1 mg / mL concentrate for infusion solution
klorfarabin
1. What Evoltra is and what it is used for
Evoltra contains the active substance clofarabine. Clofarabine belongs to the group of medicines called cytostatic/cytotoxic medicines (medicines used to treat cancer). It works by inhibiting the growth of these abnormal white blood cells to eventually obliterate them. It works best against cells that divide quickly – like cancer cells.
Evoltra is used to treat children (≥1 year of age), adolescents, and young adults up to 21 years of age with acute lymphocytic leukemia (ALL) when previous treatments have not worked or have stopped working. Acute lymphocytic leukemia is caused by abnormal growth of certain types of white blood cells.
2. What you need to know before using Evoltra
Do not use Evoltra
- if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6)
- if you are breast-feeding (see section “Pregnancy and breast-feeding” below)
- if you have severe kidney or liver problems
You should inform your doctor if you have any of these conditions. If you are the parent of a child being treated with Evoltra, tell your doctor if any of them fit your child.
Warnings and cautions
You should tell your doctor if any of these are true for you. Evoltra may not be suitable for you.
- if you have had a severe reaction after a previous use of this medicine
- if you have kidney disease or have had one before
- if you have liver disease or have had one before
- if you have heart disease or have had one before.
You should immediately inform your doctor or healthcare provider if you experience any of the following, as treatment may then need to be stopped:
- if you get a fever or high temperature – clofarabine reduces the number of blood cells is formed in bone marrow one, you may be more likely to get the infection you
- if you have difficulty breathing, have heavy breathing, or shortness of breath
- if you feel a change in your heart rhythm
- if you suffer from dizziness (feeling intoxicated) or fainting – it may be a symptom of low blood pressure
- if you feel nauseous or have diarrhea (loose stomach)
- If your urine is darker than usual – it is important to drink plenty of water to avoid dehydration
- if you get a rash with blisters or sores in your mouth
- if you lose your appetite, feel unwell, vomit, have diarrhea, dark urine, and light stools, stomach pain, jaundice (yellowing of the skin and eyes) or if you feel sick, this may be a symptom of an inflammation of the liver ( hepatitis ) or liver damage (liver failure).
- if you have little or no urine production, or experience drowsiness, nausea, vomiting, shortness of breath, loss of appetite, and/or feeling weak (these may be signs of [acute] kidney failure ).
If you are the parent of a child being treated with Evoltra, tell your doctor if any of the above apply to your child.
During treatment with Evoltra, your doctor will perform regular blood tests and other tests to check your health. Due to the mechanism of action of the drug, it affects the blood and other organs.
Talk to your doctor about contraception. Young men and women must use effective contraception during and after treatment. See section “Pregnancy and breast-feeding” below. Evoltra can damage both male and female reproductive organs. Consult your doctor about what you can do to protect yourself or if you may want to start a family.
Other medicines and Evoltra
Tell your doctor or pharmacist if you are taking or have recently taken:
- heart medicine;
- any drug that affects blood pressure;
- drugs that affect the liver or kidneys;
- other medicines, including over-the-counter medicines.
Pregnancy and breastfeeding
Clofarabine should not be used during pregnancy unless clearly necessary.
Women who may become pregnant: you must use an effective contraceptive during treatment with clofarabine. Clofarabine can cause harm to the fetus when used by pregnant women. If you are pregnant or become pregnant during treatment with clofarabine, seek medical advice immediately.
Men must also use an effective contraceptive when they or their partner are being treated with clofarabine.
If you are breast-feeding, you must stop breast-feeding before starting treatment, and must not breast-feed during treatment or within 3 months after stopping treatment.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy, have a feeling of intoxication, or feel dizzy.
Evoltra contains sodium
This medicine contains 72 mg of sodium (the main ingredient in cooking/table salt) in each vial. This corresponds to 3.6% of the recommended maximum daily intake of sodium for an adult. Talk to your pharmacist or doctor if you need 5 or more vials daily during your treatment cycle for an extended period of time, especially if you have been advised to stick to a low-salt diet.
3. How to use Evoltra
Your treatment with Evoltra is prescribed by a qualified doctor with experience in the treatment of leukemia.
