accord and for up to 3 months after the end of treatment. It is recommended that men use effective contraception during treatment and for 3 months after the end of treatment. Men should consult their doctor or pharmacist if they wish to have a child during or within 3 months of treatment. Before starting treatment, patients may consult a sperm bank.

Breastfeeding

Women who are breastfeeding should inform their doctor.
During treatment with Gemcitabine Accord, breastfeeding should be discontinued.

Driving and using machines

Gemcitabine Accord may cause drowsiness, especially when taken with alcohol.
Patient should not drive or operate machinery until it is established that Gemcitabine Accord does not cause drowsiness.

Gemcitabine Accord contains

3.5 mg (<1mmol) of sodium in one 200 mg vial, 17.5 mg (<1mmol) of sodium in a 1 g vial and 35 mg (1.52 mmol) of sodium in a 2 g vial. This should be taken into account in patients on a controlled sodium diet.

3. How to use Gemcitabine Accord

The usual dose of gemcitabine is from 1000 mg to 1250 mg per square meter of body surface area. The body surface area is calculated based on the patient's height and weight. The dose of the medicine is determined based on the calculated body surface area. The dose may be changed or treatment may be delayed depending on blood test results and the patient's overall condition.
The frequency of Gemcitabine Accord infusion depends on the type of cancer being treated.
Before administering Gemcitabine Accord, the hospital pharmacist or doctor will dissolve the powder.
Gemcitabine Accord is always administered by intravenous infusion. The infusion lasts about 30 minutes.
In case of further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

In case of any of the following symptoms, tell your doctor immediately:

• Temperature 38°C or higher, sweating or other signs of infection (due to the possibility of a decrease in the number of white blood cells with fever, so-called febrile neutropenia, which occurs frequently).
• Irregular heart rhythm (arrhythmia) (not very common).
• Pain, redness, swelling or ulcers in the mouth (stomatitis) (common).
• Allergic reactions: mild to moderate skin rash (very common) and (or) itching (common), or fever (very common).
• Feeling of tiredness, fainting, rapid onset of shortness of breath or pallor (due to the possibility of a decrease in hemoglobin levels, which occurs very commonly).
• Bleeding from the gums, nose or mouth or other bleeding that cannot be stopped, red or pink urine, unexpected bruising on the skin (due to the possibility of a decrease in the number of platelets, which occurs very commonly).
• Difficulty breathing (very common in the short term after administration of Gemcitabine Accord, mild respiratory disorders may occur, which will soon pass. Less common or rare, more serious pulmonary complications may occur).
• Generalized edema, shortness of breath or weight gain, as these may be signs of fluid leakage from blood vessels to tissues (capillary leak syndrome) (very rare)
• Headache with vision disturbances, confusion, seizures or changes in vision, you should contact your doctor immediately. These may be symptoms of a very rare adverse reaction affecting the nervous system, called reversible posterior encephalopathy.
• Severe chest pain (myocardial infarction) (rare).
• Severe hypersensitivity/allergic reaction with severe skin rash, including redness and itching of the skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat and feeling of fainting (anaphylactic reaction) (very rare).
• Severe skin rash with itching, blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• Extreme fatigue and weakness, petechiae or small areas of bleeding on the skin (bruises), acute kidney failure (low urine production or absence) and signs of infection. These may be signs of thrombotic microangiopathy (formation of blood clots in small blood vessels) and hemolytic-uremic syndrome, which can lead to death (less common).
• Red, peeling, widespread rash with blisters under swollen skin (including skin folds, trunk and upper limbs) and blisters with fever - acute generalized exanthematous pustulosis (AGEP - frequency not known).

