GEMCITABINE ACCORD 2000 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine Accord 2000 mg powder for solution for infusion

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack:

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

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

Gemcitabine Accord is a medicine used to treat cancer. It belongs to a group of medicines called cytotoxics. These medicines destroy cells that are dividing, including cancer cells.

Gemcitabine Accord can be given 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:

• 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. What you need to know before you use Gemcitabine Accord

Do not use Gemcitabine Accord

Take special care with Gemcitabine Accord

Before the first infusion, blood samples will be taken to check if your liver and kidney function is correct. Also, before each infusion, blood samples will be taken to check if you have enough red blood cells to receive Gemcitabine Accord. Your doctor may decide to change the dose or delay treatment depending on your general health and if your blood cell counts are too low. Periodically, blood samples will be taken to check the function of your kidneys and liver.

Tell your doctor if:

• you have ever developed a severe skin rash, skin peeling, blisters and/or sores in the mouth after using gemcitabine.
• you have or have had liver, heart or blood vessel disease, or kidney problems, as you may not be able to be treated with gemcitabine.
• you have recently received or are going to receive radiotherapy, as there may be an early or late radiation reaction with gemcitabine.
• you have been vaccinated recently, as this may cause negative effects with gemcitabine.
• you have difficulty breathing or feel very weak and very pale (this may be a sign of kidney failure or lung problems).
• you have swelling, difficulty breathing, or weight gain, as this may be a sign of fluid loss from your capillaries to your tissues, and symptoms of a serious condition called Capillary Leak Syndrome (CLS).
• during treatment with this medicine, you have symptoms such as headache with confusion, seizures, or changes in vision. You should contact your doctor immediately, as this may be a very rare side effect of the nervous system called posterior reversible encephalopathy syndrome (PRES).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP), have been reported in association with gemcitabine treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents

This medicine is not recommended for use in children under 18 years of age due to lack of data on safety and efficacy.

Other medicines and Gemcitabine Accord

Tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccines and medicines obtained without a prescription.

Pregnancy

If you are pregnant or think you may be pregnant, tell your doctor. The use of Gemcitabine Accord should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine Accord during pregnancy. Women of childbearing age should use effective contraceptive methods during treatment with gemcitabine and for 6 months after the last administration.

Fertility

Men are advised not to father a child during treatment with Gemcitabine Accord and for 3 months after treatment. They should use effective contraceptive methods during treatment and for 3 months after stopping treatment. If you want to have a child during treatment or in the 6 months after treatment, ask your doctor or pharmacist for advice. You may want to seek information about sperm preservation before starting your treatment.

Breastfeeding

Tell your doctor if you are breastfeeding.

You must stop breastfeeding during treatment with Gemcitabine Accord.

Driving and using machines

Gemcitabine Accord may cause drowsiness, especially if you have consumed alcohol. Avoid driving or using machines until you are sure that treatment with Gemcitabine Accord does not make you drowsy.

Gemcitabine Accord contains sodium

This medicine contains 3.5 mg (less than 1 mmol) of sodium per 200 mg vial. This should be taken into account for patients on a controlled sodium diet.

3. How to use Gemcitabine Accord

The usual dose of Gemcitabine Accord is 1,000-1,250 mg per square meter of your body surface area. Your height and weight will be measured to calculate the area of your body. Your doctor will use this body surface area to calculate the correct dose for you. This dose may be adjusted or treatment delayed depending on your general health and blood cell counts.

The frequency at which you receive your Gemcitabine Accord infusion depends on the type of cancer you are being treated for.

A hospital pharmacist or doctor will have dissolved the Gemcitabine Accord powder before it is given to you.

You will always receive Gemcitabine Accord by infusion into one of your veins. The infusion will last approximately 30 minutes.

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

4. Possible side effects

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

You should contact your doctor immediately if you notice any of the following:

• irregular heartbeat (arrhythmia) (uncommon).
• pain, redness, swelling, or sores in the mouth (stomatitis) (common).
• allergic reactions: if you have a mild to moderate skin rash (very common) / itching (common), or fever (very common).
• fatigue, feeling faint, shortness of breath, or if you are pale (as you may have lower than normal hemoglobin, which is very common).
• bleeding from the gums, nose, or mouth, or any bleeding that does not stop, red or pink urine, unexpected bruising (as you may have fewer platelets than normal, which is very common).
• difficulty breathing (it is very common to have mild difficulty breathing immediately after the infusion of Gemcitabine Accord, which passes quickly; however, uncommonly or rarely, there may be more serious lung problems).
• swelling, difficulty breathing, or weight gain, as you may have fluid loss from your capillaries to your tissues (capillary leak syndrome) (very rare).
• headache with changes in vision, confusion, seizures, or fits (posterior reversible encephalopathy syndrome) (very rare).
• extreme fatigue and weakness, purpura, or small areas of bleeding in the skin (bruises), acute kidney failure (little or no urine), and symptoms of infection. These may be symptoms of thrombotic microangiopathy (blood clots forming in the small blood vessels) and hemolytic uremic syndrome, which can be fatal (uncommon).
• severe chest pain (myocardial infarction) (rare).
• severe allergic reaction with severe skin rash, including itching and redness of the skin, swelling of hands, feet, ankles, face, lips, mouth, and throat (which can cause difficulty swallowing or breathing), wheezing, rapid heartbeat, and you may feel like you are going to faint (anaphylactic reaction) (very rare).
• swelling, difficulty breathing, or weight gain, as you may have fluid loss from your capillaries to your tissues (capillary leak syndrome) (very rare).
• headache with changes in vision, confusion, seizures, or fits (posterior reversible encephalopathy syndrome) (very rare).
• severe rash with itching, blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• a red, scaly, and widespread rash with bumps under the inflamed skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (acute generalized exanthematous pustulosis (AGEP)) (frequency not known).

