Patient Medication Information: uses, side effects, how to take - Fludarabine Phosphate for Injection (Fresenius Kabi Canada)
Serious Warnings and Precautions
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection should be prescribed by a healthcare professional experienced with the use of anticancer drugs. The following are possible serious side effects:
Myelosuppression may result in death.
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What is Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection used for?
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection is used to treat adults with chronic lymphocytic leukemia (CLL) and low-grade non-Hodgkin’s lymphoma (Lg-NHL) when other treatments have not worked.
How does Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection work?
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection slows or stops the growth of cancer cells. It does this by interfering with the production of the cell’s genetic material called DNA.
What are the ingredients in Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection?
Medicinal ingredient: fludarabine phosphate
Non-medicinal ingredients: mannitol and sodium hydroxide
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection comes in the following dosage forms:
Fludarabine Phosphate Injection
Solution: 25 mg / mL fludarabine phosphate.
Fludarabine Phosphate for Injection
Powder for solution: 50 mg / vial fludarabine phosphate.
Do not use Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection if:
- you are allergic to fludarabine or any of the ingredients of this medication
- you have severe kidney problems
- you have hemolytic anemia (when red blood cells are broken down rapidly)
- you are also using a medicine called pentostatin (deoxycoformycin)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection. Talk about any health conditions or problems you may have, including if you:
- have problems with your immune system
- are not feeling very well
- have kidney problems
- have liver problems
- are over 75 years old
- need any vaccinations. Live vaccine should be avoided during and after treatment with Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection
- have skin cancer. Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection may worsen skin cancer lesions or cause them to flare-up. New skin cancers have also been reported in patients during or after Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection therapy
- have an infection associated with decreased immune function.
Other warnings you should know about:
Pregnancy and breastfeeding:
Female patients:
- If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional.
Do not use Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection if you are pregnant. It may harm your unborn baby or make you lose the pregnancy. If you are able to become pregnant:
- Avoid becoming pregnant while you are receiving Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection. Use birth control during your treatment with Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection. Continue using this birth control for at least 6 months after stopping treatment.
- Tell your healthcare professional right away if you become pregnant during your treatment.
- Do not breastfeed while you are receiving Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection.
Male patients while taking Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection and for at least 6 months after stopping treatment:
- Do not father a child.
- Use effective birth control each time you have sex with a woman who could get pregnant. Be sure to tell her you are taking Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection and that there are risks to an unborn baby should she get pregnant.
- If your sexual partner gets pregnant during your treatment, tell your healthcare professional right away.
Fertility: Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection might affect your ability to have a child in the future. Before you start Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection, you should speak with your healthcare professional about ways to protect your eggs or sperm.
If you are planning a pregnancy after your Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection treatments, you should speak with a Genetic Counselor.
Tumour Lysis Syndrome: When cancer cells are destroyed they release waste products into the blood. In some cases, Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection may cause a rapid breakdown of cancer cells making it difficult for your body to get rid of these waste products. This is called Tumour Lysis Syndrome It may cause nausea and vomiting, joint pain, kidney failure, and heart problems. Your healthcare professional may give you medications to stop this from happening.
Encephalopathy: This is a disease of the brain. It can occur during treatment or up to 4 or more years after Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection has been stopped. It can be permanent, life-threatening, or cause death. Your healthcare professional will do assessments of your nervous system to monitor for encephalopathy. This might include scans like a MRI.
When you take Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection, encephalopathy can occur:
At the recommended dose. It happens most commonly,
- when given with other drugs known to cause encephalopathy
when you have:
- Head or total body radiation therapy
- Hematopoietic Stem Cell transplantation
- Graft versus host disease
- Kidney disease
- At higher than recommended doses
Driving and using machines: Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection can cause fatigue, weakness, vision problems, confusion, agitation and seizures. This may reduce your ability to drive or use machines. Do not drive or operate machinery if Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection affects your alertness and your vision.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection:
- A medicine used to prevent blood clots called dipyridamole.
- A medicine used in the treatment of cancer called cytarabine.
How to take Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection:
- Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection will be given to you by a healthcare professional. Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection is to be given into the vein (intravenous) as an infusion.
- Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection is given in treatment cycles. These are 28 days long. You will receive Fludarabine Phosphate Injection or Fludarabine Phosphate for Injection each day of the first 5 days of each 28-day cycle. The number of cycles you have will depend on how you respond and tolerate the treatment. Usually, six 28-day cycles are required.
Usual dose:
25 mg/m2 given into the vein as an infusion over 30 minutes, once a day for the first 5 days of each 28-day cycle.
Your dose of Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection will be based on your height and weight. Your healthcare professional will tell you how much Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection you will receive. You may receive a lower dose if you have kidney problems.
Overdose:
| If you think you, or a person you are caring for, have taken too much Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection, contact a healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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Missed Dose:
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection should be given on a fixed schedule. If you miss an appointment, call your doctor for instructions.
What are possible side effects from using Fludarabine Phosphate Injection and Fludarabine Phosphate
for Injection?
These are not all the possible side effects you may have when taking Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection. If you experience any side effects not listed here, tell your healthcare professional.
