Prospecto: information for the user

Clofarabina Accord 1 mg/ml concentrate for infusion solution EFG

Clofarabina

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1.Clofarabina Accord and its use

2.What you need to know before starting to use Clofarabina Accord

3.How to use Clofarabina Accord

4.Possible adverse effects

5.Storage of Clofarabina Accord

6.Contents of the package and additional information

This medication contains the active ingredient clofarabina. Clofarabina is part of a family of medications known as antineoplastic agents. It works by making it difficult for abnormal white blood cells to grow, and then killing them. It acts more effectively on cells that multiply rapidly, such as cancer cells.

Clofarabina is 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 abnormal growth of certain types of white blood cells.

No use Clofarabina Accord:

• if you are allergicto clofarabina or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding a baby(read the section “Pregnancy and breastfeeding” included later in this document);
• 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 this medicine,inform your doctor if your child is in any of these situations.

Warnings and precautions

Inform your doctor if you are in any of the situations described below.Clofarabina Accord 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: since clofarabina reduces 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 stools);
• 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, abdominal pain, jaundice (yellowing of the skin and eyes), 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 if you experience drowsiness, nausea, vomiting, difficulty breathing, loss of appetite, and/or weakness (these may be signs of acute kidney failure or kidney failure).

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

During treatment with Clofarabina Accord, your doctor will perform blood tests and other checks periodically to monitor your health. Due to its mode of action, this medicine will have effects on the blood and other organs.

Discuss birth control measures with your doctor.Young men and women should use effective contraceptive methods during and after treatment. See the section “Pregnancy and breastfeeding” included later in this document. Clofarabina can cause damage to the reproductive organs in both males and females. Ask your doctor to explain what can be done to protect you or allow you to have children.

Use of Clofarabina Accord with other medicines

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

• 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 it is 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 suspect you are pregnant during clofarabina treatment,consult your doctor immediately.

Men should also use effective contraceptive methods and are advised not to father children while receiving this medicine and for 3 months after treatment completion.

If you are breastfeeding a baby, you should stop doing so before starting treatment and continue not to do so 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 Accord contains sodium

This medicine contains 70.77 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3.54% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 5 or more vials daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

A qualified and experienced doctor in the treatment of leukemia has prescribed this medication for you.

Your doctor will determine the appropriate dose for you based on your weight, height, and overall health.Before administration, clofarabina must be diluted in a sodium chloride solution (salt and water). 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 Accord once a day for 5 days.It will be administered to you 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 implanted. 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 prevent dehydration.

If you take more Clofarabina Accord than you should

If you think you may have been given too much medication, inform your doctor immediately.

If you forget to use Clofarabina Accord

Your doctor will tell you when you need to take this medication. If you think you have missed a dose, inform your doctor immediately.

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 side effects (may affect more than 1 in 10 people):

• anxiety, headache, fever, fatigue;
• nausea and vomiting, diarrhea (loose bowel);
• flushing (redness), inflamed and pruritic skin (itching skin), inflammation of mucous membranes (moist) of the mouth and other areas of the body;
• more infections than normal due to Clofarabina reducing the number of certain types of blood cells in your body;
• skin exanthems 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 side effects (may affect up to 1 in 10 people):

• blood infections, pneumonia, herpes zoster, infections in an implant, oral infections such as candidiasis or sores caused by a herpes;
• changes in blood biochemistry, changes in white blood cells;
• allergic reactions;
• feeling thirsty and urine that is darker or less in quantity than usual, 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;
• yellow discoloration 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 wall or bone pain, neck or back pain, pain in the extremities, muscles or joints;
• blood in the urine;
• organ insufficiencies, pain, increased muscle tension, fluid retention and swelling in some parts of the body including arms and legs, changes in mental state, feeling of heat, 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 side effects (may affect up to 1 in 100 people):

• inflammation of the liver (hepatitis).

Reporting 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 for Pharmacovigilance of Medicines for Human Use at www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the vial label and the box after CAD. The expiration date is the last day of the month indicated.

Do not freeze.

Do not use this medication if you notice discoloration.

After dilution:

Physical and chemical stability has been demonstrated for use up to 3 days at 2°C-8°C and at room temperature (up to 25°C).

From a microbiological standpoint, the medication should be used immediately. If not used immediately, the conditions and times of conservation in use will be the responsibility of the user and will normally not exceed 24 hours at 2°C – 8°C, unless the dilution takes place in a validated and controlled aseptic area.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Clofarabina Accord

The active ingredient is clofarabina. Each ml contains 1 mg of clofarabina. Each vial of 20 ml contains 20 mg of clofarabina.

The other components are sodium chloride and water for injection.

Appearance of the product and packaging size

Clofarabina Accord is a concentrate for solution for infusion. It is a transparent 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. Each box contains 1 vial,

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,

08039 Barcelona,

Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW20A

Kordin Industrial Park,

Paola, PLA3000, Malta

or

Accord Healthcare Polska Sp.z.o.o.

Ul. Lutomierska 50,

95-200, Pabianice,

Poland

This medicinal product isauthorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: October 2023

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

Instructions for the use of clofarabina by healthcare professionals

The following information is intended solely for healthcare professionals:

Special precautions for administration

Clofarabina Accord 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 the total volume needed 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 for 3 days at 2 °C to 8 °C and at room temperature (up to 25 °C). From a microbiological point of view, it must be used immediately. If it is 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 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 handled in accordance with the recommended procedures for the proper handling of antineoplastic agents. Cytotoxic drugs must be handled with caution.

It is recommended to use disposable gloves and protective clothing during the handling of clofarabina. 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.

Disposal

Clofarabina is for single use. 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.