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A - Regimen Name

ALEM Regimen
Alemtuzumab


Disease Site
Hematologic - Lymphoma - T-cell
Hematologic - Rare Diseases

(for Mycosis Fungoides/Sézary syndrome)


Intent
Palliative

Regimen Category
Evidence-informed :

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.

 
B - Drug Regimen

Week 1:

alemtuzumab

a, b, c

3 mg IV / Subcut * (first dose)
alemtuzumab

a, b, c

10 mg IV / Subcut * (second dose)
alemtuzumab

a, b, c

30 mg IV / Subcut * (third dose)
(This drug is not publicly funded. Universal compassionate access program is available. )


Weeks 2 to 13:

alemtuzumab

a, b, c

30 mg IV / Subcut * 3 times per week
(This drug is not publicly funded. Universal compassionate access program is available. )

a. Although not approved by Health Canada, alemtuzumab has been given subcutaneously instead of intravenously; the incidence of infusion reactions may be lower.

b. Gradual dose escalation is required at the initiation of therapy and after treatment interruptions of 7 days or more. In most patients, escalation to 30mg can be accomplished in 3-7 days.  Initial doses can be administered in various ways; sequentially (daily on days 1 to 3) and on alternate days (i.e. days 1, 3, and 5).  Both schedules were used in clinical trials.

c. Single doses of alemtuzumab greater than 30 mg or cumulative weekly doses of greater than 90 mg should not be administered since higher doses are associated with an increased incidence of pancytopenia.

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C - Cycle Frequency

For a usual total of 13 weeks (1 week dose escalation, 12 weeks maintenance), unless disease progression or unacceptable toxicity occurs.  

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Other Supportive Care:

  • Diphenhydramine 50mg PO and acetaminophen 650mg PO 30 minutes before infusion; add meperidine 25mg IV and hydrocortisone 200mg IV with ≥ grade 3 reaction with prior infusion
  • Trimethoprim/sulfamethoxazole DS twice daily three times per week and famciclovir (or equivalent) 250mg bid during treatment and for 2 months after or until CD4+ count ≥ 200 cell/uL
  • Allopurinol and hydration to reduce the risk of tumour lysis syndrome are recommended.
 
J - Administrative Information

Approximate Patient Visit
IV: 3 hours; SC: 1 hour
Pharmacy Workload (average time per visit)
8.334 minutes
Nursing Workload (average time per visit)
32.33 minutes
 
K - References

Alemtuzumab drug monograph, Cancer Care Ontario.

Lundin J, Hagberg H, Repp R, et al. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antiody) in patients with advanced mycosis fungoides/Sézary syndrome. Blood 2003;101(11) 4267-4272.

September 2019 New ST-QBP regimen


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M - Disclaimer

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.