Merck KGaA, Darmstadt, Germany, which operates this website, uses the firm name "Merck KGaA, Darmstadt, Germany," in the United States and Canada, and also uses "EMD Serono" in healthcare, "MilliporeSigma" in life science and "EMD Performance Materials" in the performance materials business. Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. The company assumes no duty to update the information to reflect subsequent developments. Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose. We are called MSD everywhere, except in the United States and Canada where we are known as Merck & Co Inc, Kenilworth, NJ USA, http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf, http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf, https://www.businesswire.com/news/home/20200824005125/en/, solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or. “These approvals reinforce our commitment to innovative research that will continue to help more patients with cancer in Japan.”. KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. Adult Indications: Additional Dosing Regimen of 400 mg Every 6 Weeks. Patients with advanced disease face a poor prognosis and are in critical need of new treatment options,” said Jannie Oosthuizen, president, MSD Japan. Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Japan. The pharmacokinetic modeling data was supported by an interim analysis of pharmacokinetic, efficacy and safety data from KEYNOTE-555 from a cohort of patients (Cohort B) treated with KEYTRUDA 400 mg Q6W. Adverse reactions occurring in patients with MSI-H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. {{ search.results.length }} matching results. KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC). In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. Wenn Sie diese Webseite besuchen, stimmen Sie dieser Tatsache automatisch zu. If you would like further information on accommodation, please contact HR at 855-444-5678. KEYTRUDA can cause immune-mediated nephritis. Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%).
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