Gemcitabine Hospira 1000 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gemcitabine Hospira 1000 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, as you may need to read it again.
• If you have any 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 this leaflet:

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

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

Gemcitabine Hospira (gemcitabine) – ATC code L01BC05.

Gemcitabine Hospira belongs to a group of medicines called "cytotoxic agents", which are anticancer drugs. These medicines destroy dividing cells, including cancer cells.

Gemcitabine may be given alone or in combination with other antineoplastic agents (e.g., cisplatin, paclitaxel, carboplatin), depending on the type of cancer.

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

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

2. What you need to know before using Gemcitabine 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 breastfeeding.

Warnings and precautions

Before the first infusion, blood samples will be taken to check whether your liver and kidneys are functioning properly.

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

Depending on your general health condition and blood test results, your doctor may decide to adjust the dose or delay treatment with gemcitabine if your blood cell count is too low.

Blood samples will be taken periodically to assess liver and kidney function.

Talk to your doctor or nurse before receiving gemcitabine if:

• you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after using gemcitabine.

• you have or have previously had liver, heart, or vascular diseases.

• you have recently received, or are scheduled to receive, radiotherapy.

• you have recently been vaccinated.

• you have difficulty breathing or feel very weak and look very pale (this may be a symptom 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 immediate medical attention if you notice any 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 safety and efficacy data.

Other medicines and gemcitabine

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including vaccines.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or planning to become pregnant, consult your doctor. Gemcitabine should be avoided during pregnancy. Women of childbearing potential must use effective contraception during treatment with gemcitabine and for 6 months after the last dose.

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

Breastfeeding

Inform your doctor if you are breastfeeding.

You must interrupt breastfeeding 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 treatment ends. Men are advised to use effective contraception during treatment with gemcitabine and for 3 months after the last dose.

If you wish to father a child during treatment or within 3 months after treatment, you should seek advice from your doctor or pharmacist. You may wish to discuss sperm preservation before starting treatment.

Driving and use of machines

Treatment with gemcitabine may cause drowsiness, especially if you have consumed alcohol. You should not drive or operate machinery until you are certain that treatment with gemcitabine does not cause drowsiness or dizziness.

Gemcitabine Hospira contains sodium

Gemcitabine Hospira 1,000 mg concentrate for solution for infusion

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

3. How to use Gemcitabine Hospira

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

Your height and weight will be measured to determine your body surface area. Your doctor will use this information to calculate the appropriate 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 blood tests, your general health condition, and any adverse reactions you may experience.

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

Gemcitabine will always be administered to you as an infusion (a slow injection through an intravenous drip) into one of your veins. The infusion will last approximately 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 concerns about the dose you are receiving, or any other questions about the use of this medicine, speak with your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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).
• Tiredness, feeling faint, shortness of breath, or paleness (as you may have less hemoglobin 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 tiredness and weakness, purple spots or small areas of bleeding under the skin (bruising), 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 experience mild breathing difficulty shortly after gemcitabine infusion, which quickly resolves; however, more serious lung problems may occur uncommonly or rarely).
• Severe chest pain (myocardial infarction) (rare).
• Severe hypersensitivity/allergic reaction with severe skin rash including itching and redness of the skin, swelling of hands, feet, ankles, face, lips, mouth, and throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat, and feeling faint (anaphylactic reaction) (very rare).
• Generalized swelling, difficulty breathing, or weight gain, as you may experience leakage of fluid from small blood vessels into tissues (capillary leak syndrome) (very rare).
• Headache with changes in vision, confusion, seizures, or convulsions (reversible posterior encephalopathy syndrome) (very rare).
• Severe rash with itching, blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• Generalized red, scaly rash with inflamed bumps under the skin (including skin folds, trunk, and upper limbs) and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis [AGEP]) (frequency not known).

