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Clofarabine (Intravenous route)

Pronunciation:

kloe-FAR-a-been

Brand Names:

  • Clolar

Dosage Forms:

  • Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Chemical—

Purine Nucleoside Analog

Uses of This Medicine:

Clofarabine injection is used to treat acute lymphoblastic leukemia (ALL), a cancer of the white blood cells, in patients who have already used at least 2 other cancer medicines.

Clofarabine is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by clofarabine, other unwanted effects can occur. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of using it.

This medicine is to be given 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clofarabine injection in children 1 year of age and older.

Older adults—

Appropriate studies on the relationship of age to the effects of clofarabine injection have not been performed in the geriatric population. Safety and efficacy have not been established in elderly patients 65 years of age.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

  • Anemia (low red blood cells) or
  • Infection (eg, bacteria, fungus, virus) or
  • Liver disease or
  • Neutropenia (low white blood cells) or
  • Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

You will receive this medicine while you or your child are in a hospital or cancer treatment center. A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

While you are receiving clofarabine, it is important that you drink extra fluids so you will pass more urine. This will help prevent unwanted effects on the kidney.

Precautions While Using This Medicine:

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Clofarabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. 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, a cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • 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 and toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious type of reaction called the tumor lysis syndrome. This syndrome may cause you to have high amounts of uric acid in the blood (hyperuricemia). 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; rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Call your doctor right away if you have dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; a fast or irregular heartbeat; shortness of breath; or swelling of the hands, ankles, feet, or lower legs. These may be symptoms of rare but serious conditions called capillary leak syndrome or systemic inflammatory response syndrome (SIRS).

Check with your doctor right away if you have stomach pain, pale stools, or dark urine; a loss of appetite; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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
Abdominal or stomach pain or tenderness
area rash
black, tarry stools
bleeding gums
blood in the urine or stools
bloody nose
blurred vision
burning or stinging of the skin
chest pain
chills
clay-colored stools
cold or flu-like symptoms
confusion
cough or hoarseness
dark urine
decreased urine output
diarrhea
difficult or labored breathing
dilated neck veins
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
facial swelling
fainting
fast, pounding, or irregular heartbeat or pulse
feeling of warmth
fever
flushing, redness of the skin
headache
irregular breathing
itching
itching in the genital area
joint pain, stiffness, or swelling
lightheadedness
loss of appetite
lower back or side pain
nausea
nervousness
pain
painful cold sores or blisters on the lips, nose, eyes, or genitals
painful or difficult urination
pale skin
pinpoint red spots on the skin
pounding in the ears
rapid, shallow breathing
redness of the face, neck, arms, and occasionally, upper chest
redness, swelling, or skin pain
scaling of the skin on the hands and feet
severe abdominal or stomach cramps with pain
skin rash
slow or fast heartbeat
small red or purple spots on the skin
sneezing
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sweating
swelling of the ankles, feet, or lower legs
swelling or inflammation of the mouth
swollen glands
tenderness
tightness in the chest
tingling of the hands and feet
troubled breathing with exertion
ulcers, sores, or white spots in the mouth
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
unusually warm skin
vomiting
vomiting of blood
warmth on the skin
watery and severe diarrhea, which may also be bloody
weight gain
yellow eyes or skin
Less common
Agitation
bloating
blue lips and fingernails
chest pain or discomfort
cloudy urine
constipation
coughing that sometimes produces a pink frothy sputum
darkened urine
decrease or increase in the amount of urine
decreased level of consciousness
depression
difficult, fast, or noisy breathing, sometimes with wheezing
dry mouth
general feeling of discomfort or illness
hives
hostility
hyperventilation
increased sweating
indigestion
irritability
muscle aches and pains
muscle twitching
pain or tenderness around the eyes and cheekbones
pains in the stomach, side, or abdomen, possibly radiating to the back
rapid weight gain
restlessness
seizures (convulsions)
shaking
shivering
stuffy or runny nose
swelling of the eyelids, face, lips, or hands
trouble sleeping
Incidence not known
Blistering, peeling, or loosening of the skin
red irritated eyes
red skin lesions, often with a purple center

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
Back pain
bone pain
bruises on the skin
cracked lips
difficulty with moving
difficulty with swallowing
discouragement
dry skin
fear
feeling sad or empty
feeling unusually cold
injection site pain
itching, pain, redness, swelling, tenderness, or warmth on the skin at the injection site
lack or loss of strength
loss of interest or pleasure
muscle pain or stiffness
pain in the limbs
pain in the rectum
right upper stomach pain and fullness
skin discoloration
sore mouth or tongue
swollen joints
tiredness
trouble concentrating
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusually warm skin
weight loss
white patches with diaper rash

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: 11/4/2014

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