NELARABINE

Background and Date of Approval

Nelarabine is a nucleoside metabolic inhibitor approved by the Food and Drug Administration (FDA) on October 28, 2005. It is indicated for the treatment of T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients with disease that is refractory to or has relapsed following at least two prior chemotherapy regimens. Approval was based on the induction of complete responses; randomised trials demonstrating improved survival have not been conducted.

Uses

Nelarabine is used to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two prior chemotherapy regimens. It is primarily indicated for patients with refractory or relapsed disease, aiming to induce complete remission.

How is it administered?

Nelarabine will be administered by your healthcare professional in a hospital setting. It is important not to self-administer the medication, as it requires proper monitoring and administration by trained professionals to ensure safety and effectiveness.

Side Effects

Side effects are unwanted symptoms caused by medicines. Although all drugs can cause side effects, not everyone experiences them. Common side effects of Nelarabine: Decreased blood counts (low red blood cells, low white blood cells, low platelets) Fatigue or feeling more tired than usual Pale skin or difficulty breathing Fever or signs of infection Bruising easily or unusual bleeding Stomach issues such as nausea, vomiting, diarrhoea, and constipation Headache Sleepiness Blurry eyesight Serious side effects of Nelarabine: Unexplained muscle pain, tenderness, or weakness (could be a sign of serious muscle problems)

Warnings

Neurologic Adverse Reactions : You should monitor for signs of neurotoxicity, such as somnolence, confusion, convulsions, ataxia, paresthesias, and hypoesthesia. Severe reactions can include coma, status epilepticus, or Guillain-Barré-like syndrome. Hematologic Adverse Reactions : Be aware of risks like leukopenia, thrombocytopenia, anaemia, neutropenia, and febrile neutropenia. Regular blood count monitoring is essential. Pregnancy : Avoid using nelarabine if you are pregnant or planning to become pregnant, as it can harm the fetus, causing malformations and anomalies. Women should not become pregnant during treatment. Hyperuricemia : Administer intravenous hydration to manage the risk of tumour lysis syndrome and consider using allopurinol in patients at risk for hyperuricemia. Vaccinations : Avoid administering live vaccines to immunocompromised patients undergoing nelarabine treatment.

Precautions

Patients receiving nelarabine should be closely monitored for neurologic toxicity, including confusion or convulsions, as severe reactions like coma or Guillain-Barré syndrome may occur. Regular blood count checks are necessary to detect hematologic issues such as leukopenia or thrombocytopenia. Nelarabine should be avoided during pregnancy due to potential fetal harm, and live vaccines should not be given to immunocompromised patients on treatment.

Word of Advice

Be sure to follow your medical team's directions carefully when taking nelarabine, because it can lead to severe side effects affecting your nervous system and blood counts. Make sure to go to every single follow-up visit for necessary blood work and check-ups. Tell your physician immediately if you are pregnant, planning a pregnancy, or breastfeeding, since nelarabine poses risks to an unborn child. Stay away from live vaccines throughout your course of treatment, and get in touch with your doctor if you notice any strange or unexpected symptoms.

References

1. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Nelarabine. [Updated 2020 May 1]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548515/ 2. Boddu PC, Senapati J, Ravandi-Kashani F, Jabbour EJ, Jain N, Ayres M, Chen Y, Keating MJ, Kantarjian HM, Gandhi V, Kadia TM. A phase 1 study to evaluate the safety, pharmacology, and feasibility of continuous infusion nelarabine in patients with relapsed and/or refractory lymphoid malignancies. https://pubmed.ncbi.nlm.nih.gov/36448227/ 3. Kathpalia M, Mishra P, Bajpai R, Bhurani D, Agarwal N. Efficacy and safety of nelarabine in patients with relapsed or refractory T-cell acute lymphoblastic leukemia: a systematic review and meta-analysis. https://pubmed.ncbi.nlm.nih.gov/35727338/ 4. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021877s005lbl.pdf

Frequently Asked Questions

What is Nelarabine used for?

Nelarabine is used to treat T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two chemotherapy regimens.

What is the classification of Nelarabine?

Nelarabine is classified as a nucleoside metabolic inhibitor. It is a chemotherapy drug that works by interfering with DNA synthesis in cancerous T-cells, leading to their death.

When was nelarabine approved?

Nelarabine was approved by the U.S. Food and Drug Administration (FDA) on October 28, 2005. It was approved for the treatment of T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients whose disease has not responded to or has relapsed after at least two prior chemotherapy regimens.

How long does a nelarabine infusion take?

A nelarabine infusion typically takes about 1 hour to complete. However, the exact duration may vary depending on individual patient factors and the healthcare provider's instructions.

Is Nelarabine a chemotherapy?

Yes, nelarabine is a chemotherapy drug. It works by targeting and killing cancerous T-cells in conditions like T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma.

Available Brands 2

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS