Cytarabine Pfizer 500 mg powder and solvent for solution for injection and for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cytarabine Pfizer 500 mg powder and solvent for injectable solution and for infusion

Read the entire 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Citarabina Pfizer is and what it is used for

Citarabina Pfizer is used in adults and children. The active substance is cytarabine.

Cytarabine belongs to a group of medicines called cytotoxic agents; these medicines are used to treat acute leukaemias (blood cancer resulting in too many white blood cells in the blood), including prophylaxis and treatment of central nervous system (CNS) involvement or CNS leukaemia (meningeal leukaemia). Cytarabine interferes with the proliferation of cancer cells, which are eventually destroyed.

Cytarabine is also used to treat certain types of chronic leukaemia.

Induction of remission involves intensive treatment aimed at reducing the extent of leukaemia. When successful, blood cell balance is partially restored and your health improves. This period of relative good health is called remission.

Maintenance treatment is a less intensive therapy intended to keep the remission going for as long as possible. Relatively low doses of cytarabine are used to keep the leukaemia under control and prevent it from worsening.

2. What you need to know before using Citarabina Pfizer

Do not use Citarabina Pfizer:

• If you are allergic to cytarabine or any of the other ingredients of this medicine (listed in section 6).
• If you are already taking medicines that reduce the bone marrow's ability to produce blood cells.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Citarabina Pfizer.

• If your bone marrow is affected, treatment should be started under close medical supervision.
• Cytarabine markedly reduces the production of blood cells in the bone marrow. This may increase the risk of infections or bleeding. Blood cell counts may continue to decrease for up to one week after stopping treatment. Your doctor will perform periodic blood tests and examine your bone marrow if necessary.
• If you have or have had liver or kidney problems. During treatment with cytarabine, your liver and kidney functions should be monitored. If your liver and/or kidneys are not functioning properly before treatment, cytarabine should only be administered with extreme caution.
• If you have or have had gout, as cytarabine may cause an increase in uric acid levels.
• Serious and sometimes potentially life-threatening adverse effects may occur in the central nervous system, intestines, or lungs.
• If you are receiving cytarabine intravenously in combination with intrathecal methotrexate, as you may experience serious adverse effects in your nervous system, especially in young patients and adolescents.
• If you need to be vaccinated while undergoing treatment with this medicine, as live or attenuated virus vaccines must not be administered and the response to inactivated or killed vaccines may be reduced.

If you are in any of the situations listed above, consult your doctor before using Citarabina Pfizer.

Children and adolescents

The safety of this medicine has not been established for use in infants.

Using Citarabina Pfizer with other medicines

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

• If you are receiving medicines containing 5-fluorocytosine (a medicine used to treat fungal infections).
• If you are taking medicines containing beta-acetyldigoxin, used to treat certain heart conditions.
• If you are taking gentamicin (an antibiotic used to treat bacterial infections).
• If you are receiving medicines containing cyclophosphamide, vincristine, and prednisone, used in cancer treatment regimens.
• If you are receiving intravenous cytarabine in combination with intrathecal methotrexate.

Pregnancy, breastfeeding, and fertility If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor before using this medicine.

Pregnancy

You must not become pregnant while you or your partner are being treated with cytarabine. If you are sexually active, you are advised to use effective contraception to prevent pregnancy during treatment, regardless of your sex. Cytarabine may cause congenital abnormalities, so it is important to inform your doctor if you think you may be pregnant. Both men and women should use effective contraception during treatment and for 6 months after the last dose.

Contraception in women of childbearing potential

Women must always use effective contraceptive methods (contraception) to prevent pregnancy during treatment and for 6 months after the last dose. Talk to your doctor about which contraceptive methods are suitable for you and your partner.

Contraception in men

Male patients with female partners of childbearing potential must always use highly effective contraceptive methods to prevent pregnancy during treatment and for 3 months after the last dose.

Breastfeeding

Breastfeeding must be discontinued during treatment with Citarabina Pfizer and for at least one week after the last dose, or the treatment should be discontinued, as this medicine could be harmful to breastfed infants.

Fertility

Due to the potential risk of infertility after treatment, you should consider the possibility of preserving sperm before starting treatment with cytarabine.

Driving and using machines It is unknown whether Citarabina Pfizer has any effect on the ability to drive or operate machinery. However, you should not drive if you experience any adverse events (such as nausea or vomiting) that could impair your ability to drive or operate machinery.

