Patient Medication Information: uses, side effects, how to take - Fludara (Sanofi Genzyme, A Division of Sanofi-Aventis Canada)
ABOUT THIS MEDICATION
What the medication is used for:
FLUDARA is an anticancer drug. It can be given either by slow infusion (with a drip) into the veins (intravenously), or by mouth as tablets.
FLUDARA (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.
FLUDARA (tablets) is used as a second line treatment in patients with chronic lymphocytic leukemia (CLL) 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. FLUDARA works by hindering the production of new DNA. Therefore, when the cells take up FLUDARA, it stops the growth of new cells. It has been discovered that FLUDARA 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 FLUDARA 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.
FLUDARA should not be used with a drug called pentostatin (deoxycoformycin).
What the medicinal ingredient is:
Injection: fludarabine phosphate (as the sodium salt)
Tablets: fludarabine phosphate
What the nonmedicinal ingredients are:
Injection: mannitol and sodium hydroxide
Tablets: microcrystalline cellulose, lactose monohydrate, colloidal silicone dioxide, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, talc, titanium dioxide and ferric oxide
What dosage forms it comes in:
FLUDARA is available as an injection and as a tablet.
Injection: Each vial contains 50 mg of fludarabine phosphate as a freeze-dried solid. The product is reconstituted with sterile water before intravenous injection.
Tablets: Each salmon-pink coloured tablet contains 10 mg of fludarabine phosphate. Tablets are supplied in blister packs packaged inside child-resistant containers.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
FLUDARA 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 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 FLUDARA, 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. FLUDARA may harm an unborn child
- are breast feeding
need any vaccinations. Live vaccine should be avoided
during and after treatment with FLUDARA
FLUDARA can harm an unborn baby. FLUDARA should not be used during pregnancy unless clearly necessary. If you are pregnant, it is important to discuss with your doctor prior to starting FLUDARA 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 FLUDARA 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 FLUDARA. 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 FLUDARA therapy.
FLUDARA 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 FLUDARA 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 FLUDARA 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:
FLUDARA should be administered under the supervision of, or prescribed 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.
Injection: 25 mg/m2 of body surface area once a day for 5 consecutive days.
Tablets: 40 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 28day cycles are required.
FLUDARA tablets can be taken on an empty stomach or with food. Swallow the tablets whole with water. Do not chew, break or crush the tablets.
FLUDARA tablets must not be removed from their packaging until ready to use.
FLUDARA tablets must not be touched by pregnant women.
Unused FLUDARA tablets should be returned to a pharmacist for safe disposal.
Overdose:
If you take more FLUDARA than you should, talk to your doctor, nurse, pharmacist, or call your local poison control centre right away.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
If you miss a dose or vomit after taking a tablet, ask your doctor how to continue with the treatment. Do not take a double dose.
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 FLUDARA.
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 reactions (pulmonary hypersensitivity)
- pain in your side, blood in your urine
- of red or purple discolorations on the skin caused by bleeding underneath the skin
- shortness of breathe
The following side effects have been reported rarely:
- coma
- seizures
- agitation
- blindness
- pain in the eye
- heart failure
- irregular heartbeat
- inflammation of the bladder
red and flaky skin (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)
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 | T | ||
| cough, trouble breathing, fever / pneumonia | T | |||
| fever, chills, feeling unwell, pain / infection | T | |||
| numb or weak limbs / motor disturbances | T | |||
| blurred vision / changes in vision | T | |||
Uncommon
| difficulty breathing, rash, itching / allergic reaction | T | ||
| pain in your side, blood in your urine / infection | T | ||
| tar-coloured or bloody stool / bleeding in the digestive system | T | ||
| chest pain / heart failure, irregular heartbeat | T | ||
| extreme fatigue, unusual bruising, excessive bleeding after injury / reduction in blood cell production by the bone marrow | T |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Symptom / effect 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 | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| T | ||||
| T | ||||
| loss of hearing | T | |||
| Rare | coma, seizures, agitation / severe central nervous system effects | T | ||
| red and flaky skin / severe skin disorder | T | |||
| pain in your eyes, blindness | T | |||
This is not a complete list of side effects. For any unexpected effects while taking FLUDARA, contact your doctor or pharmacist.
HOW TO STORE IT
Please note the expiry date on the pack. Do not use after this date.
Store FLUDARA tablets between 15EC and 30EC. Do not freeze.
Store FLUDARA out of the reach of children and pets.
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: | |||
| Toll-free telephone: | 866-234-2345 | ||
| Online: | www.healthcanada.gc.ca/medeffect | ||
| Complete a Canada Vigilance Reporting form and: | |||
| Fax toll-free | 1-866-678-6789 | ||
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 plus the full product monograph, prepared for health professionals, can be found at: www.genzyme.ca or by contacting the sponsor, Genzyme Canada Inc., at: 1-877-220-8918.
Date of approval: April 19, 2011
© 2009, Genzyme Canada Inc.
® FLUDARA is a registered trademark exclusively licensed to Genzyme Corporation.