Side effects with Gemcitabine Accord may include:

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

• low white blood cell count
• difficulty breathing
• vomiting
• nausea
• hair loss
• liver problems: identified through abnormal blood test results
• blood in the urine
• abnormal urine tests: protein in the urine
• pseudogripal syndrome, including fever
• edema (swelling of ankles, fingers, feet, face)

Common (may affect up to 1 in 10 people)

• anorexia (loss of appetite)
• headache
• insomnia
• drowsiness
• cough
• stuffy nose
• constipation
• diarrhea
• itching
• excessive sweating
• muscle pain
• back pain
• fever
• weakness
• chills
• infections

Uncommon (may affect up to 1 in 100 people)

• interstitial lung disease (scarring of the lungs)
• bronchospasm (wheezing)
• abnormal chest X-ray/scan (scarring of the lungs)
• heart failure
• stroke
• severe liver damage, including liver failure
• kidney failure

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

• low blood pressure
• skin peeling, ulceration, or blistering
• large blisters on the skin and skin suppuration
• reactions at the injection site
• severe lung inflammation that causes respiratory failure (adult respiratory distress syndrome)
• late radiation toxicity (a severe sunburn-like skin rash) that can occur in skin that has been previously exposed to radiation.
• fluid in the lungs
• radiation-associated lung damage (radiation toxicity)
• gangrene of the fingers or toes
• inflammation of the blood vessels (peripheral vasculitis)

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

• increased platelet count
• inflammation of the lining of the large intestine, caused by reduced blood supply (ischemic colitis)
• low hemoglobin levels, low white blood cell count, and low platelet count can be detected through blood tests.
• thrombotic microangiopathy: blood clots forming in the small blood vessels

Frequency not known

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

You may experience any of these symptoms and/or conditions. You should tell your doctor as soon as possible if you start experiencing side effects.

Reporting of side effects

If you experience side effects, consult your doctor or hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemcitabine Accord

Keep out of the reach and sight of children.

Do not use Gemcitabine Accord after the expiry date (EXP) stated on the pack. The expiry date is the last day of the month stated.

Sealed vial: this medicine does not require any special storage conditions.

Reconstituted solution: the product should be used immediately. When prepared according to the instructions, the chemical and physical properties of the reconstituted gemcitabine solutions have been shown to be stable for 21 days stored at 25°C. Further dilution can be performed by a healthcare professional. Reconstituted gemcitabine solutions should not be refrigerated, as crystallization may occur.

This medicine is for single use only. Any unused product should be disposed of in accordance with local requirements.

6. Container contents and additional information

What Gemcitabina Accord contains

The active ingredient is gemcitabine. Each vial contains 2000 mg of gemcitabine (as gemcitabine hydrochloride).

The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid, and sodium hydroxide.

Appearance of Gemcitabina Accord and container contents

Gemcitabina Accord 2000 mg is a white or off-white powder for solution for infusion, packaged in a vial. Each vial contains 2000 mg of gemcitabine. Each Gemcitabina Accord package contains 1 vial.

The 2000 mg vials are sold in single-unit packages.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Manufacturer

Accord Healthcare Polska, s.p.o.o

Ul. Lutomierska, 50

95-200 Pabianice

Poland

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

Date of last revision of this leaflet: January 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

The following information is intended for healthcare professionals only:

Instructions for use, handling, and disposal

1. Use aseptic techniques during the reconstitution and any subsequent dilution of gemcitabine for intravenous infusion administration.
2. Calculate the dose and the number of Gemcitabina Accord vials needed.
3. Reconstitute each 2000 mg vial with 50 ml of sterile sodium chloride injection solution, 9 mg/ml (0.9%), without preservatives. Shake to dissolve. The total volume after reconstitution is 52.6 ml (2000 mg vial). The resulting gemcitabine concentration from this dilution is 38 mg/ml, considering the volume displacement of the lyophilized powder. It can be further diluted with a sodium chloride injection solution, 9 mg/ml (0.9%), without preservatives.

The reconstituted solution is a clear, colorless, or pale yellow solution.

1. Before administration, the medicinal products should be visually inspected for potential particles in suspension and/or discoloration. If particles are observed, the solution should not be administered.
2. The reconstituted gemcitabine solutions should not be refrigerated, as crystallization may occur. Chemical and physical stability 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 storage conditions and periods before use will be the responsibility of the user and should not exceed 24 hours at room temperature, unless the reconstitution/dilution is carried out under controlled and validated aseptic conditions.
3. The gemcitabine solutions should be used once only. Any unused or waste product should be disposed of in accordance with local regulations for cytotoxic medicinal products.

Precautions for preparation and administration

Normal safety measures for cytostatic agents should be taken into account when preparing and disposing of the infusion solution. Handling of the solution should be performed in a safety cabinet, and protective clothing and gloves should be worn. If a safety cabinet is not available, the equipment should be supplemented with masks and eye protection.

If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be rinsed immediately and thoroughly with plenty of water. If irritation persists, a doctor should be consulted. If the solution spills on the skin, it should be rinsed thoroughly with plenty of water.

Disposal

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