Severe neurologic adverse reactions including altered mental states, severe somnolence, 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. Close monitoring is strongly recommended, and nelarabine should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria grade 2 or greater .
Nelarabine belongs to the group of medicines called antineoplastics. It is used to treat specific types of cancer called T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) .
Nelarabine 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 good this medicine will do as well as the possible risks of using it. This medicine is usually given to patients who have already used at least two other cancer medicines first .
Nelarabine is to be administered only by or under the supervision of your doctor .
This medicine is available only with your doctor's prescription .
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:
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.
Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of nelarabine in children .
Although appropriate studies on the relationship of age to the effects of nelarabine have not been performed in the geriatric population, no geriatrics-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving nelarabine. Also, serious nervous system problems may be more likely to occur in the elderly .
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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 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.
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:
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 .
You will receive this medicine while you are in a hospital or cancer treatment center. A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins .
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 .
Make sure your doctor knows if you are pregnant or breastfeeding before you receive this medicine. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away .
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 any of these symptoms occur with this medicine: 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 might get the infection the immunization 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 :
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 taking nelarabine .
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 immediately if any of the following side effects occur:
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:
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.