Risk of severe if not fatal skin reactions with Pembrolizumab (Keytruda)

Risk of severe if not fatal skin reactions with Pembrolizumab (Keytruda)

Last Updated on April 19, 2017 by Joseph Gut – thasso

March 21, 2017 – Health Canada just communicated this important safety information: Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) under treatment of patients with Pembrolizumab (Keytruda) have been reported internationally in the clinical trials and post-marketing setting. There were 8 cases of SJS (1 of them with a fatal outcome) and 2 cases of TEN (1 of them with a fatal outcome). Of these reports, one case of SJS was reported in Canada.

Stevens-Johnson Syndrome (SJS)

In Canada, Pembrolizumab (Keytruda), a programmed death receptor-1 (PD-1) blocking antibody (a so-called checkpoint inhibitor), is indicated for the treatment of patients with unresectable or metastatic melanoma who have not received prior treatment with Ipilimumab (Yervoy). Pembrolizumab (Keytruda) is also authorized under the notice of compliance with conditions (NOC/c) policy for the treatment of patients with i) unresectable or metastatic melanoma and disease progression following Ipilimumab (Yervoy) therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor, and ii) metastatic non-small cell lung carcinoma (NSCLC) whose tumours express PD-L1 (as determined by a validated test) and who have disease progression on or after platinum-containing chemotherapy.

The potential risk of SJS and TEN with Pembrolizumab (Keytruda) use was evaluated using currently available safety data from the published literature and the manufacturer’s global safety database (which includes both clinical trial serious adverse events and post-marketing reports). One fatal case of SJS in a clinical trial and one fatal case of TEN in the post-marketing setting have been reported internationally in patients treated with Pembrolizumab (Keytruda). Including these cases, there have been 8 cases of SJS (6 in clinical trials, and 2 post-marketing) and 2 of TEN (both post-marketing). Of these 10 reports, one case of SJS was reported in Canada. Two of the 10 reports had a temporal association with Pembrolizumab (Keytruda) use, had few confounding factors, and had skin biopsies that were consistent with SJS or TEN. These cases come out of approximately 11,000 patients in clinical trials and 27,000 patients in the post-marketing setting who have been treated with Pembrolizumab (Keytruda).

Healthcare professionals including oncologists, nurses, hospital pharmacists, emergency room staff, and cancer clinic staff should i) counsel patients about the benefits and risks of Pembrolizumab (Keytruda), including the risk and early symptoms of SJS and TEN, ii) suspend Pembrolizumab (Keytruda) treatment and refer for immediate specialized evaluation and treatment if a patient reports any severe skin reaction, or in a case of suspected SJS or TEN, and iii) permanently discontinue Pembrolizumab (Keytruda) if SJS or TEN is confirmed.

Patients should inform their healthcare professional if they are experiencing a side effect related to Pembrolizumab (Keytruda) use, and both, healthcare professionals and patients alike may report any case of severe skin reactions or suspected SJS or TEN or any other serious or unexpected side effects when receiving Pembrolizumab (Keytruda) to Merck Canada Inc. or Health Canada since managing marketed health product-related side effects largely depends on these contributions.

These are the addresses:

Merck Canada Inc., Pharmacovigilance
16750 Trans -Canada Hwy.
Kirkland, Québec, H9H 4M7
Fax.: 1-800-3693090

Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-964-6522
Fax: 613-952-7738

You can report any suspected adverse reactions associated with the use of health products to Health Canada by i) calling toll-free at 1-866-234-2345, or by ii) Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Outside of Canada, healthcare professionals and patients alike may report any case of severe skin reactions or suspected SJS or TEN or any other serious or unexpected side effects when receiving Pembrolizumab (Keytruda) to their country specific Merck (or Merck, Sharp & Dohme (MSD) where it applies)  Pharmacovigilance Center or to the county specific registration authority’s Pharmacovigilance Center.

Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Your opinion

Comment

@peepso_user_30549(sajibuni)
Hello Everyone out there,I am here to give my testimony about a Herbalist doctor who helped me . I was infected with HERPES SIMPLEX VIRUS five years ago, i went to many hospitals for cure but there was no solution, so I was thinking how can I get a solution out so that my body can be okay. One day I was in the river side thinking where I can go to get solution. so a lady walked to me telling me why am I so sad and i open up all to her telling her my problem, she told me that she can help me out, she introduce me to a doctor who uses herbal medication to cure HERPES SIMPLEX VIRUS and gave me his email, so i mail him. He told me all the things I need to do and also give me instructions to take, which I followed properly. Before I knew what is happening after two weeks the HERPES SIMPLEX VIRUS that was in my body got vanished . so if you are also heart broken and also need a help, you can also email him at dr.chalaherbalhome@gmail.com or Contact him today on whatsapp number +2348165102815 and you will have a testimony. He can also cure other diseases like
CANCER.
HEPATITIS A B&C
DIABETES.
SINUSITIS.
CUSTOPATION.
HERPES SIMPLEX VIRUS.
INFERTTILITY.
HIV AND AIDS
WARTS
MISCARRIAGES
ABSCESS
ANCANTHOMA
ANCANTHOSIS
ACNE.
AND MANY MORE.
CONTACT HIM NOW AND BE FREE FOR LIFE.THANK YOU DR.CHALA FOR THE LIFE YOU HAVE GIVING ME GOD WILL BLESS YOU AND YOUR GOOD WORK
2 years ago