Nelarabine Injection

IMPORTANT WARNING:

Nelarabine injection should be given only under the supervision of a doctor with experience in the use of chemotherapy medications for cancer.

Nelarabine may cause severe damage to your nervous system, which may not go away even when you stop using the medication. Tell your doctor if you have ever been treated with chemotherapy given directly into the fluid surrounding the brain or spine or radiation therapy to the brain and spine and if you have or have ever had any problems with your nervous system. A doctor or nurse will monitor you while you receive nelarabine injection and for at least 24 hours after each dose. If you experience any of the following symptoms, call your doctor immediately: extreme sleepiness; confusion; numbness and tingling in the hands, fingers, feet, or toes; problems with fine motor skills such as buttoning clothing; muscle weakness; unsteadiness while walking; weakness when standing up from a low chair or while climbing stairs; increased tripping while walking over uneven surfaces; uncontrollable shaking of a part of your body; decreased sense of touch; inability to move any part of the body; seizures; or coma (loss of consciousness for a period of time).

Talk to your doctor about the risks of using nelarabine.

WHY is this medicine prescribed?

Nelarabine is used to treat certain types of leukemia (cancer that begins in the white blood cells) and lymphoma (cancer that begins in the cells of the immune system) that have not improved or that have come back after treatment with other medications. Nelarabine is in a class of medications called antimetabolites. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Nelarabine injection comes as a liquid to be given intravenously (into a vein) by a doctor or nurse in a hospital or clinic. It is usually given to adults once a day on the first, third, and fifth days of the dosing cycle. It is usually given to children once a day for 5 days. This treatment is usually repeated every 21 days. Your doctor may delay your treatment if you experience certain side effects.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using nelarabine injection,

• tell your doctor and pharmacist if you are allergic to nelarabine, any other medications, or any of the ingredients in nelarabine injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention adenosine deaminase inhibitors such as pentostatin (Nipent). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you or your partner are pregnant or plan to become pregnant. If you are female, you will need to take a pregnancy test before you begin receiving nelarabine and should not become pregnant while you are using nelarabine. If you are male, you and your female partner should use birth control during your treatment and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while using nelarabine, call your doctor immediately. Nelarabine may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using nelarabine.

• you should know that nelarabine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• do not have any vaccinations during your treatment with nelarabine without talking with your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Call your doctor right away if you are unable to keep an appointment to receive a dose of nelarabine.

What SIDE EFFECTS can this medicine cause?

Nelarabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• loss of appetite
• stomach pain or swelling
• sores on the mouth or tongue
• headache
• dizziness
• difficulty falling asleep or staying asleep
• depression
• pain in your arms, legs, back, or muscles
• swelling of the hands, arms, feet, ankles, or lower legs
• blurred vision

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• pale skin
• shortness of breath
• fast heartbeat
• chest pain
• cough
• wheezing
• unusual bleeding or bruising
• nosebleeds
• small red or purple dots on the skin
• fever, sore throat, chills, or other signs of infection
• extreme thirst
• decreased urination
• sunken eyes
• dry mouth and skin

Nelarabine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• pale skin
• shortness of breath
• extreme tiredness
• fever, sore throat, chills, or other signs of infection
• unusual bruising or bleeding
• numbness and tingling in the hands, fingers, feet, or toes
• confusion
• muscle weakness
• inability to move any part of the body
• seizures
• coma

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to nelarabine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.