25 mg / ml concentrate for solution for injection / infusion
What Fludarabine Actavis is and what it is used for
Fludarabine Actavis is an anti-cancer drug.
Fludarabine Actavis is used for treating chronic B-cell lymphocytic leukemia (B- CLL ) in patients with adequate blood cell production. This form of cancer affects a type of white blood cell (so-called lymphocytes ).
Treatment of chronic lymphocytic leukemia with Fludarabine Actavis should only be started in patients with advanced disease with disease-related symptoms or signs of worsening of the disease.
Fludarabine phosphate contained in Fludarabine Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Fludarabine Actavis
Do not use Fludarabine Actavis
- if you are allergic to fludarabine phosphate or any of the other ingredients of this medicine (listed in section 6).
- if you are breast-feeding
- if you have severe renal impairment
- if you have red blood cell deficiency, due to a certain type of anemia (decompensated hemolytic anemia ). Your doctor will inform you if you have this disease.
Warnings and cautions
Talk to your doctor or nurse before using fludarabine phosphate if:
- you have impaired liver function. Your doctor may then prescribe this medicine with caution.
- you have some kind of kidney disease. Your kidney function should then be checked regularly. If the kidneys are found not to function normally, this medicine may need to be given in a lower dose. If your kidney function is severely impaired, you will not receive this medicine. Patients 65 years of age or older should have their kidney function checked before starting treatment.
- you do not feel well. Your doctor may decide not to give this medicine, or give this medicine with caution. This is important if your bone marrow is not functioning normally or if you are susceptible to infection.
- you get unusual bruises, bleed more than usual after injury, or if you suffer from an infection. The number of normal blood cells may be low and you may need to take blood samples regularly during treatment.
- The disease itself and the treatment can cause a decrease in the number of blood cells and your immune system can attack other parts of the body (an autoimmune disease), it can also attack the red blood cells (so-called “autoimmune hemolysis”). This condition can be life-threatening. If you develop this condition, additional medications may be needed, such as blood transfusions (radiation-treated blood, see below) and cortisone.
- If you need a blood transfusion and are being treated (or have been previously treated) with this medicine, tell your doctor. He will then make sure that you will receive blood that has undergone special treatment (irradiated). There have been severe complications, even with fatal outcomes, after non-irradiated blood was given.
- If you need to have your stem cell collected and treated with (or have been treated with) this medicine, tell your doctor.
- There is only limited information on the effects of Fludarabine Actavis in patients 75 years of age or older. Your doctor will use the medicine with caution if you are in this age group.
- If you have very severe chronic lymphocytic leukemia, your body may not be able to get rid of the waste products from the cells destroyed by Fludarabine Actavis. This is called tumor lysis syndrome and can cause dehydration, kidney failure, and heart problems. Your doctor is aware of this and may prescribe other medicines to prevent this from happening.
- If you experience any abnormal symptoms coming from the nervous system, tell your doctor. This is because when using a dose that is four times higher than recommended, severe symptoms from the central nervous system (brain and spinal cord) such as blindness, coma, and death have been reported.
- Tell your doctor if you notice any skin changes either while you are taking this medicine or after you have finished your treatment. The doctor should examine the severity of the skin changes. If you have skin cancer, the damaged parts of the skin may deteriorate further when you use this medicine.
- Men and women of childbearing potential must use reliable contraception during treatment and at least 6 months after stopping treatment.
- Discuss with your doctor if you need to be vaccinated. Live vaccines should be avoided during and after treatment with Fludarabine Actavis.
Children and young people
Fludarabine Actavis is not recommended for use in children and adolescents below 18 years. There is no information available for the use of Fludarabine Actavis in children.
Other medicines and Fludarabine Actavis
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
It is especially important to tell your doctor about:
- Pentostatin (deoxycoformycin), which is also used to treat B- KLL. Taking these two medicines together can cause severe lung problems (which can be life-threatening), so the combination with Fludarabine Actavis is not recommended.
- Dipyridamole (or other similar substances), used to prevent blood clots. They may reduce the effect of Fludarabine Actavis.
- Cytarabine ( Ara-C ), used to treat chronic lymphocytic leukemia. If Fludarabine Actavis is combined with cytarabine, the active form of cytarabine ( Ara-CTP ) may increase in leukemia cells. However, the overall level of cytarabine in the blood and elimination from the blood did not appear to have changed.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Fludarabine Actavis treatment can harm the unborn baby. You should not be given Fludarabine Actavis if you are pregnant unless necessary, and if the potential benefits outweigh the possible risks to the unborn baby. If you are a woman of childbearing potential, you must avoid becoming pregnant during treatment and for at least 6 months after stopping treatment. Tell your doctor immediately if you become pregnant during treatment.
Men of childbearing potential treated with Fludarabine Actavis must use reliable contraception during treatment and up to 6 months after stopping treatment.
It is not known if the medicine is excreted in breast milk in women treated with Fludarabine Actavis. However, in animal studies, medicine has been found in breast milk. Therefore, you should not breast-feed during treatment with this medicine.
Driving and using machines
Some people experience fatigue, weakness, visual disturbances, confusion or upset, or seizures during treatment with Fludarabine Actavis. Avoid driving and using machines until you are sure you are not affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Fludarabine Actavis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.
How to use Fludarabine Actavis
Fludarabine Actavis should be given under the supervision of a doctor who specializes in cancer treatment.
