MabCampath (alemtuzumab) - Risk of Haemophagocytic Lymphohistiocytosis, Stroke (including ischaemic and haemorrhagic stroke), and Glomerulonephritis
- Starting date:
- June 22, 2020
- Posting date:
- June 22, 2020
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information, Product Safety, Product label update
- Audience:
- Healthcare Professionals, Hospitals
- Identification number:
- RA-73387
Last updated: 2020-06-22
Audience
Healthcare professionals including haematologists, oncologists, neurologists, family physicians, emergency physicians, internists, transplant surgeons and hospital pharmacists
Key messages
- Life-threatening and sometimes fatal cases of haemophagocytic lymphohistiocytosis (HLH), stroke (including ischaemic and haemorrhagic stroke), and glomerulonephritis have been reported in patients with B-cell chronic lymphocytic leukemia (B-CLL) who were receiving MabCampath (alemtuzumab).
-
MabCampath (alemtuzumab) is a monoclonal antibody indicated for the treatment of:
- patients with previously untreated progressive B-cell chronic lymphocytic leukemia (B-CLL), and
- B-CLL patients who have been treated with alkylating agents and who have failed fludarabine therapy.
-
Healthcare professionals are advised to:
- Immediately evaluate patients who show symptoms of pathologic immune activation (fever, rash, lymphadenopathy, hepatosplenomegaly, serious hematologic abnormalities) and consider a diagnosis of HLH.
- Inform patients about the risk of stroke and educate them about the early signs and symptoms.
- Monitor clinically significant changes in serum creatinine, and abnormal microscopic urine analysis results, which may indicate glomerulonephritis.
- The MabCampath Canadian Product Monograph has been updated to include this new safety information.
Issue
New safety information from post-market use of MabCampath has been reported and includes serious and sometimes fatal adverse reactions of haemophagocytic lymphohistiocytosis (HLH), stroke (including ischaemic and haemorrhagic stroke), and glomerulonephritis.
Products affected
MabCampath® (alemtuzumab) 30 mg/mL, 1mL vial
Background information
MabCampath (alemtuzumab) is a monoclonal antibody indicated for the treatment of patients with previously untreated progressive B-cell chronic lymphocytic leukemia (B-CLL). MabCampath is also indicated for the treatment of B-CLL patients who have been treated with alkylating agents and who have failed fludarabine therapy.
Serious and sometimes fatal adverse reactions of haemophagocytic lymphohistiocytosis (HLH), stroke (including ischaemic and haemorrhagic stroke), and glomerulonephritis have been identified from post-market use of MabCampath (alemtuzumab). The risks of HLH, stroke, and glomerulonephritis and related risk minimisation measures have been included in the Warnings and Precautions and Post-Market Adverse Drug Reactions sections of the Canadian Product Monograph (CPM) for MabCampath.
In October 2019, Health Canada communicated safety information for LEMTRADA (alemtuzumab), including risks of haemophagocytic lymphohistiocytosis (HLH), and associated serious cardiovascular reactions, including stroke. LEMTRADA is a drug that contains the same active ingredient, alemtuzumab, as MabCampath, but is used for a different indication, management of multiple sclerosis (MS), and with a different dosing regimen than MabCampath. At the time, Health Canada communicated this safety information associated only with LEMTRADA since the identified risks were not specifically related to MabCampath.
Haemophagocytic lymphohistiocytosis (HLH)
HLH is a life-threatening syndrome of pathologic immune activation characterized clinically by signs and symptoms of extreme systemic inflammation. Symptoms include but are not limited to fever, rash, lymphadenopathy, hepatosplenomegaly and serious hematologic abnormalities. It is associated with high mortality rates if not recognized early and treated promptly. Symptoms have been reported to occur within a few months following the initiation of treatment, and are commonly observed in association with infections.
Who is affected
Information for consumers
MabCampath is used for the treatment of patients with a previously untreated type of cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made) called progressive B-cell chronic lymphocytic leukemia (B-CLL). MabCampath is also used for the treatment of patients with B-CLL when certain chemotherapy treatments have been unsuccessful.
New side effects related to excessive stimulation of the immune system, stroke, and inflammation of the kidney have been reported in association with the use of MabCampath. These can be serious, life-threatening or even fatal.
Patients receiving MabCampath should immediately speak with their healthcare professional if they experience any of the following symptoms, which may be associated with these conditions:
- An inflammatory condition known as haemophagocytic lymphohistiocytosis: persistent fever, swollen lymph glands, enlarged spleen or liver, bruising and skin rash, and abnormal blood values.
- Stroke (poor blood flow to the brain): drooping of parts of the face, weakness on one side of the body, difficulty talking, and sudden severe headache.
- An inflammation of the tiny filters in the kidney known as glomerulonephritis: swelling in the face, hands, feet and abdomen, high blood pressure, and pink, cola-colored or foamy urine.
Information for healthcare professionals
Serious cases of haemophagocytic lymphohistiocytosis (HLH), stroke (including ischaemic and haemorrhagic stroke), and glomerulonephritis have been reported in patients treated with MabCampath. Healthcare professionals are advised to:
- Immediately evaluate patients who show symptoms of pathologic immune activation (see signs and symptoms described above) and consider a diagnosis of HLH.
- Advise patients about the increased risk of stroke and provide education about early signs and symptoms.
- Monitor clinically significant changes in serum creatinine, and abnormal microscopic urine analysis.
Action taken by Health Canada
Health Canada worked with sanofi-aventis Canada Inc. to update the MabCampath Canadian Product Monograph to include this new safety information. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect⢠e-Notice email notification system as well as social media channels including LinkedIn and Twitter.
Report health or safety concerns
Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any case of serious or unexpected side effects in patients receiving MabCampath should be reported to sanofi-aventis Canada Inc. or Health Canada.
sanofi-aventis Canada Inc.,
2905 Place Louis-R.-Renaud,
Laval (Québec) Canada, H7V 0A3
Telephone number: 1-800-589-6215
Email: Canada.pharmacovigilance@sanofi.com
To correct your mailing address or fax number, contact sanofi-aventis Canada Inc.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
⢠Calling toll-free at 1-866-234-2345; or
⢠Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
E-mail: hc.mhpd-dpsc.sc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Sincerely,
Original signed by
Sophia Kajla
Medical Head, General Medicines Canada
sanofi-aventis Canada Inc.