Other possible side effects of Gemcitabine Accord:

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

• Low white blood cell count
• Difficulty breathing
• Vomiting
• Nausea
• Hair loss
• Liver function disorders, which are 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 side effects (may affect up to 1 in 10 people)

• Lack of appetite
• Headache
• Insomnia
• Drowsiness
• Cough
• Rhinitis
• Constipation
• Diarrhea
• Itching
• Excessive sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Infections

Less common side effects (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 side effects (may affect up to 1 in 1,000 people)

• Low blood pressure
• Peeling of the skin, blistering or ulcers on the skin
• Formation of large blisters on the skin and leakage from the skin
• Reactions at the injection site
• Severe pneumonia leading to respiratory failure (adult respiratory distress syndrome)
• Skin rash similar to severe sunburn, which may occur on skin previously exposed to radiation
• Fluid in the lungs
• Lung damage associated with radiation therapy (radiation toxicity)
• Gangrene in fingers and toes
• Vasculitis (peripheral vasculitis)

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

• Increased platelet count
• Inflammation of the large intestine due to reduced blood flow (ischemic colitis)
• Low hemoglobin level (anemia) and low white blood cell and platelet count detected in blood tests
• Thrombotic microangiopathy: formation of blood clots in small blood vessels

Side effects with unknown frequency

• Sepsis: when bacteria and their toxins circulate in the blood and start damaging organs
• Pseudoscleroderma: redness of the skin with swelling

In case of any of the above side effects, tell your doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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, you can help provide more information on the safety of this medicine.

5. How to store Gemcitabine Accord

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Unopened vial: This medicinal product does not require any special storage conditions.
Reconstituted solution: The medicine should be used immediately after preparation. The physical and chemical stability of the gemcitabine solution prepared according to the instructions has been demonstrated for 21 days at 25°C. Medical staff may further dilute the solution. The prepared solution should not be stored in the refrigerator, as the medicine may crystallize.
The medicine is for single use only. Any unused solution should be disposed of in accordance with applicable regulations.

6. Contents of the packaging and other information

What Gemcitabine Accord contains

The active substance of the medicine is gemcitabine. Each vial contains 200 mg, 1 g or 2 g of gemcitabine (as gemcitabine hydrochloride).
The other excipients are: mannitol (E421), sodium acetate trihydrate, hydrochloric acid and sodium hydroxide.

What Gemcitabine Accord looks like and contents of the pack

Gemcitabine Accord is a white or almost white powder for solution for infusion in a vial. Each vial contains 200 mg, 1 g or 2 g of gemcitabine. Each pack contains one vial of Gemcitabine Accord.
The 200 mg, 1 g and 2 g vials are available in individual packs.

Marketing authorization holder and manufacturer:

Marketing authorization holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer and importer
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands

This medicinal product 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: December 2023

The following information is intended for healthcare professionals only:

Instructions for preparation, administration of the medicine and disposal of its residues

• 1. Preparation of the gemcitabine solution and further dilution of the solution for intravenous infusion should be carried out under aseptic conditions.
• 2. Calculate the dose and number of Gemcitabine Accord vials required.
• 3. For reconstitution, add 5 ml to a 200 mg vial, 25 ml to a 1000 mg vial, and 50 ml to a 2000 mg vial of sterile sodium chloride injection solution without preservatives. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial), 26.3 ml (1000 mg vial) or 52.6 ml (2000 mg vial). Reconstitution results in a solution of gemcitabine with a concentration of 38 mg/ml and includes the volume left when transferring the lyophilized powder. The product can be further diluted with sterile sodium chloride injection solution without preservatives. The prepared solution should be clear, colorless or straw-colored.
• 4. Before parenteral administration of the medicinal product, the solution should be inspected visually for particulate matter and changes in color. If the solution contains visible particles, the medicine should not be administered.
• 5. Reconstituted gemcitabine solution should not be stored in the refrigerator, as the product may crystallize. Chemical and physical stability of the solution has been demonstrated for 21 days at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for the storage period and storage conditions before use lies with the user. In this case, the solution should not be stored for more than 24 hours at room temperature, unless reconstitution and/or dilution of the solution was carried out under controlled and validated aseptic conditions.
• 6. Gemcitabine solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local regulations.

Precautions when preparing and administering the medicine:

When preparing and disposing of the infusion solution, standard safety precautions for handling cytotoxic medicines should be followed. Preparation of the infusion solution should be carried out in a protective cabinet using protective clothing and gloves. If a protective cabinet is not available, a mask and protective glasses should be used in addition.
In case of accidental contact of the solution with the eyes, severe irritation may occur. The eyes should be rinsed immediately with water. If irritation persists, consult a doctor. If the solution comes into contact with the skin, the skin should be washed thoroughly with water.

Disposal of residues of the medicine

Any unused product should be disposed of in accordance with local regulations.