GEMCITABINE HOSPIRA 200 mg CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Gemcitabina Hospira 200 mg concentrate for solution for infusion

gemcitabine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Gemcitabina Hospira is and what it is used for

Gemcitabina Hospira (gemcitabine) – ATC code L01BC05.

Gemcitabina Hospira belongs to a group of medicines called “cytotoxics” which are used to treat cancer. These medicines destroy cells that are dividing, including cancer cells.

Gemcitabine can be given alone or in combination with other anticancer medicines (for example, cisplatin, paclitaxel, carboplatin), depending on the type of cancer you have.

Gemcitabina Hospira is used to treat the following types of cancer:

• a type of lung cancer called non-small cell lung cancer (NSCLC), given alone or with cisplatin,
• pancreatic cancer,
• breast cancer, given with paclitaxel,
• ovarian cancer, given with carboplatin,
• bladder cancer, given with cisplatin.

2. What you need to know before you use Gemcitabina Hospira

Do not use gemcitabine if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• you are breast-feeding.

Warnings and precautions

Before the first infusion, blood samples will be taken to check if your liver and kidneys are working well.

Before each infusion, blood samples will also be taken to check if you have enough blood cells to receive treatment with gemcitabine.

Depending on your general state of health and the results of your blood tests, your doctor may decide to change the dose or postpone treatment with gemcitabine if your blood cell count is too low.

Periodically, blood samples will be taken to check your liver and kidney function.

Tell your doctor or nurse before receiving gemcitabine if:

• you have ever developed a severe skin rash or peeling, blisters, and/or sores in the mouth after using gemcitabine.
• you have or have had liver, heart, or vascular disease
• you have received radiation therapy in the last few days or are going to receive radiation therapy
• you have been vaccinated recently
• you have difficulty breathing or feel very weak and are very pale (may be a sign of kidney failure).

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

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use other medicines, including vaccines.

Pregnancy, breast-feeding, and fertility

Pregnancy

If you are pregnant or planning to become pregnant, consult your doctor. The use of gemcitabine should be avoided during pregnancy. Women of childbearing age should use effective contraceptive methods during treatment with gemcitabine and for up to 6 months after the last dose.

Your doctor will inform you about the possible risks of using gemcitabine during pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding.

You must stop breast-feeding during treatment with gemcitabine.

Fertility

If you are a man, you should avoid fathering a child during treatment with gemcitabine and for 3 months after the end of treatment. It is recommended that men use effective contraceptive methods during treatment with gemcitabine and for 3 months after the last dose. If you wish to father a child during treatment or in the 3 months following treatment, you should seek advice from your doctor or pharmacist. You may want to seek information about sperm preservation before starting treatment.

Driving and using machines

Treatment with gemcitabine may cause drowsiness, especially if you have consumed alcohol. You should not drive or use machines until you are sure that treatment with gemcitabine does not make you drowsy or dizzy.

Gemcitabina Hospira contains sodium

Gemcitabina Hospira 200 mg concentrate for solution for infusion

This medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

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3. How to use Gemcitabina Hospira

Your doctor will calculate the initial dose of gemcitabine and it will depend on the type of cancer you have and your body surface area in square meters (m2).

Your height and weight will be measured to calculate your body surface area. Your doctor will use this information to calculate the correct dose. The usual dose is between 1,000 mg/m2 and 1,250 mg/m2.

This dose may be adjusted or treatment delayed depending on the results of your blood tests, your general state of health, and any side effects you may have.

The frequency at which you will receive a dose of gemcitabine by infusion will depend on the type of cancer for which you are being treated.

Gemcitabine will always be given to you as an infusion (a slow injection through a drip) into one of your veins. The infusion will take about 30 minutes.

Since you will receive gemcitabine under the supervision of a doctor, it is unlikely that you will receive an incorrect dose. However, if you have any doubts about the dose you receive or if you have any other questions about the use of this medicine, talk to your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

• Bleeding from the gums, nose, or mouth, or any bleeding that does not stop, reddish or pink urine, unexpected bruising (as you may have fewer platelets than normal, which is very common).
• Fatigue, feeling of fainting, getting breathless easily, or if you are pale (as you may have fewer red blood cells than normal, which is very common).
• Mild or moderate skin rash (very common) / itching (common), or fever (very common); (allergic reactions).
• Temperature of 38°C or higher, sweating, or other signs of infection (as you may have fewer white blood cells than normal, accompanied by fever, also known as febrile neutropenia) (common).
• Pain, redness, swelling, or sores in the mouth (stomatitis) (common).
• Irregular heartbeat (arrhythmia) (uncommon).

Extreme fatigue and weakness, purple spots or small areas of bleeding on the skin (bruises), acute kidney failure (low or no urine production), and signs of infection. These may be signs of thrombotic microangiopathy (blood clots forming in small blood vessels) (very rare) and hemolytic uremic syndrome (uncommon), which can be fatal.

