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PEMAZYRE dosing and administration — 5 of 5
Dose modifications for PEMAZYRE (2/2)
Dose modifications may be needed in cases of hyperphosphataemia and serous retinal detachment1
Dose modifications for serous retinal detachment1
Asymptomatic
Continue PEMAZYRE at current dose
Monitoring should be performed as described in the “Warnings and precautions” section of the Swissmedic Professional Information
Moderate decrease in visual acuity
(Best corrected visual acuity 20/40 or better or ≤3 lines decreased vision from baseline); limiting instrumental activities of daily living
Withhold until resolution
If improved on subsequent examination, PEMAZYRE should be resumed at the next lower dose level
If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered
Marked decrease in visual acuity
(Best corrected visual acuity worse than 20/40 or >3 lines decreased vision from baseline up to 20/200); limiting activities of daily living
Withhold until resolution
If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower
If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered
Visual acuity worse than 20/200 in affected eye
Limiting activities of daily living
Withhold until resolution
If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower
If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered
Continue PEMAZYRE at current dose
Monitoring should be performed as described in the “Warnings and precautions” section of the Swissmedic Professional Information
Withhold until resolution
If improved on subsequent examination, PEMAZYRE should be resumed at the next lower dose level
If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered
Withhold until resolution
If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower
If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered
Withhold until resolution
If improved on subsequent examination, PEMAZYRE may be resumed at 2 dose levels lower
If symptoms recur, persist or examination does not improve, permanent discontinuation should be considered
Adapted from Swiss Professional Information PEMAZYRE® (pemigatinib) on www.swissmedicinfo.ch; ref. 1.
For further information, please refer to the PEMAZYRE Swissmedic Professional Information.1
Date of preparation: April 2023
References
- Swiss Professional Information PEMAZYRE® (pemigatinib) on www.swissmedicinfo.ch.
- Rizvi S and Borad MJ. The rise of the FGFR inhibitor in advanced biliary cancer: the next cover of Time magazine? J Gastrointest Oncol. 2016;7:789–96.
- Ghouri YA, et al. Cancer review: Cholangiocarcinoma. J Carcinog. 2015;14:1.
- Sharma P and Yadav S. Demographics, tumor characteristics, treatment, and survival of patients with Klatskin tumors. Ann Gastroenterol. 2018;31:231–6.
- Blechacz B. Cholangiocarcinoma: Current knowledge and new developments. Gut Liver. 2017;11:13–26.
- Valle JW, et al. New horizons for precision medicine in biliary tract cancers. Cancer Discov. 2017;7:943–62.
- Bañales JM, et al. Cholangiocarcinoma 2020: The next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557–88.
- Bañales JM, et al. Expert consensus document: Cholangiocarcinoma: Current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016;13:261–80.
- Bertuccio P, et al. A comparison of trends in mortality from primary liver cancer and intrahepatic cholangiocarcinoma in Europe. Ann Oncol. 2013;24:1667–74.
- Blechacz B, et al. Clinical diagnosis and staging of cholangiocarcinoma. Nat Rev Gastroenterol Hepatol. 2011;8:512–22.
- Forner A, et al. Clinical presentation, diagnosis and staging of cholangiocarcinoma. Liver Int. 2019;39(suppl 1):98–107.
- Vogel A, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34:127–40.
- Lowery MA, et al. Comprehensive molecular profiling of intrahepatic and extrahepatic cholangiocarcinomas: potential targets for intervention. Clin Cancer Res. 2018;24:4154–61.
- Jain A, et al. Cholangiocarcinoma with FGFR genetic aberrations: A unique clinical phenotype. JCO Precis Oncol. 2018;2:1–12.
- Ross JS, et al. New routes to targeted therapy of intrahepatic cholangiocarcinomas revealed by next-generation sequencing. Oncologist. 2014;19:235–42.
- Farshidfar F, et al. Integrative genomic analysis of cholangiocarcinoma identifies distinct IDH-mutant molecular profiles. Cell Rep. 2017;18:2780–94.
- Graham RP, et al. Fibroblast growth factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Hum Pathol. 2014;45:1630–8.
- Churi CR, et al. Mutation profiling in cholangiocarcinoma: Prognostic and therapeutic implications. PLoS One. 2014;9:e115383.
- Arai Y, et al. Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma. Hepatology. 2014;59:1427–34.
- Borad MJ, et al. Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma. Curr Opin Gastroenterol. 2015;31:264–68.
- Silverman IM, et al. Clinicogenomic analysis of FGFR2-rearranged cholangiocarcinoma identifies correlates of response and mechanisms of resistance to pemigatinib. Cancer Discov. 2021;11:326–39.
- Barr FG. Fusion genes in solid tumors: The possibilities and the pitfalls. Expert Rev Mol Diagn. 2016;16:921–3.
- Liu PCC, et al. INCB054828 (pemigatinib), a potent and selective inhibitor of fibroblast growth factor receptors 1, 2, and 3, displays activity against genetically defined tumor models. PLoS One. 2020;15:e0231877.
- Abou-Alfa GK, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: A multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21:671–84.
All references are available upon request
Abbreviations
Abbreviated Prescribing Information
▼ This medicinal product is subject to additional monitoring. For further information, see product information Pemazyre on www.swissmedicinfo.ch.
Revision date: January 2023. Marketing authorisation holder: Incyte Biosciences International Sàrl, CH-1110 Morges. Refer to www.swissmedicinfo.ch for detailed information.
Resources and support
For further information, please refer to the PEMAZYRE Swissmedic Professional Information.1
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