Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
NELA
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
The information provided in this document is intended for use only in the management of adults with leukemia, and for cancer centres with expertise in treating acute leukemia.
For the treatment of patients with relapsed or refractory T-cell ALL and T-cell lymphoblastic lymphoma.
| nelarabine | 1500 mg /m² | IV | Days 1, 3, 5 |
| (This drug is not currently publicly funded for this regimen and intent) | |||
REPEAT EVERY 21 DAYS
Until evidence of disease progression, unacceptable toxicity, or until the patient becomes a candidate for bone marrow transplant
Minimal
- Also refer to CCO Antiemetic Recommendations.
Other Supportive Care:
-
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
-
Prophylaxis for tumour lysis syndrome is recommended.
-
Consider antiviral and other prophylaxis for infection based on institutional guidelines.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
The following are suggested modifications:
|
Toxicity / Grade
|
Action
|
|
Platelets < 100 x 109/L and/or ANC < 1.5 x 109/L OR Febrile neutropenia
|
Hold until recovery
|
|
Grade 3 non-hematologic toxicity (NOT including neurotoxicity)
|
Hold until recovery
|
|
Grade 4 non-hematologic toxicity OR
Grade 2 or greater neurotoxicity OR rhabdomyolysis, drug-related increases in CPK
|
Discontinue
|
Hepatic Impairment
Nelarabine has not been studied in hepatic impairment. Patients with hepatic impairment should be monitored closely for toxicities.
Renal Impairment
Nelarabine has not been studied in renal impairment.
Nelarabine and ara-G are partially renally excreted. No dosage adjustment is recommended for CrCl ≥ 50 ml/min. No dosing data available for CrCl < 50 ml/min; monitor these patients closely as there may be an increased risk of adverse effects.
Dosage in the Elderly
No dosage adjustment is recommended in the elderly; however, these patients may have reduced renal function (see dosage with renal impairment). Patients over age 65 had increased rates of neurologic adverse effects.
Refer to nelarabine drug monograph(s) for additional details of adverse effects.
The following adverse effects were observed in adults treated with single-agent nelarabine.
|
Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
|
|
*Signs and symptoms may include somnolence, confusion, altered level of consciousness, seizures, ataxia, paresthesias and hypoesthesia. Severe effects may include coma, status epilepticus, myelopathy, craniospinal demyelination or ascending neuropathy resembling Guillain-Barre syndrome.
Refer to nelarabine drug monograph(s) for additional details
- Avoid concomitant use with adenosine deaminase inhibitors (pentostatin) as it can reduce conversion of nelarabine pro-drug to its active form
- Avoid concomitant intrathecal chemotherapy; cases of fatal neurotoxicity have been reported.
Refer to nelarabine drug monograph(s) for additional details
Administration
- Should not be diluted prior to administration
- Compatible with PVC infusion bags and glass containers.
- Infuse each dose IV over 2 hours.
- Visually inspect for particulates and discolouration prior to administration.
- Store unopened vials at 25oC with excursions permitted between 15-30oC
Contraindications
- Patients who have a hypersensitivity to this drug or any of its components
- Concurrent intrathecal chemotherapy or craniospinal radiation
Warnings/Precautions
- Patients who have had prior craniospinal irradiation, pre-existing CNS disease, or prior intrathecal therapy may be at increased risk of severe neurologic adverse effects
- Use caution with driving or using machinery as drowsiness, dizziness, or other neurologic effects may occur with treatment
- Avoid live vaccines, since they may result in serious or fatal infections in immunocompromised patients
Pregnancy/Lactation
- This treatment is not recommended for use in pregnancy. Adequate contraception should be used by patients and their partners while on treatment and after the last treatment dose. Recommended methods and duration of contraception may differ depending on the treatment. Refer to the drug monograph(s) for more information.
- Breastfeeding is not recommended during this treatment and after the last treatment dose. Refer to the drug monograph(s) for recommendations after the last treatment dose (if available).
- Fertility effects: Unknown
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
Recommended Clinical Monitoring
- CBC; Baseline and before each cycle
- Liver function tests; Baseline and before each cycle
- Renal function tests; Baseline and before each cycle
- Clinical toxicity assessment for neurotoxicity, infections and bleeding, tumour lysis syndrome, GI, musculoskeletal and respiratory effects; At each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
back to top
DeAngelo DJ, Yu D, Johnson JL, et al. Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801. Blood 2007;109(12):5136-42.
Nelarabine drug monograph. Ontario Health (Cancer Care Ontario).
February 2024 Expanded into full regimen monograph
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.