Fludarabine Phosphate Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||CLL (Chronic Lymphocytic Leukemia), Leukemia, Chronic Lymphocytic (Chronic Lymphocytic Leukemia)|
|Form:||Liquid solution, Intravenous (IV), Powder|
|Ingredients:||Fludarabine phosphate, mannitol, sodium hydroxide|
About This Medication
What the Medication is Used For
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection is an anticancer drug. It is given by slow infusion (with a drip) into the veins (intravenously).
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection is used as a second line treatment in patients with chronic lymphocytic leukemia (CLL) and low-grade non-Hodgkin's lymphoma (Lg-NHL) who have failed other conventional treatments.
In CLL and Lg-NHL, too many abnormal lymphocytes are produced and lymph nodes start to grow in various regions of your body. The abnormal lymphocytes either do not work properly or are too young (immature) to fight infection well. If there are too many of these abnormal lymphocytes, they push aside healthy blood cells in the bone marrow where most of the new blood cells are formed. Without enough healthy blood cells, infections, anemia, bruising, excessive bleeding or even organ failure can result.
What it Does
All cells of the body produce new cells like themselves by dividing. For this purpose, the cells' genetic material (DNA) must be copied and reproduced. Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection work by hindering the production of new DNA. Therefore, when the cancer cells take up Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection, it stops the growth of new cancer cells. It has been discovered that fludarabine phosphate works especially well against some cancers of the type of white blood cells called lymphocytes.
When it Should not be Used
You must not use Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection if any of the following apply to you:
- Allergy (hypersensitivity) to any of the ingredients of this medication
- Kidney function is severely reduced
- Low red blood cell count because of a certain type of anemia (hemolytic anemia). Your doctor will have told you if you have this condition.
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection should not be used with a drug called pentostatin (deoxycoformycin).
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
mannitol and sodium hydroxide
What Dosage Forms it Comes In
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection are available as injection.
Fludarabine Phosphate Injection
Each mL of solution contains 25 mg of fludarabine phosphate.
Fludarabine Phosphate for Injection
Each vial contains 50 mg of fludarabine phosphate as a freeze dried solid. The product is reconstituted with sterile water before intravenous injection.
Warnings and Precautions
Serious Warnings and Precautions
Fludarabine phosphate should be prescribed by a doctor experienced with the use of anticancer drugs.
The following are possible serious side effects:
- Central nervous system problems including blindness, coma, and death at doses four times greater than the recommended dose for CLL. This has been rarely reported at the recommended dose for CLL.
- Low red blood cell count due to a break down of red blood cells (hemolytic anemia) may result in death.
- Lung toxicity resulting in death when used in combination with pentostatin (deoxycoformycin).
BEFORE you use Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection talk to your doctor if you:
- Have a low red blood cell count;
- Are not feeling very well;
- Have kidney problems;
- Have liver problems;
- Are over 75 years old;
- Have herpes zoster (shingles);
- Need a blood transfusion;
- Are pregnant. Fludarabine phosphate may harm an unborn child;
- Are breast-feeding;
- Need any vaccinations. Live vaccine should be avoided during and after treatment with fludarabine phosphate.
Fludarabine phosphate can harm an unborn baby. Fludarabine phosphate should not be used during pregnancy unless clearly necessary. If you are pregnant, it is important to discuss with your doctor prior to starting fludarabine phosphate treatment.
Men and women who may still be fertile must use a reliable form of contraception during and for at least 6 months after stopping treatment. Women should avoid becoming pregnant while on fludarabine phosphate therapy.
If your disease is very severe, your body may not be able to get rid of all the waste products from the cells destroyed by fludarabine phosphate. This may cause dehydration, kidney failure and heart problems. Your doctor will be aware of this and may give you other drugs to stop this from happening (see Side Effects section).
The worsening or flare-up of pre-existing skin cancer lesions as well as new onset of skin cancer has been reported in patients during or after fludarabine phosphate therapy.
Fludarabine phosphate may reduce the ability to drive or use machines, since e.g., fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed. Do not drive or operate machinery if fludarabine phosphate affects your alertness and your vision.
Interactions With This Medication
This medicine should not be used with a drug called pentostatin (deoxycoformycin).
The effectiveness of Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection may be reduced by medications containing dipyridamole and similar substances.
