Consumer Information for: FLUDARABINE PHOSPHATE FOR INJECTION
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
FLUDARABINE PHOSPHATE FOR INJECTION is an anticancer drug. It can be given by slow infusion (with a drip) into the veins (intravenously).
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 FOR INJECTION works by hindering the production of new DNA. Therefore, when the cells take up FLUDARABINE PHOSPHATE FOR INJECTION, it stops the growth of new 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 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 FOR INJECTION should not be used with a drug called pentostatin (deoxycoformycin).
What the medicinal ingredient is
Fludarabine Phosphate
What the non-medicinal ingredients are
Mannitol and sodium hydroxide.
What dosage form it comes in
FLUDARABINE PHOSPHATE FOR INJECTION is supplied as 2 mL per vial of 50 mg fludarabine phosphate, 50 mg of mannitol and 6.60 mg of sodium hydroxide.
Fludarabine for intravenous administration is supplied in a single vial carton and is a single use vial.
Warnings and precautions
Serious Warnings and Precautions
FLUDARABINE PHOSPHATE FOR INJECTION should be prescribed by a doctor experienced with the use of anticancer drugs.
The following are possible serious side effects:
- Decreased production of the blood cells by the bone marrow (bone marrow suppression). The protection against infections, the ability of blood cells to carry oxygen, or blood clotting can be affected. It may result in death.
- 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 breakdown 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 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 or intend to become pregnant. FLUDARABINE PHOSPHATE FOR INJECTION may harm an unborn child
- are breast feeding
- need any vaccinations. Live vaccine should be avoided during and after treatment with FLUDARABINE PHOSPHATE FOR INJECTION
- have had a skin cancer. 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 FOR INJECTION therapy
- have a disease associated with decreased immune function.
FLUDARABINE PHOSPHATE FOR INJECTION can harm an unborn baby. FLUDARABINE PHOSPHATE FOR INJECTION 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 FOR INJECTION 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 FOR INJECTION therapy.
When cancer cells are destroyed they release waste products into the blood. In some cases, 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 may cause nausea and vomiting, joint pain, kidney failure, and heart problems. Your physician may give you medications to stop this from happening.
Encephalopathy is a disease of the brain. It can occur during treatment or up to 4 or more years after FLUDARABINE PHOSPHATE FOR INJECTION has been stopped. It can be irreversible, life-threatening, or cause death.
When you take 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.
FLUDARABINE PHOSPHATE FOR INJECTION 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 FOR INJECTION 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 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
Usual Dose
FLUDARABINE PHOSPHATE FOR INJECTION should be administered by a qualified physician experienced in the use of anticancer 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.
The recommended dose is 25mg/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.
Overdose
If you take more FLUDARABINE PHOSPHATE FOR INJECTION than you should, talk to your doctor, nurse, pharmacist, or call your local poison control centre right away.
Missed Dose
If you miss a dose, ask your doctor how to continue with the treatment. Do not take a double dose.
Side effects and what to do about them
The following side effects have been reported very commonly:
- decreased production of the blood cells by the bone marrow (bone marrow suppression) which may cause:
- increased risk of serious infections such as pneumonia or viral infections (like latent viral reactivation, e.g., Herpes zoster virus, Epstein-Barr-virus, Progressive multifocal leucoencephalopathy)
- anemia (reduced number of red blood cells)
- abnormal bleeding or bruising
- fever
- feeling tired
- feeling weak
- cough
- nausea
- vomiting
- diarrhea
The following side effects have been reported commonly:
- loss of appetite
- numb or weak limbs
- 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 (edema)
Prolonged vomiting, diarrhea, or mouth sores may limit
your fluid intake. This can make you prone to dehydration.
Contact your doctor if these symptoms persist for 24 hours.
The following side effects have been reported uncommonly:
- bleeding in the digestive system
- confusion
- pulmonary injury, with symptoms such as difficulty breathing and shortness of breath
- pain in your side, blood in your urine, or a reduced amount of urine
- red or purple discolourations on the skin caused by bleeding underneath the skin
The following side effects have been reported rarely:
- coma
- seizures
- agitation
- blindness
- pain in the eye
- heart failure
- irregular heartbeat
- inflammation of the bladder
- skin and/or mucous membrane reaction with redness, inflammation, blistering and erosion (e.g. Stevens- Johnson syndrome, Lyell’s syndrome or toxic epidermal necrosis)
- skin cancer
- Epstein-Barr virus associated lymphoproliferative disorder (disorders of the lymph system due to a viral infection)
The following side effects for which frequency is unknown:
- bleeding (hemorrhage) including the following:
- bleeding from a ruptured blood vessel in the brain (cerebral hemorrhage),
- lung bleeding (pulmonary hemorrhage),
- eye bleeding (includes retinal hemorrhage)
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| 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 red-brown urine/ rapid breakdown of red blood cells (also called hemolytic anemia) | ✔ | ||
| Confusion/ severe 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 | ✔ | ||
| Unknown frequency | |||
| Headache with nausea and vomiting, seizure, visual disturbances (vision loss), confusion, muscle spasm, drowsiness | ✔ | ||
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
Store all drugs properly. Keep out of the reach and sight of children and pets.
The expiry date is printed on the label. Do not use after this date.
Store FLUDARABINE PHOSPHATE FOR INJECTION under refrigeration between 2°C and 8°C. Do not freeze. Discard unused portion.
Reporting side effects
You can help improve the safe use of health products 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:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited:
at: 1-800-268-4127 ext. 1255005 (English)
or 1-877-777-9117 (French)
or druginfo@tevacanadacom
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Last revised: March 1, 2016
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