• Difficulty breathing (it is very common to have mild difficulty breathing immediately after gemcitabine infusion, which passes soon, however, uncommonly or rarely, there may be more serious lung problems).
• 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).
• Generalized swelling, difficulty breathing, or weight gain, as you may suffer from fluid leakage from small blood vessels to 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 peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• Generalized red and scaly 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).

Other side effects with Gemcitabina Hospira 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: detected by abnormal blood test results
• Blood in the urine
• Abnormal urine test results: protein in the urine
• Pseudo-flu syndrome, including fever
• Swelling of ankles, fingers, feet, face (edema)

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

• Lack of appetite (anorexia)
• Headache
• Insomnia
• Drowsiness
• Cough
• Stuffy nose
• Constipation
• Diarrhea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Infections

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

• Hardening of the walls of the lung air sacs (interstitial pneumonitis)

• Wheezing (bronchospasm)
• Scarring of the lungs (abnormal chest X-ray)
• Heart failure
• Kidney failure
• Severe liver damage, including liver failure
• Stroke (cerebral infarction)

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

• Low blood pressure.
• Peeling of the skin, ulcers, or blisters.
• Peeling of the skin and blisters on the skin.
• Reactions at the injection site.
• Severe lung inflammation that causes respiratory failure (adult respiratory distress syndrome).
• Skin rash similar to a severe sunburn that can occur in skin that has been previously exposed to radiation therapy (radiation recall dermatitis).
• Fluid in the lungs.
• Hardening of the walls of the lung air sacs associated with radiation therapy (radiation-induced toxicity).
• Gangrene of the toes or fingers.
• 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 by blood tests.
• Blood clots forming in small blood vessels (thrombotic microangiopathy)

Not known:(cannot be estimated from the available data)

• A condition in which eosinophils, a type of cell that is normally found in the blood, accumulate in the lungs (eosinophilic pneumonia)

• Redness of the skin with swelling (pseudocellulitis)
• When bacteria and their toxins circulate in your blood and start to damage your organs (sepsis)

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

Talk to your doctor if you are concerned about any of the side effects.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemcitabina Hospira

Healthcare professionals will store and administer gemcitabine and follow these guidelines:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of the month stated.
• Store in a refrigerator (2°C - 8°C).
• This medicine is for single use only; unused medicine will be disposed of in accordance with local regulations.

6. Contents of the pack and other information

Composition of Gemcitabina Hospira:

• The active substance of Gemcitabina Hospira is gemcitabine (as gemcitabine hydrochloride). The solution has a concentration of 38 mg/mL, which means that each milliliter of the solution contains 38 milligrams of gemcitabine (as gemcitabine hydrochloride).

• The other ingredients of this medicine are: water for injections, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Appearance and packaging

• Gemcitabina Hospira is a clear, colorless or pale yellow solution

• Gemcitabina Hospira is presented in glass vials

• Three sizes of glass vials are marketed, which contain:

200 mg of gemcitabine (as gemcitabine hydrochloride) in 5.3 mL of solution

1,000 mg of gemcitabine (as gemcitabine hydrochloride) in 26.3 mL of solution

2,000 mg of gemcitabine (as gemcitabine hydrochloride) in 52.6 mL of solution

• Each vial is packaged in an individual outer packaging

Marketing Authorization Holder:

Pfizer, S.L.

Avenida de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Pfizer Service Company BV

Hoge Wei 10

1930, Zaventem

Belgium

Date of the last revision of thisleaflet:April 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.gob.es/

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The following information is intended exclusively for healthcare professionals:

Instructions for use, handling, and disposal

Use

• Consult the Summary of Product Characteristics to calculate the dose and the number of vials required.

• The solution needs to be diluted: An authorized diluent for the concentrated gemcitabine solution for infusion is sodium chloride 9 mg/mL (0.9%) solution for injection (without preservative). Follow aseptic technique during the dilution of Gemcitabine concentrate, prior to administration.

• Prior to administration, parenteral drugs should be inspected visually for particulate matter or discoloration. If particles are observed, do not administer.

• After dilution, chemical and physical stability has been demonstrated during use for:

From a microbiological point of view, the product should be used immediately. If not, the in-use storage times and conditions before use are the responsibility of the user and should not exceed 24 hours at 2 °C to 8 °C, unless the dilution has taken place in controlled and validated aseptic conditions.

Handling

• Usual safety precautions for cytostatics should be taken into account when preparing and disposing of the infusion solution. Handling of the infusion solution should be carried out in a safety cabinet and with protective gloves and gowns worn. If a safety cabinet is not available, a mask and protective glasses should be added to the equipment.

• If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be rinsed immediately with water. If irritation persists, medical attention should be sought. If the skin is splashed with the solution, it should be rinsed thoroughly with water.

Disposal

Gemcitabina Hospira is for single use only. Disposal of unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations for cytotoxic agents.