Citarabina Pfizer contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; i.e., essentially “sodium-free”.

3. How to use Cytarabine Pfizer

Method and routes of administration

Cytarabine Pfizer should only be administered under the supervision of a physician experienced in the use of this type of treatment. Consult your doctor or pharmacist if you have any questions.

Cytarabine Pfizer may be administered intravenously as a rapid injection (bolus) or by infusion, subcutaneously, or intrathecally.

If in doubt, consult your doctor or nurse again.

Dosage

Your doctor will determine the dose, duration of treatment, and most appropriate route of administration for you, based on your condition—whether as induction therapy or maintenance therapy—and according to your body weight or body surface area and your response to treatment.

Your doctor will inform you of the number of treatment cycles you require.

During treatment, you will need frequent examinations, including blood tests. Your doctor will tell you how often these are needed and will perform regular tests of:

• Blood, to check for low blood cell counts that may require treatment.
• Liver (also via blood tests) to ensure that cytarabine is not adversely affecting liver function.
• Kidneys (also via blood tests) to ensure that cytarabine is not adversely affecting kidney function.
• Blood uric acid levels: cytarabine may increase blood uric acid levels. If your uric acid levels become too high, you may be given another medication.

If you receive more Cytarabine Pfizer than you should

This medicine will be administered in a hospital setting, so it is unlikely that you will receive more cytarabine than prescribed; however, some of the known serious adverse effects of the medicine may occur, such as mouth ulcers, or there may be a reduction in white blood cell and platelet counts (which contribute to blood clotting). In such cases, you may require antibiotics or blood transfusions. Mouth ulcers can be treated to reduce discomfort during healing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, Citarabina Pfizer can cause adverse effects, although not everyone experiences them.

The adverse effects of cytarabine depend on the dose. The gastrointestinal tract is usually the most affected organ, as well as the blood.

Very common adverse effects (may affect more than 1 in 10 patients) include:

• Infections, systemic infection, pneumonia.
• Reduction in the number of red blood cells, white blood cells and/or platelets in the blood.
• Bone marrow suppression, i.e., impairment of the immune system with loss of the ability to fight infections or diseases.
• Impairment of normal brain and cerebellar* function, drowsiness*.
• Eye corneal disorder*.
• Fluid accumulation in the lungs*, difficulty breathing*.
• Nausea, vomiting, diarrhea, inflammation or ulcers in the mouth or anus, abdominal pain.
• Liver function abnormalities.
• Rash, hair loss.
• Fever, cytarabine syndrome (characterized by muscle and bone pain, sometimes chest pain, fever, conjunctivitis, rash and malaise, usually appearing 6–12 hours after administration and treated with corticosteroids).
• Changes in the appearance of bone marrow and blood cells.

Common adverse effects (may affect up to 1 in 10 patients) include:

• Inflammation of a portion of the intestine with intestinal cell death (necrotizing colitis)*.
• Skin ulcers, skin peeling*.

Adverse effects with unknown frequency (cannot be estimated from available data) include:

• Severe allergic reaction.

• Inflammation at the injection site.

• Localized pus formation in the liver*.

• Fluid retention of allergic origin.

• Loss of appetite.

• Personality changes*.

• Neurotoxicity, nerve inflammation, headache, dizziness, coma*, disturbances in motor and sensory function of the peripheral nervous system* (when administered intrathecally); in children, a rare inflammatory disorder may occur causing damage to the tissue covering the nerves (necrotizing leukoencephalopathy), leg and lower body paralysis (paraplegia), progressive ascending paralysis, progressive toxicity, seizures.

• Conjunctivitis (eye infection that may be associated with rash), hemorrhagic conjunctivitis*, blindness (when administered intrathecally).

• Inflammation of the tissue covering the heart (pericarditis), slower than normal heart rate or rhythm (sinus bradycardia).

• Heart disease (cardiomyopathy)*, enlargement of the heart (cardiomegaly)*.

• Blockage and inflammation of the blood vessel at the injection site (thrombophlebitis).

• Sore throat, shortness of breath, inflammation of part of the lung tissue*.

• Esophageal ulcer, esophagitis, gastrointestinal ulcer*, presence of cysts in the intestinal wall*, peritonitis*, intestinal cell death*, inflammation of the pancreas (pancreatitis).

