Clofarabine Teva 1 mg/ml concentrate for infusion solution EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Clofarabine Teva 1 mg/ml concentrate for solution for infusion EFG
Read the entire 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.
- If you experience any side effects, talk to your doctor, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Clofarabine Teva is and what it is used for
- What you need to know before using Clofarabine Teva
- How to use Clofarabine Teva
- Possible side effects
- How to store Clofarabine Teva
- Contents of the pack and other information
1. What Clofarabina Teva is and what it is used for
Clofarabina Teva contains the active substance clofarabine. Clofarabine belongs to a family of medicines called antineoplastic agents. It works by interfering with the growth of abnormal white blood cells, which it subsequently kills. It is more effective against cells that multiply rapidly, such as cancer cells.
Clofarabina Teva 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 failed or 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 Teva
Do not use Clofarabine Teva
- 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 section “Pregnancy and breastfeeding” below);
- if you have severe kidney or liver problems.
Tell your doctor if you are in any of the situations listed above. If you are the parent of a child being treated with Clofarabine Teva, inform the doctor if your child is in any of these situations.
Warnings and precautions
Talk to your doctor before starting treatment with Clofarabine Teva.
Tell your doctor if you are in any of the situations listed below. Clofarabine Teva 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 symptoms, as treatment may need to be stopped:
- fever or high temperature – because clofarabine reduces the bone marrow's ability to produce blood cells, you may be more prone to infections;
- difficulty breathing, shortness of breath, or faster breathing;
- changes in your heart rate;
- dizziness (feeling faint) or fainting – this could indicate low blood pressure;
- nausea or diarrhoea (loose stools);
- darker than usual urine – it is important to drink plenty of water to avoid dehydration;
- blistering rash or mouth ulcers;
- loss of appetite, nausea (feeling unwell), vomiting, diarrhoea, dark urine, pale stools, stomach pain, jaundice (yellowing of the skin and eyes), or general malaise – these may be signs of liver inflammation (hepatitis) or liver damage (liver failure);
- reduced urine output or no urine production, or 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 Teva, inform the doctor if your child experiences any of the symptoms listed above.
During treatment with Clofarabine Teva, 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. Men and women who can become pregnant must use effective contraception during and after treatment. See the section “Pregnancy and breastfeeding” below. 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.
Children
A safe and effective dosage recommendation has not been established for patients under 1 year of age.
Using Clofarabine Teva with other medicines
Tell your doctor if you are taking, using, or have recently taken or 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 foetus. If you are pregnant or become pregnant during treatment with clofarabine, contact a doctor immediately.
Men should also use effective contraception and should be advised not to attempt to father a child while receiving clofarabine and for 3 months after the end of treatment.
If you are breastfeeding, you must stop before starting treatment and continue not to breastfeed during treatment and for 2 weeks after the end of treatment.
Driving and use of machines
Do not drive or operate tools or machinery if you feel dizzy, lightheaded, or faint.
Clofarabine Teva contains sodium
This medicine contains 70.8 mg of sodium (the main component of table/cooking salt) per 20 ml vial. This corresponds to 3.54% of the maximum daily recommended sodium intake for an adult.
3. How to use Clofarabine Teva
A qualified and experienced physician in the treatment of leukemia has prescribed Clofarabine Teva for you.
Your doctor will determine the appropriate dose for you based on your weight, height, and health status. Before administration, Clofarabine Teva must be diluted in a sodium chloride solution (salt and water). Inform your doctor if you are following a sodium-restricted diet, as this may affect how the medicine is administered.
Your doctor will administer Clofarabine Teva 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 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 condition and may adjust the dose depending on your response to treatment. It is important that you drink plenty of water to avoid dehydration.
If you use more Clofarabine Teva than you should
If you think you may have been given more medicine than you should have, inform your doctor immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service (91) 562 04 20; alternatively, consult your doctor as soon as possible after taking the medicine or contact the nearest hospital emergency department.
If you forget to use Clofarabine Teva
Your doctor will advise you when this medicine needs to be administered. If you think you have missed a dose, inform your doctor without delay.
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 will experience them.
Very common (may affect more than 1 in 10 people)
- anxiety, headache, fever, fatigue;
- nausea and vomiting, diarrhoea (loose bowels);
- redness, inflamed and itchy skin, inflammation of the moist mucous linings of the mouth and other areas of the body;
- more infections than usual because Clofarabine Teva may reduce the number of certain types of blood cells in your body;
- skin rashes which may be itchy, skin redness, pain or peeling affecting also the palms of the hands and soles of the feet, or small red or purple spots under the skin surface.
