Cytarabine Pfizer 100 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 100 mg powder and solvent for solution for injection and infusion

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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 side 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 leukemias (blood cancer causing an excess of white blood cells in the blood), including prophylaxis and treatment of central nervous system (CNS) involvement or meningeal leukemia. Cytarabine interferes with the proliferation of cancer cells, which are eventually destroyed.

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

Remission induction involves intensive treatment aimed at reducing the extent of leukemia. When successful, the balance of blood cells normalizes to some degree and your health improves. This period of relative good health is called remission.

Maintenance therapy is a milder treatment intended to keep the remission lasting as long as possible. Relatively low doses of cytarabine are used to keep the leukemia under control and prevent its recurrence.

2. What you need to know before using Citarabina Pfizer

Do not use Citarabina Pfizer:

• If you are allergic to cytarabine or to 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 treatment with Citarabina Pfizer.

• If your bone marrow is affected, treatment should begin under close medical supervision.
• Cytarabine markedly reduces the production of blood cells in the bone marrow. This may increase susceptibility to 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, if necessary, examine your bone marrow.
• If you have or have had liver or kidney problems. Your liver and kidney function should be monitored during treatment with cytarabine. 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 elevated uric acid levels.
• Severe and sometimes potentially fatal 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 on 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 should 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 using, have recently used, or might need to use 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 cytarabine intravenously 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, consult 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 malformations, so it is important to inform your doctor if you think you may be pregnant. Both men and women must use effective contraception during treatment and for 6 months after the last dose.

Contraception in women of childbearing potential

Women must always use effective methods of contraception to prevent pregnancy during treatment and for 6 months after the last dose. Consult your doctor about which contraceptive methods are appropriate 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 treatment must be discontinued, as this medicine could be harmful to breastfed infants.

Fertility

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

Driving and using machines It is unknown whether Citarabina Pfizer has any effect on the ability to drive vehicles 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., it is essentially “sodium-free”.

3. How to use Cytarabine Pfizer

Method and routes of administration

Cytarabine Pfizer must 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 doubts.

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

If in doubt, please consult your doctor or nurse again.

Dosage

Your doctor will determine the dose and duration of treatment, as well as the 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 advise 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 function (also via blood tests) to ensure that cytarabine is not adversely affecting liver function.
• Kidney function (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 are too high, you may be given another medication.

If you receive more Cytarabine Pfizer than you should

This medicine will be administered to you in a hospital setting, so it is unlikely that you will receive more cytarabine than intended. However, some of the known serious adverse effects of the medicine may occur, such as mouth ulcers, or a reduction in white blood cells and platelets (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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Citarabina Pfizer may produce adverse effects, although not everyone will experience them.

The adverse effects of cytarabine depend on the dose. The gastrointestinal tract and blood are usually the most affected.

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 ability to fight infections or diseases.
• Disturbance in 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 dysfunction.
• 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; 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 death of intestinal cells (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*.

• Allergy-related fluid retention.

• Loss of appetite.

• Personality change*.

• 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), abnormally slow heart rate or rhythm (sinus bradycardia).

• Heart disease (cardiomyopathy)*, increased heart size (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, esophageal inflammation, gastrointestinal ulcer*, presence of cysts in the intestinal wall*, peritonitis*, death of intestinal cells*, inflammation of the pancreas (pancreatitis).

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

• Urticaria, skin spots, itching.

• Urine retention, kidney impairment.

• Chest pain.

• Reaction at the injection site.

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

• Due to high-dose cytarabine only

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 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 it is damaged or opened.

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

6. Contents of the pack and other information

Composition of Cytarabine 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 pack

Cytarabine Pfizer is supplied in a pack containing 1 vial with lyophilized powder and 1 ampoule with solvent. The vial contains the lyophilized active substance, a crystalline, odourless, whitish powder. The ampoule contains 5 ml of solvent, water for injections.

Cytarabine Pfizer 100 mg is available in two pack sizes: 1 vial + 1 ampoule and 100 vials + 100 ampoules (hospital pack).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Actavis Italy S.p.A.

Viale Pasteur, 10

20014 Nerviano

Italy

Date of the most recent revision of this leaflet: December 2022

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