Revlimid (lenalidomide) - Letter to Health Professionals

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This is duplicated text of a letter from Celgene.
Contact Celgene for a copy of any references, attachments or enclosures.

Approval with conditions of REVLIMID^® for use in the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5Q cytogenetic abnormality with or without additional cytogenetic abnormalities

Celgene

15 January 2008

Dear Health Care Professional(s),

Health Canada has granted a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) policy for REVLIMID^® (lenalidomide) 5 mg and 10 mg capsules for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. This approval is conditional, and further follow up is necessary to verify clinical benefit.

REVLIMID^® is only available through a controlled distribution program called RevAid^SM. Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, REVLIMID^® can only be dispensed to patients who are registered and meet all the conditions of the RevAid^SM program. For more information on RevAid^SM, please call 1-888-RevAid1 (1-888-738-2431) or log onto www.RevAid.ca.

Approval is based on rates of RBC-transfusion independence seen in the pivotal Phase 2 study.

Transfusion independence was seen in 99/148 (67%) patients.

The dose of REVLIMID^® was reduced or interrupted at least once due to an adverse event in 83.8% of patients. A second dose reduction or interruption due to adverse events was required in 49.3% of patients.

Indications and Clinical Use

REVLIMID^® is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Mechanism of Action

The mechanism of action of REVLIMID^® remains to be fully characterized.

Serious Warnings and Precautions

Based on the safety data gathered during the MDS study as well as studies conducted using REVLIMID^® in other indications, the following list is a summary of the most serious warnings and precautions. For a complete list and further details for those on this list, please refer to the Product Monograph.

REVLIMID^® should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

• Potential for human birth defects, stillbirths, and spontaneous abortions.
• Neutropenia and Thrombocytopenia.
• Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Adverse Reactions

The majority of REVLIMID^®-treated patients experienced adverse reactions at some time. Due to adverse reactions, eighty-four (83.8) percent of MDS patients had to have a dose delay or reduction during the study for the indication. Fifty percent of patients had to have a second dose delay/reduction.

The most frequently reported adverse events regardless of causality or severity were neutropenia (63.5%), thrombocytopenia (62.2%), diarrhea (54.1%), pruritus (43.9%), rash (35.8%) and fatigue (35.8%).

For further details, see the REVLIMID^® Product Monograph.

Dosage and Administration

The recommended starting dose of REVLIMID^® is 10 mg daily.
For information on dose adjustments, see the REVLIMID^® Product Monograph.

Should you have medical enquiries regarding REVLIMID^®, please contact our Medical Information Department at 1-888-RevAid1 (1-888-738-2431).

Original signed by

Zlata Caric, MD
Medical Director