Prospecto:Information for the User

Clofarabina Teva 1 mg/ml Concentrate for Solution for Infusion EFG

Read this prospectus carefully before starting to use this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor.
• If you experience adverse effects,consult your doctor, eveniftheyare not listed in this prospectus. See section 4.

1.What Clofarabina Teva is and for what it is used

2.What you need to knowbeforestarting touse Clofarabina Teva

3.How to use Clofarabina Teva

4.Possible adverse effects

5.Storage of Clofarabina Teva

6.Contents of the package and additional information

Clofarabina Teva contains the active ingredient clofarabina.Clofarabina is part of a group of medicines called antineoplastic agents. It works by making it difficult for abnormal white blood cells to grow, and then killing them. It is more effective on cells that multiply quickly, such as cancer cells.

Clofarabina Tevais used to treat children (≥ 1 year of age), adolescents, and young adults up to 21 years of age with acute lymphoblastic leukemia (ALL) in whom previously administered treatments have not worked or have stopped working. Acute lymphoblastic leukemia is caused by the abnormal growth of some types of white blood cells.

Do not use Clofarabina Teva

• if you are allergicto clofarabina or to any of the other ingredients ofthis medicine (listed in section 6).
• if you are breastfeeding(read the section “Pregnancy and breastfeeding” below)
• if you have severe kidney or liver problems.

Inform your doctor if you are in any of the situations described above.If you are the father or mother of a child being treated with Clofarabina Teva,inform your doctor if your child is in any of these situations.

Warnings and precautions

Consult your doctor before starting to use Clofarabina Teva.

Inform your doctor if you are in any of the situations described below.Clofarabina Teva may not be a suitable treatment for you:

• if you have had a severe reactionto this medicine in the past;
• if you have any kidney diseaseor have had it in the past;
• if you have any liver diseaseor have had it in the past;
• if you have any heart diseaseor have had it in the past.

Inform your doctor or healthcare professional immediatelyif you experience any of the following problems, as it may be necessary to stop treatment:

• if you have a fever or high temperature- as clofarabina can reduce the number of blood cells produced by the bone marrow, you may be more susceptible to infections;
• if you experience breathing difficulties, feeling of lack of air, or have to breathe more quickly;
• if you notice any change in your heart rate;
• if you experience dizziness (feeling of impending loss of consciousness) or fainting- this may be a sign of low blood pressure;
• if you have nausea or diarrhea (loose bowel movements);
• if your urine appears darker than usual- it is essential to drink plenty of water to avoid dehydration;
• if you develop a rash with blisters or mouth ulcers.
• if you lose your appetite, experience nausea (feeling of discomfort), vomiting, diarrhea, dark urine, and pale stools, or generally feel unwell, these may be signs of liver inflammation (hepatitis) or liver damage (hepatic failure).
• if you produce little or no urine, or experience drowsiness, nausea, vomiting, breathing difficulties, loss of appetite, and/or weakness (these may be signs of acute kidney failure or renal failure).

If you are the father or motherof a child being treated with Clofarabina Teva,inform your doctor if your child is in any of the situations described above.

During treatment with Clofarabina Teva, your doctor will perform blood tests and other checks at regular intervals to monitor your health. Due to its mode of action, this medicine will affect your blood and other organs.

Discuss contraceptive measures with your doctor.Men and women who may become pregnant should use effective contraceptive methods during and after treatment. See the section “Pregnancy and breastfeeding” below. Clofarabina Teva can cause damage to male and female reproductive organs. Ask your doctor to explain what can be done to protect you or allow you to have children.

Children

No safe and effective dosage recommendation has been established for patients under 1 year of age.

Use of Clofarabina Teva with other medicines

Inform your doctor if you are taking/using or have taken/used recently:

• heart disease medicines;
• any medicine that affects blood pressure;
• medicines that affect the liver or kidneys;
• other medicines, even those purchased without a prescription.

Pregnancy and breastfeeding

Clofarabina is not recommended during pregnancy, unless clearly necessary.

