Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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 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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 Type 4, Live
- Adenovirus Vaccine Type 7, 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
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
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
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.
CON-XXXXXXXX