Common (may affect up to 1 in 10 people)
- blood infections, pneumonia, shingles (herpes zoster), infections in an implant, mouth infections such as sores and cold sores;
- changes in blood biochemistry, changes in white blood cells;
- allergic reactions;
- feeling thirsty and darker urine 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 colour, 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 levels 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 renal failure or kidney failure).
Uncommon (may affect up to 1 in 100 people)
- inflammation of the liver (hepatitis).
Frequency not known (cannot be estimated from available data)
- intestinal inflammation;
- inflammation of the pancreas (pancreatitis);
- blistering rash on the skin and mucous membranes of the mouth, nose, eyes and genitals (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Clofarabine Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the vial and on the carton following EXP. The expiry date refers to 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, storage times and conditions prior to use are the responsibility of the user and should not usually exceed 24 hours at 2–8°C, unless the dilution has been carried out under controlled, aseptic, and validated conditions. Do not freeze.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Clofarabine Teva
- The active substance is clofarabine. Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine.
- The other components are sodium chloride, hydrochloric acid (to adjust pH), and water for injections.
Nature of the medicinal product and package contents
Clofarabine Teva is a concentrate for solution for infusion. It is a clear, almost colourless solution which must be 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. The vials may or may not be individually wrapped in a protective sleeve.
Each carton contains 1 or 4 vials.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Teva Pharma, S.L.U.
C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta.
28108 Alcobendas, Madrid
Spain
Manufacturer
S.C. SINDAN-PHARMA S.R.L.
11th Ion Mihalache Boulevard
Bucharest 1
011171
Romania
This medicinal product is authorised in the member states of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria Clofarabin Actavis 1 mg/ml concentrate for solution for infusion
Germany Clofarabin-ratiopharm 1 mg/ml concentrate for solution for infusion
Spain Clofarabine Teva 1 mg/ml concentrate for solution for infusion EFG
Italy Clofarabine Teva
United Kingdom Clofarabine Teva 1 mg/ml Concentrate for solution for infusion
(Northern Ireland)
Romania Clofarabine Teva 1 mg/ml concentrate for solution for infusion
Date of the most recent review of this package leaflet: November 2023
The reference medicinal product containing clofarabine has been authorised under "exceptional circumstances". This type of approval means that, due to the rarity of the disease, complete information on this medicinal product could not be obtained.
The European Medicines Agency will review any new information about the medicinal product annually, and this package leaflet will be updated as necessary.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
<---------------------------------------------------------------------------------------------------------------?
This information is intended for healthcare professionals only:
Special precautions for administration
Clofarabine Teva 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 into an intravenous infusion solution containing 9 mg/ml sodium chloride (0.9%) to achieve a total 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, then diluted, and subsequently administered through a 0.22-micron in-line filter integrated into the administration set).
Recommended dilution table according to the recommended dose of 52 mg/m²/day of clofarabine | ||
Body surface area (m²) | Concentrate (ml)* | Total diluted volume |
≤ 1.44 | ≤ 74.9 | 100 ml |
1.45 to 2.40 | 75.4 to 124.8 | 150 ml |
2.41 to 2.50 | 125.3 to 130.0 | 200 ml |
*Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. Therefore, in patients with a body surface area ≤ 0.38 m², only part of the contents of a single vial will be needed to achieve the recommended daily dose of clofarabine. Conversely, in patients with a body surface area > 0.38 m², the contents of 1 to 7 vials will be required to achieve the recommended daily dose of clofarabine. |
The diluted concentrate should be a clear, colourless solution. It must be inspected visually before administration to ensure there are no 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 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, aseptic, and validated conditions. Do not freeze.
Handling instructions
Handling should follow recommended procedures for the safe handling of antineoplastic agents. Cytotoxic drugs must be handled with caution.
Disposable gloves and protective clothing are recommended when handling Clofarabine Teva. If the product comes into contact with the eyes, skin, or mucous membranes, immediately rinse the affected area thoroughly with plenty of water.
Pregnant women should not handle Clofarabine Teva.
Disposal
Clofarabine Teva is for single use only.
Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations for cytotoxic agents.