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.

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.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster 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
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Levoketoconazole
• Methotrexate
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• 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:

• Anemia (low red blood cells) or
• Bleeding problems (eg, hemorrhage) 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.

The medicine is usually given every day for 5 days. Each treatment usually takes about 2 hours.

You may receive other medicines to help prevent vomiting or other side effects before starting treatment with this medicine.

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. Female patients should use an effective form of birth control during treatment with this medicine and for at least 6 months after your last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose. 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, trouble breathing, 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.

This medicine may cause acute kidney failure. Tell your doctor right away if you have decrease in how much or how often you urinate, confusion, dizziness, headache, rapid weight gain, seizures, or swelling of your hands, ankles, or feet after receiving this medicine.

Cancer medicines can cause nausea, vomiting, or diarrhea, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any side effects that might happen.

This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

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 in the genital area

itching or skin rash

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

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

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

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.