Clofarabine Accord 1 mg/ml concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clofarabine Accord 1 mg/ml concentrate for solution for infusion EFG

Clofarabine

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

Contents of the leaflet

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

1. What Clofarabine Accord is and what it is used for

This medicine contains the active substance clofarabine. Clofarabine belongs to a family of medicines known as antineoplastic agents. It works by interfering with the growth of abnormal white blood cells, which it subsequently kills. It is most effective against cells that multiply rapidly, such as cancer cells.

Clofarabine 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 previous treatments have either not worked or have stopped working. Acute lymphoblastic leukemia is caused by the abnormal growth of certain types of white blood cells.

2. What you need to know before using Clofarabine Accord

Do not use Clofarabine Accord:

• if you are allergic to clofarabine or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding (see the section “Pregnancy and breastfeeding” included later in this document);
• if you have severe kidney or liver problems.

Tell your doctor if you are in any of the situations described above. If you are the parent of a child being treated with this medicine, inform the doctor if your child is in any of these situations.

Warnings and precautions

Tell your doctor if you are in any of the situations described below. Clofarabine Accord may not be an appropriate treatment for you:

• if you have previously experienced a serious reaction to this medicine;
• if you have or have had kidney disease;
• if you have or have had liver disease;
• if you have or have had heart disease.

Contact your doctor or healthcare provider immediately if you experience any of the following problems, as treatment may need to be stopped:

• if you develop fever or high temperature: because clofarabine reduces the bone marrow’s ability to produce blood cells, you may be more prone to infections;
• if you experience difficulty breathing, shortness of breath, or faster breathing;
• if you notice any changes in your heart rate;
• if you feel dizzy (as if you might faint) or faint: these may be signs of low blood pressure;
• if you have nausea or diarrhea (loose stools);
• if your urine appears darker than usual: it is important to drink plenty of fluids to avoid dehydration;
• if you develop a blistering rash or mouth ulcers;
• if you lose your appetite, have nausea (feeling unwell), vomiting, diarrhea, dark urine, pale stools, stomach pain, jaundice (yellowing of the skin and eyes), or generally feel unwell—these may be symptoms of liver inflammation (hepatitis) or liver damage (liver 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 injury or kidney failure).

If you are the parent of a child being treated with clofarabine, inform the doctor if your child experiences any of the problems listed above.

During treatment with Clofarabine Accord, your doctor will perform regular blood tests and other examinations to monitor your health. Due to its mechanism of action, this medicine may affect the blood and other organs.

Talk to your doctor about contraception measures. Young men and women should use effective contraception during and after treatment. See the section “Pregnancy and breastfeeding” included later in this document. Clofarabine may cause damage to both male and female reproductive organs. Ask your doctor to explain what can be done to protect you or to allow you to have children in the future.

Using Clofarabine Accord with other medicines

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

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

Pregnancy and breastfeeding

Clofarabine is not recommended during pregnancy unless clearly necessary.

Women of childbearing potential: you must use an effective method of contraception during treatment with clofarabine and for 6 months after the end of treatment. Administration of clofarabine to pregnant women may cause harm to the fetus. If you are pregnant or become pregnant during treatment with clofarabine, contact your doctor immediately.

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

If you are breastfeeding, you must stop before starting treatment and remain off breastfeeding throughout treatment and for 2 weeks after treatment ends.

Driving and use of machines

Do not drive or operate tools or machinery if you feel dizzy, lightheaded, or faint.

Clofarabine Accord contains sodium

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

Consult your doctor or pharmacist if you require 5 or more vials per day over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to use Clofarabine Accord

A qualified and experienced physician in the treatment of leukemia has prescribed this medicine for you.

Your doctor will determine the appropriate dose for you based on your weight, height, and overall health condition. Before administration, clofarabine must be diluted in a sodium chloride solution (salt and water). Inform your doctor if you are on a sodium-restricted diet, as this may affect how the medicine is administered.

Your doctor will administer Clofarabine Accord once daily for 5 days. It will be given as an intravenous infusion through a thin, long tube inserted into a vein (an IV drip) or through a small medical device implanted under the skin (port-a-cath), if you (or your child) have one. The infusion will be given 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 depending on your response to treatment. It is important that you drink plenty of fluids to avoid dehydration.

If you use more Clofarabine Accord than you should

If you think you may have received more medicine than you should have, inform your doctor immediately.