Women of childbearing age:you should use an effective contraceptive method during clofarabina treatment and for 6 months after treatment completion. Administration of clofarabina to pregnant women can cause fetal damage. If you become pregnant or become pregnant during clofarabina treatment,consult your doctor immediately.

Men should also use effective contraceptive methods and be advised not to attempt to conceive a child while receiving clofarabina, and for 3 months after treatment completion.

If you are breastfeeding, you should stop before starting treatment and continue not to breastfeed during treatment and for 2 weeks after treatment completion.

Driving and operating machines

Do not drive or operate tools or machines if you feel dizzy, vertigo, or are about to faint.

Clofarabina Teva contains sodium

This medicine contains 70.8 mg of sodium (main component of table salt/for cooking) in each 20 ml vial. This is equivalent to 3.54% of the maximum daily sodium intake recommended for an adult.

A qualified and experienced doctor in the treatment of leukemia has prescribed Clofarabina Teva for you.

Your doctor will determine the appropriate dose for you based on your weight, height, and overall health.You must inform your doctor if you are following a low-sodium diet, as this may affect how the medication is administered to you.

Your doctor will administer Clofarabina Teva once a day for 5 days.You will receive it as an infusion through a long, thin tube inserted into a vein (a catheter) or a small medical device implanted under the skin (port-a-cath), if you (or your child) have one. The infusion will be administered over a 2-hour period. If you (or your child) weigh less than 20 kg, the infusion time may be longer.

Your doctor will monitor your health and may adjust the dose based on your response to treatment. It is essential to drink plenty of water to avoid dehydration.

If you use more Clofarabina Teva than you should

If you believe you may have received more medication than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service (91) 562 04 20; or consult your doctor as soon as possible after taking the medication or contact the nearest Hospital Emergency Department.

If you forgot to use Clofarabina Teva

Your doctor will instruct you on when to receive this medication. If you believe you have missed a dose, inform your doctor promptly.

If you have any other questions about using this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people)

• anxiety, headache, fever, fatigue;
• nausea and vomiting, diarrhea (loose bowel);
• redness, inflamed and itchy skin, inflammation of mucous membranes (moist) in the mouth and other areas of the body;
• more infections than normal due to Clofarabina Teva reducing the number of certain types of blood cells in your body;
• skin rashes that can itch, redness, pain or peeling of the skin that also affects the palms of the hands and soles of the feet, or small red or purple spots under the surface of the skin.

Common (may affect up to 1 in 10 people)

• blood infections, pneumonia, shingles, infections in an implant, oral infections such as sores and cold sores;
• changes in blood biochemistry, changes in white blood cells;
• allergic reactions;
• feeling thirsty and darker or less frequent urine, decreased or loss of appetite, weight loss;
• agitation, irritability or restlessness;
• numbness or weakness in legs and arms, numbness of the skin, drowsiness, dizziness, tremor;
• hearing problems;
• fluid accumulation around the heart, rapid heart rate;
• low blood pressure, swelling due to intense bruising;
• bleeding through small blood vessels, rapid breathing, nasal bleeding, respiratory difficulties, feeling of lack of air, cough;
• bloody vomiting, stomach pain, pain in the buttocks;
• bleeding inside the head, stomach, intestine or lungs, mouth or gums, oral ulcers, inflammation of the mouth lining;
• yellowing of the skin and eyes (also called jaundice) or other liver disorders;
• bruises, hair loss, changes in skin color, increased sweating, dry skin or other skin problems;
• chest or bone pain, neck or back pain, pain in the extremities, muscles or joints;
• blood in the urine;
• organ failures, pain, increased muscle tension, fluid retention and swelling in some parts of the body including arms and legs, changes in mental state, feeling hot, cold or feeling "strange";
• Clofarabina may alter blood concentrations of certain substances. Your doctor will perform blood tests periodically to evaluate if your body is functioning correctly;
• liver damage (liver failure)
• little or no urine, drowsiness, nausea, vomiting, difficulty breathing, loss of appetite and/or weakness (possible signs of acute kidney failure or renal failure).

