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Fludarabine (Intravenous route)

Pronunciation:

floo-DAYR-a-been

Dosage Forms:

  • Solution
  • Powder for Solution

Warnings:

Intravenous route(Powder for Solution;Solution)

Can severely suppress bone marrow function and when used at high doses in dose-ranging studies in patients with acute leukemia, was associated with severe neurologic effects, including blindness, coma, and death. Life-threatening and sometimes fatal autoimmune hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia has been reported to occur after one or more cycles of treatment. Closely monitor patients for hemolysis. In a clinical investigation using fludarabine for injection in combination with pentostatin (deoxycoformycin) for the treatment of refractory CLL, there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine for injection in combination with pentostatin is not recommended .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Uses of This Medicine:

Fludarabine injection belongs to the group of medicines called antimetabolites. It is used to treat a type of cancer of the white blood cells called B-cell chronic lymphocytic leukemia (CLL). This medicine is used in patients with CLL who have already been treated with an alkylating agent (e.g., bendamustine) that did not work well. .

Fludarabine injection interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by fludarabine injection, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with fludarabine injection, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Fludarabine injection is to be administered only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fludarabine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of fludarabine injection in geriatric patients.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Pentostatin
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone marrow problems (e.g., anemia, neutropenia, or thrombocytopenia)—Fludarabine injection may worsen these conditions.
  • Chickenpox (including recent exposure) or
  • Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body.
  • Gout (history of) or
  • Kidney stones (history of)—Fludarabine may increase levels of uric acid in the body, which can cause gout or kidney stones.
  • Infection—Fludarabine injection may decrease your body's ability to fight infection.
  • Kidney disease—Use with caution. Effects of fludarabine injection may be increased because of slower removal of the medicine from the body.
  • Transfusions—Non-irradiated blood transfusion may increase the risk of side effects of fludarabine injection.

Proper Use of This Medicine:

This medicine may cause nausea and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.

This medicine is given through a needle placed in one of your veins. It is usually given every day for 5 days. This 5-day treatment is given again every 28 days until your body responds to the medicine. Each treatment usually takes about 30 minutes.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

While you are being treated with fludarabine injection, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Fludarabine injection may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Fludarabine injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection (e.g. pneumonia). It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination; shortness of breath; or unusual bleeding or bruising.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

You should not use this medicine if you are also taking pentostatin (Nipent®). Taking it together with this medicine may increase the chance of serious side effect.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 6 months after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause unusual weakness, trouble in thinking, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
Arm, back, or jaw pain
black, tarry stools
blood in the urine or stools
chest pain or discomfort
chest tightness or heaviness
constipation
cough or hoarseness
coughing or spitting up blood
fast or irregular heartbeat
fever or chills
general feeling of discomfort or illness
lower back or side pain
nausea
pain
painful, burning, or difficult urination
pale skin
pinpoint red spots on the skin
shortness of breath
sneezing
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, severe
sweating
swelling
tender, swollen glands in the neck
thickening of bronchial secretions
troubled breathing
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
wheezing
Less common
Agitation
aneurysm
bleeding gums
blurred vision
confusion
decreased urine output
difficulty in breathing or swallowing
dilated neck veins
dizziness
extreme fatigue
fainting
fast, pounding, or irregular heartbeat or pulse
headache
increased menstrual flow or vaginal bleeding
irregular breathing
loss of hearing
nosebleeds
numbness or tingling in the fingers, toes, or face
pain, redness, or swelling in the arm or leg
paralysis
prolonged bleeding from cuts
seizures
slurred speech
sudden and severe inability to speak
temporary blindness
weakness in the arm or leg on one side of the body, sudden and severe
weight gain
Rare
Blindness
continuing vomiting
dark-colored urine
drowsiness
frequent urination
hives
itching
light-colored stools
loss of appetite
loss of consciousness
lower abdominal cramping
muscle tremors
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid, deep breathing
restlessness
skin rash
stomach pain
trouble speaking, thinking, or walking
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Abdominal pain
bladder pain
body aches or pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
cloudy urine
congestion
diarrhea
difficulty in moving
dry mouth or throat
flushed, dry skin
frequent urge to urinate
fruit-like breath odor
increased hunger
increased thirst
increased urination
joint pain
muscle aching or cramping
muscle pains or stiffness
runny nose
swollen joints
trouble in swallowing
voice changes
weight loss
Less common
Abdominal fullness
bluish color of skin
changes in skin color
cracked lips
dandruff
decrease in height
decreased urination
difficulty in sleeping
discouragement
feeling sad or empty
gaseous abdominal pain
heartburn
irritability
loss of interest or pleasure
lightheadedness
oily skin
pain or tenderness around the eyes and cheekbones
rapid breathing
recurrent fever
stuffy nose
sunken eye
trouble concentrating
wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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