Other adverse effects with Gemcitabine 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 tests: protein in the urine
• Flu-like syndrome, including fever
• Swelling of ankles, fingers, feet, face (edema)

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

• Loss of appetite (anorexia)
• Headache
• Insomnia
• Drowsiness
• Cough
• Nasal congestion
• Constipation
• Diarrhea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Infections

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

• Thickening of the walls of the lung alveoli (interstitial pneumonitis)
• Wheezing (spasm of the airways)
• Scarring of the lungs (abnormal chest X-ray/scan)
• 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
• Skin peeling, ulceration, or blistering
• Severe skin peeling and blistering
• Reactions at the injection site
• Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)
• Sunburn-like skin rash that may occur in skin previously exposed to radiotherapy (late radiation-associated skin toxicity)
• Fluid in the lungs
• Thickening of the walls of the lung alveoli associated with radiotherapy (radiation-associated toxicity)
• Gangrene of the toes or fingers
• Inflammation of blood vessels (peripheral vasculitis)

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

• Increased number of platelets
• Inflammation of the lining of the large intestine due to reduced blood supply (ischemic colitis)
• Low hemoglobin (anemia), low white blood cells, and low platelet count detectable by blood tests
• Blood clots forming in small blood vessels (thrombotic microangiopathy)

Not known: (cannot be estimated from available data)

• A condition in which eosinophils, a type of cell normally found in the blood, accumulate in the lungs (pulmonary eosinophilia)
• Skin redness with swelling (pseudocellulitis)
• When bacteria and their toxins circulate in the blood and begin to damage organs (sepsis)

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

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

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemcitabine 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 stated on the vial and carton after "EXP" (CAD). The expiry date refers to the last day of the month indicated.
• Store in a refrigerator (2 °C–8 °C).
• This medicine is for single use only; any unused medicine will be disposed of according to local regulations.

6. Contents of the pack and other information

Composition of Gemcitabine Hospira:

• The active substance in Gemcitabine Hospira is gemcitabine (as gemcitabine hydrochloride). The solution has a concentration of 38 mg/mL, meaning that each milliliter of solution contains 38 milligrams of gemcitabine (as gemcitabine hydrochloride).

• The other components of this medicinal product are: water for injections, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH).

Appearance of the product and contents of the container

• Gemcitabine Hospira is a clear, colourless or pale yellow solution.

• Gemcitabine Hospira is presented in glass vials.

• Three sizes of glass vials are marketed, containing:

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

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

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

• Each vial is individually packaged in an outer carton.

Marketing Authorization Holder:

Pfizer, S.L.

Avenida de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer responsible:

Pfizer Service Company BV

Hermeslaan 11

1932 Zaventem

Belgium

Date of the most recent review of this package leaflet: April 2024

Detailed and up-to-date 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/

The following information is intended exclusively for medical or healthcare professionals:

Instructions for use, handling, and disposal

Administration

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

• Dilution of the solution is required: An approved diluent for gemcitabine concentrate for infusion solution is sodium chloride 9 mg/mL (0.9%) solution for injection (without preservative). Follow aseptic technique during dilution of Gemcitabine concentrate prior to administration.

• Prior to administration, parenteral medicines should be visually inspected for particulate matter and discoloration. If particulate matter is observed, the solution must not be administered.

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

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

Handling

• Standard safety precautions for cytotoxic agents should be observed when preparing and disposing of the infusion solution. The handling of the infusion solution must be carried out in a safety cabinet, wearing protective gloves and gowns. If a safety cabinet is not available, a protective mask and safety goggles should be added to the protective equipment.

• If the solution comes into contact with the eyes, severe irritation may occur. Eyes should be thoroughly and immediately rinsed with water. If irritation persists, medical advice must be sought. If the solution splashes onto the skin, the skin should be thoroughly rinsed with water.

Disposal

Gemcitabine Hospira is for single use only. Any unused medicinal product and all materials that have come into contact with it must be disposed of in accordance with local regulations for cytotoxic agents.