If you forget to use Clofarabine Accord

Your doctor will advise you when this medicine needs to be administered. If you think a dose has been missed, inform your doctor immediately.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• anxiety, headache, fever, fatigue;
• nausea and vomiting, diarrhea (loose bowels);
• flushing (reddening), inflamed and pruritic skin (itchy skin), inflammation of the moist mucous linings of the mouth and other areas of the body;
• increased infections due to clofarabine possibly reducing the number of certain types of blood cells in your body;
• skin rashes that may itch, redness, pain or peeling of the skin affecting the palms of the hands and soles of the feet, or small red or purple spots under the surface of the skin.

Common adverse 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 herpes;
• changes in blood biochemistry, changes in white blood cells;
• allergic reactions;
• feeling thirsty and darker or less urine than usual, decreased or loss of appetite, weight loss;
• agitation, irritability or restlessness;
• numbness or weakness in arms and legs, skin numbness, drowsiness, dizziness, tremor;
• hearing problems;
• fluid accumulation around the heart, rapid heartbeat;
• low blood pressure, lumps due to severe bruising;
• bleeding through very small blood vessels, rapid breathing, nosebleeds, breathing difficulties, shortness of breath, cough;
• vomiting blood, stomach pain, pain in the buttocks;
• bleeding inside the head, stomach, intestine or lungs, mouth or gums, mouth ulcers, inflammation of the lining of the mouth;
• yellowing of the skin and eyes (also known as jaundice) or other liver disorders;
• bruising, hair loss, changes in skin coloration, increased sweating, dry skin or other skin problems;
• chest wall or bone pain, neck or back pain, pain in limbs, muscles or joints;
• blood in the urine;
• organ failure, pain, increased muscle tension, fluid retention and swelling of certain parts of the body including arms and legs, changes in mental state, feeling hot, cold or feeling "strange";
• clofarabine may alter blood concentrations of certain substances. Your doctor will perform periodic blood tests to assess whether your body is functioning properly.
• liver damage (liver failure).
• little or no urine, drowsiness, nausea, vomiting, difficulty breathing, loss of appetite and/or weakness (possible signs of acute kidney injury or kidney failure).

Uncommon adverse effects (may affect up to 1 in 100 people):

• inflammation of the liver (hepatitis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clofarabine Accord

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

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

Do not freeze.

Do not use this medicine if discoloration is observed.

After dilution:

Physicochemical stability in use has been demonstrated for up to 3 days at 2°C–8°C and at room temperature (up to 25°C).

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the conditions and duration of storage in use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless the dilution takes place under validated and controlled aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clofarabine Accord

The active substance is clofarabine. Each ml contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine.

The other components are sodium chloride and water for injections.

Appearance of the product and pack sizes

Clofarabine Accord is a concentrate for solution for infusion. It is a clear, almost colourless solution which is prepared and diluted before use. It is supplied in 20 ml glass vials. The vials contain 20 mg of clofarabine and are supplied packed in a carton. Each carton contains 1 vial.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est, 6th floor,

08039 Barcelona,

Spain

Manufacturer

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 is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: October 2023

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

Instructions for the use of clofarabine for healthcare professionals

The following information is intended exclusively for healthcare professionals:

Special administration precautions

Clofarabine Accord 1 mg/ml concentrate for solution for infusion must be diluted before administration. It should be passed through a sterile 0.2-micron syringe filter, then diluted in an intravenous infusion solution containing 9 mg/ml sodium chloride (0.9%) to obtain the total required volume according to the examples provided in the table below. However, the final dilution volume may vary depending on the patient's clinical condition and the physician's judgment. (If a 0.2-micron syringe filter cannot be used, the concentrate should be pre-filtered through a 5-micron filter, diluted, and then administered through a 0.22-micron in-line filter integrated into the administration set).

The diluted concentrate must be a clear, colorless solution. It should be inspected visually before administration to ensure there are no 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 standpoint, it should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2 °C to 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions. Do not freeze.

Handling instructions

Handling should follow recommended procedures for the safe manipulation of antineoplastic agents. Cytotoxic drugs should be handled with caution.

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

Pregnant women should not handle clofarabine.

Disposal

Clofarabine is for single use only. Any unused medicine and all materials that have come into contact with it should be disposed of in accordance with local regulations.