CITARABINE PFIZER 100 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND FOR INFUSION

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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 is Cytarabine Pfizer and what is it used for
2. What you need to know before you use Cytarabine Pfizer
3. How to use Cytarabine Pfizer
4. Possible side effects
5. Storage of Cytarabine Pfizer
6. Contents of the pack and other information

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

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

Cytarabine belongs to a group of medicines called cytotoxics; these medicines are used to treat acute leukemias (blood cancer where you have too many white blood cells in the blood), which includes prophylaxis and treatment of central nervous system (CNS) involvement (meningeal leukemia). Cytarabine interferes with the proliferation of cancer cells, which are eventually destroyed.

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

Induction of remission consists of intensive treatment to reduce the extent of leukemia. When it works, the balance of blood cells becomes normalized to some extent, and your health improves. This period of relative good health is called remission.

Maintenance treatment is a milder treatment to make the remission that occurs last as long as possible. Quite low doses of cytarabine are used to keep leukemia under control and prevent it from worsening.

2. What you need to know before you use Cytarabine Pfizer

Do not use Cytarabine Pfizer:

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Cytarabine Pfizer.

• If your bone marrow is affected, treatment should be initiated under close medical supervision.
• Cytarabine markedly reduces the production of blood cells in the bone marrow. This can increase the predisposition to infections or bleeding. Blood cell counts may continue to decrease until one week after treatment is stopped. Your doctor will perform regular 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 function should be monitored. If your liver and/or kidney are not functioning properly before treatment, cytarabine can only be administered with extreme caution.
• If you have or have had gout, as cytarabine may cause an increase in uric acid.
• Severe and sometimes potentially fatal side effects can occur in the central nervous system, intestines, or lungs.
• If you are given cytarabine intravenously in combination with methotrexate intrathecally, you may experience severe side effects in your nervous system, especially in young patients and adolescents.
• If you need to be vaccinated while being treated with this medicine, as live or attenuated vaccines should not be administered, and the response to killed or inactivated vaccines may be diminished.

If you are in any of the above cases, consult your doctor before using Cytarabine Pfizer.

Children and adolescents

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

Using Cytarabine Pfizer with other medicines

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

• If you receive medicines containing 5-fluorocytosine (a medicine used to treat fungal infections).
• If you take medicines containing beta-acetyldigoxin, which is used to treat certain heart conditions.
• If you take gentamicin (an antibiotic to treat bacterial infections).
• If you receive medicines containing cyclophosphamide, vincristine, and prednisone, which are used in cancer treatment programs.
• If you are given cytarabine intravenously in combination with methotrexate intrathecally.

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 should not become pregnant while you or your partner are being treated with cytarabine. If you are sexually active, you are advised to use effective contraceptive methods to avoid pregnancy during treatment, regardless of your sex. Cytarabine may cause birth defects, so it is essential that if you think you are pregnant, you inform your doctor. Both men and women should use effective contraceptive methods during treatment and for 6 months after the last dose.

Contraception in women of childbearing age

Women should always use effective contraceptive methods (contraception) to avoid pregnancy during treatment and for 6 months after the last dose. Consult your doctor about the contraceptive methods that are suitable for you and your partner.

Contraception in men

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

Breastfeeding

Breastfeeding should be discontinued during treatment with Cytarabine Pfizer and for at least one week after the last dose or treatment should be discontinued, as this medicine may be harmful to breastfed babies.

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 not known if Cytarabine Pfizer has any effect on the ability to drive or use machines. However, you should not drive if you experience any adverse event (nausea or vomiting) that affects your ability to drive or use machines.

Cytarabine Pfizer contains sodium

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

3. How to use Cytarabine Pfizer

Method and route of administration

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

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

In case of doubt, consult your doctor or nurse again.

Posology

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

Your doctor will indicate the number of treatment cycles you need.

During treatment, you will require frequent examinations, including blood tests. Your doctor will tell you how often you need to do this and will perform regular checks on:

• Blood to check if you have low blood cell counts that require treatment.
• Liver (also through blood tests) to check that cytarabine does not negatively affect its function.
• Kidneys (also through blood tests) to check that cytarabine does not negatively affect their function.
• Uric acid levels in the blood: cytarabine may increase uric acid levels in the blood. If your uric acid levels are too high, you may be given another medicine.

If you receive more Cytarabine Pfizer than you should

This medicine will be administered to you in the hospital, so it is unlikely that you will receive more cytarabine than you should; however, some of the known serious side effects of the medicine, such as mouth ulcers, may appear, or the white blood cell and platelet count in the blood may decrease. In such cases, you may need antibiotics or blood transfusions. Mouth ulcers can be treated to reduce discomfort during the healing process.

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

4. Possible side effects

Like all medicines, Cytarabine Pfizer can cause side effects, although not everybody gets them.

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

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

• Infections, generalized infection, pneumonia.
• Reduction in the number of red blood cells, white blood cells, and/or platelets in the blood.
• Depression of the bone marrow, i.e., alteration of the immune system with loss of the ability to fight infections or diseases.
• Alteration of normal brain and cerebellum function*, feeling of sleepiness*.
• Disorder of the cornea of the eye*.
• Fluid accumulation in the lungs*, difficulty breathing*.
• Nausea, vomiting, diarrhea, inflammation or ulcers in the mouth or anus, abdominal pain.
• Liver alteration.
• Rash, hair loss.
• Fever, cytarabine syndrome (consisting of muscle pain, bone pain, and sometimes chest pain, fever, conjunctivitis, rash, and discomfort, which usually appears 6-12 hours after administration and is treated with corticosteroids).
• Changes in the appearance of bone marrow and blood cells.

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

• Inflammation of a portion of the intestine with cell death (necrotizing colitis)*.
• Ulcers on the skin, peeling*.

Side effects of unknown frequency (cannot be estimated from the available data) include:

• Severe allergic reaction.
• Inflammation at the injection site.
• Localized pus formation in the liver*.
• Fluid retention of allergic origin.
• Lack of appetite.
• Personality change*.
• Toxicity to the nervous system, nerve inflammation, headache, dizziness, coma*, alterations in motor and sensory function of the peripheral nervous system* (when administered intrathecally), in children, a rare inflammatory disorder that causes damage to the material covering the nerves (leukoencephalopathy) may appear, paralysis of the legs and lower body (paraplegia), progressive ascending paralysis, progressive toxicity, seizures.
• Conjunctivitis (infection in an area of the eye that may be accompanied by a rash), conjunctivitis with bleeding*, blindness (when administered intrathecally).
• Inflammation of the tissue covering the heart (pericarditis), slower than normal heart rate (sinus bradycardia).
• Heart disease (cardiomyopathy)*, increased heart size (cardiomegaly)*.
• Obstruction and inflammation of the blood vessel where the injection is performed (thrombophlebitis).
• Sore throat, shortness of breath, inflammation of a part of the lung tissue*.
• Ulcer in the esophagus, inflammation of the esophagus, gastrointestinal ulcer*, presence of cysts in the intestinal wall*, peritonitis*, death of intestinal cells*, pancreatitis (inflammation of the pancreas).
• Yellowish skin color, liver damage*, increased bilirubin levels*.
• Hives, skin spots, itching.
• Urinary retention, kidney alteration.
• Chest pain.
• Reaction at the injection site.
• Rash on the palms of the hands and soles of the feet.

• Due solely to high doses of cytarabine

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the vial and label after EXP. The expiry date is the last day of the month shown.

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

Any unused product or waste material should 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 pack contents

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

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

Not all 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 last revision of this leaflet: December 2022

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