PEMAZYRE dosing and administration — 3 of 5
PEMAZYRE allows simple dose modifications
Tablets are available in 3 strengths (13.5 mg, 9 mg and 4.5 mg) to enable dose modification as needed1
Recommended dose
13.5 mg
taken orally once daily for 14 days on, followed by 7 days off therapy
First dose reduction
9 mg
taken orally once daily for 14 days on, followed by 7 days off therapy
Second dose reduction
4.5 mg
taken orally once daily for 14 days on, followed by 7 days off therapy
Permanently discontinue if unable to tolerate PEMAZYRE 4.5 mg once daily1
Adapted from reference 1.
For further information, please refer to the PEMAZYRE Swissmedic Professional Information.1
Special populations
Interaction with other medicinal products and other forms of interaction
Special populations
Elderly patients
Renal impairment
Hepatic impairment
Children and adolescents
Interaction with other medicinal products and other forms of interaction
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References
- PEMAZYRE® (pemigatinib) Swissmedic Professional Information, June 2021; https://www.swissmedicinfo.ch/ (accessed 02 December 2021).
- 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.
- Valle JW, et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl 5):v28–v37.
- Lamarca A, et al. Advanced intrahepatic cholangiocarcinoma: Post hoc analysis of the ABC-01, -02, and -03 clinical trials. J Natl Cancer Inst. 2020;112:200–10.
- Valle JW, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362:1273–81.
- Lamarca A, et al. Second-line FOLFOX chemotherapy versus active symptom control for advanced biliary tract cancer (ABC-06): A phase 3, open-label, randomised, controlled trial. Lancet Oncol. 2021;22:690–701.
- 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.
- Mosele F, et al. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: A report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020;31:1491–505.
- 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
1L
first-line
2L
second-line
ABC
advanced biliary cancer
AR
adverse reaction
ASC
active symptom control
BRAF
v-raf murine sarcoma viral oncogene homolog B1
BTC
biliary tract cancer
CCA
cholangiocarcinoma
CI
confidence interval
CNS
central nervous system
CR
complete response
CYP2B6
cytochrome P450 2B6
CYP3A4
cytochrome P450 3A4
dCCA
distal cholangiocarcinoma
DOR
duration of response
eCCA
extrahepatic cholangiocarcinoma
ECOG PS
Eastern Cooperative Oncology Group Perfomance Status
EGFR
epidermal growth factor receptor
ESMO
European Society for Medical Oncology
EU
European Union
FGFR
fibroblast growth factor receptor
FOLFOX
folinic acid, fluorouracil and oxaliplatin
HR
hazard ratio
iCCA
intrahepatic cholangiocarcinoma
IDH
isocitrate dehydrogenase
KM
Kaplan-Meier
KRAS
Kirsten rat sarcoma viral oncogene homolog
MATE1
multidrug and toxin extrusion protein 1
MDT
multidisciplinary team
mg
milligram
mg/dL
milligram per decilitre
MSI-H
microsatellite instability-high
NGS
next-generation sequencing
NTRK
neurotrophic tyrosine receptor kinase
OCT
optical coherence tomography
OCT2
organic cation transporter-2
ORR
overall response rate
OS
overall survival
pCCA
perihilar cholangiocarcinoma
PFS
progression-free survival
P-gp
P-glycoprotein
PI
Prescribing Information
PPES
palmar-plantar erythrodysaesthesia syndrome
PR
partial response
RECIST
Response Evaluation Criteria in Solid Tumours
SOC
standard of care
Abbreviated Prescribing Information
▼ This medicinal product is subject to additional monitorings. For further information, see product information Pemazyre on www.swissmedicinfo.ch.
PEMAZYRE (pemigatinib), tablets of 13.5 mg, 9 mg, 4.5 mg. I: : As monotherapy for the treatment of adults with locally advanced, unresectable or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one line of systemic therapy. P: Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with biliary tract cancer. FGFR2 fusion positivity status must be confirmed prior to initiation of therapy. Pemazyre 13.5 mg is taken orally once per day for 14 days, followed by 7 days off therapy. For dose adjustments due to adverse reactions, see www.swissmedicinfo.ch.For patients with severe hepatic or renal impairment, the dose should be reduced to the next lower strength. CI: : Hypersensitivity to the active substance or to any of the excipients. Concomitant use with St John’s wort. W/P: Pemazyre is associated with hyper- and hypophosphatemia, serous retinal detachment, dry eye and blood creatinine increase. Pemazyre can cause fetal harm. Women of childbearing potential should be advised not to become pregnant and men not to father a child during treatment. IA: Concomitant administration with proton pump inhibitors, strong CYP3A4 inhibitors or inducers should be avoided. Administration should be separated by at least 6 hours before or after administration of P-gp substrates with a narrow therapeutic index. Close clinical surveillance is recommended when co-administered with CYP2B6 substrates. UE: The most common adverse reactions (≥ 30%) were hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, nausea, dysgeusia, stomatitis, constipation and dry mouth. The most common serious adverse reactions were hyponatremia and increased blood creatinine. For further information on UE, see www.swissmedicinfo.ch. Dispensing cat.: A. Revision date: June 2021. 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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