- fever
- feeling tired
- feeling weak
- cough
- nausea
- vomiting
- diarrhea
- loss of appetite
- visual problems (blurred vision)
- inflammation or sores of the mouth, lips and digestive track
- skin rash
- generally feeling unwell
- chills
- build-up of fluid in the body (swelling)
- bruising
Prolonged vomiting, diarrhea, or mouth sores may limit your fluid intake. This can make you prone to dehydration. Contact your doctor if these symptoms last for 24 hours.
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection can cause abnormal blood test results. Your healthcare professional will do blood tests during your treatment. These will tell your healthcare professional how Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection is affecting your blood.
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
| VERY COMMON | ||||
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Myelosuppression (decreased blood cell production including neutropenia (low white blood cell count), anemia (low red blood cell count) thrombocytopenia (low platelet count): any unusual bruising, more bleeding than usual after injury, frequent infections. This may also lead to an increased risk of (serious) infections, caused by organisms, that usually do not cause disease in healthy persons (opportunistic infections) including a late reactivation of viruses, for example herpes zoster. | ✓ | |||||
| Pneumonia (lung infection): cough, trouble breathing, chest pain with or without fever | ✓ | |||||
| COMMON | ||||||
| Infection: fever, chills, feeling unwell, pain | ||||||
| Peripheral neuropathy: pain, numbness or weakness in the arms and / or legs, dropping things from your hands, trouble with tasks like walking, picking up items, or moving your limbs | ✓ | |||||
| Richter’s Syndrome (rare type of lymphoma): Rapid and dramatic increase in the size of the lymph nodes in the neck, abdomen, armpit or groin; night sweats, weight loss, fever, palpitations, fatigue, shortness of breath, dizziness | ✓ | |||||
| UNCOMMON | ||||||
| Allergic reaction: difficulty breathing, rash, itching | ✓ | |||||
| Tumour Lysis Syndrome (the sudden, rapid death of cancer cells due to treatment): pain in your side, blood in your urine, a reduced amount of urine | ✓ | |||||
| Bleeding in the digestive system: tar-coloured or bloody stool | ✓ | |||||
| Hemolytic Anemia (rapid breakdown of red blood cells): yellowing of the skin or eyes and/or red-brown urine | ✓ | |||||
| Confusion: problems with short-term memory, difficulty carrying out tasks, poor attention span, unclear speech and difficulty in following a conversation | ✓ | |||||
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
| Autoimmune reactions: (when the immune system mistakenly attacks our own cells): can lead to various symptoms depending on the affected part of the body, such as fatigue, dizziness or light-headedness, low grade fever, muscle aches, swelling, skin rash | ✓ | |||||
| Lung injury: difficulty breathing and shortness of breath | ✓ | |||||
| RARE | ||||||
| Heart Failure: palpitations (you suddenly become aware of your heartbeat), irregular heartbeat, chest pain | ✓ | |||||
| Epstein Barr Virus-associated lymphoproliferative disorder (disorders of the lymph system due to a viral infection): fever, sore throat, swollen lymph nodes, spleen or liver enlargement, jaundice, high white blood cell count, low red blood cell count, abnormal bleeding or bruising, excessive bleeding, unintentional weight loss, night sweats, loss of appetite, weakness, dizziness, bone pain, rashes, frequent infections, headaches, seizures, confusion, nausea and vomiting | ✓ | |||||
| Coma: prolonged state of unconsciousness | ✓ | |||||
| Seizures: temporary confusion, a staring spell, jerking movements of the arms and legs that can't be controlled, Loss of consciousness or awareness, Cognitive or emotional changes | ✓ | |||||
| Agitation: feeling of aggravation, annoyance, restlessness, or nervousness | ✓ | |||||
| Lyell’s syndrome, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (severe skin reactions): redness, inflammation, blistering, tissue break down | ✓ | |||||
| Pain in your eyes/Blindness (lack of vision) | ✓ | |||||
| Cystitis (inflammation of the bladder): feeling the need to urinate more often, sudden desire to pee, pain/ burning with urination, dark or foul-smelling pee | ✓ | |||||
| UNKNOWN FREQUENCY | ||||||
| Neurological Disorders: headache with nausea and vomiting, seizure, visual disturbances (vision loss), confusion, muscle spasm, drowsiness | ✓ | |||||
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
Hemorrhage including
| ✓ | |||||
| Transfusion-associated severe allergic reaction: back pain, dark urine, chills, fainting or dizziness, fever, flank pain, skin flushing, shortness of breath or itching | ✓ | |||||
| Skin cancer: a pearly or waxy bump, flesh-colored or brown scar-like lesion, bleeding or scabbing sore that heals and returns, firm and red nodule, flat lesion with a scaly and crusted surface, large brownish spot with darker speckles, a mole that changes in appearance or that bleeds, painful lesion that itches or burns. Usually occurs in sun-exposed areas of your body, such as your neck or face | ✓ | |||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Please note the expiry date on the pack. Do not use after this date.
Keep out of the reach and sight of children.
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection should be stored under refrigerated condition between 2 °C and 8 °C.
If you want more information about Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection:
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.fresenius-kabi.com/en-ca/, or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8