Medications listed here may also be marketed under different names in different countries. Patients with serum bilirubin levels above the upper limit of normal or AST or ALT levels >2.5 x upper limit of normal were not enrolled in Trial ET743-SAR-3007. Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. Please click here to see the full Prescribing Information. In postmarketing experience, QT prolongation, and torsades de pointes have been observed in patients who develop hypokalemia while taking ZYTIGA®. more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT.

Avoid frequent dose adjustments. Assess CPK levels prior to each administration of YONDELIS®. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding potential benefits and further benefits of ERLEADA® ZYTIGA®, BALVERSATM and niraparib. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO™ and for 3 months after the last dose. Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess - ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)]. Urothelial Cancer or bladder cancer is where tumours develop in the inner lining of the bladder, and in some cases, spreads into the bladder muscle 6. Français | Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA® compared with 9% of patients treated with placebo. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension. Median time to the first occurrence of Grade 3 or 4 neutropenia was 16 days (range: 8 days to 9.7 months). Monitor for hyperphosphatemia and follow the dose modification guidelines when required [see Dosage and Administration (2.2, 2.3)]. Median time to first occurrence of Grade 3 or 4 CPK elevations was 2 months (range: 1 to 11.5 months). [1] ERLEADA® was also approved for the treatment of nmCRPC by the European Commission on January 12, 2019. Please get in touch with the Janssen company in your country for more information. Janssen’s Balversa (erdafitinib), a kinase inhibitor, became the first in market targeted therapy after receiving accelerated approval from the US Food and Drug Administration. Follow us at www.twitter.com/JanssenGlobal. Assess LVEF by echocardiogram (ECHO) or multigated acquisition (MUGA) scan before initiation of YONDELIS® and at 2- to 3-month intervals thereafter until YONDELIS® is discontinued. “This was groundbreaking for us on many levels—this was the first Janssen Oncology compound developed from discovery all the way to approval; our first drug using pharmacodynamically guided treatment dosing, which means a patient’s dose is adjusted based on their phosphate levels; and our first drug developed with a companion diagnostic,” Patel says.



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