Patient Medication Information: uses, side effects, how to take - Fludarabine Phosphate Injection (Mylan Pharmaceuticals)
ABOUT THIS MEDICATION
What the medication is used for:
FLUDARABINE PHOSPHATE INJECTION is a cytotoxic (anti-cancer) drug. It is given by slow infusion (with a drip) into the veins (intravenously).
FLUDARABINE PHOSPHATE INJECTION is used for the treatment of a type of cancer known as chronic lymphocytic leukemia (CLL). FLUDARABINE PHOSPHATE INJECTION is usually used as a second line treatment of CLL, this is, if a previous treatment has failed or stopped working. It may also be used in to treat low-grade non-Hodgkin's lymphoma (Lg-NHL). CLL and Lg-NHL are cancers of a type of white blood cells called lymphocytes.
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 works by hindering the production of new DNA. Therefore, when the cancer cells take up FLUDARABINE PHOSPHATE 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 FOR INJECTION if any of the following apply to you:
Pregnant or breast-feeding
- Allergy (hypersensitivity) to any of the ingredients of this medication
- Kidney function is severely reduced
- Number of red blood cells is reduced due to a break down of these cells (hemolytic anemia).
FLUDARABINE PHOSPHATE INJECTION should not be used with a drug called pentostatin (deoxycoformycin).
What the medicinal ingredient is:
Fludarabine Phosphate
What the important nonmedicinal ingredients are:
Mannitol and sodium hydroxide.
What dosage forms it comes in:
FLUDARABINE PHOSPHATE 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
- When used at doses four times greater than the recommended dose for chronic lymphocytic leukemia (CLL), a third of patients experienced severe central nervous effects including blindness, coma and death. Such effects are rare or uncommon but have been reported in patients who receive the recommended dose for CLL (see Side Effects section).
- Some patients treated with fludarabine phosphate have had rapid breakdown of red blood cells which in some cases was severe or resulted in death. This can happen whether you have previously been treated with FLUDARABINE PHOSPHATE INJECTION or not (Side Effects section).
- This medicine should not be used with a drug called pentostatin (deoxycoformycin).
BEFORE you use FLUDARABINE PHOSPHATE FOR INJECTION talk to your doctor if:
- Your kidneys do not work well
- Your liver does not work well
- You are not feeling very well
- You are over 75 years old
- You have or have had herpes zoster (shingles)
You need a blood transfusion and you are undergoing, or
have received treatment with FLUDARABINE PHOSPHATE INJECTION
Special regular check-ups will be necessary if you are over 75 years old or your liver or kidneys do not work well.
The number of normal blood cells may be reduced and so you will have regular blood tests during treatment.
Your ability to become pregnant or father a child may be affected by taking FLUDARABINE PHOSPHATE INJECTION. It is important to discuss fertility with your doctor before you start 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.
Check with your doctor about any vaccinations you may need, because live vaccinations should be avoided during and after treatment with FLUDARABINE PHOSPHATE INJECTION.
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 INJECTION. 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 happening (see Side Effects section).
Reversible worsening or flare-up of pre-existing skin cancer has been reported in some patients during or after fludarabine phosphate therapy.
Progression of the disease has been commonly reported.
The effect of treatment with FLUDARABINE PHOSPHATE INJECTION on the ability to drive and operate machines has not been evaluated. Do not drive or operate machines if fatigue or changes in vision occur.
INTERACTIONS WITH THIS MEDICATION
This medication 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. If you are taking any other medicines regularly, tell your doctor.
PROPER USE OF THIS MEDICATION
Fludarabine Phosphate injection (25 mg/mL) is NOT for direct injection. Fludarabine Phosphate injection MUST be diluted with recommended intravenous infusion solutions.
Usual dose:
The following instructions apply to the use of
FLUDARABINE PHOSPHATE INJECTION, unless indicated otherwise by your physician. Please follow them carefully.
How and when should FLUDARABINE
PHOSPHATE INJECTION be taken?
FLUDARABINE PHOSPHATE INJECTION 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.
The recommended dose is 25mg/ m2 of body surface area.
Your doctor will calculate your individual dose which has to be given daily in the form of a solution directly into the blood stream through a vein once a day for 5 consecutive days. This five day course of treatment will normally be repeated every 28 days as prescribed by your doctor. Usually six 28-day cycles are required.
The dosage may be decreased or the repeat course delayed if side effects are a problem. If you have kidney problems you will receive a reduced dose and you will have regular blood tests.
How should FLUDARABINE PHOSPHATE
INJECTION be handled?
Due to the toxic nature of anti-cancer drugs such as FLUDARABINE PHOSPHATE INJECTION, special protective measures for handling are advised. Please ask your doctor or pharmacist.
Overdose:
In the case of an overdose your doctor will stop the therapy and treat the symptoms.
Missed Dose:
Your doctor will set the times at which you are to receive this medicine. If you think you may have missed a dose, contact your doctor as soon as possible.
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)
- pneumonia
- fever
- feeling tired
- feeling weak
- a reduction in the number of blood cells
- cough
- nausea
- vomiting
- diarrhea
Serious infections have occurred in patients treated with FLUDARABINE PHOSPHATE INJECTION.
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
- chills
- 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
- confusion
- allergic type reaction (pulmonary hypersensitivity)
- pain in your side, blood in your urine
The following side effects have been reported rarely:
- coma
seizures
agitation
- blindness
- pain in the eye
- heart failure
- irregular heart beat
- inflammation of the bladder
- red and flaky skin (e.g., Stevens-Johnson syndrome or toxic epidermal necrosis)
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 doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Vomiting, diarrhea (24 hours)/ dehydration | |||
| Cough, trouble breathing, fever /pneumonia | ||||
| Fever, chills, feeling unwell, pain/ infection | ||||
| Numb or weak limbs/ motor disturbance | ||||
Blurred vision/ changes in vision | ||||
| Uncommon | Difficulty breathing, rash, itching/ allergic reaction | |||
| Pain in your side, blood in your urine/ infection | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom / effect Uncommon (cont’d) 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 an/or red-brown urine/ rapid breakdown of red blood cells (also called hemolytic anemia) Confusion/ severe central nervous system effects Loss of hearing | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or | ||
| 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 INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
Store all drugs properly and keep them out of the reach of children.
The expiry date is printed on the label. Do not use after this date.
Store FLUDARABINE PHOSPHATE INJECTION under refrigeration between 2°C and 8°C. Do not freeze. Discard unused portion.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
--------------------------------------------------------------------------
- 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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 can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Revised on: June 24, 2014.
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-800-575-1379
www.mylan.ca