Clolar

Generic Name: clofarabine (Intravenous route)

kloe-FAR-a-been

Commonly used brand name(s)

In the U.S.

• Clolar

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Chemical Class: Purine Nucleoside Analog

Uses For Clolar

Clofarabine belongs to the group of medicines known as antineoplastics. It is used to treat a type of cancer of the white blood cells called acute lymphoblastic leukemia (ALL) in patients 1 to 21 years of age who have already used at least two other cancer medicines.

Clofarabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells also may be affected by clofarabine, other effects also occur. Some of these effects may be serious and must be reported to your doctor.

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

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

Before Using Clolar

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clofarabine in children.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies 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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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)—May make these conditions worse.

• Hematopoietic stem cell transplant (HSCT) (bone marrow transplant), history of—Use with caution. May increase the risk of having serious liver problems.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Clolar

While you are receiving clofarabine, it is important that you drink extra fluids so you will pass more urine. This will help prevent certain side effects.

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 prevent these effects or make them less severe.

You will receive this medicine while you 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 that is placed in one of your veins. It is usually given every day for 5 days. This 5-day treatment is given again every 2 to 6 weeks until your body responds to the medicine. Each treatment usually takes about 2 hours a day.

Precautions While Using Clolar

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 clofarabine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Clofarabine 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.

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 from a lying or sitting position suddenly; 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 yellow skin or eyes, because these may be signs of a serious liver condition called jaundice.

Make sure your doctor knows if you are pregnant or breastfeeding before you receive this medicine. 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.

Clolar Side Effects

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 pain


• abdominal 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 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 from a lying or sitting position suddenly


• 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


• shortness of breath


• 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


• stomach pain


• 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


• wheezing


• yellow eyes or skin

Less common

• Agitation


• anxiety


• 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 with 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.

See also: Clolar side effects (in more detail)

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More Clolar resources

• Clolar Side Effects (in more detail)
• Clolar Use in Pregnancy & Breastfeeding
• Clolar Drug Interactions
• Clolar Support Group
• 0 Reviews for Clolar - Add your own review/rating

• Clolar Prescribing Information (FDA)


• Clolar Consumer Overview


• Clolar Monograph (AHFS DI)


• Clolar MedFacts Consumer Leaflet (Wolters Kluwer)


• Clofarabine Professional Patient Advice (Wolters Kluwer)

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