Tell your doctor if you are taking cytarabine.
If you are taking any other medicines regularly, tell your doctor.
Proper use of This Medication
Fludarabine phosphate should be administered under the supervision of, or prescribed by, a qualified physician experienced in the use of anti-cancer treatment. The dose you receive or should take varies with your body surface area. Technically this is measured in square meters (m2), but actually is worked out from your height and weight.
Injection: 25 mg/m2 of body surface area once a day for 5 consecutive days.
This five-day course of treatment will normally be repeated every 28 days. Usually six 28 day cycles are required.
|In the event of an overdose, you should IMMEDIATELY contact either your doctor, the nearest hospital emergency department or poison control centre.|
Side Effects and What to do About Them
The most frequently reported side effects and those that are more clearly related to the drug are reported below with their frequencies (very common: 10% and more; common: 1% and more, but less than 10%; uncommon: 0.1% and more, but less than 1%; rare: less than 0.1%).
The following side effects have been reported very commonly:
- infection (like latent viral reactivation, e.g., herpes zoster virus, Epstein-Barr-virus, Progressive multifocal leucoencephalopathy)
- feeling tired
- feeling weak
- a reduction in the number of blood cells
Serious infections have occurred in patients treated with fludarabine phosphate.
Prolonged vomiting and/or diarrhea or mouth sores and diarrhea may limit your fluid intake and you may be prone to dehydration. Contact your doctor if these symptoms persist for 24 hours.
The following side effects have been reported commonly:
- a reduction in blood cell production by the bone marrow (myelosuppression)
- loss of appetite
- numb or weak limbs
- visual problems (blurred vision)
- inflammation of the lining of the mouth
- skin rash
- generally feeling unwell
- build up of fluid in the body (edema)
Myelosuppression may result in anemia, abnormal bleeding or bruising and reduced resistance to infections.
The following side effects have been reported uncommonly:
- a significant reduction in the number of red blood cells
- bleeding in the digestive system
- allergic type reactions (pulmonary hypersensitivity)
- pain in your side, blood in your urine
The following side effects have been reported rarely:
- pain in the eye
- heart failure
- irregular heartbeat
- inflammation of the bladder
- red and flaky skin (e.g., Stevens-Johnson syndrome or toxic epidermal necrosis)
- skin cancer
When used at doses four times greater than the recommended dose for chronic lymphocytic leukemia (CLL), a third of patients experienced severe central nervous system effects including blindness, coma and death. Such effects are rare (coma, seizures and agitation) or uncommon (confusion) but have been reported in patients who receive the recommended dose for CLL. These effects usually begin from three to eight weeks after treatment has been given but may occur earlier or later.
If you notice any unwanted effects, or if you are unsure about the effect of this product, please inform your doctor.
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom/effect||Talk with your
|Common||vomiting, diarrhea (24 hours)/ dehydration||✓|
|cough, trouble breathing, fever/ pneumonia||✓|
|fever, chills, feeling unwell, pain/infection||✓|
|numb or weak limbs/motor disturbances||✓|
|blurred vision/changes in vision||✓|
|Uncommon||difficulty breathing, rash, itching/allergic reaction||✓|
|pain in your side, blood in your urine/infection||✓|
|tar-coloured or bloody stool/bleeding in the digestive system||✓|
|chest pain/heart failure, irregular heartbeat||✓|
|extreme fatigue, unusual bruising, excessive bleeding after injury/reduction in blood cell production by the bone marrow||✓|
|yellowing of the skin or eyes and/or redbrown urine/rapid breakdown of red blood cells (also called hemolytic anemia)||✓|
|confusion/sever e central nervous system effects||✓|
|loss of hearing||✓|
|Rare||coma, seizures, agitation/severe central nervous system effects||✓|
|red and flaky skin/severe skin disorder||✓|
|pain in your eyes, blindness||✓|
This is not a complete list of side effects. For any unexpected effects while taking Fludarabine Phosphate for Injection contact your doctor or pharmacist.
How to Store It
Please note the expiry date on the pack. Do not use after this date.
Store out of the reach of children and pets.
Fludarabine Phosphate Injection and Fludarabine Phosphate for Injection should be stored under refrigerated condition between 2 0C and 8 0C.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd. at: 1-877-821-7724