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 worsen or if any side effects not mentioned in the leaflet occur, 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 anti-cancer 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 you have enough blood cells to receive Gemcitabine Accord. Depending on your general condition and in case of excessive reduction of 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 after taking gemcitabine, or if you have had mouth sores or ulcers,
• if you have or have had liver, heart, vascular, or kidney disease, as gemcitabine may be contraindicated,
• if you have been or will be undergoing radiotherapy, as early or late radiation reactions may occur with gemcitabine,
• if you have been recently vaccinated, as this may affect the efficacy of gemcitabine,
• if you experience difficulty breathing or weakness and pale skin (which 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 into tissues, a serious condition called capillary leak syndrome.
• if you experience headaches 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 leukoencephalopathy syndrome.

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 symptoms related to these severe skin reactions, 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 is limited data on the safety and efficacy of gemcitabine 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 using Gemcitabine Accord during pregnancy. Your doctor will inform you about the risks associated with using 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. Patients 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 delayed depending on blood test results and the patient's general condition. The frequency of Gemcitabine Accord infusion depends on the type of cancer being treated. Before administration, the hospital pharmacist or doctor will dissolve the powder. Gemcitabine Accord is always administered by intravenous infusion. The infusion lasts about 30 minutes. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, contact your doctor immediately:

• A temperature of 38°C or higher, sweating, or other signs of infection (due to the possibility of a decrease in white blood cell count 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 tired, fainting, rapid breathing, or pale skin (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 platelet count, which occurs very commonly).
• Difficulty breathing (very common in the short term after administration of Gemcitabine Accord, mild respiratory disorders may occur, which usually resolve quickly. 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 into 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 leukoencephalopathy syndrome.
• Severe chest pain (myocardial infarction) (rare).
• Severe 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 faint (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 (not very common).
• Red, peeling, widespread rash with blisters under 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 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 indicated by 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

Uncommon 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 the 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

If you experience any of the above side effects, contact your doctor immediately.

Reporting side effects

If you experience any side effects, including those not mentioned 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, Urzędzie 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. Solution after reconstitution: 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 local requirements.

6. Contents of the packaging and other information

What Gemcitabine Accord contains

The active substance of Gemcitabine Accord 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 off-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 vials of Gemcitabine Accord 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 solution for injection 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). The solution may be further diluted with sterile sodium chloride solution for injection without preservatives. The prepared solution should be clear, colorless, or straw-colored.
• 4. Before parenteral administration, the product should be inspected visually for particulate matter and discoloration. If the solution contains visible particles, the medicine should not be administered.
• 5. The reconstituted solution should not be stored in the refrigerator, as the product may crystallize. The 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 time and 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 has taken place in controlled and validated aseptic conditions.
• 6. Gemcitabine Accord solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

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 worn. If the solution comes into contact with the eyes, it may cause severe irritation. 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

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