Pronunciation:

nel-AR-a-been

Brand Names:

• Arranon

Dosage Forms:

• Solution

Warnings:

Severe neurologic adverse reactions, including altered mental states, severe somnolence, CNS effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis, have been reported with the use of nelarabine. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. Cessation of therapy has not always resulted in a full recovery from these adverse reactions. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue nelarabine for neurologic adverse reactions of NCI Common Toxicity Criteria (CTCAE) for adverse events Grade 2 or greater .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Nelarabine injection is used to treat specific types of cancer called T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). This medicine is usually given to patients who have already received at least two other cancer medicines.

Nelarabine belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by nelarabine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious, but may cause concern.

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

This medicine is to be given only by or under the 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 nelarabine injection in children 1 year of age and older. However, safety and efficacy have not been established in children younger than 1 year of age.

Older adults—

Although appropriate studies on the relationship of age to the effects of nelarabine injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney or nervous system problems, which may require caution and an adjustment in the dose for patients receiving nelarabine injection.

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, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Pentostatin
• Poliovirus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• 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:

• Blood problems (eg, anemia, neutropenia) or
• Hyperuricemia (high uric acid in the blood) or
• Kidney disease or
• Liver disease or
• Nervous system problems—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infections.

Proper Use of This Medicine:

A doctor or other trained health professional will give you or your child this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

This medicine usually comes with patient information or directions. Read them carefully and make sure you understand them before receiving this medicine. If you have any questions, ask your doctor.

While you are using this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Nelarabine sometimes causes 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 lessen these effects if they bother you.

Precautions While Using This Medicine:

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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during treatment to keep from getting pregnant. Men should use an effective form of birth control (eg, condoms) during treatment and for at least 3 months after the last dose to prevent pregnancy in a sexual partner. If a pregnancy occurs while using the medicine, tell your doctor right away.

Do not use this medicine together with pentostatin (Nipent®). Using these medicines together may increase your chance for more serious side effects.

Nelarabine can cause serious nervous system problems. This may be more likely in patients who have had cancer treatment or radiation treatment to the head or back in the past. Check with your doctor right away if you or your child have a headache, dizziness, numbness and tingling in the hands, fingers, feet, or toes, extreme sleepiness, seizures, clumsiness or unsteadiness while walking, or weakness in the arms, hands, legs, or feet.

While you are being treated with nelarabine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Nelarabine may lower your body's resistance and there is a chance you or your child might get the infection the vaccination 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 taken oral polio vaccine within the last several months. 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.

Nelarabine 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 get a fever or chills, 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 or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious reaction called tumor lysis syndrome (TLS). Call your doctor right away if you or your child have a change in how much or how often you urinate, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or feel tired.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are using nelarabine.

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 cramps

anxiety

black, tarry stools

bleeding gums

blood in the urine or stools

bloody nose

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in walking and balance

chest pain

chills

clumsiness or unsteadiness

cold sweats

coma

convulsions

cool, pale skin

cough or hoarseness

decreased or uncontrolled urination

difficulty with breathing

discouragement

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

fast or irregular heartbeat

feeling sad or empty

feeling unusually cold

fever

flushed, dry skin

fruit-like breath odor

headache

incoordination

increased hunger

increased thirst

increased urination

irritability

loss of appetite

loss of interest or pleasure

lower back, side, or stomach pain

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

muscle pain

muscle spasms (tetany) or twitching

muscle weakness

nausea or vomiting

nervousness

nightmares

numbness, tingling, pain, or weakness in the hands, feet, fingertips, or mouth

pain or tenderness around the eyes and cheekbones

painful or difficult urination

pale skin

paralysis or severe weakness of the legs

pinpoint red spots on the skin

rapid breathing

seizures

shakiness and unsteady walk

shivering

sleepiness or unusual drowsiness

slurred speech

small red or purple spots on the skin

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stuffy or runny nose

sunken eyes

sweating

swelling of the hands, ankles, feet, or lower legs

swollen glands

tightness in the chest

trouble concentrating

trouble sleeping

troubled breathing with exertion

uncontrolled bowel movements

unexplained weight loss

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual tiredness or weakness

wrinkled skin

yellow eyes or skin

Less common

Change in taste

loss of memory

loss of taste

problems with memory

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

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

full or bloated feeling

joint pain

lack or loss of strength

muscle aching or stiffness

pain in the arms or legs

pressure in the stomach

swelling of the abdomen or stomach area

swelling or inflammation of the mouth

swollen joints

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.