Rare (may affect up to 1 in 100 people)

• inflammation of the liver (hepatitis).

Unknown frequency (cannot be estimated from available data)

• inflammation of the intestine;
• inflammation of the pancreas (pancreatitis);
• skin rash with blisters on the skin and mucous membranes of the mouth, nose, eyes and genitals (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe vial label and on the boxafter CAD. The expiration date is the last day of the month indicated.

Do not freeze.

The diluted concentrate is chemically and physically stable in PVC bags for 3 days at a temperature between 2°C and 8°C and at room temperature (up to 25°C). From a microbiological standpoint, it should be used immediately. If not, the storage times during use and the previous conditions are the responsibility of the user and should not exceed usually 24 hours at 2-8°C, unless the dilution has been performed in controlled and validated aseptic conditions. Do not freeze.

Medicines should not be disposed of through drains. Ask your pharmacisthow to dispose ofthepackaging and of themedicines that you no longerneed.By doing so, you will help protect the environment.

Clofarabina Teva Composition

• The active ingredient is clofarabina. Each ml of concentrate contains 1 mg of clofarabina. Each vial of 20 ml contains 20 mg of clofarabina.
• The other components are sodium chloride, hydrochloric acid (for pH adjustment) and water for injection preparations.

Appearance of the product and contents of the package

Clofarabina Teva is a concentrate for solution for infusion. It is a clear and almost colorless solution that is prepared and diluted before use. It is supplied in glass vials of 20 ml. The vials contain 20 mg of clofarabina and are supplied in a box. The vials may or may not be wrapped in a protective sleeve.

Each box contains 1 or 4 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

S.C. SINDAN-PHARMA S.R.L.

11th Ion Mihalache Boulevard

Bucharest 1

011171

Romania

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

AustriaClofarabin Actavis 1 mg/ml Concentrate for the preparation of an infusion solution

GermanyClofarabin-ratiopharm 1 mg/ml Concentrate for the preparation of an infusion solution

SpainClofarabina Teva 1 mg/ml concentrate for solution for infusion EFG

ItalyClofarabina Teva

United Kingdom Clofarabine Teva 1 mg/ml Concentratefor solution for infusion

(Northern Ireland)

RomaniaClofarabina Teva 1 mg/ml concentrate for solution for infusion

Last date of revision of thissummary of product characteristics:November 2023

The reference medicinal product containing clofarabina has been authorized in"exceptional circumstances". This authorization modality means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency will review any new information available on the medicinal product annually and this summary of product characteristics will be updated as necessary.

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Special precautions for administration

Clofarabina Teva 1 mg/ml concentrate for solution for infusion must be diluted before administration. It must be passed through a sterile syringe filter of 0.2 microns, to then dilute it in an intravenous infusion solution with 9 mg/ml of sodium chloride (0.9%) to obtain a total volume according to the examples provided in the table below. However, the final dilution volume may vary depending on the clinical condition of the patient and the doctor's criteria. (If it is not possible to use a 0.2 micron syringe filter, the concentrate must be pre-filtered through a 5 micron filter, diluted and then administered through a 0.22 micron filter integrated into the administration line).

The diluted concentrate must be a clear and colorless solution. It is essential to visually inspect it before administration to rule out the presence of particles or signs of discoloration.

The diluted concentrate is chemically and physically stable in PVC bags for 3 days at a temperature between 2°C and 8°C and at room temperature (up to 25°C). From a microbiological point of view, it must be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution has been performed in controlled and validated aseptic conditions. Do not freeze.

Instructions for handling

It must be acted upon in accordance with the recommended procedures for the proper handling of antineoplastic agents. Cytotoxic agents must be handled with caution.

The use of disposable gloves and protective clothing is recommended during the handling of Clofarabina Teva. If the product comes into contact with the eyes, skin or mucous membranes, rinse the area immediately with plenty of water.

Pregnant women should not handle Clofarabina Teva.

Disposal

Clofarabina Teva is for single use only.

The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations for cytotoxics.