Clolar

DRUG DESCRIPTION

Clolar (clofarabine) injection contains clofarabine, a purine nucleoside metabolic inhibitor. Clolar (1 mg/mL) is supplied in a 20 mL, single-use vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative free.

What are the possible side effects of clofarabine (Clolar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling...

Read All Potential Side Effects and See Pictures of Clolar

What are the precautions when taking clofarabine (Clolar)?

Before using clofarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow suppression), kidney disease, liver disease, recent/current infections.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured,...

Read All Potential Precautions of Clolar


Clolar Consumer (continued)

SIDE EFFECTS: Pain at the injection site, tiredness, flushing, headache, dizziness, lightheadedness, fainting, drowsiness, back pain, stomach pain, diarrhea, nausea, vomiting, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Treatment with clofarabine may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, taking long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next dose of clofarabine. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, tell your doctor immediately.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, muscle/joint pain, lack of urine, swelling feet/ankles, mental/mood changes (e.g., anxiety, depression), dark urine, yellowing skin/eyes, fast/difficult breathing, fast heartbeat.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Clofarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Tell your doctor immediately if you experience symptoms such as low back/side pain (flank pain), red/pinkish urine, painful urination, or muscle spasms/weakness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using clofarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow suppression), kidney disease, liver disease, recent/current infections.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Males and females must use 2 reliable forms of birth control (e.g., condoms and birth control pills) during treatment with this drug. Talk with your doctor about effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Clolar Patient Information Including Side Effects

Brand Names: Clolar

Generic Name: clofarabine (Pronunciation: kloe FAR a been)

  • What is clofarabine (Clolar)?
  • What are the possible side effects of clofarabine (Clolar)?
  • What is the most important information I should know about clofarabine (Clolar)?
  • What should I discuss with my healthcare provider before receiving clofarabine (Clolar)?
  • How is clofarabine given (Clolar)?
  • What happens if I miss a dose (Clolar)?
  • What happens if I overdose (Clolar)?
  • What should I avoid while receiving clofarabine (Clolar)?
  • What other drugs will affect clofarabine (Clolar)?
  • Where can I get more information?

What is clofarabine (Clolar)?

Clofarabine is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Clofarabine is used to treat acute lymphoblastic leukemia (a type of blood cancer) in children and young adults up to 21 years old.

Clofarabine is usually given after other cancer medicines have been tried without successful treatment.

Clofarabine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of clofarabine (Clolar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • runny or stuffy nose, cough, rapid breathing and heart rate, trouble breathing, swelling and pain in any part of your body;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting;
  • numbness or redness on the palms of your hands or the soles of your feet;
  • jaundice (yellowing of the skin or eyes); or
  • signs of infection such as fever, chills, sore throat, flu symptoms, pale skin, easy bruising or bleeding (nosebleeds, bleeding gums), purple or red pinpoint spots under your skin, loss of appetite, mouth sores, unusual weakness.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea, rectal pain;
  • headache, muscle or joint pain;
  • mild itching or skin rash;
  • feeling tired, anxious, irritable; or
  • warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clofarabine (Clolar)?

Do not use clofarabine without telling your doctor if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are receiving clofarabine, whether you are a man or a woman. Clofarabine use by either parent may cause birth defects.

If you have liver or kidney disease, you may need a dose adjustment or special tests to safely receive clofarabine.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Do not miss any follow-up visits to your doctor.

Clofarabine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Clofarabine can be harmful to the liver or kidneys, and these effects are increased when you also use other medicines that can harm the liver or kidneys. During your 5-day treatment with clofarabine, you may need to avoid using certain medications. Discuss all treatment options with your doctor if you regularly use any other medications.

Tell your caregivers at once if you have a serious side effect such as rapid breathing and heart rate, trouble breathing, painful swelling, numbness or tingling, feeling like you might pass out, lower back pain, blood in your urine, urinating less than usual, or jaundice (yellowing of the skin or eyes).

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