• Yellowing of the skin, liver damage*, increased bilirubin levels*.

• Urticaria, skin spots, itching.

• Urinary retention, kidney impairment.

• Chest pain.

• Reaction at the injection site.

• Skin rash on the palms of the hands and soles of the feet.

• Redness, pain or inflammation of the ears that may occur during or shortly after cytarabine treatment (known as "cytarabine ears" or auricular erythema).

• Inflammation of the sweat glands, which may sometimes cause painful red plaques on the skin (known as neutrophilic eccrine hidradenitis).

• Due to high-dose cytarabine only

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cytarabine Pfizer

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the vial and label after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice that it is damaged or opened.

Any unused product or waste material must be disposed of in accordance with local regulations.

6. Contents of the container and other information

Composition of Citarabina Pfizer

• The active substance is cytarabine.
• The other components are hydrochloric acid 10% (for pH adjustment), sodium hydroxide 10% (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

Citarabina Pfizer is supplied in a pack containing 1 vial with lyophilized powder and 1 ampoule with solvent. The colorless glass vial with a bromobutyl rubber stopper contains the lyophilized active substance, appearing as a crystalline, odorless, whitish powder. The ampoule contains 10 ml of solvent, water for injections. The colorless glass ampoule has a red ring and a white break point.

Citarabina Pfizer 500 mg is available in the presentation of 1 vial + 1 ampoule.

Marketing Authorization Holder

Pfizer, S.L.
Avda. de Europa, 20 B
Parque Empresarial La Moraleja
28108 Alcobendas (Madrid)
Spain

Manufacturer

Latina Pharma S.p.A.
Via Murillo, 7
04013 Sermoneta (LT)
Italy

Date of latest revision of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

----------------------------------------------------------------------------------------------This information is intended for healthcare professionals only:

Consult local guidelines for cytotoxic agents.

Reconstitution of the lyophilized powder prior to administration

Dissolve the powder of Citarabina Pfizer 500 mg in the total volume (10 ml) of the solution from the solvent ampoule. If reconstituted as indicated, a solution of 50 mg/ml is obtained.

Intravenous administration

For intravenous administration (by infusion), the recommended solutions for preparing dilution are:

• 5% Dextrose in water
• 5% Dextrose in 0.2% sodium chloride
• 0.9% Sodium chloride

The infusion time for each dose ranges between 1 and 3 hours.

Intrathecal administration

Do not use solvents containing benzyl alcohol or preservatives. Use immediately.

High-dose administration

Do not use solvents containing benzyl alcohol.

Incompatibilities

Cytarabine is physically incompatible with heparin, insulin, 5-fluorouracil, penicillins such as oxacillin or penicillin-G, and methylprednisolone hemisuccinate.

This medicinal product must not be mixed with others except those mentioned in the section above, "Intravenous administration".

Compatibility must be ensured before mixing with any other substance.

Special storage precautions

Unopened vial: 5 years.

Reconstituted solution:

Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures not exceeding 30°C and for 48 hours when refrigerated at 2°C–8°C.

From a microbiological standpoint, the product should be used immediately after reconstitution. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Guidelines for handling cytotoxic agents

Administration:

Must be administered by, or under the direct supervision of, a physician experienced in the use of chemotherapeutic agents for cancer.

Preparation (Recommendations):

1. Chemotherapeutic agents should be prepared for administration only by trained personnel familiar with the safe handling procedures.
2. Operations such as dilution and transfer to syringes must be performed only in a designated area.
3. Personnel performing these procedures must wear appropriate protective clothing, gloves, and eye protection.
4. Pregnant women should avoid handling cytotoxic agents.

Contamination:

1. In case of contact with skin or eyes, the affected area should be washed thoroughly with abundant water or physiological saline. A mild cream may be used to treat transient skin irritation. If eyes are affected, seek medical attention.
2. In case of spillage, personnel should wear gloves and clean up spilled material using a sponge designated for this purpose in the area. Rinse the area twice with water. Place all solutions and sponges into a plastic bag and seal it tightly.

Disposal:

Syringes, containers, absorbent materials, solutions, and any other contaminated materials must be placed in a tightly sealed plastic bag or other leak-proof container and incinerated at 1100°C.

Disposal of unused medicinal product and all materials that have come into contact with it must comply with local regulations.