Arranon is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Arranon injection is used to treat T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Arranon can be used to treat both adults and children.

Arranon may cause serious side effects of the central nervous system, such as problems with balance, coordination, or fine motor skills. These symptoms may not go away even after you stop receiving Arranon. Talk with your doctor if you have concerns about any possible long-term side effects.

Do not use Arranon if you are pregnant. It could harm the unborn baby. You should not breast-feed while you are using nelarabine.

Before you receive this medicine, tell your doctor if you have liver or kidney disease, a nerve disorder, a history of chemotherapy or radiation treatment of your head, neck, or spinal cord.

Arranon can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while you are being treated with Arranon. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

You should not be treated with Arranon if you are allergic to nelarabine.

To make sure Arranon is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• a nervous system disorder; or

• prior chemotherapy or radiation treatment of your head, neck, or spinal cord.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Arranon if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.

A man receiving Arranon should use a condom during treatment, and for at least 3 months after treatment ends.

You should not breast-feed while you are receiving Arranon.

Arranon is given as an infusion into a vein. A healthcare provider will give you this injection.

This medication is usually given every day or every other day for 5 days in a row every 3 weeks. Your treatment schedule may be different. Follow your doctor's instructions.

Arranon injection must be given slowly, and the infusion can take up to 2 hours to complete.

Nelarabine can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Usual Adult Dose of Arranon for Acute Lymphoblastic Leukemia:

1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days

Comments:
-Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
-The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Usual Adult Dose of Arranon for Lymphoma:

1500 mg/m2 IV over 2 hours on days 1, 3, and 5 repeated every 21 days

Comments:
-Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
-The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Usual Pediatric Dose of Arranon for Acute Lymphoblastic Leukemia:

650 mg/m2 IV over 1 hour daily for 5 consecutive days repeated every 21 days

Comments:
-Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
-The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

Usual Pediatric Dose of Arranon for Lymphoma:

650 mg/m2 IV over 1 hour daily for 5 consecutive days repeated every 21 days

Comments:
-Measures should be taken to prevent hyperuricemia such as hydration, urine alkalinization, and prophylaxis with allopurinol.
-The recommended duration of therapy has not been clearly established. In clinical trials, therapy was usually continued until there was evidence of disease progression, unacceptable toxicity, loss of benefit, or the patient became a candidate for bone marrow transplant.

Uses: For the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. This use is based on the induction of complete responses.

You should not be treated with Arranon if you are allergic to nelarabine.

To make sure Arranon is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• a nervous system disorder; or

• prior chemotherapy or radiation treatment of your head, neck, or spinal cord.

You may need to have a negative pregnancy test before starting this treatment.

Do not use Arranon if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.

A man receiving Arranon should use a condom during treatment, and for at least 3 months after treatment ends.

You should not breast-feed while you are receiving Arranon.

Call your doctor for instructions if you miss an appointment for your Arranon injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. You may feel drowsy for several days after you are treated with Arranon.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Arranon. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

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

Nelarabine may cause serious side effects of the central nervous system. These symptoms may not go away even after you stop receiving Arranon. Tell your doctor if you have:

• extreme drowsiness;

• loss of balance or coordination;

• problems with walking;

• numbness or tingly feeling in your hands or feet;

• problems with buttoning clothes or picking up small items with your fingers;

• a seizure; or

• weakness or loss of movement in any part of your body.

Also call your doctor at once if you have:

• unexplained muscle pain, tenderness, or weakness;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common Arranon side effects may include:

• drowsiness (for several days after your injection);

• nausea, vomiting, diarrhea, constipation;

• numbness or tingling;

• headache, tiredness; or

• blurred vision.

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.

Other drugs may interact with nelarabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.