Nelarabine

** PATIENT INFORMATION**
** Nelarabine (nel ar' a been ) Injection**

Read the Patient Information that comes with nelarabine injection before you or your child starts treatment with nelarabine injection. Read the information you get each time before each treatment with nelarabine injection. There may be new information. This information does not take the place of talking with the doctor about your or your child's medical condition or treatment. Talk to your or your child's doctor, if you have any questions.

** What is the most important information I should know about nelarabine injection?**
** Nelarabine Injection may cause blood related adverse reactions.** Your doctor will do blood tests regularly during treatment to monitor blood counts, including platelets.
** Nelarabine Injection may cause serious nervous system problems including:**

• extreme sleepiness
• seizures
• coma
• numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy)
• weakness and paralysis

** Call the doctor right away if you or your child has the following symptoms:**

• seizures
• numbness and tingling in the hands, fingers, feet, or toes
• problems with fine motor skills such as buttoning clothes
• unsteadiness while walking
• increased tripping while walking
• weakness when getting out of a chair or walking upstairs

** These symptoms may not go away even when treatment with nelarabine injection is stopped.**

** What is nelarabine injection?**
Nelarabine Injection is an anti-cancer medicine used to treat adults and children who have:

• T-cell acute lymphoblastic leukemia (T-ALL)
• T-cell lymphoblastic lymphoma (T-LBL)

** What should you tell the doctor before you or your child starts nelarabine injection?**
Tell the doctor about all health conditions you or your child have, including if you or your child:

• have any nervous system problems.
• have kidney problems.
• are breastfeeding or plan to breastfeed. It is not known whether nelarabine injection passes through breast milk. You should not breastfeed during treatment with nelarabine injection.
• are pregnant or plan to become pregnant. Nelarabine Injection can harm your unborn baby. You should not become pregnant while you are taking nelarabine injection. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.
• are male (including if you have had a vasectomy) with a sexual partner who is pregnant, think that they may be pregnant, or who could become pregnant. You should use condoms during sexual intercourse during treatment with nelarabine injection and for 3 months after last dose.

Tell the doctor about all the medicines you or your child take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

** How is nelarabine injection given?**
Nelarabine Injection is an intravenous medicine. This means it is given through a tube in your vein.

** What should you or your child avoid during treatment with nelarabine injection?**

• You or your child should not drive or operate dangerous machines. Nelarabine Injection may cause sleepiness during and for several days after treatment.
• You or your child should not receive vaccines made with live germs during treatment with nelarabine injection.

** What are the possible side effects of nelarabine injection?**
** Nelarabine Injection may cause serious nervous system problems.** See "What is the most important information I should know about nelarabine injection?"
** Nelarabine Injection may also cause:**

• decreased blood counts such as low red blood cells, low white blood cells, and low platelets. Blood tests should be done regularly to check blood counts. Call the doctor right away if you or your child:
• is more tired than usual, pale, or has trouble breathing
• has a fever or other signs of an infection
• bruises easy or has any unusual bleeding
• stomach area problems such as nausea, vomiting, diarrhea, and constipation
• headache
• sleepiness
• blurry eyesight

Call your doctor right away if you experience unexplained muscle pain, tenderness, or weakness while taking nelarabine injection. This is because on rare occasions, muscle problems can be serious.
These are not all the side effects associated with nelarabine injection. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

** General Advice about nelarabine injection**
This leaflet summarizes important information about nelarabine injection. If you have questions or problems, talk with your or your child's doctor. You can ask your doctor or pharmacist for information about nelarabine injection that is written for healthcare providers.
For more information, go to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

** Manufactured by**
** Zydus Lifesciences Ltd.**
Ahmedabad, India
** Distributed by**
** Zydus Pharmaceuticals (USA) Inc.**
Pennington, NJ 08534

Rev.: 04/25

This Patient Information has been approved by the U.S. Food and Drug Administration.