Your doctor will calculate the right dose for you based on your height, weight, and how you feel. Before you receive Evoltra, dilute it with a sodium chloride solution (salt and water). Tell your doctor if you are on a controlled salt diet as it may affect how you get your medicine.
Your doctor will give you Evoltra once a day for 5 days. It is given as an infusion through a long thin tube that goes into a vein (a drip) or into a small medical device that is inserted under the skin ( port-a-cath ) if you (or your child) have received one. implanted. Infusion one is given over 2 hours. If you (or your child) weigh less than 20 kg, the infusion time may be longer.
Your doctor will check your health and may change your dose depending on how you react to the treatment. It is important to drink plenty of water to avoid dehydration.
If you take more Evoltra than you should
Tell your doctor straight away if you think you have been given too much medicine.
If you forget to use Evoltra
Your doctor will tell you when to take this medicine. Tell your doctor if you think you have missed a dose.
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 user in 10):
- anxiety, headache, fever, fatigue;
- nausea and vomiting, diarrhea (loose stomach);
- redness, itchy and inflamed skin, inflammation of the mucous membranes of the mouth and other places;
- you may get more infections than usual because Evoltra reduces the number of certain blood cells in the body;
- skin rash that may cause itchy, red, painful, or scaly skin including on the palms and soles of the feet or small red or red-violet spots under the skin.
Common (may affect up to 1 in 10 people):
- infection in the blood, pneumonia, shingles, implant infections, infection in the mouth such as cod and cold sores;
- changes in blood composition, changes in white blood cells;
- allergic reactions;
- thirst and dark-colored urine or less urine than normal decreased appetite or loss of appetite, weight loss;
- anxiety, irritation, or restlessness;
- numbness or weakness in the arms and legs, numbness in the skin, drowsiness, dizziness, tremors;
- hearing problems;
- water accumulations around the heart, fast heart rate;
- low blood pressure bumps on larger bruises;
- leakage from small blood vessels, rapid breathing, nosebleeds, difficulty breathing, shortness of breath, cough;
- bloody vomiting, abdominal pain, pain in the rectum;
- bleeding inside the head, stomach, intestines or lungs, mouth or gums, cold sores, inflammation of the oral cavity;
- yellowing of the skin and eyes (also called jaundice) or other liver diseases;
- bruising, hair loss, changes in skin color, increased sweating, dry skin, or other skin problems;
- pain in the chest or sternum, neck or back pain, pain in limbs, muscles, or joints;
- blood in the urine;
- organ failure, pain, increased muscle tension, water retention and swelling in parts of the body including arms and legs, changes in the state of mind, feeling hot, cold, or abnormal;
- clofarabine can affect the level of certain substances in the blood. Your doctor will perform regular tests to check that your body is functioning properly.
- liver damage (liver failure).
- if you have little or no urine production, or experience drowsiness, nausea, vomiting, shortness of breath, loss of appetite, and/or feeling weak (these may be signs of [acute] kidney failure ).
Uncommon side effects (may affect up to 1 in 100 people ):
- inflammation of the liver ( hepatitis ).
5. How to store Evoltra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial or carton after EXP. The expiration date is the last day of the specified month.
Do not freeze. After reconstitution and dilution, Evoltra should be used immediately or within 24 hours if stored in a refrigerator (2 ° C – 8 ° C).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is clofarabine. Each ml contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine.
The other ingredients are sodium chloride and water for injections.
What the medicine looks like and the contents of the pack
Evoltra is a concentrate for solution for infusion. It is a clear, almost colorless solution that is prepared and diluted before use. It is supplied in 20 ml glass vials. The vials contain 20 mg of clofarabine and are packaged in a box. Each box contains 1, 3, 4, 10, or 20 vials, but not all pack sizes may be marketed.
Marketing Authorisation Holder
Genzyme Europe BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Manufacturer
Genzyme Ltd.
37 Hollands Road
Haverhill, Suffolk
CB9 8PU
United Kingdom
SANOFI WINTHROP INDUSTRY
30-36, Gustave Eiffel Avenue
37100 Tours
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00