The dose you receive depends on your body size. It varies depending on the body surface area. It is measured in square meters (m 2 ) and is calculated using length and weight. The recommended dose is 25 mg / m 2 body surface area. It is given either as an injection or as an infusion (drip) directly into a vein once a day for 5 consecutive days every 28 days. The five-day regimen is repeated every 28 days until your doctor considers that the best effect has been achieved (usually after 6 rounds). The dose can be reduced or the treatment postponed depending on any side effects. If you have kidney problems or if you are over 65, your kidneys will be checked regularly. If your kidneys do not function normally, you may receive a lower dose of this medicine. If you have severe kidney function, you will not receive this medicine (see also section 2, “Do not use Fludarabine Actavis”).
The safety of this medicine in children and adolescents under 18 years of age has not been established and treatment is not recommended.
If any of the contents of Fludarabine Actavis come in contact with your skin, nose, or lips, wash thoroughly with soap and water. If you get the solution in your eyes, rinse thoroughly with large amounts of water. Avoid inhaling vapors from the solution.
If you use more Fludarabine Actavis then you should
In case of overdose, your doctor may discontinue treatment and treat any symptoms that may occur.
Symptoms of overdose may include delayed blindness, coma, and death caused by toxicity (toxicity) to the central nervous system. High doses can lead to a marked decrease in the number of blood cells.
If you forget to take Fludarabin Actavis
Your doctor will make a schedule for when you will receive the medicine. Contact your doctor immediately if you suspect you have missed a dose.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you are not sure what the side effects are, ask your doctor to explain them to you.
Some side effects can be life-threatening. You must contact your doctor immediately if you notice any of the following:
- Difficulty breathing, coughing, or chest pain with or without fever. These symptoms may be signs of a lung infection ( pneumonia ).
- Unusual bruising, bleeding more than usual after injury or if you appear to be susceptible to infection. These symptoms can be caused by a decreased number of blood cells. This can also lead to an increased risk of (serious) infections, caused by organisms, which do not normally cause diseases in healthy people (opportunistic infections ), including a late reactivation of viruses such as herpes zoster.
- Pain in the side, blood in the urine, or decreased urine output. These symptoms may be signs of tumor lysis syndrome (see section 2 “Warnings and precautions”).
- Skin and/or mucosal changes with redness, inflammation, blistering, and tissue degradation. These symptoms may be signs of a severe allergic reaction ( Lyell’s syndrome, Stevens-Johnson syndrome).
You have palpitations (if you suddenly become aware of your heartbeat) or chest pain. These symptoms may be signs of heart problems.
Listed below are other possible side effects according to how common they are. The rare side effects (which may affect up to 1 in 1000 people) were mainly reported after marketing.
Very common (may affect more than 1 in 10 people):
- The infection you (some serious)
- Decreased white blood cell count ( neutropenia )
- Reduced red blood cell count ( anemia )
- Vomiting, diarrhea, nausea
Common (may affect up to 1 in 10 people):
- Other blood-related cancers ( myelodysplastic syndrome, acute myeloid leukemia ). Most patients with these conditions have previously, or concomitantly or later been treated with other anticancer medicines ( alkylating agents, topoisomerase inhibitors ) or radiation
- Bone marrow suppression ( myelosuppression )
- Severe loss of appetite leading to weight loss ( anorexia )
- Numbness or weakness in arms and legs ( peripheral neuropathy )
- Visual disturbances
- Inflammation of the oral mucosa ( stomatitis )
- Swelling due to severe fluid retention ( edema )
- Mucositis of the digestive system from the mouth to anus ( mucositis )
- General malaise.
Uncommon (may affect up to 1 in 100 people):
- Attack of the immune system on parts of the body or red blood cells (an autoimmune disease )
- Pulmonary toxicity, scar tissue throughout the lungs ( pulmonary fibrosis ), pneumonia ( pneumonia ), shortness of breath ( dyspnoea )
- Bleeding in the stomach or intestines
- Altered levels of enzymes in the liver or pancreas.
Rare (may affect up to 1 in 1000 people):
- Diseases affecting the lymphatic system due to a viral infection ( EBV associated proliferative lymphatic disease )
- Inflammation or damage to the optic nerve ( optic neuritis optic neuropathy )
- Heart failure
- Irregular heartbeat ( arrhythmia )
- Skin cancer
Has been reported (occurs in an unknown number of users)
- Inflammation of the bladder, which can cause pain when urinating, and can lead to blood in the urine ( hemorrhagic cystitis )
- Cerebral hemorrhage
- Bleeding in the lungs.
5. How to store Fludarabine Actavis
Keep this medicine out of the sight and reach of children.
Vial before opening:
Store at 2-8 ° C.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Fludarabine Actavis diluted in 9 mg/ml (0.9%) sodium chloride solution is stable for at least 28 days in PVC and PE bags at 2-8 ºC and 25 ° C under light protection.
From a microbiological perspective, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions before use is the responsibility of the user. This storage should normally not be longer than 24 hours at 2 ºC-8 ° C unless mixing has been performed under controlled and validated aseptic conditions.
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
- The active substance is fludarabine phosphate. 1 ml of concentrate contains 25 mg of fludarabine phosphate. Each 2 ml vial contains 50 mg of fludarabine phosphate.
- The other ingredients are disodium phosphate dihydrate, water for injections, sodium hydroxide (for pH adjustment).
What the medicine looks like and the contents of the pack
Fludarabine Actavis is a clear, colorless, or almost colorless solution.
The vial in stained glass (type I) with bromobutyl rubber stopper and metal capsule (aluminum) with polypropylene disc. The vial will be packed with or without a protective plastic film.
2 ml vial
5 x 2 ml vial
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Actavis Group PTC ehf.
Actavis Italy SpA
Via Pasteur 10
20014 Nerviano (Milan)